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More information on how to order and additional ZeptoMetrix products can be found at: www.zeptometrix.com
About ZeptoMetrix® ZeptoMetrix, an Antylia Scientific company, is an established industry leader in the design, development, and delivery of innovative, quality solutions to the infectious disease diagnostics market. Our expertise and abilities in molecular diagnostics, including external quality controls, verification panels, proficiency panels, customized and OEM products/services, have set the industry standard for performance and reliability and make ZeptoMetrix the preferred choice for independent third-party quality control materials.
Pneumonia is a form of acute respiratory infection, that is common in all age groups and can cause mild to life-threatening illness. It is also the single largest infectious cause of death in children worldwide.
According to the World Health Organization(WHO), pneumonia killed more than 808,000 children under the age of 5 in 2017, accounting for 15% of all deaths of children under 5 years. Notably, in China, non-invasive pneumococcal diseases(NIPD), result in approximately 550,000 cases annually, leading to around 6,000 deaths. Meanwhile, invasive pneumococcal diseases (IPD) are more severe, with over 7,200 cases of pneumococcal meningitis reported each year. The average treatment cost per case of IPD is approximately CNY 64,000, and the case-fatality rate exceeds 10%. Behind these stark numbers lie the heavy burdens on countless families and an urgent public health challenge.
Facing this challenge, CanSino Biologics Inc.(Stock Code: 688185.SH, 6185.HK, “CanSinoBIO” or “the Company”) has developed and launched its 13-valent pneumococcal conjugate vaccine, trade name “iPneucia®”, optimized for China’s local pneumococcal epidemiology, aiming to provide more precise and safer protection for Chinese children.
The main advantage of iPneucia® is its deep optimization based on China’s local epidemiological characteristics. Streptococcus pneumoniae is categorized into different serotypes based on polysaccharide structure and biochemical traits. However, not all serotypes pose the same threat; their pathogenicity and disease burden vary. Research indicates that serotypes 19F, 19A, 7F, and 3 are the four most burdensome for Chinese children, accounting for over 60% of cases. These serotypes are also characterized by high resistance and high risk of sequelae. Given these risks, iPneucia® is specifically designed to target these four high-risk serotypes, and clinical data show that the geometric mean concentration (GMC) of antibodies against these four serotypes in iPneucia® is significantly higher than in the control group. This targeted protection strategy greatly enhances the precision of prevention, reducing disease risks at the source.
The breakthrough of iPneucia® lies not only in its enhanced targeting serotypes protection effect, but also in its carrier technology. It pioneers a dual-carrier conjugate process that adopts CRM197 and tetanus toxoid(TT) as carrier proteins. This approach effectively avoids immune interference caused by excessive use of a single carrier and reduces the risk of immune suppression when co-administered with other vaccines, enhancing immunogenicity. Moreover, iPneucia® also adopts a more advanced carrier protein conjugation process, ensuring consistent polysaccharide antigen content across all serotypes, significantly reducing competition between components.
Notably, the process of using CRM197 carrier as carrier protein in iPneucia® does not require formaldehyde for detoxification, which improves vaccine safety. This is also supported by data from Menhycia, another CRM197-based vaccine developed by CanSinoBIO. Post-marketing surveillance data on adverse events following immunization (AEFI) for recipients of the Menhycia show a apparently decline in the incidence of AEFI, fever, and local induration..
In summary, iPneucia® offers precise protection by targeting key serotypes and innovative protein carrier technology, resulting in enhanced effectiveness while minimizing the risk of adverse reaction. It also utilize a mature production process that excludes phenol, further improving its safety profile. CanSinoBIO presents a superior option for preventing pneumococcal diseases in Chinese children.
As a leader in innovative vaccines, CanSinoBIO always dedicated to scientific research and exploration in vaccine development. The company strives to create innovative, high-quality, and affordable vaccines. CanSinoBIO is committed to tackling global health challenges and improving the health and well-being of children around the world.
– Kidney Disease Treatment into a New Era of Precision Management
At the 62nd Congress of the European Renal Association (ERA 2025), Everest Medicines presented new results findings on both NEFECON® (budesonide delayed release capsules), the world’s first and only approved therapy that directly targets the underlying cause of IgA nephropathy (IgAN), and EVER001, a next-generation covalent reversible BTK inhibitor. The latest results provide robust evidence for NEFECON®’s efficacy across the full disease spectrum and reinforce its foundational role in the emerging IgAN treatment strategy: “Treat the Cause, Treat Early, Treat All”. The nine studies covered biomarker-based prediction, treatment outcomes across various diagnostic timelines and baseline kidney function levels, long-term treatment durability, and mechanistic insights.
Two studies further validated the critical role of NEFECON® in targeting the underlying mechanisms of IgA nephropathy (IgAN), reinforcing its position as the first-line etiological treatment for the disease. One study, based on the “Four-Hit” hypothesis, demonstrated that NEFECON® significantly impacts the first three pathogenic steps, ultimately reducing the risk of kidney function deterioration by 50%. Another study found that reductions in pathogenic Gd-IgA1 and polymeric IgA levels during the first two months of treatment closely correlated with improvements in proteinuria, suggesting their potential as predictive biomarkers to guide treatment.
Two additional studies confirmed the clinical benefits of “Treat Early” with NEFECON®. A subanalysis of the NefIgArd study showed that patients who began treatment within six months of diagnosis experienced greater kidney protection and more significant reductions in proteinuria compared to those diagnosed earlier. This highlights the importance of early intervention to slow disease progression and achieve better long-term outcomes. Another prospective study supported this finding, showing that earlier treatment may more effectively reduce pathogenic immune factors and control inflammation, potentially preventing disease relapse or irreversible progression.
