Pharma Archives - Page 2 of 60

OBI-902 has been granted by US FDA for Orphan Drug Designation for the Treatment of Cholangiocarcinoma

OBI-902 is the first ADC utilizing OBI’s proprietary GlycOBI glycan-based ADC enabling technology for evaluation of safety and efficacy in patients with Cancer.

OBI Pharma, a clinical-stage oncology company (4174.TWO) received notification from the US FDA stating that the request for Orphan Drug Designation of OBI-902 TROP2 ADC for the treatment of Cholangiocarcinoma has been granted. OBI-902 is the first OBI-developed ADC that incorporates our proprietary site-specific glycan-conjugated ADC enabling technology.

Cholangiocarcinoma is a rare and lethal malignancy with fewer than 50,000 patients in the United States and a 5-year survival rate ranging from 2% and 23% depending on disease stage, histological subtype, and localization[1]. At present, there are no FDA approved ADC therapies for cholangiocarcinoma.

To encourage the industry to develop new treatment options for rare diseases, the US FDA grants Orphan Drug Designation to experimental therapies that have the potential to treat these diseases. In the United States, a rare disease is defined as any condition that affects fewer than 200,000 patients. After granting Orphan Drug Designation, the US FDA qualifies companies or drug developers incentives such as tax credits for clinical trials, exemption from user fees, and marketing exclusivity[2].

In August 2025, OBI launched a phase I/II clinical trial in the United States and Taiwan, recruiting patients with advanced solid tumors. The objectives of the trial are to study the safety, pharmacokinetics, and preliminary efficacy profile of OBI-902 in these patient populations.

Heidi Wang, Ph.D, OBI Pharma’s Chief Executive Officer noted, “Based on our preclinical data, OBI-902 has several important advantages over other TROP2 ADCs either approved or in development; including high stability in blood circulation, excellent bystander effect that extends the killing to neighboring cancer cells lacking TROP2 expression, potential ability to overcome drug resistance, and outstanding activity in animal and organoid models of cancer. Importantly, this marks the first time an ADC that incorporates OBI’s proprietary GlycOBI® ADC technology is being evaluated in patients, including those diagnosed with cholangiocarcinoma. We look forward to investigating this potential best-in-class TROP2 ADC in the clinic.”

About OBI-902
OBI-902 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill tumor cells and with a drug-antibody ratio (DAR) of 4. TROP2 is highly expressed in a variety of solid tumors such as breast, lung, biliary, bile duct (cholangiocarcinoma), ovarian, gastric, and many other cancer types, rendering it an ideal target for cancer therapy.

OBI-902 is a novel site-specific glycan-conjugated ADC using OBI’s proprietary GlycOBI platform, which provides improved stability and enhanced hydrophilicity. OBI-902 demonstrated remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in various animal models. The IND of OBI-902 was cleared by the US FDA on April 30, 2025.

Since December 2021, OBI has been granted by Biosion, Inc. (www.biosion.com) an exclusive, worldwide (except in China) license to a TROP2 targeting antibody amino acid sequence. Biosion holds exclusive rights to that antibody sequence in China. OBI holds worldwide commercial rights to OBI-902, except for the rights pertaining to the antibody in China.

About GlycOBI®
OBI has developed a unique clinical stage, glycan-based site-specific ADC technology (GlycOBI®), which is in a ‘Plug and Play’ format and compatible with any antibodies, linkers, and payloads in drug-antibody ratio (DAR) up to 16. Utilizing OBI’s proprietary dual-function enzyme (EndoSymeOBI®) and linker technology (HYPrOBI®), homogenous ADCs are manufactured with an efficient and scalable process under GMP conditions. The conjugation process of GlycOBI® avoids disrupting the antibody structure and ensures the ADC has similar biophysical characteristics to the native antibody. Furthermore, OBI’s linker technology has improved conjugation efficiency of the payload, reduced aggregation propensity, which provides advantages on manufacturing ADC products. GlycOBI® conjugated ADCs have overcome the limitations of traditional ADCs and achieved better antitumor activity and stability in various in vivo animal studies. GlycOBI®, EndoSymeOBI®, and HYPrOBI® are part of the armamentarium of OBI’s Obrion™ ADC Enabling Technologies that also include ThiOBI® and GlycOBI DUO™. OBI-902 is the first ADC utilizing OBI’s Obrion™ ADC enabling technology for evaluation of safety and efficacy in Cancer, currently under Phase I/II clinical trial in the US and Taiwan.

About OBI Pharma
OBI is a clinical stage global oncology company that is headquartered in Taiwan and established in 2002. Its mission, together with its wholly owned subsidiary OBI Pharma USA, Inc., is to develop novel therapeutic agents for patients with high unmet medical needs.

OBI’s primary focus is the development of novel ADCs, including the first-generation cysteine-based TROP2 ADC, OBI-992. Using the company’s proprietary ADC enabling technology, GlycOBI®, powered by EndoSymeOBI® and HYPrOBI®; OBI has created its next-generation novel ADC pipeline, including monospecific: OBI-902 (TROP2), OBI-904 (Nectin-4), bispecific single payload (HER2 x TROP2), and bispecific, dual payload (cMET x HER3) ADCs. To broaden the applicability of linker technology, HYPrOBI®, OBI further developed a novel ThiOBI® platform to enable irreversible cysteine-based conjugation. Additionally, OBI’s pipeline includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme that is highly expressed in tumors. Additional information can be found at www.obipharma.com.

GlycOBI®, EndoSymeOBI®, ThiOBI® and HYPrOBI®are registered trademarks of OBI Pharma. Obrion™ and GlycOBI DUO™ are trademarks under registration.

1 National Institute of Health for Rare Diseases. Sept. 2025
https://rarediseases.info.nih.gov/diseases/9304/cholangiocarcinoma

2 US FDA website. Designating an Orphan Product: Drugs and Biological Products Sept.25 https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products

Forward-Looking Statements
Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma’s reports and presentations, including OBI Pharma’s filings with the Taiwan Securities and Futures Bureau.

COMPANY CONTACT:
Kevin Poulos, Chief Business Officer
OBI Pharma USA, Inc.
+1 (619) 537 7698, ext. 102
kpoulos@obipharma.com

SOURCE: OBI Pharma USA, Inc.

Kangji Medical and Knight Bidco Jointly Dispatch Scheme Document for Privatisation Proposal

Kangji Medical Holdings Limited (Kangji Medical or the Company, HKG: 9997) and Knight Bidco Limited (the Offeror) today announced that a circular in relation to the proposed privatisation of Kangji Medical (the “Scheme Document) has been published, setting out the terms and conditions of the proposed privatisation of Kangji Medical (the Proposal) by way of a scheme of arrangement.

