Category: BioTech

HighTide Therapeutics to Showcase New Analyses of Phase 2 MASH/T2DM Studies of Berberine Ursodeoxycholate (HTD1801) and Pre-Clinical Results of Rimtoregtide (HTD4010) in Presentations at EASL Congress 2025

HighTide Therapeutics, Inc. (HKG: 2511), a clinical stage biopharmaceutical company specializing in the development of multifunctional multi-targeted therapies for chronic liver and metabolic diseases, announced today that it will present at the EASL Congress 2025, taking place from May 7-10, 2025 in Amsterdam. The presentations include post-hoc analyses of two Phase 2 clinical studies of berberine ursodeoxycholate (HTD1801), a gut-liver anti-inflammatory metabolic modulator, being developed for treatment of metabolic dysfunction-associated steatohepatitis (MASH) and type 2 diabetes mellitus (T2DM). A third presentation will present preclinical results for rimtoregtide (HTD4010), a peptide derived from the Reg3a protein, in liver failure in mice.

“Effects of Berberine Ursodeoxycholate (HTD1801) in Patients with At-risk MASH and T2DM”
(Presentation SAT-440, Poster Presentation, May 10, 8:30 AM CET)

About the Abstract: Due to the ongoing unmet medical need, clinical development in MASH focuses on patients who are at a higher risk of disease progression and outcomes due to the presence of moderate to advanced fibrosis (defined as at-risk MASH). The purpose of this analysis was to assess the effects of HTD1801 in patients with at-risk MASH and T2DM as defined by baseline MRI cT1 >875 ms. Eighteen weeks of treatment with HTD1801 resulted in substantial improvements in key hepatic and cardiometabolic parameters in patients with at-risk MASH and compared to placebo, twice as many patients achieved a reduction in liver fat content (MRI-PDFF) or fibroinflammation (cT1) that have been associated with improvements in liver histology. These data are particularly insightful as HTD1801 continues to be evaluated in an ongoing paired biopsy study of patients with at-risk MASH and pre-diabetes or diabetes.

“Effects of Berberine Ursodeoxycholate (HTD1801) in Chinese Patients with T2DM and Presumed MASLD”
(Presentation SAT-432, Poster Presentation, May 10, 8:30 AM CET)

About the Abstract: T2DM typically coexists with other metabolic abnormalities such as hyperlipidemia, obesity, and MASH that can exacerbate T2DM and can lead to a worse prognosis with increased risk for mortality and cardiovascular outcomes. In a Phase 2 study in patients with T2DM, HTD1801 achieved the primary endpoint with a significant decrease in HbA1c. Based on the latest diagnostic criteria, it is likely that a substantial subgroup of the study may have had concurrent metabolic dysfunction-associated steatotic liver disease (MASLD). The purpose of this analysis was to evaluate the benefits of HTD1801 in patients with T2DM and MASLD identified by baseline controlled attenuation parameter values >288 dB/M (correlated to 5% liver fat content). HTD1801 treatment demonstrated both dose-dependent improvements in cardiometabolic and hepatic parameters in patients with T2DM and MASLD. These data suggest HTD1801 can comprehensively address metabolic and cardiovascular risk factors beyond glycemic control.

“A Comparison of the Protective Effects of Rimtoregtide (HTD4010) and DUR-928 on Acute Liver Failure in Mice”
(Presentation FRI-141, Poster Presentation, May 9, 8:30 AM CET)

About the Abstract: The purpose of this study was 1) to test the potential protective effects of HTD4010 in an LPS-induced model mimicking acute liver failure in mice and 2) compare these effects to DUR-928, which is currently in late-stage development for the treatment of alcohol-associated hepatitis. In an LPS-induced mouse model mimicking acute liver failure, HTD4010 resulted in significant improvement in survival rates (greater than 2-fold) compared to the model control.  These protective effects of HTD4010 were significantly greater than DUR-928.  These findings provide evidence that HTD4010 may have a beneficial effect on acute liver conditions including alcohol-associated hepatitis and other acute-inflammatory-related conditions.

About Berberine Ursodeoxycholate
Berberine ursodeoxycholate (HTD1801) is an orally delivered, gut-liver anti-inflammatory metabolic modulator being developed for the treatment of metabolic and digestive diseases. HTD1801, an ionic salt of berberine and ursodeoxycholate, is a new molecular entity with a unique dual mechanism of action: AMP kinase activation and NLRP3 inflammasome inhibition. These two key mechanistic pathways have been associated with improvements in insulin resistance, glucose metabolism, lipid metabolism, and hepatic inflammation, potentially providing a comprehensive treatment platform for the multifaceted nature of complex metabolic diseases. HTD1801 is being developed for multiple indications. HTD1801 met the primary endpoint in two Phase 3 clinical trials in patients with type 2 diabetes mellitus (T2DM), demonstrating a clinically meaningful effect on HbA1c. In both trials, key secondary endpoints were achieved, suggesting multiple advantages of HTD1801 including improvement in cardiometabolic risk indicators. In addition to T2DM, HTD1801 efficacy in treating metabolic dysfunction-associated steatohepatitis (MASH) has been demonstrated in a Phase 2a clinical trial, and a global multicenter Phase 2b trial assessing the histologic benefit of HTD1801 is currently ongoing, with topline results expected in 2025.

About Rimtoregtide
Rimtoregtide (HTD4010) is a clinical-stage compound in development for acute inflammatory-related indications including alcoholic hepatitis (AH). It is a peptide derived from the Reg3a protein with immunomodulatory, anti-inflammatory, and anti-apoptotic effects. HTD4010 has been evaluated in animal models of acute pancreatitis and acute liver failure, where protective effects were observed. A completed Phase 1 clinical trial of HTD4010 in healthy subjects demonstrated a favorable safety profile. AH is caused by chronic heavy alcohol abuse or a sudden, drastic increase in alcohol consumption. It is characterized by severe inflammation and, ultimately, liver failure and death. There is currently no approved treatment for AH and only a few drug candidates are in clinical development. The current standard of care focuses on symptom management, including abstinence, treating inflammation and providing nutrition.

About HighTide Therapeutics
HighTide Therapeutics, Inc. (HKG: 2511) is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional, multi-targeted therapies with poly-indication potential across metabolic diseases with significant unmet medical needs. HighTide is currently developing several clinical assets and associated global intellectual property rights, and advancing multiple mid-to-late-stage clinical trials including therapies for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes mellitus (T2DM), severe hypertriglyceridemia (SHTG) and primary sclerosing cholangitis (PSC). Berberine ursodeoxycholate (HTD1801), HighTide’s lead drug candidate, received Fast Track designation from the United States Food and Drug Administration for both MASH and PSC and Orphan Drug designation for PSC. HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project in China.

For more information, please visit www.hightidetx.com
Contact: pr@hightidetx.com

Everest Medicines Announces Approval of ‘B’ Marker Removal from Company’s Stock Code by the Hong Kong Stock Exchange

Everest Medicines (HKG: 1952, Everest, or the Company), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that The Stock Exchange of Hong Kong Limited (the Stock Exchange) has approved the Company’s application to remove the “B” marker from its stock short name, as the company has satisfied the requirements of the listing rules at the Stock Exchange.