Finally, two studies provided strong clinical evidence supporting NEFECON®’s “Treat All” strategy by confirming its broad applicability across different patient types. A subanalysis of the NefIgArd study found that NEFECON® effectively reduced proteinuria and preserved kidney function across all baseline eGFR levels. A separate multicenter study showed that patients with active pathological changes, such as endocapillary hypercellularity or crescent formation, experienced even more pronounced improvements in proteinuria and delayed disease progression.
NEFECON® is the first and only fully approved etiological treatment for IgAN in China, the U.S., and Europe. It has been included in the KDIGO 2024 Clinical Practice Guideline For The Management Of Immunoglobulin A Nephropathy (IgAN) And Immunoglobulin A Vasculitis (IgAV) (public review draft). With updated data presented at ERA 2025, NEFECON® further solidified its position as a first-line cornerstone therapy, demonstrating a clear mechanism of action, sustained long-term benefits, and suitability for a wide range of patients. As NEFECON® continues to gain approvals across global markets, expand reimbursement coverage in China, and advance in tandem with diagnostic tools such as the Gd-IgA1 diagnostic kit under development, Everest Medicines is building a comprehensive “diagnosis-treatment-monitoring” ecosystem. This integrated approach is designed to shift IgAN management from symptomatic support toward precise, long-term disease control.
In parallel, Everest Medicines’ proprietary next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor, EVER001, was featured in a focused oral presentation at the 62nd Congress of the European Renal Association (ERA 2025). EVER001 has best-in-class potential for the treatment of primary membranous nephropathy (pMN) and other autoimmune kidney diseases such as IgAN, MCD, FSGS, and LN, targeting a global patient population of over 10 million. As no drug is currently approved for pMN, EVER001 offers a promising new option. Preliminary results from the ongoing Phase 1b/2a trial show that EVER001 is well tolerated and demonstrates strong clinical and immunological responses, including reductions in proteinuria and anti-PLA2R autoantibodies. The study also includes long-term follow-up data, supporting its potential in chronic disease management. Everest Medicines is continuing to expand clinical research to gather more data across patient groups and longer treatment durations.
This advancement complements NEFECON® and exemplifies Everest Medicines’ “dual-engine” strategy, which combines in-licensed and internally developed innovations to broaden its kidney disease pipeline. Together, NEFECON® and EVER001 empower Everest Medicines to build a precise and durable kidney disease management ecosystem, accelerating global expansion and providing patients with accessible, effective treatment options.
At the 62nd European Renal Association Congress (ERA 2025), Everest Medicines unveiled new clinical data on EVER001 (previously known as XNW1011), a next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor, in patients with primary membranous nephropathy (pMN). This marks the first time EVER001’s clinical data have been unveiled at an international academic congress. This initial unveiling of the preliminary data at an international congress focuses on pMN. The results showed encouraging signals in terms of novel mechanism, preliminary efficacy, and safety. These findings provide a solid foundation for future therapeutic strategies in proteinuric autoimmune glomerular diseases including pMN and demonstrate Everest’s advancing innovation capabilities and global development momentum.
EVER001 is a covalent reversible BTK inhibitor with potentially best-in-class characteristics for the treatment of primary membranous nephropathy (pMN) and other autoimmune renal diseases, including IgA nephropathy (IgAN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and lupus nephritis (LN). These conditions affect over 10 million patients worldwide. There are approximately 2 million pMN patients in China alone and nearly 220,000 across the United States, Europe, and Japan. There are currently no approved therapies globally, and existing treatments rely heavily on non-specific immunosuppressants, which have limited efficacy and safety concerns, highlighting the urgent need for novel mechanism-based therapies.
Everest Medicines holds global rights to EVER001 for the treatment of renal diseases. As a covalent reversible BTK inhibitor, EVER001 combines high target-binding affinity with enhanced selectivity, helping to reduce off-target toxicity seen in earlier-generation BTK inhibitors. Its favorable safety and efficacy profile supports its potential to become a new standard of care across proteinuric glomerular diseases.
At ERA 2025, preliminary data from the ongoing Phase 1b/2a trial showed that EVER001 was well tolerated and demonstrated promising efficacy in patients with primary membranous nephropathy (pMN). The study enrolled 31 biopsy-confirmed pMN patients who were positive for anti-PLA2R autoantibodies and received either low or high doses of EVER001 over a 36-week treatment period, with extended follow-up for some
participants. By week 12, anti-PLA2R autoantibody levels dropped by 62.1% in the low-dose group and 87.3% in the high-dose group. Both cohorts saw reductions of approximately 93% by week 24, with 76.9% and 81.8% of patients, respectively, achieving immunologic complete remission. For 24-hour proteinuria, the low-dose group achieved a 78.0% reduction at week 36, sustained through week 52, with 69.2% reaching clinical remission. In the high-dose group, proteinuria declined by 70.1% at week 24, with 80.0% of patients achieving clinical remission.
EVER001 was generally well tolerated. No clinically significant adverse events commonly associated with covalent irreversible BTK inhibitors—such as bleeding, arrhythmia, severe infections, or liver dysfunction—were observed. Most treatment-related adverse events were mild to moderate (Grade 1–2), further supporting its long-term therapeutic potential.