The document is now available on the Stock Exchange of Hong Kong’s website. (website link)

The Proposal represents an attractive opportunity for Scheme Shareholders to realise their investment in the Company with certainty amidst market volatility, potential geopolitical risk, industry and macro uncertainty.

Recommendation
The Independent Board Committee (“IBC”), having considered the Proposal, the Scheme, and the Special Deal, and having taken into account the advice of the Independent Financial Adviser, considers that the Proposal, the Scheme, and the Special Deal are fair and reasonable insofar as the Independent Shareholders are concerned.

Accordingly, the IBC recommends that the Independent Shareholders vote in favour of various resolutions to render the Scheme effective.

Further information on the reasons for the IBC’s recommendation, and the Independent Financial Adviser’s report are available in the Scheme Document.

Action required by Scheme Shareholders
All shareholders are advised to review the Scheme Document. Shareholders should refer to the Scheme Document for further information regarding the Proposal, the Scheme and the Special Deal, as well as the Notices of the Court Meeting and the EGM, together with the forms of proxy in relation thereto.

In accordance with the directions of the Grand Court, the Court Meeting will be held at 10:00 a.m. (Hong Kong time) on 10 November 2025 at United Conference Centre, 10/F, United Centre, 95 Queensway, Admiralty, Hong Kong. The EGM will be held at the same place and on the same date at 10:30 a.m.

Kangji Medical shareholders should carefully read the Scheme Document in its entirety before making a decision with respect to the Scheme.

Background to the Proposal

On 17 July 2025, the Offeror requested the Board to put forward the Proposal to the Shareholders for the privatisation of the Company by way of a scheme of arrangement under section 86 of the Companies Act. Upon completion of the Proposal, the Company will become a wholly-owned subsidiary of the Offeror and the listing of the Shares will be withdrawn from the Stock Exchange.

Kangji Medical Holdings Limited
Kangji Medical is a medical device group founded in 2004 with headquarters at Hangzhou, Zhejiang Province, China. It was listed at the mainboard of the Stock Exchange of Hong Kong in June 2020 (Stock Code: 9997.HK). The Company specialize in the design, development, manufacture and sale of minimally invasive surgery instruments and accessories (“MISIA”) . It strives for the mission of “providing physicians with high-quality products and services, and dedicating to improve people’s health”. The Company offers a comprehensive product portfolio to provide physicians and hospitals one-stop and tailored surgical solutions primarily for four major surgical specialties, including obstetrics and gynecology, general surgery, urology, and thoracic surgery. It also committed to developing an internationally recognized minimally invasive surgery instruments and accessories platform with global coverage.

About Knight Bidco Limited
Each of the Offeror, MidCo and TopCo is a newly incorporated company in the Cayman Islands with limited liability and an investment holding company set up solely for the purposes of implementing the Proposal. As at the Latest Practicable Date, the Offeror is wholly owned by MidCo, which in turn is wholly owned by TopCo. As at the Latest Practicable Date, TopCo is held by the Consortium Members, as to approximately 25.53% by Fortune Spring ZM, approximately 14.47% by Fortune Spring YG, approximately 24.38% by TPG Asia VII, approximately 5.01% by Keyhole, approximately 5.69% by Knight Success, approximately 4.56% by NewQuest V and approximately 20.36% by Al-Rayyan Holding. As at the Latest Practicable Date, save as disclosed in the section headed “11. Shareholding Structure of the Company” in Part VII – Explanatory Memorandum of the Scheme Document, none of TPG Asia VII, Keyhole, Knight Success, NewQuest V and Al-Rayyan Holding is a Shareholder.

Kangji Medical is controlled by Mr. Zhong and his spouse Ms. Shentu who together hold 52.98% of the shares in Kangji Medical. Following the privatisation of Kangji Medical, Mr. Zhong and Ms. Shentu will remain the largest shareholders in the ultimate parent company of the Offeror, holding 40.00% of the shares in TopCo via Fortune Spring ZM and Fortune Spring YG. Further details are available in the Scheme Document.

Each of the Founder Entities is a business company incorporated in the British Virgin Islands.

Knight Success is a newly incorporated company in Singapore with limited liability and an investment holding company. Keyhole is an exempted company incorporated in the Cayman Islands with limited liability and an investment holding company. TPG Asia VII is a company incorporated in Singapore with limited liability. Each of Knight Success and Keyhole is either wholly owned or controlled by TPG Asia VII, which is in turn controlled by TPG Asia GenPar VII Advisors, Inc. and ultimately controlled by TPG Inc., a publicly traded Delaware corporation (NASDAQ).

TPG is a leading global alternative asset management firm founded in 1992 with more than US$269 billion of assets under management as of 30 June 2025. For many years, TPG has been investing in transformation, growth, and innovation and aims to build dynamic products and strategies for its investors while also instituting discipline and operational excellence across its investment strategies and performance of its portfolios.

NewQuest V is a company incorporated in Singapore with limited liability and an investment holding company. NewQuest V is wholly owned by NewQuest Asia Fund V, L.P., which is in turn controlled by NewQuest Asia Fund V GP Ltd. and ultimately controlled by TPG Inc., a publicly traded Delaware corporation (NASDAQ).

Established in 2011, NewQuest is one of Asia’s leading secondary private equity platforms with the most experienced secondary team in Asia across five offices. Since its founding, NewQuest has focused on working with GPs to create bespoke, tailored solutions to meet liquidity and other strategic needs of private asset owners and their stakeholders. Starting from a strategic partnership forged in 2018, NewQuest became wholly owned by TPG in January 2022.

Al-Rayyan Holding is a limited liability company established in 2012 under the regulations of the Qatar Financial Centre Authority in the State of Qatar, and is a 100%-owned indirect subsidiary of QIA, the sovereign wealth fund of the State of Qatar. QIA was founded in 2005 to invest and manage the state reserve funds. QIA is among the largest and most active sovereign wealth funds globally. QIA invests across a wide range of asset classes and regions as well as in partnership with leading institutions around the world to build a global and diversified investment portfolio with a long-term outlook. As at the Latest Practicable Date, Al-Rayyan Holding and its concert parties (other than those who are, or deemed to be, acting in concert with Al-Rayyan Holding solely in connection with the Consortium) are not interested in any Shares.

All capitalized terms which are used in this press release but not otherwise defined herein shall have the meanings ascribed to them in the Scheme Document dated 13 October 2025. This press release should be read in conjunction with the Scheme Document, a copy of which is available on (website link).

TruMerit’s Peter Preziosi Elected President of the Conference of NGOs in Consultative Relationship With the United Nations

TruMerit President and CEO Peter Preziosi has been elected President of the Conference of Non-Governmental Organizations in Consultative Relationship with the United Nations, also known as CoNGO.