“We are very pleased that Everest Medicines has satisfied the market capitalization/revenue test under Rule 8.05(3) of the Listing Rules and successfully removed the ‘B’ marker – a significant milestone for the Company in the capital markets that could lead to wider investor participation.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Moving forward, we will continue to deepen our ‘dual-engine strategy’, enhancing our commercial excellence and advance our first-in-class and best-in-class assets with global rights to maximize synergies. With global rights to EVER001, we will actively explore partnership opportunities outside of China to leverage international expertise and optimize commercial value, while further enhancing Everest’s global visibility and presence. Everest will leverage its established efficient commercial platform to solidify our position in key therapeutic areas, advance innovation on our mRNA platform, and strive to become a leading biopharma in the Asia-Pacific region by 2030.

The removal of the “B” marker reflects a comprehensive evaluation of Everest Medicines’ robust R&D pipeline, commercialization capabilities, and overall business fundamentals. Listed on the Stock Exchange in October 2020, Everest has adopted a “dual-engine” strategy, focusing on high-value therapeutic areas while striving to develop first-in-class or best-in-class innovative treatments. The company has established a strong and synergistic platform across nephrology, infectious diseases, and autoimmune diseases, with three commercialized products already driving rapid revenue growth.

According to the company’s 2024 financial results, total revenue reached RMB706.7 million, representing a 461% year-over-year increase and exceeding our revenue guidance of RMB700 million, and achieved commercial-level profitability for the full year of 2024.

NEFECON®, as the only approved IgAN therapy in China, generated RMB353.4 million in revenue for the year, representing a year-over-year increase of 1,581%. NEFECON® was also included in China’s National Reimbursement Drug List (NRDL), effective January 1, 2025.

As the first-in-class fluorocycline antibiotic, XERAVA® (eravacycline) maintained robust growth with generated RMB352.8 million in revenue in 2024, representing a 256% year-on-year increase.

VELSIPITY® (etrasimod), a best-in-class therapy for autoimmune diseases, has been received regulatory approvals in Macau and Singapore, the product was subsequently commercially launched in December in Guangdong province under the “Hong Kong and Macau Medicine and Equipment Connect” policy. In parallel, New Drug Applications (NDAs) for VELSIPITY® have been officially accepted in both mainland China and Hong Kong in December 2024.

EVER001, for which Everest holds global rights, delivered positive results from the preliminary analysis of our Phase 1b/2a trial and is progressing steadily through global development. EVM16, our personalized therapeutic mRNA cancer vaccine, completed first patient dosing in an investigator-initiated clinical trial (IIT) in March 2025. EVM14, our off-the-shelf tumor-associated antigen (TAA) vaccine, received Investigational New Drug (IND) approval from the U.S. FDA, and we plan to submit an IND application to China’s NMPA in the first half of this year. The in vivo CAR-T program is expected to achieve preclinical candidate milestone later this year. These programs are supported by our commercial-scale, GMP-compliant manufacturing facility in Jiashan, Zhejiang, which provides integrated R&D, production, and commercialization capabilities across mRNA and other pipeline platforms.

CIRC: Attained a New High in Fiscal Year 2024

– Continuoued to consolidate The leading position of nuclear medicine and facilitated the development of nuclear medical equipment as a new engine

In recent years, with the launch of top-level design for nuclear medicines and the implementation of supporting policies, the domestic nuclear medicine industry has ushered in a golden period of development. According to the data analysis of BCC Research, there will be a growth in the global nuclear medicine market from $12.6 billion in 2023 to $21 billion by the end of 2029, with a compound annual growth rate (CAGR) of 8.29% during the forecast period from 2024 to 2029. Meanwhile, Medraysintell, a market intelligence agency specializing in radiotherapy and nuclear medicine, predicts that there will be a growth of about $30 billion in the global nuclear medicine market in 2030.

As a leading nuclear medicine company in China, CIRC (01763.HK) recently disclosed its annual report for 2024 as of December 31st. In 2024, CIRC achieved a remarkable growth in revenue and net profit, which not only delivered a satisfactory answer on the performance level, but also showed a strong technical transformation capability in nuclear medicine research and development.

Year-by-year growth facilitated nuclear medical equipment to become a new engine
According to the financial data, CIRC achieved revenue of RMB 7.575 billion in 2024, with a year-on-year increase of 14.2%, and the net profit of RMB 880 million, with a year-on-year increase of 13.3%.

From the perspective of branch business, all fields have blossomed in an all-round way. As the core pillar of the company, the nuclear medicine business achieved revenue of RMB 4.168 billion, accounting for 55% of the total revenue. Among them, the income of imaging diagnosis and therapeutic radiopharmaceuticals increased by 4.1% year-on-year, and the distribution of medical centers all over the country achieved remarkable results. The income of Technetium-labeled medicines increased by 8.7% year-on-year. The breath test business continued to maintain a stable high market share, achieving revenue of RMB 2.35 billion, by a year-on-year increase of 1.1%.

It is worth noting that in 2024, CIRC accelerated the localization of high-end radiotherapy equipment, and nuclear medical equipment and related services became the new engine of growth, with revenue reaching RMB 1.223 billion, a year-on-year increase of 31.0%. The new generation of Precision radiation therapy planning system was successfully approved for medical device registration certificate, and the world’s first spiral tomotherapy system, Tomo C, was delivered to Shandong Cancer Hospital for installation, which was successfully selected intothe 2024 high-end medical equipment promotion and application project of two ministries and commissions (Ministry of Industry and Information Technology/National Health Commission) and Tianjin First (Set) Major Technical Equipment Promotion and Application Guidance Catalog (Version 2024), with sales during the year leading in the domestic market.

CIRC recorded RMB 716.1 million in revenue from radioactive source products, representing a year-on-year increase of 22.2%. Gamma knife source and non-destructive testing radioactive source continued to maintain a stable and high market share. CNNC Qinshan Isotope successfully obtained the Class A radiation safety license, and the cobalt-60 radioactive source production line delivered 2 million curies.

40-year solid accumulation in nuclear technology laid a solid foundation

As the main body of the nuclear technology application industry of CNNC, CIRC has been accumulated in the industry for over 40 years, forming a “6+N” industrial layout with six major businesses as the core, including nuclides, nuclear medicines, nuclear medical equipment, integrated solution for nuclear medicine, radioactive source and application, and irradiation application. During the Reporting Period, CIRC achieved 224 patent authorizations, with a total of 969 valid patents, and continued to maintain the leading position of the R&D investment intensity in the industry.

In the field of nuclear medicine research and development, CIRC has demonstrated a strong technical capability from research results turned into technologies. Sodium fluorine-18 injection obtained the drug registration certificate from the National Medical Products Administration and was approved for marketing, filling the market gap of PET diagnostic imaging agent in the field of bone imaging in China. Iodine-131-MIBG injection is close to the end of Phase III clinical trial. After the drug is launched, it will provide a new diagnostic method for neuroendocrine tumors such as pheochromocytoma and neuroblastoma. It is worth noting that CIRC has proactively laid out integrated diagnosis and treatment drugs, and the research and development of Lutetium-177oxyoctreotide injection is progressing smoothly, marking a strategic upgrade from simple diagnosis to precise diagnosis and treatment.

In addition to stabilizing the base of nuclear medicine, CIRC has gradually increased its emphasis on nuclear medical equipment. According to the sales data in recent years, the income of nuclear medical equipment has steadily increased. In 2024, a new generation of Gamma Knife was approved, which integrated CBCT image guidance, six-dimensional bed auto-correction, and other intelligent technologies, and the treatment efficiency was improved by 30%. In the Class A large-scale medical equipment market, CIRC occupies an absolute dominant position through its holding subsidiary, CNNC ACCURAY. In February this year, 19 of the 28 high-end radiotherapy equipment in the second round of Class A large-scale medical equipment licensing list released by the National Health Commission came from CNNC ACCURAY, accounting for 68% of the market. It is worth noting that the breakthroughs in the fields of Cobalt-60-based Stereotactic Therapy System also promote the localization of radiotherapy equipment.