EVER001 is expected to generate strong portfolio synergies with Everest’s commercial-stage product, NEFECON®, the first and only fully approved etiological treatment for IgAN in China, the U.S., and Europe. NEFECON® was added to China’s National Reimbursement Drug List (NRDL) in November 2024, and has been included in the KDIGO 2024 Clinical Practice Guideline For The Management Of Immunoglobulin A Nephropathy (IgAN) And Immunoglobulin A Vasculitis (IgAV) (public review draft), making it the only targeted therapy endorsed by both international and Chinese guidelines, establishing its position as a first-line therapy. To further enhance its IgAN strategy, Everest is also developing a diagnostic test for Gd-IgA1, enabling earlier detection, more accurate disease stratification, and treatment monitoring.
By integrating diagnostics and therapeutics into a unified care model, Everest is leading the transition from supportive care to precision, disease-modifying treatment for immune-mediated kidney diseases such as IgAN. This holistic strategy aims to improve disease detection and management standards and establish a comprehensive, long-term renal care platform.
With EVER001 and NEFECON® advancing in parallel, Everest is driving innovation in nephrology with the goal of setting new global treatment standards. The presentation of EVER001 at ERA 2025 marks a pivotal milestone in its clinical development and demonstrates the international visibility of China-originated innovations. Everest continues to pave the way for globally competitive novel therapies to reach patients around the world.
Key Highlights – Clinical trial to evaluate the safety and efficacy of YK012 in primary membranous nephropathy – Globally, this is the first bispecific CD19-directed CD3 T cell engager immunotherapy for this autoimmune disease – Milder T cell activation than Blincyto and Target cell-dependent T cell activation – Multiple CR cases observed in ongoing r/r NHL Phase Ia trial and r/r ALL Phase Ib/II trial
Excyte, a global clinical-stage biotechnology company, announced first patient has been dosed for YK012, the world’s first patient T cell engager that entered into clinical trial for primary membranous nephropathy (pMN). The patient remained well after administration with no adverse reactions witnessed to date.
pMN is an autoimmune disease caused by the attack of autoantibodies against podocyte antigens leading to the in situ production of immune complexes. pMN is the most common cause of primary nephrotic syndrome in non-diabetic adults worldwide, accounting for 20% to 37% of affected individuals, and as high as 40% in adults over 60 years of age (1). Currently, 20-30% of pMN cases are resistant to current therapies like rituximab and cyclophosphamide and relapse rates can be high (2).
A clear regulatory pathway in this orphan disease in US could make YK012 one of the first approved TCE in the autoimmune space with many other autoimmune and oncology indications to follow. Excyte would file for US investigational new drug (IND) application imminently.
The study aims to evaluate the safety, tolerability, and preliminary efficacy of YK012 in PMN patients. Led by Professor Minghui Zhao and Prof Zhao Cui from Peking University First Hospital, the trial is planned to be conducted across multiple centers in China. The clinical trial for this indication in the United States will be collaboratively executed by Excyte and its international partners.
“YK012 is a T-cell engaging bispecific antibody targeting both CD19 and CD3, activating T-cell immunity via CD3 while targeting CD19—the most widely expressed tissue-specific marker during B-cell development and thereby enabling B-cell reset. Our data illustrated YK012 mediated significant B cell depletion and have illustrated in current clinical studies extended half-life and limited cytokine release in patients,” said Mr. Andrew Meng, chairman and COO at Excyte. “We look forward to collaborating with regulatory authorities to make YK012 available to this patient population with a high unmet medical need.”
In December 2024, YK012 obtained Clinical Trial Approval Notice (No. CXSL2400727) from China’s National Medical Products Administration (NMPA) and was registered on ClinicalTrials.gov (NCT06982729). With the first patient dosed in pMN, Excyte now has a global presence in autoimmune diseases in additional to oncology indications such as NHL and ALL. Earlier this year, Excyte also secured clinical trial approval for systemic lupus erythematosus (SLE), with Professor Xiaofeng Zeng from Peking Union Medical College Hospital serving as Principal Investigator.
About Excyte Biopharma Ltd. Excyte Ltd. was co-founded by Dr Qing’an Yuan and Mr Andrew Meng , biotech industry veterans with decades of antibody engineering experiences. The company has also established a U.S.-based wholly-owned subsidiary, Excyte LLC, forming a dual-engine drug R&D hub spanning China and the U.S. Excyte is dedicated to developing innovative bispecific antibody drugs for hematologic cancers, multiple myeloma, solid tumors, autoimmune diseases, and other conditions. Excyte’s FIST platform and next generation assets possess features such as long-acting, low-toxicity, and high-yield technological innovations. For more information, please visit https://www.iExcyte.com/
– Over 1,000 investment and business matching meetings lined up underscoring Hong Kong’s role as a healthcare investment hub
– ASGH brought together more than 2,900 participants from 42 countries and regions – Medical Fair attracted some 13,000 buyers from 57 countries and regions – The two flagship events together resulted in over 390 deal-making sessions and more than 660 business matching meetings – Collaboration agreements were signed during the events, covering areas including patient care, diagnostic solutions, innovative medical devices, and medical imaging
The fifth Asia Summit on Global Health (ASGH) and the 16th Hong Kong International Medical and Healthcare Fair (Medical Fair), both organised by the Hong Kong Trade Development Council (HKTDC), have drawn to a successful close. As flagship events of International Healthcare Week (IHW), both ASGH and the Medical Fair brought global healthcare stakeholders together, including government officials and organisations, research pioneers, investors, and business leaders. ASGH attracted over 2,900 participants from 42 countries and regions, while the Medical Fair received some 13,000 buyers from 57 countries and regions. Over 390 one-on-one deal-making sessions and more than 660 business matching meetings were arranged, facilitating over 1,000 high-quality collaborations and connections. The IHW continues to foster global exchange and cooperation, putting a spotlight on Hong Kong’s vast potential in healthcare investment and trade, and reinforcing its position as a regional leading medical hub.