CoNGO | TruMerit
Conference of Non-Governmental Organizations in Consultative Relationship with the United Nations, also known as CoNGO and TruMerit

CoNGO is an international non-governmental organization founded in 1948 that relates to the United Nations through its General Consultative Status granted by the United Nations Economic and Social Council (ECOSOC). It has 525 member organizations from around the world and 106 associate members.

Dr. Preziosi was elected to serve for the 2025-29 term this week at the 28th CoNGO General Assembly, which took place in New York with the virtual participation of organizations from around the world. He succeeds the Rev. Dr. Liberato C. Bautista, the main representative to the UN for the General Board of Church and Society of The United Methodist Church, who has served as CoNGO’s President since 2017 and also held the post from 2007 to 2011.

TruMerit has been a member of CoNGO since 2018 and is active in the organization’s affairs, having served as the organization’s Secretary to the CoNGO Board and as chair of its Membership Committee.

Dr. Preziosi is the first Registered Nurse to serve as CoNGO President. He is a nonprofit executive who since early 2023 has led TruMerit, formerly known as CGFNS International, a health workforce development organization committed to advancing the ethical mobility and professional growth of health workers worldwide. Previously, he was employed by the World Health Organization to help establish its technology-driven global learning center, the WHO Academy.

Dr. Bautista, the former President of CoNGO, extended his warm congratulations to Dr. Preziosi on his election. “His experience at TruMerit and at WHO, coupled with his profound dedication to multilateralism and his engagement with civil society, provide a basis for optimism regarding CoNGO’s future. In an era where the voice and influence of civil society are of paramount importance in shaping a shared future that upholds human dignity and rights, as well as planetary sustainability, Dr. Preziosi’s leadership is expected to enhance CoNGO’s role as a pivotal supporter and advocate for democratic and equitable participation within the United Nations and beyond,” he stated.

“CoNGO has long been a vital convener of NGOs, a bridge between civil society and an advocate for their engagement at the United Nations, as well as a steadfast champion of inclusive multilateralism – a concept that, unfortunately, is increasingly under attack,” said Preziosi.

“In response, let us assert civil society participation at the United Nations not as a plea, but as a principle – one that is essential to legitimate, effective, and ethical multilateralism, and thereby is critical to the attainment of the Sustainable Development Goals and adherence to the rule of law,” he said.

About CoNGO (Conference of Non-Governmental Organizations in Consultative Relationship with the United Nations)
The Conference of Non-Governmental Organizations in Consultative Relationship with the United Nations (CoNGO) is an independent, international membership association founded in 1948, the year of the Universal Declaration of Human Rights. As a non-governmental organization (NGO) in general consultative status with the UN Economic and Social Council, our work relates to the entire United Nations System: the Secretariat, Agencies, Treaty Bodies, Regional Commissions, Institutes, Summits and World Conferences.

CoNGO wholeheartedly endorses the goals and values enshrined in the United Nations Charter and is a strong advocate for multilateralism to resolve global political, environmental, health, and other threats. Close to 30 CoNGO Substantive Committees (called NGO Committees) related to CoNGO in New York, Geneva, Vienna, and regions worldwide demonstrate our commitment to supporting the mission of the United Nations, systemwide. CoNGO has a membership of diverse NGOs working in consultation with the United Nations, in collaboration with each other, and in cooperation with other like-minded stakeholders. ngocongo.org

About TruMerit
TruMerit is a worldwide leader in healthcare workforce development. Formerly known as CGFNS International, the organization has a nearly 50-year history supporting the career mobility of nurses and other healthcare workers – and those who license and hire them – by validating their education, skills, and experience as they seek authorization to practice in the United States and other countries. As TruMerit, this mission has been expanded to building workforce capacity that meets the needs of people in a rapidly evolving global health landscape. Through its Global Health Workforce Development Institute, the organization is advancing evidence-based research, thought leadership, and advocacy in support of healthcare workforce development solutions, including globally recognized practice standards and certifications that will enhance career pathways for healthcare workers. www.trumerit.org

Contact Information
David St. John
dstjohn@trumerit.org

SOURCE: TruMerit

Counterfeit Products Sold Online in Malaysia Threaten Halal Compliance, Consumer Health, and the E-Commerce Sector, Says Muslim Consumers Association (PPIM)

The Muslim Consumers’ Association of Malaysia today expressed deep concern over the emergence of counterfeit health products sold online with fake halal certificates.

Nadzim Johan, Chief Activist of Persatuan Pengguna Islam Malaysia (PPIM), urged the authorities to investigate and take immediate action against the companies involved.

Nadzim warned that if not addressed promptly, these illegal practices could endanger public health and erode the confidence of Muslims in Malaysia regarding syariah compliance and guidance. He also stressed that this issue threatens local syariah-compliant businesses operating on e-commerce platforms.

PPIM has held urgent discussions with Holista Colltech Limited (“Holista”) concerning a recent police report filed by the company in Malaysia.

The report was lodged regarding counterfeit PRISTIN® Omega-3 fish oil products being sold on two popular e-commerce platforms, Lazada and Shopee.

Holista, headquartered in Petaling Jaya and listed on the Australian Securities Exchange, filed the report with the Royal Malaysia Police after obtaining samples of the counterfeit products.

Independent laboratory testing revealed that the counterfeit products were made from low-grade palm oil instead of fish-derived Omega-3.

Holista is Malaysia’s market leader in Omega-3 supplements, sold under two flagship brands – PRISTIN® GOLD OMEGA-3 FISH OIL 1200MG SOFTGEL and PRISTIN® OMEGA-3 FISH OIL 1200MG. Both products are halal-certified.

Nadzim emphasized that Holista’s genuine products are only available through pharmacies licensed by the Ministry of Health Malaysia and via Holista’s official online stores, Alterni.com and Holista.global.

“We are deeply concerned about the emergence of such counterfeit products. With the rapid growth of e-commerce in Malaysia, we fear that other counterfeit cases may exist and remain undetected by the authorities,” said Nadzim.

He further highlighted three critical issues:

1. Halal certification is a core element of the Islamic faith. Any blatant misuse of the halal logo undermines the trust of Muslims in Malaysia and globally in the certification of products, their sources, and production processes.

2. Such counterfeit products deliberately evade regulatory oversight governing supplement safety and compliance. Not only do they fail to support health, but they actively endanger consumers.

3. As a Muslim-majority country with a large young population, Malaysia is a thriving e-commerce market, respected globally for its adherence to Islamic practices and halal compliance. Violations of this nature will have severe repercussions for syariah-compliant businesses if not dealt with decisively.

PPIM has called on the Malaysian Communications and Multimedia Commission (MCMC) – which oversees online activities – and the Department of Islamic Development Malaysia (JAKIM), under the Ministry of Religious Affairs, to investigate the e-commerce platforms used for selling these counterfeit products and to identify the companies or individuals involved.