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Facing the explosive growth of the nuclear medicine market, CIRC Accelerated Pharmaceutical Center continues to expand its nationwide network layout. In 2024, a new positron emission drug production line has been added in Lanzhou, with a total of 23 lines put into operation; Newly added Fuzhou Technetium Drug Production Line, with a total of 27 units put into operation. CIRC has built the first 10,000 Curie level lutetium-177 production line and a thousand level germanium-gallium [68Ge-68Ga] generator production line in the country, achieving a breakthrough in the localization of high-end nuclides.

It is worth noting that CIRC has created a hierarchical innovation ecosystem through the “Parent-Subsidiary Collaboration” model. In 2024, its subsidiaries, CNNC HEADWAY (breath test) and CNNC Chengdu Gaotong (nuclide), were awarded the national level specialized, refined, and new “little giants” enterprise, bringing the total number of specialized, refined, and new enterprises under CIRC to 18. Among them, CNNC HEADWAY dominates the breath testing market with its integrated solution of “medicine box+instrument”, while CNNC Chengdu Gaotong has become a benchmark in the field of nuclear technology application through its full chain layout of “Nuclide-Drug-Equipment”. This innovative system, resembling an “Aircraft carrier battle group”, provides sustainable momentum for the company’s long-term growth.

Expanding Development Space with Globalization Layout

As the main force of CNNC Group’s march towards people’s life and health science and technology and the main channel for the transformation of advanced nuclear science and technology achievements, CIRC responds to the Group’s “Overall&Coordination” internationalization strategy and the national “the Belt and Road” initiative, vigorously promotes the internationalization strategy and constantly expands overseas markets. By 2024, the export revenue will reach RMB 627 million, and the products will be exported to dozens of countries and regions such as Brazil, Peru, and Nigeria.

At the beginning of this year, we successfully signed a contract for the supply of equipment for a million curies design source gamma irradiation station in Bangladesh. This is another equipment supply project for irradiation stations that has landed after winning the bid for the Bangladesh Institute of Nuclear Agriculture’s design source gamma irradiation station project in 2024. After its completion and operation, the irradiation station will mainly serve the irradiation sterilization of medical products in Bangladesh, significantly improving the quality level and production processing capacity of local medical products, assisting the development of Bangladesh’s medical industry, and benefiting local people’s livelihoods.

In Nigeria, CIRC successfully signed a contract for the overall supply of nuclear medical equipment, achieving the first successful landing of the Group’s nuclear medical equipment overall supply project. In addition, CIRC actively expands into the ASEAN market and successfully exports cold chain drugs to Thailand; We have also signed strategic cooperation agreements with multiple entities in Brazil to support the signing of a memorandum of understanding on strategic cooperation in the field of nuclear technology applications between the National Atomic Energy Agency and Brazil.

Conclusion

Against the backdrop of policy support and sustained market demand, CIRC stated to focus on the “Do as the Demard of the Country” and further deepen the coordinated development of nuclear medicine and high-end equipment around the “Healthy China” strategic framework. According to its 2025 plan, key projects such as Qinshan Isotope Base, Phase I of Jiajiang Radioactive Source Base, and Phase I of North China Pharmaceutical Base will be promoted according to milestones, involving nuclide production, radioactive source manufacturing, and pharmaceutical supply chain layout. At the same time, CIRC will enhance its digital diagnosis and treatment service capabilities through the iteration of smart nuclear medicine projects, and plans to launch no less than 3 intelligent systems within this year.

At the international level, CIRC will continue the market expansion strategy along the “the Belt and Road”, rely on the existing business models such as radiation station equipment export, nuclear medical equipment overall solution output, focus on the cooperation in South America, Southeast Asia, the Middle East, North Africa and other regional markets, and further improve the global market penetration rate in the future or through localized cooperation.

The management of the Company stated that in 2025, CIRC will continue to strengthen technological innovation, improve the modern industrial system, accelerate the cultivation and development of new quality productivity, continuously enhance core functions, improve core competitiveness, and accelerate the establishment of an internationally-renowned supply group of technology, product and service in isotope and radiation.

Berberine Ursodeoxycholate (HTD1801) Consistently Demonstrates Comprehensive Benefits for Patients with Type 2 Diabetes Mellitus, Approaching NDA

  • HighTide Therapeutics Announces HTD1801 Meets the Primary Endpoints in Two Phase 3 Clinical Trials in Patients with Type 2 Diabetes Mellitus

HighTide Therapeutics, Inc. (HKG: 2511), a clinical-stage biopharmaceutical company specializing in the development of multifunctional, multi-targeted therapies for chronic liver and metabolic diseases, today announced that two Phase 3 trials (SYMPHONY 1 and SYMPHONY 2) of berberine ursodeoxycholate (HTD1801) in Chinese patients with type 2 diabetes mellitus (T2DM) met their primary endpoints and gated secondary endpoints.

The results of these two Phase 3 clinical trials provide robust evidence that HTD1801 delivers comprehensive benefits for patients with T2DM. Based on these highly positive read-outs, HighTide plans to submit a new drug application (NDA) for HTD1801 as a treatment for T2DM to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) later this year.

SYMPHONY 1 (NCT06350890) and SYMPHONY 2 (NCT06353347) are randomized, double-blind, placebo-controlled, Phase 3 clinical trials designed to evaluate the efficacy and safety of HTD1801 in adults with T2DM and inadequate glycemic control despite using diet and exercise (SYMPHONY 1; N=407) or Metformin (SYMPHONY 2; N=549). The primary endpoint in both studies was the change in HbA1c from baseline with HTD1801 compared to placebo after 24 weeks of treatment. Gated secondary endpoints included the percentage of subjects achieving HbA1c <7.0%, change in fasting plasma glucose (FPG), low-density lipoprotein cholesterol (LDL-C), glutamyl transpeptidase (GGT), and high-sensitivity C-reactive protein (hs-CRP).

The primary endpoint was achieved in both trials, showing a clinically meaningful, consistent glucose-lowering effect of HTD1801
SYMPHONY 1 (HTD1801 as monotherapy): At week 24, the reduction from baseline in HbA1c with HTD1801 (-1.3%) was superior to placebo. Further, those with more severe disease had a greater decrease with HTD1801: reduction in HbA1c was -1.5% for those with a baseline HbA1c ≥8.5%.

SYMPHONY 2 (HTD1801 as an add-on therapy to Metformin): At week 24, the reduction from baseline in HbA1c with HTD1801 (-1.2%) was superior to placebo. Further, those with more severe disease had a more significant decrease with HTD1801: reduction in HbA1c was -1.6% for those with a baseline HbA1c ≥8.5%.

In both Phase 3 trials, the efficacy on HbA1c reduction in patients treated with HTD1801 was sustained through week 24.