Dr Peter K N Lam, Chairman of the HKTDC, said: “The Asia Summit on Global Health and the Hong Kong International Medical and Healthcare Fair concluded with outstanding results driving new collaborations and investments, and injecting new momentum into the healthcare industry. The events brought together leaders across government, business, academia, and investment to tackle today’s healthcare challenges, highlighting Hong Kong’s unique advantages as an international innovation and technology hub under its ‘eight centres’ positioning, actively advancing medical technology, connecting global innovation resources, and paving the way for a healthier and more inclusive future.”
Over 80 industry experts shared insights on healthcare development The two-day ASGH, jointly organised by the HKSAR Government and the HKTDC under the theme ‘Fostering Global Collaboration for a Shared Future’, focused on a wide spectrum of topics including public health, medical technology breakthroughs, healthy ageing and global business and investment collaboration. The event featured more than 80 speakers comprising government officials and organisations, research pioneers, investors, and business leaders from around the world, all contributing valuable insights to advance global well-being.
Prof Lo Chung-mau, Secretary for Health of the HKSAR Government, delivered a keynote speech during the Plenary Session I: Shaping a More Equitable and Sustainable Health System. Other distinguished speakers, including Dr Wu Xiaobin, Vice President of China Pharmaceutical Innovation and Research Development Association; Martin Taylor, Representative to China, World Health Organization; Prof Nancy Ip, President of the Hong Kong University of Science and Technology; and Frédéric Rimattei, Special Envoy for International Affairs of the President of French University Hospitals National Association, shared their insights on tackling global healthcare challenges, offering inspiration for the international healthcare community.
In Plenary Session II: Fostering Global Collaboration for a Shared Future, speakers engaged in a lively discussion on trends in global healthcare collaboration. Among them was Ambassador George Hara, Group Chairman and CEO of DEFTA Partners and former Special Advisor to the Cabinet Office of the Prime Minister of Japan, who remarked that more advanced technology and new government regulations are needed to reach a compromise between companies’ profits and patients’ needs.
During the Dialogue with Global Pioneer in Health session,Prof John Hardy, Chair of Molecular Biology of Neurological Disease of UCL Queen Square Institute of Neurology, shared his latest research findings and advanced developments in Alzheimer’s disease.
The summit co-organised sessions under the overarching theme, Shaping the Future of Healthcare, with the Hong Kong University of Science and Technology for the first time. The discussion focused on the potential of AI in healthcare and how innovation could drive breakthroughs in the field. Dr Alex Ng, President of Tencent Healthcare, commented: “One uniqueness of tech companies is that they can be easily distracted by the latest thing. But you do need companies with patience and perseverance to stay in healthcare and make it work.” ProfGraham Cooke, Vice-Dean (Research) Medicine of Imperial College London, also noted that embedding patient needs into healthcare systems is critical, as many innovations fail in translation due to a lack of this focus, with universities playing a key role as innovation drivers.
In Beyond ‘Healthy China 2030’: Driving Health Innovation, speakers explored opportunities in the mainland healthcare market. Marc Horn, Executive Vice President of Merck and President of Merck China, highlighted the two-phase approach of “China for China” followed by “China for the globe”, emphasising healthcare collaboration to develop advanced treatments for global benefit. Dr Zhang Lianshan, Executive Vice President of Jiangsu Hengrui Pharmaceuticals Co., Ltd., stated: “We would like to see our health innovation have realisation of its value, not only in China, but also outside of China. That is why we are talking about Globalisation, where we can achieve maximum value.”
With growing global attention on healthy ageing, the summit introduced a dedicated Silver Health Chapter. A highlight was the thematic session titled Surfing the Silver Tsunami: Advancements in Geriatrics and Longevity Technology, where Prof Jean Woo, Director of Chinese University of Hong Kong Jockey Club Institute of Ageing, Prof James L. Kirkland, Director of Cedars-Sinai’s Centre for Advanced Gerotherapeutics, and fellow experts explored both the challenges and opportunities posed by ageing populations. Prof Jean Woo highlighted that rapid population ageing is reshaping the global healthcare and socioeconomic landscape. As a city with one of the world’s longest life expectancies, Hong Kong must take early action to strengthen elderly care policies and better allocate health resources. Prof James L. Kirkland also noted that geriatricians ultimately aim to help patients with multiple illnesses reduce medication use while treating their conditions more effectively, enhancing their overall quality of life.
Over 390 deal-making sessions and cooperation agreements open new global opportunities A key feature of the summit was the ASGH Deal-Making session, which facilitated one-on-one meetings both online and offline, aiming to connect investors and projects in the healthcare sector from around the world to promote global collaborations. Investment projects spanned pharmaceuticals, medical devices and diagnostics, smart healthcare, and community health and wellness and more than 390 one-on-one meetings were successfully arranged for angel investors, venture capitalists, corporate venture arms, private equity firms and family offices.
The summit facilitated the signing of cooperation agreements, such as those between Gleneagles Hospital Hong Kong and Emerging Viral Diagnostics, and a tripartite collaboration with PanopticAI and SmartCare, HKSH Medical Group and United Imaging Healthcare, China Resources Guangdong Pharmaceuticals and Hong Kong Medtech Association, Hugobiotech and Bridgeway Healthcare Technology, Canossa Hospital and KA Imaging, and others. These agreements covered diverse healthcare areas, including patient care, diagnostic solutions, innovative medical devices, medical imaging and more. Under the tripartite collaboration agreement between Gleneagles Hospital Hong Kong, PanopticAI, and SmartCare, the integration of PanopticAI’s camera-based vital signs monitoring technology and SmartCare’s patient-centered consultation platform will be implemented into Gleneagles clinic in the future.