Nadzim added that industry players, including pharmacy chains and the Malaysian Dietary Supplement Association, should also hold urgent discussions to address growing concerns among consumers, particularly Muslims.

About PPIM

Persatuan Pengguna Islam Malaysia (PPIM) was established in June 1997 by a group of doctors, university lecturers, Islamic academician and individuals, in view of the problems faced by Muslim consumers in identifying Halal products. PPIM is an educational organisation for Muslims about Halal products. Its official website provides Halal and Haram products list, FAQs, forum, downloads, consumer complaint and latest news.

PPIM Media contact person:
Puan Zura
Email address: ppimmedia1@gmail.com,
Mobile number: 013-6116666

Sichuan Neautus TCM Files for Hong Kong IPO to Accelerate Domestic and Global Expansion

Company leverages dual-market strategy and technology-driven standardization to strengthen its leadership in China’s TCM sector and enter international markets.

Sichuan Neautus Traditional Chinese Medicine Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange. The IPO is intended to raise capital to support the company’s expansion both domestically and internationally amid rapid modernization of China’s traditional Chinese medicine (TCM) industry.

Founded in 2021, Chengdu, China, Neautus has grown into a leading player in the herbal decoction pieces market, with annual revenue exceeding RMB 1.2 billion.

Dual Growth Engines
Neautus operates a “dual-engine” growth model, balancing institutional sales and consumer demand.

The company supplies more than 1,000 major hospitals in China and is continuing to grow. And through its B2B platform, “Jinfang Caotang,” which is an online platform aimed at meeting the demands of approximately 90,000 TCM clinics in China, the company has seen significant success. Since the launch of “Jinfang Caotang,” the platform has attracted over 5,200 registered TCM clinics within a year, signaling high growth.

In the consumer market, Neautus specializes in ready-to-consume herbal supplements aimed at a diverse demographic of Traditional Chinese Medicine (TCM) users in China. Additionally, the company has expanded its reach into overseas markets, including Hong Kong, Taiwan, Vietnam, and Malaysia.

Technology-Driven Standardization
Neautus is the first company worldwide to apply DNA barcoding technology to identify herbal materials, a standard recognized by both the Chinese and British Pharmacopoeias. This achievement earned the company the National Science and Technology Progress Award (Second Class). In recent years, Neautus has also obtained a series of high-level certifications—from “Chengdu Digital Workshop” to Sichuan Province’s “Advanced Smart Factory”—highlighting its advancement toward Intelligentization 2.0.

Market Tailwinds and Global Expansion
Supported by national policies promoting standardization, Frost & Sullivan projects China’s TCM market will exceed RMB 599.3 billion by 2030. IPO proceeds will fund overseas capacity, international certifications, cross-border e-commerce, regional acquisitions, and entry into European and U.S. markets. The company is also planning on developing AI-assisted diagnostic tools via its “Jinfang Cloud” platform.

IPO Outlook
The IPO underscores Sichuan Neautus’s role in transforming the TCM industry from traditional manufacturing to value-driven healthcare innovation, while further strengthening its position as an industry leader and advancing the sector toward higher standards and quality.

About Sichuan Neautus Traditional Chinese Medicine Co., Ltd.
Sichuan Neautus Traditional Chinese Medicine Co., Ltd. specializes in high-quality herbal decoction pieces and health supplements, combining technology, traceability, and research to serve domestic and international markets.

Everest Medicines Announces 2025 Interim Results: ‘Dual-Engine’ Strategy Driving Strong Synergies Between Commercialization and R&D

On August 29, Everest Medicines (HKG: 1952) announced its interim results for the six months ended June 30, 2025. The Company’s total revenue for the first half of 2025 reached RMB 446 million, representing 48% year-over-year growth, while operating expenses as a percentage of revenue decreased by 40.1 percentage points, reflecting strong operational efficiency. Non-IFRS loss narrowed by 31%, and gross margin excluding non-cash items was 76.4%. As of the end of June, the Company maintained a solid cash balance of RMB 1.6 billion. Additionally, with the successful completion of a share placement on August 1, which generated net proceeds of HK$1.553 billion, Everest’s total cash position increased further, providing a strong foundation for commercialization expansion and R&D investment. Supported by the excellent performance of its core products, Everest remains confident in achieving its full-year revenue guidance of RMB 1.6 to 1.8 billion and expects to turn operating cash flow positive in Q4.

BOCOM International released its latest report today, noting that the strong sales performance of Everest Medicines’ Nefecon(R) far exceeded expectations. The institution significantly raised its revenue forecasts for 2026–2027 and lifted its target price to HK$84. The report highlighted a rich pipeline of catalysts from the second half of 2025 through 2026, including the approval, commercialization, and reimbursement negotiations of etrasimod in China, as well as potential BD opportunities for the Company’s proprietary pipeline. BOCOM International believes the current valuation remains attractive and reiterated its “Buy” rating.

“In the first half of 2025, Everest Medicines accelerated its transformation into a leading global biopharmaceutical company by deepening our ‘dual-engine’ strategy. We have built a commercialization platform anchored by two blockbusters covering high-potential markets and powered by the in-house discovery and clinical translation of in vivo CAR-T and mRNA therapeutic cancer vaccine platforms.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.

Core Products Deliver Strong Growth, Driving Commercial Platform Momentum
NEFECON(R), the blockbuster product in the renal portfolio, delivered particularly strong performance. As the first and only fully approved etiological treatment for IgA nephropathy (IgAN) in China, the United States, and Europe, NEFECON(R) generated revenue of RMB 303 million in the first half of 2025, representing 81% year-over-year growth. However, our first half revenue was artificially low due to a supply constraint that was rooted in both strong market demand and a delay in regulatory approval of a supplemental application for production scale up designed to ensure supply stability. This has been fully resolved since our supplemental application was approved by the China CDE on Aug 1, 2025. Following the supplemental application was approved by the China CDE in August, supply capacity increased significantly. Cumulative sales from January to August reached RMB 825 million, including RMB 520 million in August alone, reflecting strong market demand. Full-year sales are expected to reach RMB 1.2–1.4 billion, with continued strong growth projected in 2026, potentially reaching RMB 2.4–2.6 billion.

Another Core product XERAVA(R), As the world’s first fluorocycline antibiotic recorded RMB 143 million in the first half of 2025, up 6% year-over-year. In-hospital sales increased 37% year-over-year, driven by Everest’s core hospital strategy.

Additionally, VELSIPITY(R) (etrasimod), a best-in-disease therapy for moderately to severely active ulcerative colitis (UC), is positioned as Everest’s next growth engine, with its NDA in mainland China expected to be approved in the first half of 2026. The localized production project for VELSIPITY(R) was officially launched at the Jiashan manufacturing site in March 2025, providing strong support for its future commercialization.