In both trials, gated secondary endpoints were achieved, suggesting multiple advantages of HTD1801 beyond glucose-lowering including improvement in cardiometabolic risk indicators
At week 24, in both studies, the proportion of patients who achieved HbA1c <7.0% was significantly higher in the HTD1801 treatment groups compared to placebo. Improvements in HbA1c with HTD1801 were parallelled with significant improvements in postprandial and fasting plasma glucose compared with placebo. In addition, HTD1801 demonstrated lipid-lowering effects, including significant reductions in low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). Moreover, HTD1801 treatment led to reductions in key inflammatory biomarkers – glutamyl transpeptidase (GGT) and high-sensitivity C-reactive protein (hs-CRP) – both of which are associated with cardiovascular risk in patients with T2DM.

Favorable safety and tolerability profile
Overall, safety and tolerability were favorable and consistent with previous clinical trials of HTD1801. The most commonly reported adverse events were gastrointestinal. In both studies <2% of patients discontinued early due to an adverse event. The incidence of hypoglycemia was low, with no severe hypoglycemia events reported.

“The encouraging results from these studies suggest that HTD1801 may offer a novel and improved therapeutic option for patients with T2DM,” said Dr. Linong Ji, the leading principal investigator for the two Phase 3 clinical trials and former Vice President of the International Diabetes Federation (IDF), Director of the Peking University Diabetes Center and Director of the Department of Endocrinology and Metabolism, Peking University People’s Hospital. “As an innovative drug candidate, HTD1801 exhibits a unique dual mechanism of action – AMP kinase activation and NLRP3 inflammasome inhibition – that is distinct from any existing T2DM drugs on the market. It is an oral therapy designed to deliver comprehensive clinical benefits – not only lowering blood glucose but also improving lipid metabolism and exerting anti-inflammatory effects – thereby potentially reducing diabetes-related complications and addressing significant unmet clinical needs. With continued clinical exploration, HTD1801 is expected to further expand its application to benefit patients globally. In today’s pharmaceutical landscape, investment has become heavily concentrated on GLP-1-based drug development. While GLP-1 therapies hold significant clinical value, they do not adequately address the full spectrum of pathophysiological mechanisms underlying T2DM. To truly meet the multifaceted needs of T2DM management, continued innovation across a diverse range of therapeutic targets remains essential.”

“We extend our deepest gratitude to the patients who participated in these pivotal trials,” said Dr. Liping Liu, HighTide’s founder and CEO. “HTD1801’s innovative dual-action approach – targeting both metabolic regulation and inhibiting inflammation – represents a potential breakthrough in diabetes treatment. We look forward to sharing data from the 28-week open-label extension of these studies and a Phase 3 head-to-head comparison with the dapagliflozin; we will continue to explore the clinical potential of HTD1801 to provide patients with chronic metabolic diseases a comprehensive treatment solution.”

About Type 2 Diabetes Mellitus (T2DM)
According to the International Diabetes Federation (IDF), 537 million adults (ages 20-79) were living with diabetes in 2021, and this number is projected to grow to 783 million (representing 1 in 8 adults) by 2045, of these, around 90% are T2DM cases. China has the largest population of diabetes patients worldwide, estimated to be 141 million in 2021, and projected to grow to 174 million in 2045. Diabetes is a global societal burden leading to over 6 million deaths per year. To address this urgent challenge, there is a critical need for innovative therapies that can deliver comprehensive clinical benefits for patients worldwide.

About Berberine Ursodeoxycholate (HTD1801)
Berberine ursodeoxycholate (HTD1801) is an orally delivered, gut-liver anti-inflammatory metabolic modulator being developed for the treatment of metabolic and digestive diseases. HTD1801, an ionic salt of berberine and ursodeoxycholate, is a new molecular entity with a unique dual mechanism of action: AMP kinase activation and NLRP3 inflammasome inhibition. These two key mechanistic pathways have been associated with improvements in insulin resistance, glucose metabolism, lipid metabolism, and hepatic inflammation, potentially providing a comprehensive treatment platform for the multifaceted nature of complex metabolic diseases.

HTD1801 is being developed for multiple indications. In addition to T2DM, its efficacy in treating metabolic dysfunction-associated steatohepatitis (MASH) has been demonstrated in a Phase 2a clinical trial and a global multicenter Phase 2b trial assessing the histologic benefit of HTD1801 is currently ongoing, with topline results expected in 2025.

About HighTide Therapeutics
HighTide Therapeutics, Inc. (HKG: 2511) is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional, multi-targeted therapies with poly-indication potential across chronic liver and metabolic diseases with significant unmet medical needs. HighTide is currently developing several clinical assets and associated global intellectual property rights, and advancing multiple mid-to-late-stage clinical trials including therapies for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes mellitus (T2DM), severe hypertriglyceridemia (SHTG) and primary sclerosing cholangitis (PSC). Berberine ursodeoxycholate (HTD1801), HighTide’s lead drug candidate, received Fast Track designation from the United States Food and Drug Administration for both MASH and PSC and Orphan Drug designation for PSC. HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project in China.

For more information, please visit www.hightidetx.com.
Contact: pr@hightidetx.com

analytica Vietnam 2025 Concludes with Record-Breaking Attendance and Exhibitor Participation

analytica Vietnam 2025, the leading international trade fair for laboratory technology, biotechnology, analysis, and diagnostics, successfully concluded its 9th edition, held from 2–4 April 2025 at the Saigon Exhibition and Convention Center (SECC). Organised by MMI Asia Pte Ltd, a wholly owned subsidiary and regional headquarters of Messe München GmbH (MMG), in collaboration with Vietnam Exhibition and Event Services Co., Ltd (VNEES), and supported by the Ministry of Science and Technology of Vietnam, the event surpassed all previous records in attendance and international participation. This milestone reinforces analytica Vietnam’s reputation as Southeast Asia’s premier platform for scientific innovation, cross-border collaboration, and advanced laboratory solutions.

The exhibition welcomed 6,657 visitors, including 5,908 unique attendees from 37 countries, reflecting a 23% increase in unique visitors compared to the 2023 edition. This growth highlights the region’s increasing demand for cutting-edge laboratory technologies and the growing prominence of the event on the international stage.


Impressive Growth and Strong International Participation

analytica Vietnam 2025 experienced exceptional expansion, with a 52% increase in exhibitors. The exhibition hosted over 300 companies and brands across a 7,000 sqm exhibition space, a 56% increase in space compared to 2023. A notable 71% of exhibitors were international, underscoring the event’s rising international appeal and establishing it as a key meeting point for global industry leaders.

Prakash Mishra, Head of Vietnam SLS Commercial at Merck Vietnam, remarked, “The quality of visitors this year has been very good—we’ve met professionals from across Asia, Europe, and even the US who are genuinely interested in understanding and entering the Vietnam market. For us, this has been an excellent opportunity to connect with both local and international partners. It’s encouraging to see Vietnam gaining more visibility on the global stage, and analytica Vietnam has played a key role in that. Overall, it’s been a strong start to the year, and we’re leaving the show with meaningful leads and a very positive outlook.”

Key Show Features and Highlights

Academic Conference

The concurrent academic conference attracted 770 participants, a notable increase from the 582 attendees in 2023. The conference provided a comprehensive program featuring industry experts and thought leaders, addressing key research trends, technological advancements, and challenges faced by the laboratory and biotechnology sectors.

Southeast Asia’s First Live Lab Premiere

A key highlight of analytica Vietnam 2025 was the debut of Southeast Asia’s first Live Lab, attracting over 770 participants. This immersive experience offered live demonstrations in a real laboratory environment, allowing attendees to interact with experts and explore the latest technologies in action. It provided valuable, hands-on insights into the practical applications of modern lab workflows.