In addition to its discussion sessions, the summit also featured the ASGH Business Hub, showcasing more than 170 innovative technology companies related to the healthcare industry from 13 countries and regions, including the mainland (Shanghai and Xiamen), Australia, and Thailand, presenting projects and solutions across key areas such as medical innovation, smart healthcare, AI, big data, telemedicine, and cybersecurity. Zhong Wei, Co-founder of Mitrassist Lifesciences, joined the Shanghai Pavilion and said that ASGH helped them bring non-invasive medical monitoring technologies to Southeast Asia, Africa, and other Belt and Road Initiative countries.
Medical Fair Drives Industry Innovation and Fosters Business Collaboration The Medical Fair, organised by the HKTDC and co-organised by the Hong Kong MedTech Association, was held alongside ASGH. The Association—formerly known as the Hong Kong Medical and Healthcare Device Industries Association—held a renaming ceremony during the fair, showcasing the deep integration of medical technology and the industry.
The fair brought together some 300 exhibitors from 13 countries and regions, featuring first-time pavilions from the United Kingdom, Thailand and Israel, along with debut exhibitors from Singapore, Germany, Italy and Luxembourg. In addition, seven local universities, over 30 innovative technology companies at the Hong Kong Science and Technology Parks pavilion, and more than 20 medical enterprises brought by the Hong Kong MedTech Association participated. The Hong Kong Council of Social Service also participated in the fair for the first time. Under the theme Innovations Boosting Smart Health Experience, the exhibition spotlighted three major areas: MedTech, GeronTech and green solutions, with many exhibits featuring applications of AI.
Many exhibitors and buyers successfully expanded their networks and forged new partnerships at the exhibition. Among them was Hong Kong exhibitor Eieling Technology, a company founded to commercialise research outcomes from the Hong Kong Polytechnic University. The firm showcased its non-invasive liver examination technology, which utilises transient elastography technology. Co-founder and CEO Xiaojia Jia noted that only about four companies worldwide possess this technology, making it a major draw for buyers. “During the exhibition, we received intention orders worth several million Hong Kong dollars from mainland China, Hong Kong, Indonesia, and Thailand, involving around ten devices. This is our third year participating, and we’ve observed a significant rise in buyers’ professionalism during our discussions. We look forward to exhibiting again next year.”
Karel Lee, CEO of Neoneco from Korea, sourced innovative medical products at the fair with a minimum budget of USD100,000 and he has already identified RhinoCare, an exhibitor from the Israeli pavilion, for its nasal decongestion device, and is also interested in a medical examination device from a Hong Kong exhibitor. Lee stated, “The exhibition allows us to meet with exhibitors face-to-face, build trust, and accelerate the decision-making process. The HKTDC’s Click2Match platform also facilitated efficient business matching. I have already connected with ten exhibitors, and another twenty reached out to me after learning about my sourcing needs. This is one of Asia’s premium medical sourcing events, and we will definitely return next year.”
Beyond business deals, insightful forums were arranged during the Medical Fair to give inspiration to industry buyers. These included The Latest Development of Regulatory Collaboration on Medical Devices in the Greater Bay Area, The MedTech Nexus of the Greater Bay Area, co-organised with the Hong Kong MedTech Association, and Fostering Silver Economy, Leading Quality Elderly & Rehabilitation Care Practices, co-organised with the HKCSS. These forums attracted a strong attendance and offered valuable insights into healthcare. Selected sessions are available for replay on the Fair’s website for extended engagement.
This year’s Fair continued to adopt the EXHIBITION+ hybrid model. Global exhibitors, industry professionals, and buyers could make use of the Click2Match and explore sourcing opportunities via HKTDC Sourcing (hktdc.com Sourcing). Click2Match will remain available until 4 June.
About HKTDC The Hong Kong Trade Development Council (HKTDC) is a statutory body established in 1966 to promote, assist and develop Hong Kong’s trade. With over 50 offices globally, including 13 in Mainland China, the HKTDC promotes Hong Kong as a two-way global investment and business hub. The HKTDC organises international exhibitions, conferences and business missions to create business opportunities for companies, particularly small and medium-sized enterprises (SMEs), in the mainland and international markets. The HKTDC also provides up-to-date market insights and product information via research reports and digital news channels. For more information, please visit: www.hktdc.com/aboutus.
– Asia Summit on Global Health and Medical and Healthcare Fair open concurrently – Global healthcare leaders gather in Hong Kong to forge new collaboration opportunities
– The Asia Summit on Global Health (ASGH) gathers over 80 government officials and organisations, research pioneers, investors, and business leaders to explore international collaboration on medical technology, silver health, and healthcare systems. A dedicated “Silver Health Chapter” debuts this year to spotlight the ageing population. – Renowned speakers include Prof John Hardy, the “father of Alzheimer’s disease genetic studies”; Dr Victor Yosef Melt Campos, Chair (2024-2025) of APEC Health Working Group and General Director of International Cooperationat the Ministry of Health of Peru; and Martin Taylor, Representative to China of the World Health Organization. They will share insights on the latest developments in medical innovation. – The Hong Kong International Medical and Healthcare Fair (Medical Fair) focuses on MedTech,GeronTech, and green solutions, featuring the latest medical health devices, products, and solutions including many AI-powered innovations. – The Medical Fair has attracted some 300 exhibitors from 13 countries and regions. Participating with pavilions for the first time are Israel, Thailand, and the UK, along with debut exhibitors from Singapore, Germany, Italy and Luxembourg.