Global Proprietary Pipeline Value Emergingï¼ŒStrong Prospects for Blockbuster Potential
Everest continues to focus on achieving key breakthroughs in its proprietary pipeline, while accelerating the clinical development and global expansion of innovative assets with global rights. EVER001 (civorebrutinib), the next-generation covalent reversible BTK inhibitor, has delivered encouraging Phase 1b/2a clinical data in primary membranous nephropathy (pMN). With potential applications in IgAN, minimal change disease (MCD), and FSGS, covering a patient population of more than 10 million worldwide, EVER001 represents a significant market opportunity, with projected global peak sales exceeding RMB 10 billion. A global Phase II basket trial is expected to be initiated in the first half of 2026.

Leveraging its industry-leading mRNA therapeutic cancer vaccine platform and in vivo CAR-T platform, the Company is building a globally competitive R&D pipeline. EVM18, the in vivo CAR-T program, has completed multiple non-human primate (NHP) trials and achieved preclinical proof-of-concept, with first-in-human data expected by the end of 2025. EVM16, the personalized therapeutic mRNA cancer vaccine, has initiated its first-in-human trial in China, with patient dosing completed. In the investigator-initiated trial (IIT), dose escalation in the low- and mid-dose cohorts has been completed, with encouraging preliminary data observed. EVM14, an off-the-shelf tumor-associated antigen (TAA) vaccine, has received IND approval from the U.S. FDA and acceptance from China’s NMPA. The Phase I trial in the U.S. is currently underway, with first patient enrollment expected by September 2025. EVM15, the immune-modulatory cancer vaccine, has completed preclinical proof-of-concept and identified its clinical candidate.

Strategic Repositioning to Bolster Global Competitiveness
During the reporting period, the Hong Kong Stock Exchange approved the removal of the “B” marker from Everest’s stock short name, reflecting recognition of the Company’s strong R&D pipeline, commercialization capabilities, and overall business fundamentals. In addition to the successful top-up placement, Everest invested approximately US$30.9 million in I-Mab (Nasdaq: IMAB) in August 2025. Following the transaction, Everest increased its ownership in I-Mab to approximately 16.1%, becoming its single largest shareholder, further strengthening its global presence in next-generation immuno-oncology therapies.

Analysts noted that Everest’s “dual-engine” strategy is rapidly delivering results. On the one hand, the Company’s powerful commercial platform—anchored by NEFECON(R) and VELSIPITY(R) and supported by XERAVA(R), Cefepime-taniborbactam, EVER001, and other high-potential assets—is expected to generate synergies with total peak sales exceeding RMB 25 billion globally. On the other hand, Everest’s in vivo CAR-T and mRNA therapeutic cancer vaccine platforms provide significant long-term growth potential through global development and partnership opportunities.

Lepu Biopharma (2157.HK) announces 2025 interim results

ADC pipeline with multiple products entering key clinical stages
Revenue increased by 350% year-on-year

Focusing on the field of tumor treatment, innovative biopharmaceutical company Lepu Biopharma Co., Ltd. (Lepu Biopharma or the Company, HKG: 2157) announced its interim results for the first half of 2025. During the reporting period, the Company’s business showed strong growth momentum, achieving profitability for the first time. Core product sales and international licensing business progressed in tandem, with multiple ADC pipeline products entering key clinical stages and global commercialization efforts accelerating.

Lepu Biopharma is an innovation-driven biopharmaceutical company focusing on oncology therapeutics, in particular, targeted therapy and oncology immunotherapy, with a strong China foundation and global vision. Lepu Biopharma is dedicated to developing innovative ADCs through our comprehensive and advanced ADC technology development platform and we aim to develop optimal and innovative drugs to better serve the unmet medical needs of cancer patients. The Company is committed to continuously developing a market-differentiating pipeline by fully integrating independent innovation capabilities and strategic collaborations. The Company has established and is progressively expanding our internal manufacturing capabilities, driven by the business needs stemming from the upcoming commercialization of our ADC candidates.

Currently, Lepu Biopharma has strategically designed our pipeline with a range of oncology products. For clinical-stage candidates, the Company has one clinical/commercialization-stage drug candidate; nine clinical-stage drug candidates, including one co-developed through a joint venture; and three clinical-stage combination therapies of our candidates. One of our drug candidates has obtained marketing approval with respect to two of its targeted indications, with clinical trials for other indications ongoing. Among the nine clinical-stage drug candidates, seven are targeted therapeutics and two are immunotherapeutics, which are an oncolytic virus drug and T cell agonistic antibody.

As of the end of the reporting period, Lepu Biopharma has achieved significant milestones in the monetisation of our R&D capabilities through commercialization and BD activities: PUYOUHENG (Pucotenlimab Injection) has completed the full commercialization process and is currently under a rapid sales growth, and four other products, CMG901, MRG007 and two pre-clinical TCE assets have also been licensed out through our BD activities. Notably, CMG901’s global rights have been licensed to AstraZeneca, and MRG007’s rights for regions outside Greater China have been licensed to ArriVent. Two pre-clinical TCE assets have entered into a collaboration with Excalipoint.

Revenue scale achieved a 3.5-fold leapfrog growth, with comprehensive improvement in financial indicators
In the first half of 2025, the Company made significant progress in advancing its product pipeline and business operations, recording a total revenue of approximately RMB466 million, which was an increase of 350% of the same period in 2024 at RMB133 million. For licensing activities, the Company has recognized approximately RMB309 million in revenue primarily from the out-licensing of MRG007. The Company recorded a revenue of approximately RMB151 million for the sales of PUYOUHENG (Pucotenlimab Injection), marking a significant increase of 58.8% from the sales recorded in the same period in 2024. In addition, the Group recognized approximately RMB6.3 million in revenue for the provision of CDMO services.

During the reporting period, the Company achieved profitability for the first time, with a profit of approximately RMB 29.3 million, marking a turnaround from a loss in the same period of 2024. Net cash generated from operating activities was approximately RMB 46.7 million, and cash and cash equivalents increased to approximately RMB 473 million, representing a positive net operating cash flow compared to the same period in 2024. Research and development expenses amounted to approximately RMB 202 million, representing a decrease of 6.6% compared to the same period in 2024. While ensuring the advancement of core pipelines, cost control measures have shown tangible results.

The Company actively develops cooperative relationships with various business channel partners. As of June 30, 2025, the Company completed the tendering process on the procurement platform in 28 provinces of the PRC. We have covered approximately 118 cities in the PRC through various sales channels, and we will further expand our sales network.

ADC pipeline enters the critical phase with multiple products, potential for combination therapy highlighted, and fruitful international licensing results
In the first half of 2025, the Company remained focused on the research and development of its drug candidates, while continuously assessing market demand and competitive landscape relating to the range of oncology therapeutics and the broad spectrum of indications covered by its drug candidates, in order to maximize the competitiveness of its products pipeline. In particular, MRG003 for NPC nears approval and other key drug candidates advance to pivotal clinical stage.