Hosted Buyer Program:

analytica Vietnam 2025 welcomed 544 Hosted Buyers from Vietnam and neighboring countries including Laos, Cambodia, Thailand, and Malaysia. With over 700 pre-arranged meetings, the program fostered meaningful business engagement, paving the way for strategic partnerships and regional growth across the laboratory and analytical sectors.

Startup Pavilion

The Startup Pavilion showcased emerging companies in the laboratory sector, spotlighting innovations and new technologies that are poised to shape the future of the industry. This section of the exhibition offered a platform for fresh ideas and groundbreaking solutions that are advancing laboratory technology.

Lab Design and Construction Forum

The Lab Design and Construction Forum delved into the future of sustainable and efficient laboratory infrastructure. The forum featured insights from industry leaders and experts on how modern design principles are transforming laboratory facilities to meet the growing demands of science, research, and industry.

Innovation Zone

The Innovation Zone was a dedicated space showcasing breakthrough technologies that are transforming laboratory operations and industry practices. Attendees had the opportunity to explore cutting-edge products and solutions that are shaping the future of laboratory technology.

Exclusive Lab Tours

Specially curated Lab Tours took participants behind the scenes of leading research and testing facilities in Vietnam. These tours offered a deeper understanding of local industry advancements and provided insights into the real-world applications of the technologies showcased at the event.

Future Editions: analytica Convention 2026 in Hanoi & analytica Vietnam 2027 in Ho Chi Minh City

Building on the remarkable success of analytica Vietnam 2025, MMI Asia is set to extend its reach across Vietnam. The analytica Convention 2026 will take place from April 22–24, 2026, at the International Exhibition Center (ICE) in Hanoi. Designed as an exclusive gathering, this event will feature a top-tier scientific conference and a focused showcase of laboratory technologies, offering industry professionals and academics in Northern Vietnam direct access to global innovations.

The full-scale edition of analytica Vietnam will return to Ho Chi Minh City from March 31 to April 2, 2027, at the Saigon Exhibition and Convention Center (SECC). With expectations for greater international presence and broader industry coverage, the 2027 edition will continue to serve as a strategic hub for technology exchange, partnerships, and market expansion in Southeast Asia.

About analytica Vietnam

analytica Vietnam is the premier trade fair for laboratory technology, analysis, and biotechnology in Southeast Asia. Organized by Messe München, the event brings together industry professionals, researchers, and policymakers to showcase the latest technologies,exchange knowledge, and foster business collaborations. analytica Vietnam features an exhibition, conference, pre-event laboratory tours, buyer-seller programs, and networking opportunities, providing a comprehensive platform for the laboratory and biotechnology industries in the region. The upcoming edition is set to take place from April 2 to 4, 2025 at the SECC – Saigon Exhibition and Convention Center. More details can be found at https://www.analyticavietnam.com/.

About analytica worldwide

Messe München is the world’s leading trade fair organizer for laboratory technology, analysis and biotechnology. The international network of exhibitions includes analytica, analytica China, analytica Anacon India & India Lab Expo, analytica Vietnam and analytica Lab Africa. 

About MMI Asia Pte Ltd

Established in 1992, MMI Asia is the wholly owned subsidiary and the regional headquarters of Messe München GMBH (MMG) and is one of the world largest and leading exhibition organizers. MMI Asia’s portfolio of events include editions of worldleading trade fairs from Munich – transport logistic & air cargo, analytica, ceramitec; as well as industry-specific events such as Glasstech and Fenestration Asia, Asia Climate Forum, and Singapore International Water Week. MMI Asia also provides consultancy in professional trade fair and conference management to government bodies, international trade and promotion organizations, and trade associations. For more information, please visit www.mmiasia.com

About Messe München

As one of the world’s leading trade fair organizers, Messe München presents the world of tomorrow at its about 90 trade fairs worldwide. These include twelve of the world’s leading trade fairs such as bauma, BAU, IFAT, electronica, and ISPO. Messe München’s portfolio comprises trade fairs for capital and consumer goods, as well as for new technologies. Together with its subsidiaries, it organizes trade fairs in China, India, Brazil, South Africa, Turkey, Singapore, Vietnam, Hong Kong, Thailand, and the U.S. With a network of more than 15 affiliated companies and almost 70 representations worldwide, Messe München is active in more than 130 countries. The more than 150 events held annually attract around 50,000 exhibitors and around three million visitors in Germany and abroad.

Exhibition Contact:
MMI Asia Pte. Ltd.
Daniel Shi
Exhibition Director
daniel@mmiasia.com.sg

Press Contact:
MMI Asia Pte. Ltd.
Joey NgMarketing Executive
joey@mmiasia.com.sg 

Hebe Biotechnology Appoints Industry Insider Dr. Hannes Hentze as Chief Development Officer to Advance Next-Generation GLP-1 RA Weight Loss Therapy

April 9, Hebe Biotechnology Pte Ltd (Hebe Bio), a Singapore-based innovator in metabolic health therapeutics, today announced the appointment of Hannes Hentze, PhD, MBA as Chief Development Officer (CDO), effective April 1, 2025. Dr. Hentze will lead the global development strategy for the company’s next-generation GLP-1 receptor agonist (GLP-1 RA), a cutting-edge weight loss therapy designed to enhance efficacy and tolerability, addressing the global obesity challenge.

Strategic Leadership for a Transformative Therapy

Dr. Hentze brings over two decades of experience in pharmaceutical development, specializing in oncology, metabolic disorders, and biologics. His background spans academic research (IMCB, NTU), biotech ventures (S*BIO, ES Cell International, ASLAN), and large pharmaceutical players (Schering-Plough, MSD). Most recently, he served as Associate Director of Translational Sciences at EDDC (A*STAR).

At Hebe Bio, Dr. Hentze will spearhead preclinical and translational development, guiding clinical trial readiness, regulatory strategy, and strategic partnerships to accelerate the GLP-1 RA program’s global commercialization.

Sam Lim, MD, PhD, MBA, CEO of Hebe Bio, remarked, “We are thrilled to welcome Hannes to our leadership team. His deep expertise in metabolic drug development and his visionary approach align perfectly with our mission to deliver transformative therapies. His leadership will be pivotal as we accelerate our GLP-1 RA candidate, which has the potential to redefine standards in weight management and healthspan extension.”

Advancing Innovation in Metabolic Health

Hebe Bio’s GLP-1 RA therapy integrates cutting-edge science to optimize fat loss in the context of maintaining muscle mass, while minimizing common side effects associated with existing therapies. Preclinical data on Hebe Bio’s lead molecules have demonstrated superior efficacy and tolerability, positioning it as a next-generation solution for truly sustainable, healthspan-extending weight loss therapy.

Dr. Hentze expressed enthusiasm about his new role at Hebe Bio: “Joining Hebe Bio is a unique opportunity to make a real impact in a critical area of global health. Our GLP-1 RA candidate has the potential to shift the obesity treatment paradigm, and I look forward to collaborating with the exceptional Hebe Bio team, and our global partners to bring this therapy to patients worldwide.”

About Hebe Biotechnology Pte Ltd

Hebe Biotechnology is a Singapore-headquartered biopharmaceutical company dedicated to pioneering next-generation therapies for metabolic and chronic diseases. By combining advanced research with strategic global partnerships, Hebe Bio is committed to delivering patient-centric solutions that address unmet medical needs.