International Healthcare Week (IHW), organised by the Hong Kong Trade Development Council (HKTDC), officially opened today. One of its flagship events, the fifth Asia Summit on Global Health (ASGH), takes place today and tomorrow (26 and 27 May) at the Hong Kong Convention and Exhibition Centre (HKCEC). Under the theme Fostering Global Collaboration for a Shared Future, the summit brings together more than 80 healthcare leaders and experts from around the world to explore the future direction of the industry and collaboration opportunities. Another flagship event, the 16th Hong Kong International Medical and Healthcare Fair (Medical Fair), also kicks off today (26 to 28 May), and features some 300 exhibitors from 13 countries and regions, showcasing cutting-edge MedTech, GeronTech, and green solutions, including many AI-powered innovations, to foster global industry collaboration.
The ASGH opened with welcome remarks delivered by HKTDC Chairman Dr Peter K N Lam. “The global health sector is currently facing challenges, including a resurgence in infectious diseases, coupled with the growing needs of an ageing population and ongoing health equity concerns. These issues demand urgent attention and collective action to protect communities worldwide. Now in its fifth edition, ASGH is a key event for the global healthcare industry, and we are proud that connections made through ASGH have enabled many new investments and collaborations in healthcare innovation. Alongside ASGH, the Hong Kong International Medical and Healthcare Fair is taking place. There, you will find the latest HealthTech solutions from around the globe, with a particular focus on hospital equipment, rehabilitation, elderly care and biotech. As anchor events of the International Healthcare Week, ASGH and Medical Fair highlights Hong Kong’s commitment to working with partners to nurture an innovative health and medical sector,” Dr Lam said.
In his opening speech, Hong Kong SAR Chief Executive John Lee said: “Under the theme of “Fostering Global Collaboration for a Shared Future”, this summit reaffirms Hong Kong’s pivotal role as a leading health innovation hub in the region. Under the “one country, two systems” principle, Hong Kong enjoys unique connectivity with both Mainland China and the world. As the world’s freest economy and one of the top three international financial centres, we offer an efficient, open and fair business environment with robust intellectual property protection. We maintain free flows of information, capital, goods and talent. We are also emerging as a leading hub for scientific innovation, technological advancement and world-class education.”
Prof Cao Xuetao, Vice-Minister of the National Health Commission of the People’s Republic of China, gave special remarks, noting: “China continues to open up and welcomes leading foreign-owned hospitals into the market through investment or joint ventures. We hope that our global partners can further localise and upgrade their mid-to-high-end products, resulting in win-win outcomes for all.”
Additionally, Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), delivered remarks at the opening session via video link and stated, “The theme of ASGH could not be more appropriate given the challenges facing global health at the moment. The WHO Pandemic Agreement has been adopted recently. It was negotiated over the past three and a half years and shows a true spirit of international collaboration for global health. By working together, we can build a healthier, safer, and fairer world for all.”
Global industry leaders gather to explore opportunities for international collaboration Today’s Plenary Session I: Shaping a More Equitable and Sustainable Health System, featured keynote remarks by Prof Lo Chung-mau, Secretary for Health of the HKSAR Government, and Feng Haicang, Level I Bureau Rank Official of Department of Consumer Goods Industry, Ministry of Industry and Information Technology of the People’s Republic of China.
Prof Lo Chung-mau, stated: “A sustainable health system requires talents and enough healthcare manpower. While the Government has been addressing the issue of manpower shortage through a multipronged strategy, by increasing the number of intakes for local universities and admitting qualified non-locally trained healthcare workers, the 2024 Policy Address announced that the Government supports the plan to establish a third medical school. Indeed, Hong Kong has already hosted two top 30 world class medical schools but we have the ability and the need to develop the third one which shall adopt an innovative strategic positioning in pursuit of complementary development with the two existing ones.”
The session was moderated by Prof Tsui Lap-chee, Chairman of the University of Hong Kong Foundation for Educational Development and Research, focused on key issues faced by healthcare systems in addressing global challenges. Distinguished speakers included Martin Taylor, Representative to China of the WHO; and Prof Nancy Ip, President of the Hong Kong University of Science and Technology. They shared valuable experiences and forward-looking insights to inspire the global healthcare field.
Prof Nancy Ip noted: “Universities are more than academic institutions. They are global connectors, neutral platforms, and also engines of innovation, uniquely positioned to bridge divides between disciplines, industries, and also nations.”
Distinguished international speakers of Plenary Session II: Fostering Global Collaboration for a Shared Future included Ambassador George Hara, Group Chairman and CEO of DEFTA Partners and former Special Advisor to the Cabinet Office of the Prime Minister of Japan. They jointly explored trends in global healthcare collaboration, injecting new ideas into constructing a more synergistic global healthcare landscape.
The summit invited Prof John Hardy, known as the “father of Alzheimer’s disease genetic studies”, Chair of Molecular Biology of Neurological Disease of UCL Queen Square Institute of Neurology, to share his outlook on future research and treatment of neurodegenerative diseases such as Alzheimer’s in the Dialogue with Global Pioneer in Health session.
Prof John Hardy remarked: “For Alzheimer’s treatment, I think that two changes can happen quite quickly: improvements in earlier diagnosis, and development of drugs that bypass the blood vessel-based amyloid. What we want to do with drugs is slow decline. If we understand what underpins that decline, it gives us targets, and we’re very excited by some of the findings in that area now.”
“Healthy China 2030” serves as the national blueprint for healthcare policy development in Mainland China. In the session Beyond “Healthy China 2030”: Driving Health Innovation, Dr Zhang Lianshan, Executive Vice President, Jiangsu Hengrui Pharmaceuticals Co., Ltd.; and Marc Horn, Executive Vice President of Merck and President of Merck China, explored opportunities in the mainland healthcare market, analysing emerging trends in China’s healthcare innovation ecosystem to open new pathways for international collaboration with other speakers.