MRG003ï¼ˆEGFR-ADC
NPC: MRG003 is under NDA review for the treatment of R/M NPC and has also been granted priority review by the CDE of NMPA. The authority is currently proceeding with the clinical and pharmaceutical evaluation of MRG003. The encouraging data of the pivotal Phase IIb clinical study for the treatment of R/M NPC was read out as “late breaking abstract (LBA)” for oral presentation at the ASCO Congress 2025. The Company is also currently conducting the Phase III clinical trial of combination therapy with MRG003 and pucotenlimab on R/M NPC. The encouraging data in phase II clinical trial of combination therapy on R/M NPC will be presented at the ESMO Congress 2025.

HNSCC: As of June 30, 2025, the Company is conducting a randomized, open-label, multicenter Phase III clinical study on HNSCC. In terms of combination therapy with MRG003 and pucotenlimab, we are currently conducting the Phase II clinical trial on HNSCC, and the encouraging data in phase II clinical trial will be presented at the ESMO Congress 2025. The European Medicines Agency (EMA) granted Clinical Trial Authorization (CTA) approvals for the Phase II clinical trial targeting LA-SCCHN in June 2025, and the Company will initiate the clinical trial in the second half of 2025.

MRG004A (TF-ADC): The Company has completed the Phase I clinical study on solid tumors in China and the encouraging Phase Ib expansion data on PC will be presented at the ESMO Congress 2025. Protocol communication with CDE for the pivotal clinical trial of MRG004A has been completed, and we have entered the Phase III clinical trial stage in August 2025. In addition, MRG004A was granted BTD by the CDE in August 2025, which offers a brand-new treatment option to patients with pancreatic cancer.

MRG006A (GPC3-ADC): MRG006A is a GPC3-targeted ADC with FIC potential globally. We received IND clearance from the FDA in January 2025. We are currently advancing Phase I clinical trial in China. In pre-clinical studies, MRG006A resulted in a robust and dose-dependent tumor growth inhibition on multiple CDX models and HCC PDX models. In the meantime, MRG006A also demonstrated good tolerability in the exploratory toxicology study.

MRG007 (CDH17-ADC): We received the IND approval from the NMPA in June 2025 and are currently conducting a Phase Ia clinical trial for the treatment of unresectable locally advanced or metastatic solid tumors. MRG007 has shown robust antitumor activity in preclinical models of GI cancers and a favorable therapeutic index based on IND enabling studies. The pre-clinical data of MRG007 was presented at the AACR Annual Meeting in April 2025. In January 2025, the Company entered into an exclusive licensing agreement with ArriVent, pursuant to which the Company has granted ArriVent exclusive rights to develop, manufacture and commercialize MRG007 outside of Greater China. Under the terms of the agreement, the Company is eligible to receive up to US$1.2 billion in total in upfront payment and development, regulatory and sales milestones, together with tiered royalties on net sales. As of June 30, 2025, the upfront payment has been received.

CG0070 (Oncolytic virus): CG0070 was granted BTD by the CDE in January 2025. CG0070 is currently in a MRCT Phase III clinical study conducted by the Company’s U.S. partner, CG Oncology. The latest encouraging data observed has been orally presented in the 120th American Urological Association Annual Meeting in April 2025. The Company has completed the Phase I clinical trial in China and are currently engaged in protocol communication with the CDE regarding the domestic bridging pivotal linical trial.

Combination therapy layout: As of June 30, 2025, the Company has completed the Phase II trial of combination therapy with MRG002 and pucotenlimab in the treatment of HER2-expressing solid tumors, which has moved to first-line treatment, and protocol communication for phase III clinical trial has been completed. The Company has observed encouraging data on UC. In terms of combination therapy with MRG003 and pucotenlimab, the Company is currently conducting the Phase II clinical trial on HNSCC, which has moved to first-line treatment, and the encouraging data in phase II clinical trial will be presented at the ESMO Congress 2025. The European Medicines Agency (EMA) granted Clinical Trial Authorization (CTA) approvals for the Phase II clinical trial targeting LA-SCCHN in June 2025, and we will initiate the clinical trial in the second half of 2025, which has been moved up to first-line treatment for advanced disease.

Preclinical: Laying the groundwork for innovative platforms and innovative targets
The Company continuously strives to build up and develop novel technology platforms as innovative engines for the Company. The Company has developed multiple innovative linker-payload platforms for ADC drug candidates, including the Hi-TOPi ADC platform and other early-stage platforms. During the reporting period, our innovative ADC platforms have achieved significant progress. Based on these innovation platforms, the Company has generated two ADC candidates, which are MRG006A with global first-in-class potential and MRG007 with global best-in-class potential, all of which have shown encouraging pre-clinical data and received IND approvals in China. Pre-clinical data of MRG007 was presented at the AACR Annual Meeting in April 2025.

On August 1, 2025, the Company entered into a licensing transaction for the license-out and/or transfer of certain intellectual property rights relating to two preclinical assets developed by the Company’s proprietary T cell engager-TOPAbody platform with Excalipoint through entering into the Intellectual Property Assignment and License Agreement.

The Company shall receive (i) an upfront payment in cash of US$10 million in aggregate, development and commercial milestone payments in cash of up to US$847.5 million in aggregate and sales royalties, holding a 10% interest, marking international recognition of the platform’s value.

Future Outlook: Accelerating the Commercialization of Core Products and Advancing Global Strategic Development
In respect of drug R&D, the Company will further focus on advancing strategic research and development priorities in next generation ADC drugs and IO bi/tri specific antibodies, while accelerating the commercialization of late-stage products. For our registrational stage product MRG003, the relevant authority is currently proceeding with the clinical and pharmaceutical evaluation in an orderly manner. The Company will concentrate our resources and endeavour to expedite the approval process. Meanwhile, our other key drug candidates are entering pivotal clinical stages. Protocol communication for the pivotal clinical trial of MRG004A has been completed, and we have entered the Phase III clinical trial stage in August 2025. In addition, we are currently conducting protocol communication with the CDE regarding the domestic pivotal clinical trial of CG0070. The Company will also explore further potential clinical value of our other innovative drug candidates, such as MRG006A and MRG007. Concurrently, the potential efficacy of combination therapies within our pipeline is being continuously explored, with greater clinical benefits striving to be delivered to a broader patient population.

In terms of domestic commercialization, the Company will take further actions to enhance the market accessibility of PUYOUHENG (Pucotenlimab Injection), accelerating market penetration at all levels to further increase market share and enhance the Company’s brand image and market recognition. At the same time, the Company will commence the preparation process for the commercial launch of MRG003 and continue to expand our marketing and commercialization teams.