Media Contact:

Ms Kung
Bright International Communications Limited
Email: ir@brightcommns.com
Mobile: +852 4637 1627
Website: www.hebebio.sg

Hua Medicine Announces 2024 Annual Results

– HuaTangNing completed its first full year for reimbursement under the National Reimbursement Drug List (NRDL), with continued expansion in hospital coverage. Compared with the 2023 year, sales volume increased by approximately 740%.

– Sales revenue increased by 234% compared with the 2023 year, with cash reserves exceeding RMB 1 billion to fully support future R&D and commercialization activities.

– A Phase I clinical study of our second-generation GKA, a once daily oral therapy, successfully completed in the United States. Our dorzagliatin-metformin fixed-dose combination formulation progressed smoothly and our product pipeline continued to advance and expand.

– The Mendelian Randomization studies of human genetic data provided scientific evidence to support the exploration of glucokinase activation in diabetic complications and new clinical indications.

– Manufacturing capacity of dorzagliatin continued to expand to meet growing market demand.

– The establishment of Hua Medicine’s pharmaceutical sales and marketing team resulted in significant sales growth in the first two months of 2025, opening a new model of innovative drug commercialization.

Hua Medicine (the Company, HKG: 2552) announced the audited full-year results of the Company and its subsidiaries for the year ended December 31, 2024 (the Reporting Period), along with the Company’s business progress in 2024 and future business outlook. Hua Medicine has made significant strides in the commercialization of its core product, the glucokinase activator (GKA) dorzagliatin (trade name: HuaTangNing,  as well as in R&D innovation and manufacturing capacity optimization, laying a solid foundation for the Company’s long-term sustainable development.

Dr. Li Chen, Founder and the Chief Executive Officer of Hua Medicine, stated: “In 2024, HuaTangNing’s market performance was very encouraging. Its inclusion in the NRDL greatly enhanced the accessibility and affordability of this innovative drug, enabling more diabetes patients to benefit. In 2025, Hua Medicine established a pharmaceutical sales and marketing team, and HuaTangNing demonstrated strong growth momentum at the start of the year. With further market expansion and increasing patient awareness, we are confident in HuaTangNing’s market growth.”

“Looking ahead, the Company will continue to explore HuaTangNing’s potential in personalized diabetes treatment and diabetes complications globally. By integrating big data and artificial intelligence technologies, we aim to expand our disease areas into immune homeostasis and neural homeostasis. We are confident with the close collaboration of Hua Medicine and its partners across the pharmaceutical R&D, production, and distribution chain, we can enable more patients to access and benefit from Chinese medicines, accelerating progress in realizing our vision ‘China leading pharmaceutical innovation to advance human health.’”

Summary of Clinical Research and Operational Progress

– Significant Revenue Growth, Strong Market Performance of HuaTangNing, and Positive Patient Feedback

– 2024 marked the first full year for which our HuaTangNing was reimbursed under the National Reimbursement Drug List (“NRDL”) in China. Sales revenue increased by 234% to RMB255.9 million for the fiscal year 2024 compared with the same period in 2023.  During the fiscal year 2024, HuaTangNing was sold in approximately 2,700 hospitals across China. As of December 31, 2024, Hua Medicine maintained a strong balance sheet with a cash balance of RMB1,139.8 million to support its full-scale commercialization, business development and R&D functions.

– Since the launch of HuaTangNing in the fourth quarter of 2022, our pharmacovigilance team has been diligently monitoring the safety of dorzagliatin in the China market, and was recently recognized by the National Adverse Drug Reaction Monitoring Center as a national example for the pharmaceutical industry. As of December 31, 2024, Hua Medicine had monitored approximately 150,000 patients who have been prescribed HuaTangNing, and dorzagliatin has been observed to be safe and well tolerated by patients.

– Effective January 1, 2025, Hua Medicine assumed full responsibility for the commercialization of HuaTangNing in China from its former sales and marketing partner, Bayer Healthcare Company Limited (“Bayer”). We recruited Mr. Lu Yu, a seasoned pharmaceutical sales executive with over 20 years of diabetes commercialization experience in China, to lead our sales and marketing efforts.

– For the two months ended February 28, 2025, Hua Medicine sold approximately 592,000 packs of HuaTangNing, representing approximately RMB73.2 million in net sales. During the same period in 2024, approximately 202,000 packs of HuaTangNing were sold, representing approximately RMB24.5 million in net sales, The difference represents a significant increase in sales over a period during which the price per pack remained the same. This demonstrates a smooth transition of HuaTangNing’s commercialization in China from Bayer to Hua Medicine, with reinvigorated growth momentum.

– Upon the termination of the Exclusive Promotion Service Agreement, the unamortized contact liabilities amounting to RMB1,243,499,000 were released to profit or loss, and will be recognized as a gain in 2025 by the Group. Both parties have confirmed in a signed letter that there are no outstanding matters arising from such termination, nor does either party owe the other party any obligation or liabilities from such separation.

– Steady Progress in R&D Innovation, Continuously Enriching Product Pipeline

– Hua Medicine made significant headway in preparing the future expansion of our glucokinase-targeted, glucose homeostasis-centered therapy into the international markets, specifically the United States. We successfully completed and announced the results of its single-ascending dose (“SAD”) study in the United States of our second generation GKA (HM-002-1005), in which we validated the feasibility of dorzagliatin as a once daily oral therapy for Type 2 diabetes (“T2D”) patients. We are currently developing the clinical dosage form for advancement of HM-002-1005 in a clinical proof-of-mechanism study.

– Hua Medicine also made significant progress in developing fixed-dose combination formulations. The Company has been advancing its dorzagliatin-metformin fixed-dose combination product candidate into commercial dosage development, with process validation expected to be completed in 2025.

– Based on human genetic data collected from studies of patients administered with dorzagliatin, the Mendelian Randomization methodology has been applied to predict the beneficial effects of dorzagliatin on related and significant diabetes complications, such as reduction in heart failure, coronary artery disease, memory loss and dyslipidemia. In addition, a separate Mendelian Randomization study provided genetic evidence supporting the causal effects of glucokinase activation on lowering the risk of frailty. These findings suggest that glucokinase activators may aid in the management of frailty and sarcopaenia in people with diabetes. We will continue our research and development efforts to explore new indications.

– Through our SENSITIZE 3 clinical study in Hong Kong, Hua Medicine is advancing the potential of dorzagliatin in prediabetes, early treatment and prevention of Type 2 diabetes. In contrast with the approved 75mg dosage form of HuaTangNing, the Company is testing new 25mg and 50mg dosage formulations to explore these potential new indications. The Company is also supporting an investigator-sponsored trial in testing dorzagliatin’s efficacy in treating MODY-2 patients who suffered from genetic mutations that de-activated glucokinase. Early studies in humans by renowned diabetes experts Dr. Juliana Chan and Dr. Linong Ji have indicated the benefit of dorzagliatin in MODY-2 patients by improving their β-cell functions and glycemic control.

– Hua Medicine is also advancing the combination of dorzagliatin with GLP-1RA, DPP-IV inhibitors and SGLT-2 inhibitor through combined effects in collecting real-world evidence and proof-of-concept studies in animal models. The synergy between dorzagliatin with these agents has the potential to expand our indication into other diseases in metabolic disorders, such as obesity and MASH. 

– Hua Medicine will continue our engagement in diabetes prevention, opportunities in longevity and prevention of memory loss and eventually find a new way to increase healthy life span and longevity in humans.