Diverse topics converge with forward-looking insights and the Silver Health Chapter explores new business opportunities For the first time, the summit co-organised two thematic sessions with the Hong Kong University of Science and Technology under the overarching theme Shaping the Future of Healthcare. Speakers included Prof Graham Cooke, Vice-Dean (Research) of Faculty of Medicine at Imperial College London. They focused on the potential of AI in the medical field, sharing with participants how innovative technologies are driving new breakthroughs in healthcare. Additionally, sessions on Peeking into the Future of Gene and Cell Therapies and Women’s Health in Focus were also closely aligned with global medical development trends.
Continuing today’s in-depth dialogues, more exciting sessions will be presented tomorrow. For the first time, the summit will feature a Silver Health Chapter focusing on addressing the challenging ageing societies. Speakers including Prof James L. Kirkland, Director of Cedars-Sinai’s Centre for Advanced Gerotherapeutics, will gather at tomorrow morning’s session Surfing the Silver Tsunami: Advancements in Geriatrics and Longevity Technology to delve into how to address the challenges brought by an ageing population, analysing future development trends and potential investment opportunities in the silver economy market.
Furthermore, globally renowned speakers will be present tomorrow to share their valuable experiences and insights. Wyman Li, Chief Operating Officer of HKSH Medical Group; Prof Karim Asehnoune, President of National Committee for Public Hospital Research (CNCR), and other speakers will analyse how to promote the sustainable development of the healthcare industry through collaboration among different stakeholders in the session, Reinventing the Business of Healthcare through Partnerships. Prof Xu Hongxi, Distinguished Professor and Honorary Dean of Shanghai University of Traditional Chinese Medicine and other guests will discuss the latest developments and commercial potential of integrating Chinese and Western medicine in the session The Convergence of Chinese and Western Medicine in Global Health. Sessions on The Next Wave of Innovations in Neuroscience, Data-driven Healthcare Transforming Patient Journey and The Changing Face of Cancer will also be held tomorrow.
A global platform for healthcare resource matchmaking to foster opportunities for innovative collaboration In addition to thematic discussions, the summit also aims to bridge global collaboration among participants. For example, the ASGH Deal-making facilitates one-on-one meetings both online and offline, aiming to connect investors and projects in the healthcare sector from around the world to promote global collaborations.
The summit has established the ASGH Business Hub, which brings together more than 170 innovative technology companies and award-winning projects from 13 countries and regions, including the mainland (Shanghai and Xiamen), Australia, and Thailand. The InnoHealth Showcase serves as a platform to explore business opportunities and innovative solutions and highlights more than 70 healthcare start-ups and projects led by the Innovation and Technology Commission, Cyberport, and six local universities. The showcase is structured around four key categories: pharmaceuticals and therapeutics, AI and Digital Health, medical devices and diagnostics, and community health and wellness. As part of the “Silver Health Chapter”, some of the showcased projects address the challenges of an ageing population, including early blood tests for Alzheimer’s disease, demonstrating cutting-edge capabilities and market potential in elderly healthcare.
Integrating global innovations to showcase the future of healthcare The Hong Kong International Medical and Healthcare Fair also opened today, organised by the HKTDC and co-organised by the Hong Kong Medical and Healthcare Device Industries Association (HKMHDIA). Under the theme Innovations Boosting Smart Health Experience, this year’s Fair focuses on three key areas: MedTech, GeronTech and green solutions, featuring the latest medical health devices, products, and solutions.
In the field of MedTech, UK exhibitor London Medical Exchange (Booth No: 3F-H15) presents a fully automated AI-powered patient monitoring system designed to improve patient care, transforming healthcare from reactive to proactive. Meanwhile, C2iTech (Booth No: 3F-G04), established by a research team from the School of Public Health at The University of Hong Kong, showcases a Respiratory Organoid Platform (ROP). By analysing nasopharyngeal or throat saliva samples from individuals, the platform predicts their likely response to respiratory virus infections, enabling more precise and personalised treatment by healthcare professionals.
In the GeronTech segment, Medmind Technology (Booth No: 3F-G04), from the Hong Kong Science and Technology Parks Corporation (HKSTP) Pavilion, introduces an app for cognitive impairment assessment. The tool allows middle-aged and elderly users to play digital mahjong and other games, with AI used to assess their cognitive status and offer personalised brain training, helping prevent and detect early signs of cognitive decline. The system can also monitor patient conditions over time.
The Hong Kong Council of Social Service (HKCSS), participating in the fair for the first time, is showcasing a range of GeronTech and related products, covering areas such as rehabilitation and mobility assistance, cognitive impairment support for patients and carers, and smart home solutions. HKCSS is also introducing its GeronTech education and rental services, along with its online platform that enables the public to learn about and hire GeronTech equipment. Users such as the elderly, people in rehabilitation, and carers can try out products, and rent or purchase them as needed, with support from a cross-disciplinary professional team. Through the Medical Fair, HKCSS aims to attract collaboration with other businesses to expand its services and benefit a wider segment of the community.
For green solutions, MassPhoton (Booth No: 3F-H18), also from the HKSTP Pavilion, presents an ultraviolet disinfection system that combines semiconductor and smart control technologies, delivering more efficient and energy-saving disinfection for air, water and surfaces.