On the international front, the Company will ramp up our efforts to expand into the global market. We will expand our international network and explore new business development cooperation opportunities. The Company will remain committed to seeking more strategic partners worldwide to develop our ADC products and other innovative candidates through partnerships, licensing agreements, or joint ventures.

Innovative Vaccine Engine Continues to Drive Growth: CanSinoBIO Enters a New Growth Cycle

In the first half of 2025, the structural transformation of the pharmaceutical industry continued to deepen. Driven by favorable policies, product upgrades, and technological innovation, the vaccine industry maintained a stable and positive growth momentum. As a leading enterprise in China’s innovative vaccine sector, CanSino Biologics Inc.(Stock Code: 688185.SH, 6185.HK, “CanSinoBIO” or “the Company”) once again delivered a solid performance.

According to its 2025 interim report, CanSinoBIO achieved revenue of RMB 382 million in the first half, up 26% from a year earlier, extending its growth streak. Although the company has yet to turn profitable, losses have narrowed significantly, with the reduction exceeding 94% compared to the same period last year. This reflects improved operational quality and lays a solid foundation for steady full-year growth. With core products selling strongly and multiple pipeline programs advancing, CanSinoBIO’s long-term growth story is steadily taking shape.

Meningococcal Vaccine Portfolio Continues to Scale Up, Unlocking Growth Drivers
CanSinoBIO’s two currently marketed meningococcal conjugate vaccines—the quadrivalent meningococcal conjugate vaccine (MCV4, Menhycia) and the bivalent meningococcal conjugate vaccine (MCV2, Menphecia)—remain the company’s key revenue drivers. In particular, the sustained scaling-up of MCV4 demonstrates strong market competitiveness and is central to CanSinoBIO’s growth narrative.

In 2024, Menhycia and Menphecia together generated nearly RMB 800 million in sales revenue, representing year-on-year growth of over 40%. In the first half of 2025, driven by deeper channel penetration and higher terminal market coverage, the sales of both vaccines continued to grow steadily. During the same period, the company’s meningococcal vaccine portfolio generated sales of over RMB 364 million, representing more than 38% year-on-year growth and providing a solid foundation for earnings.

As the only MCV4 in China, Menhycia effectively covers four meningococcal serogroups—ACYW135—and leverages the high-safety CRM197 carrier protein technology. With outstanding clinical immunogenicity and safety, it has become the preferred choice for many parents seeking meningococcal vaccination for their children.

Furthermore, Menhycia’s market potential is still being unlocked. The vaccine has been submitted to the National Medical Products Administration (NMPA) for an expanded age indication—from the current “children aged 3 months to 3 years (47 months)” to “children aged 3 months to 6 years (83 months).” If approved, this will directly broaden its coverage, strengthen penetration in the non-national immunization program market, and inject greater certainty into CanSinoBIO’s growth over the next two to three years, further consolidating the company’s leadership in the meningococcal vaccine field.

iPneucia Officially Launched, Setting a New Benchmark for Differentiated Pneumococcal Vaccine
In June, CanSinoBIO’s self-developed product—the 13-valent pneumococcal conjugate vaccine (PCV13, iPneucia)—was officially approved for market launch, marking the company’s entry into the RMB 10 billion-plus pneumococcal vaccine market and the beginning of a new growth cycle.

Pneumococcal diseases remain a serious global public health concern, with particularly high morbidity and mortality rates among children under five years old. Addressing the remaining immunization gaps in China, the launch of iPneucia fills the domestic technological void in high-end 13-valent pneumococcal conjugate vaccines, demonstrating CanSinoBIO’s leadership in differentiated innovation.

Compared with existing competing products in the market, iPneucia achieves breakthroughs in three major dimensions. First, it offers more targeted protection, focusing on four high-risk serotypes—19F, 19A, 7F, and 3—that together account for over 60% of pneumococcal disease cases among Chinese children. Clinical trial data show that its Geometric Mean Concentration (GMC) of antibodies is significantly higher than that of competing products. Second, in carrier protein technology, it adopts the globally pioneering CRM197+TT dual-carrier technology, overcoming the immune interference limitations of single-carrier vaccines. This both reduces the risk of immune suppression when co-administered with other vaccines and significantly enhances immunogenicity. Finally, in manufacturing safety, iPneucia uses an animal component–free fermentation process, reducing risks associated with animal-derived biological factors. It also employs no formaldehyde detoxification and adds no phenol during production, significantly improving vaccine safety.

With these three advantages, iPneucia could potentially become another “ace” for CanSinoBIO in the infant bacterial vaccine market, following Menhycia. Notably, iPneucia shares a highly overlapping target population with Menhycia, creating strong channel synergies that will accelerate commercialization and enable the company to quickly capture market share in the RMB 10 billion-plus pneumococcal vaccine segment.

Combination Vaccine Strategy Progresses Steadily
Beyond this, CanSinoBIO’s long-term potential lies in its continued build-out of a “Combination Vaccine” portfolio. Compared with traditional monovalent vaccines, multi-conjugate vaccine and polyvalent vaccine can prevent multiple diseases with a single injection, significantly improving vaccination efficiency and willingness—representing a key global direction in vaccine technology development.

Following the quadrivalent vaccine Menhycia and multi-valent vaccine iPneucia, CanSinoBIO’s DTcP-Hib-MCV4 pentavalent vaccine—a representative combination vaccine—has attracted strong market attention. In February this year, it received clinical trial approval, marking a “zero-to-one” breakthrough for the company in the high-end combination vaccine sector.

The DTcP-Hib-MCV4 pentavalent vaccine can simultaneously prevent pertussis, diphtheria, tetanus, Haemophilus influenzae type b (Hib) disease, and infection by the four meningococcal serogroups (ACYW135), achieving “protection against five diseases with a single shot”. This significantly reduces the number of injections and improves compliance among infants. More importantly, its core component Menhycia has already undergone commercial validation in China and enjoys a strong reputation, providing robust support for the combination vaccine’s development. This “point-to-surface” product upgrade logic enables CanSinoBIO to advance in the combination vaccine market with greater efficiency and confidence. With the government placing high importance on combination vaccine R&D and offering policy support, CanSinoBIO is well-positioned to capture this high-value market.

R&D-Driven Growth with a Clear Product Pipeline and Strong Reserves
While consolidating its existing market advantages, CanSinoBIO continues to strengthen its mid-to-long-term growth momentum through robust R&D capabilities and differentiated pipeline planning.