– Continued Expansion of Manufacturing Capacity, Plans to Launch Dorzagliatin in New Markets

– Hua Medicine continues to invest in expanding its manufacturing capacity to meet anticipated market needs in 2026 and 2027.

– Hua Medicine is also finalizing and preparing to submit registration applications for dorzagliatin to launch commercialization in the Macau and Hong Kong markets. We plan to submit both applications in 2025.

– Hua Medicine continues to strengthen its intellectual property protection globally. As of December 31, 2024, the Company owned more than 200 granted patents covering its proprietary technology worldwide.

Business outlook

– There is a great opportunity for dorzagliatin and our 2nd generation GKA in China and the global oral anti-diabetes market. 

– We will strengthen our own commercialization efforts through hub and spoke development with focus on building up a strong internal sales and medical marketing organization to drive business growth in 2025. This will allow us to rebuild our strong connections directly to the medical community and better promote HuaTangNing in China and surrounding areas.

– We continue to invest into digital technology platforms to create synergies across functions and enhance branding opportunities using AI technology.

– We are working on the registration of dorzagliatin in HK and Macau region and engage partnerships in Southeastern Asia and Belt and Road nations. In addition, business development work on our 2nd generation GKA in regions with high incidences of obesity will be continued based on the initial success of the SAD study in the United States.

Financial Summary

For the year ended December 31, 2024:

– Bank balances and cash position was approximately RMB1,139.8 million.

– Total revenue was approximately RMB255.9 million, an increase of approximately 234% compared to the full year of 2023; approximately 2,105,000 packs of HuaTangNing were sold, an increase of approximately 740% compared to the full year of 2023.

– Total other income was approximately RMB116.8 million, including approximately RMB95.7 million from the amortization of Bayer milestone income.

– Total expenditures for the year was approximately RMB493.6 million, of which R&D expenses accounted for approximately RMB215.1 million.

– Loss before tax was approximately RMB250.1 million, which was mainly attributable to the increase of selling expense and research and development expense.

Forward-Looking Statements

This document contains statements regarding Hua Medicine’s future expectations, plans, and prospects for the Company and its products. These forward-looking statements pertain only to events or information as of the date they are made and may change due to future developments. Unless required by law, we are not obligated to update or publicly revise any forward-looking statements or unexpected events after the date of such statements, regardless of new information, future events, or other circumstances. Please read this document carefully and understand that our actual future performance or results may differ materially from expectations due to various risks, uncertainties, or other legal requirements.

About Hua Medicine

Hua Medicine (The “Company”) is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine’s cornerstone product HuaTangNing(dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin for adult T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with renal function impairment.

For more information
Hua Medicine
Website:www.huamedicine.com
Investors
Email:ir@huamedicine.com
Media
Email:pr@huamedicine.com

Press Disclaimer

For accuracy and completeness in context, information related to products marketed in China in this material, especially those identified or required, should comply with documents approved by Chinese regulatory authorities.

Additionally, such information should not be interpreted as a recommendation or promotion of any drug or treatment, nor should it replace medical advice from healthcare professionals. For medical-related matters, please consult a healthcare professional.

Avantor Recognized with Two Prestigious Awards at Asia-Pacific Biopharma Excellence Awards 2025

Avantor Inc., a leading global provider of mission-critical products and services to customers in the life sciences and advanced technologies industries, was recognized  with two prestigious awards at the recent Asia-Pacific Biopharma Excellence Awards (ABEA) 2025. The recognition underscores Avantor’s commitment to providing high-quality biopharma manufacturing solutions, addressing logistics challenges and optimizing supply chain.

Specifically, Avantor was recognized for the ABEA:

  • Best Bioprocessing Supplier Award: Single Use Systems
  • Best Bioprocessing Supplier Award: Chromatography

Single-use solutions enhance flexibility and speed in biopharma manufacturing. As the only open-architecture provider, Avantor offers end-to-end design, manufacturing, and logistics support worldwide. With a diverse portfolio of chromatography resins and advanced production technologies, these solutions enable the rapid and scalable delivery of high-quality therapies.

Narayana Rao Rapolu, VP & GM, BPS AMEA, Avantor said, “We are honored by these two awards recognizing Avantor and our team’s contributions to advancing biomanufacturing. As biologics grow more complex, Avantor remains dedicated to providing innovative chromatography and single-use solutions that enhance flexibility, efficiency, and cost-effectiveness globally. Additionally, by leveraging our wide range of chromatography resins, process chemicals, and reagents, our application scientists, and customer support centers are able to provide total solutions that improve process efficiency.”

Rajesh Bhagwat, Director, Strategy & Marketing, BPS AMEA, Avantor said, “Avantor’s expertise in delivering customized, scalable solutions drives innovation in biopharmaceutical manufacturing. Our advanced chromatography resins, including PROchievA and J.T.Baker® Bakerbond®, provide unique selectivity for next-generation therapies across the Asia-Pacific region. This award reinforces our commitment to supporting customers at every stage, from small-scale development to large-scale production.”

Rajesh Bhagwat, Director, Strategy & Marketing, BPS AMEA, Avantor, receiving the Best Bioprocessing Supplier Award – Chromatography at ABEA 2025


Stephanie Chan, Head of Biopharma, SEA, Avantor, receiving the Best Bioprocessing Supplier Award – Single Use Systems at ABEA 2025

The Asia-Pacific Biopharma Excellence Awards (ABEA) recognizes exceptional Asian bioprocessing, biologistic, clinical trials and aseptic fill and finish experts, organizations and technologies. It celebrates outstanding achievements and innovations in the bioprocessing industry across the Asia Pacific region. The awards are judged by a panel of industry experts, and winners are selected based on their contributions to the advancement of the bioprocessing industry.

About Avantor

Avantor® is a leading life science tools company and global provider of mission-critical products and services to the life sciences and advanced technology industries. We work side-by-side with customers at every step of the scientific journey to enable breakthroughs in medicine, healthcare, and technology. Our portfolio is used in virtually every stage of the most important research, development and production activities at more than 300,000 customer locations in 180 countries. For more information, visit avantorsciences.com and find us on LinkedIn, X (Twitter) and Facebook.

Regional Media Contact:
Swati Chhabra
Manager – Corporate Communications, AMEA
Avantor
91-9958-404-334
swati.chhabra@avantorsciences.com

Global Media Contact:
Eric Van Zanten
Head – External Communications
Avantor
1-610-529-6219
eric.vanzanten@avantorsciences.com

Gain Therapeutics Doses First Participant in Phase 1b Clinical Trial of GT-02287 in Parkinson’s Disease

Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the dosing of the first participant with Parkinson’s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company’s lead allosteric small molecule in development for the treatment of PD with or without a GBA1 mutation.

“Initiation of dosing in our Phase 1b clinical trial represents an important step in the clinical development of GT-02287 and in Gain’s mission to deliver a disease-modifying therapy to people with Parkinson’s disease. We look forward to continued enrollment and anticipate an interim analysis from the towards the end of 2Q 2025,” said Gene Mack, President and CEO of Gain Therapeutics. 

The Phase 1b open-label, multi-center trial is designed to evaluate the safety and tolerability of GT-02287 in people with GBA1-PD and idiopathic PD. Secondary endpoints include pharmacokinetics, GCase modulation, levels of GCase substrates, and other biomarkers in plasma and cerebrospinal fluid. The trial will enroll up to 20 participants who will receive GT-02287 daily for three months. Interim data from the Phase 1b trial are anticipated at the end of 2Q 2025.