Its DTcP for infants and young children has entered priority review and is expected to fill a domestic market gap. The Tdcp for people aged 6 years old and above has completed Phase III subject enrollment, enabling full life-cycle immunization coverage. The tetanus vaccine’s registration application has been accepted, and it is expected to offer superior safety and immunogenicity data compared with existing products. The Recombinant Poliomyelitis Vaccine, funded by Gates Foundation, has initiated clinical trials in Indonesia and has also received domestic clinical trial approval. Globally innovative Protein Based Pneumococcal Vaccine (PBPV) and inhaled tuberculosis vaccines have entered clinical research and proof-of-concept validation.

The company has now built a rich pipeline covering multiple technology platforms and full life-cycle segments, including meningococcal vaccines, pneumococcal vaccines, diphtheria tetanus pertussis vaccine, polio vaccines, tuberculosis vaccines, and zoster vaccine. Several major products are entering critical stages of registration review or clinical trials. Meanwhile, CanSinoBIO’s continuous breakthroughs in key technology platforms support a strategic shift from reliance on single products to sustained pipeline output.

Overall, in the first half of 2025, CanSinoBIO maintained the strong growth momentum seen since 2024, proving that its closed-loop capabilities from product R&D to commercialization have become increasingly mature. Against the backdrop of ongoing national policy support for innovative vaccines and domestic high-end vaccine substitution, CanSinoBIO—leveraging its solid R&D foundation, differentiated pipeline layout, and efficient commercialization execution—is accelerating the realization of its long-term growth potential and moving steadily toward becoming a global leader in innovative vaccines.

Australian Breakthrough by Cholrem: Cyclodextrin Therapy Reverses Heart Disease, Hailed as Greatest Advance Since Statins

Australian Company Announces Landmark Paper Showing Cyclodextrin Therapy Reverses Heart Disease, Hailed as ‘Greatest Development Since Statins’

Cholrem Pty Ltd, an Australian pharmaceutical research company, has published a landmark study in Cardiology Research and Cardiovascular Medicine, revealing that its proprietary cyclodextrin-based therapy Cavadex reverses atherosclerotic cardiovascular disease (ASCVD), the world’s leading cause of death.

Angiogram: Plaque Reduced Within 6 Weeks

The peer-reviewed case series demonstrates rapid symptom relief and significant regression of arterial plaque, marking a potential paradigm shift in heart disease treatment. The study followed 20 high-risk patients with advanced angina, with 18 (90%) reporting substantial symptom improvement (P0.0001) compared to expected outcomes. Objective imaging confirmed unprecedented results, including Coronary Artery Calcium (CAC) score reductions (e.g., from 591 to 521) and a 70% coronary artery blockage reduced to 27%. Cavadex, formulated with 2-hydroxypropyl-β-cyclodextrin (HPβCD), stimulates the body’s natural vascular repair, offering a faster, more effective approach than existing therapies.

The late Professor Laurie G. Howes, a renowned Australian cardiologist and study co-author, called Cavadex “the greatest pharmacological development in cardiology since statins.” U.S. cardiologist Dr. James C. Roberts, who has treated hundreds with the therapy, noted, “We’re seeing rapid, profound improvements in high-risk patients, with objective plaque regression and an excellent safety profile, leveraging a TGA- and FDA-approved molecule.”

Cholrem, founded by Kyle Hodgetts – a heart disease patient who pioneered Cavadex after conventional treatments failed – has supplied over 20,000 units globally. Despite HPβCD’s non-patentable status limiting industry investment, Cholrem is driving this breakthrough forward. The company urges global medical communities to launch large-scale trials to validate these findings for millions suffering from heart disease.

About Cholrem Pty Ltd: Cholrem is dedicated to advancing cyclodextrin-based therapies to combat ASCVD, the world’s top killer, with a mission to deliver innovative, life-saving treatments. Cardiology Research and Cardiovascular Medicine Published Paper: https://www.gavinpublishers.com/article/view/cyclodextrin-therapy-for-atherosclerotic-cardiovascular-disease-a-case-series-on-plaque-regression-and-symptomatic-improvement

Contact Information
Kyle Hodgetts
Cholrem Pty Ltd Founder & CEO
info@cholrem.com
+61 424830574

SOURCE: Cholrem Pty Ltd

Everest Medicines’ New Drug Application for Etrasimod Accepted in Taiwan, Marking Another Milestone in Asia Market Access

Everest Medicines (HKG: 1952.HK, Everest) today announced that the Taiwan Food and Drug Administration (TFDA) has officially accepted the New Drug Application (NDA) for VELSIPITY(R) (etrasimod) for the treatment of patients with moderately to severely active ulcerative colitis (UC).

Building on prior approvals in Singapore, Hong Kong SAR, and Macao SAR, as well as NDA acceptance in South Korea, this marks significant progress in the commercialization of VELSIPITY(R) across Asia. In December 2024, China’s National Medical Products Administration (NMPA) officially accepted the NDA for VELSIPITY(R).

As a next-generation selective S1P receptor modulator, once-daily oral etrasimod demonstrates robust efficacy across multiple endpoints, including clinical remission, mucosal healing, endoscopic normalization and histological remission. Its clinical value has been robustly demonstrated in multiple global Phase III studies, including ELEVATE UC 52, ELEVATE UC 12 and ENLIGHT (ES101002) studies.

“The NDA acceptance for VELSIPITY(R) in Taiwan, China marks another key progress in our commercialization pathway across Asia. As the number of UC patients in Asia continues to rise, there remains a significant unmet medical need. In China alone, there were approximately 800,000 patients with UC in 2024, and the number is estimated to reach 1 million by 2030. UC patients face the dual challenges of long-term treatment and maintaining quality of life.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “This NDA acceptance underscores the clinical value of VELSIPITY(R). We remain committed to accelerating access to this innovative therapy in Mainland China and other Asian markets, supporting long-term disease management while enhancing patients’ quality of life.”

The clinical part submitted to TFDA is mainly based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) and the ENLIGHT study (ES101002). The ELEVATE UC Phase 3 registrational program evaluated the safety and efficacy of etrasimod 2 mg once-daily on clinical remission in UC patients with moderately to severely active UC who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod.

The ENLIGHT study (ES101002) conducted by Everest, is a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod in Asian countries, including China Mainland, China Taiwan and South Korea. This is the largest Phase 3 trial of moderately to severely active ulcerative colitis in Asia completed to date, with 340 eligible subjects randomized to treatment with etrasimod or placebo. The results demonstrate that treatment with etrasimod 2 mg resulted in a clinically meaningful and statistically significant improvement in the primary and all secondary endpoints. These findings provide strong evidence supporting the use of etrasimod in adult Asian patients with moderately to severely active ulcerative colitis.

As Everest’s third commercialized product, VELSIPITY(R) has been officially approved by the Guangdong Provincial Medical Products Administration for adult patients with moderately to severely active UC. It is now available at medical institutions designated under the Connect Policy in the Greater Bay Area. Additionally, Everest has launched a factory construction project at its Jiashan site to support local production of VELSIPITY(R).