The Phase 1b trial follows Gain’s successful Phase 1 study in healthy volunteers completed during Q3 2024, in which GT-02287 demonstrated a favorable safety and tolerability profile as well as plasma and CNS exposures in the projected therapeutic range. Importantly, the Phase 1 study also showed significant target engagement of GT-02287 demonstrated by a statistically significant increase in glucocerebrosidase (GCase) activity that was >50%.

For more information on the Phase 1b clinical trial, visit: https://clinicaltrials.gov/study/NCT06732180 

About GT-02287

Gain Therapeutics’ lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson’s disease (PD) with or without a GBA1 mutation. The orally administered, brain-penetrant small molecule is an allosteric enzyme modulator that restores the function of the lysosomal enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced aggregated α-synuclein, neuroinflammation and neuronal death, and improved motor function and cognitive performance. Additionally, GT-02287 significantly reduced plasma neurofilament light chain (NfL) levels, an emerging biomarker of neurodegeneration.

Compelling preclinical data in models of both GBA1-PD and idiopathic PD, demonstrating a disease-modifying effect after administration of GT-02287, suggest that GT-02287 may have the potential to slow or stop the progression of Parkinson’s disease.

Gain’s lead program in Parkinson’s disease has been awarded funding support early in its development from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency.

About Gain Therapeutics, Inc.

Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate, GT-02287 is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma exposure in the projected therapeutic range, CNS exposure, and target engagement and modulation of GCase enzyme.

Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan™ platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology.

Forward-Looking Statements

This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, statements regarding: the development of the Company’s current or future product candidates including GT-02287; expectations regarding the timing of results from a Phase 1b clinical study for GT-02287; expectations regarding the timing of patient enrollment for a Phase 1b clinical study for GT-02287; and the potential therapeutic and clinical benefits of the Company’s product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s Form 10-K for the year ended December 31, 2023 and Form 10-Q for the quarter ended September 30, 2024. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contacts:

Apaar Jammu and Chuck Padala
ajammu@gaintherapeutics.com
chuck@lifesciadvisors.com 

Media Contacts:

Russo Partners
Nic Johnson and Elio Ambrosio
nic.johnson@russopartnersllc.com
elio.ambrosio@russopartnersllc.com
(760) 846-9256

Everest Medicines Hits Three-Year High as AI+mRNA Pipeline Reshapes Valuation

Everest Medicines’ stock (1952.HK) surged today, opening higher and maintaining strong momentum throughout the trading day. By market close, the stock had risen 20.12% to HK$60.6, bringing the company’s total market capitalization to HK$19.791 billion. This marks its highest level in nearly three and a half years since September 28, 2021, while also successfully surpassing its 2020 IPO issue price of HK$55, reflecting strong investor confidence in its AI-based mRNA platform, dual-engine strategy, and future commercialization prospects.

According to the latest updates, Everest Medicines announced yesterday that the first patient has been dosed with the Company’s internally developed personalized mRNA cancer vaccine EVM16 at Peking University Cancer Hospital as part of an investigator-initiated clinical trial (IIT). Following this announcement, the company held an Investor Calls, where it provided detailed insights into its AI-based mRNA platform and pipeline advancements, highlighting progress in neoantigen prediction, vaccine development, and future commercialization strategies.

Governments worldwide continue to support mRNA-based oncology research, with leading biopharmaceutical companies such as BioNTech and Moderna achieving breakthroughs in personalized cancer vaccines. Over the next one to two years, several key milestones are expected, particularly in melanoma, pancreatic cancer, and other high-mortality cancers, further reinforcing the therapeutic potential of mRNA-driven oncology treatments.

Everest Medicines has established a fully integrated and clinically validated mRNA platform, encompassing antigen design, mRNA sequence optimization, LNP delivery system, and GMP production capabilities. The company holds global rights to its platform and pipeline, which is structured around four key areas: personalized cancer vaccines (PCV), tumor-associated antigen (TAA) vaccines, immune-modulatory cancer vaccines, and in vivo CAR-T therapies. With a comprehensive and differentiated portfolio, Everest Medicines is well-positioned in the rapidly evolving mRNA therapeutic landscape.

The success of personalized cancer vaccines depends on the ability to identify the most immunogenic tumor mutations among thousands of genetic alterations. Everest Medicine’s proprietary machine learning based neoantigen prediction algorithm (EVER-NEO-1), uses advanced deep learning technology to precisely select highly immunogenic peptide sequences, optimizing them for mRNA vaccine design.

Independent validation has shown that EVER-NEO-1’s neoantigen prediction capability meets or exceeds industry-leading standards. In head-to-head comparisons with MSKCC, a globally recognized neoantigen prediction algorithm, Everest’s model demonstrated superior performance in identifying a broader range of highly immunogenic tumor neoantigens.

In preclinical studies, EVM16 demonstrated significant tumor growth inhibition in syngeneic mouse model, with repeated dosing showing favorable safety and tolerability. Preclinical data also showed a synergistic anti-tumor effect when EVM16 was combined with a PD-1 antibody, supporting its potential use in combination therapies in clinical settings.

Additionally, Everest is advancing EVM14, its off-the-shelf TAA cancer vaccine, which has achieved key regulatory milestones. The company will submit an investigational new drug application for its TAA vaccines in China and the United States in 2025. One of EVM14’s key advantages is its ability to induce long-term immune memory and prevent tumor recurrence. In preclinical studies, 13 out of 15 mice treated with EVM14 experienced complete tumor regression, with no tumor regrowth even after re-exposure to tumor cells. Additionally, EVM14 has shown enhanced anti-tumor efficacy when combined with PD-1 inhibitors, further supporting its clinical potential.

Everest’s mRNA platform extends beyond oncology, with the company advancing immune-modulatory cancer vaccines and in vivo CAR-T therapies. The in vivo CAR-T program, leveraging mRNA/tLNP technology, has successfully achieved T cell transfection and CAR expression in non-human primate models. Compared to conventional CAR-T therapies, Everest’s in vivo CAR-T offers significant advantages, including lower production costs, enhanced safety, no need for lymphodepletion, and potential for outpatient treatment administration. Early data also suggests promising applications in refractory systemic lupus erythematosus (SLE), demonstrating its broader therapeutic potential.

Speaking at today’ s Investor Calls, Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, stated: “Everest Medicines has successfully transitioned from a license-in-driven model to a dual-engine strategy. The establishment of our proprietary mRNA platform marks a significant milestone, strengthening our in-house R&D capabilities and serving as a key driver of future growth. At the same time, we are accelerating the commercialization of our core products and remain committed to achieving our strategic goal of exceeding RMB 10 billion by 2030. Everest Medicines is poised to unlock even greater long-term value and advance toward the forefront of global biopharmaceutical innovation.”

From a capital markets perspective, Everest Medicines’ AI-based mRNA platform integrates cutting-edge antigen selection, mRNA sequence optimization, and industrial-scale production capabilities, positioning it as a strong player in the global mRNA therapeutics space. Everest Medicines is the first biopharmaceutical company in China to advance an AI-based personalized mRNA cancer vaccine into the clinical stage. BOCOM International has recognized Everest Medicines as a key innovator in mRNA cancer therapeutics, highlighting its strong pipeline catalysts, significant revenue potential, and substantial valuation upside. Everest is well-positioned to strengthen its leadership in AI-enabled mRNA innovation and drive new global collaborations in the biopharmaceutical sector.