This year’s Medical Fair has attracted some 300 exhibitors from 13 countries and regions. Participating with pavilions for the first time are Israel, Thailand, and the UK, along with debut exhibitors from Singapore, Germany, Italy and Luxembourg. Highlighting Hong Kong’s strength in medical innovation, seven local universities, over 30 innovative technology companies at the HKSTP pavilion, and more than 20 medical enterprises brought by the HKMHDIA are participating.
The exhibition features a range of thematic zones, including Biotechnology, Hospital Equipment, Rehabilitation and Elderly Care Products, and Start-up and HKMHDIA zones. Highlight exhibits include AI-powered rehabilitation systems, portable ultrasound diagnostic systems, and smart hospital robots, demonstrating the frontiers of medical and healthcare technology.
During the Medical Fair, there will be forums, seminars and networking receptions. Two forums focused on the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) healthcare sector will take place tomorrow. The morning forum titled The MedTech Nexus of the Greater Bay Area, which is co-organised with the HKMHDIA, will feature industry experts sharing insights on intellectual property strategies for biomedical innovation, ways to integrate resources for GBA market development, and successful experiences in promoting medical technology in the GBA. The afternoon forum titled The Latest Development of Regulatory Collaboration on Medical Devices in the Greater Bay Area will bring together experts from the Greater Bay Area Centre for Medical Device Evaluation and Inspection of National Medical Products Administration, the Medical Device Division of Department of Health, and SGS-CSTC Standards Technical Services Co., Ltd., to explore the latest developments, administrative systems and regulations in relevant fields, promoting cross-regional regulatory collaboration and fostering innovation through idea exchange.
Using the HKTDC EXHIBITION+ hybrid model, global exhibitors, industry professionals, and buyers can continue business matching via the Click2Match smart business matching platform until 4 June, encouraging more cooperation.
Aside from ASGH and the Medical Fair, IHW also features the Hospital Authority Convention, among many other industry events.
Thailand-listed Medeze Group Public Company Limited (“Medeze”, together with its subsidiaries, the “Medeze Group”), through its wholly owned subsidiary Medeze Treasury Pte. Ltd. (the “Offeror”), intends to make a voluntary conditional cash partial offer (the “Partial Offer”) to acquire 10.00% of the issued ordinary shares of Cordlife Group Limited (“Cordlife” or the “Offeree”), a Singapore-listed provider of cord blood banking services. The move signals Medeze’s first strategic step into the Singapore market, with the intention of exploring business opportunities with the Offeree to create long-term value and mutual benefit for both parties.
Terms of the Partial Offer
Under the terms of the Partial Offer, the Offeror is seeking to acquire 25,630,774 shares, equivalent to 10.00% of Cordlife’s total issued and paid-up ordinary shares (excluding treasury shares) (the “Shares”), at an offer price of S$0.25 per share (the “Offer Price”). This represents an attractive premium of approximately 61.3% to the last traded price of S$0.155 on 9 May 2025, and also the 12-month volume-weighted average price.
The Partial Offer will be subject to the minimum acceptance condition of the Offeror having received, by the close of the Partial Offer, valid acceptances and/or tenders in respect of not less than 25,630,774 Shares, representing 10.00% of the total number of Shares (excluding treasury shares) as at the Record Date. The Partial Offer will not become or be capable of being declared unconditional in all respects unless the above condition is satisfied.
The Partial Offer represents an attractive opportunity for Cordlife shareholders to realise part or potentially all of their investment. Based on the Offeror’s observation that the Shares of the Offeree has been thinly traded in recent years, the Offer Price reflects a healthy premium over recent trading levels.
Rationale of the Partial Offer
The Partial Offer, if successful, will allow the Offeror to increase its direct holdings (including the existing shares held by the Offeror) in the Offeree to approximately 10.68% of the total number of Shares (excluding treasury shares) as at the Record Date. Upon successful completion of the Partial Offer, the Offeror, together with Medeze, will communicate with and endeavour to explore business opportunities with the Offeree to create long-term value and mutual benefit for both parties.
The Offeror wishes to demonstrate its commitment to contribute positively to the Offeree as a long-term substantial shareholder. By acquiring a meaningful stake, the Offeror aims to collaborate with existing controlling shareholders and management to drive sustainable value creation for all stakeholders. The Offeror believes in engaging in constructive dialogue and partnership with existing shareholders and management to align on strategic priorities, governance, and operational enhancements that will benefit the Offeree’s long-term success.
If a collaboration eventuates, Medeze Group and Cordlife could provide services to each other’s customers which helps to strengthen the market position and network of Medeze Group and Cordlife. As an example and for illustrative purposes only, Medeze Group could (where permissible), offer services like analyzing and storing NK cell and hair follicle banking services to Cordlife’s customers. Cordlife (where permissible) could on the other hand offer its chromosomal and genetic analysis and screening services to Medeze Group’s customers. This collaboration can further support the growth of both Medeze Group and Cordlife at the international level.
The Medeze Group recorded total revenue of THB 874.3 million and net profit of THB 338.7 million, representing growth of 23.6% and 41.4% year-on-year respectively. Medeze Group’s asset base more than tripled to over THB 3.4 billion, following its successful listing of the Stock Exchange of Thailand and strategic reinvestment into technology and capacity.
About Medeze
The Medeze Group has been in business for more than 14 years and is a leader in the Southeast Asia stem cell storage and services market.
Recognised as the Southeast Asia Stem Cell Banking Company of the Year by Frost & Sullivan for two consecutive years (2023 and 2024), the Medeze Group has a laboratory that is accredited by the Association for the Advancement of Blood and Biotherapies (AABB) from the United States. The laboratory is equipped with modern equipment and technology in the stem cell banking industry, such as AutoXpress and Quantum Machine.
The Medeze Group is founded and headed by the incumbent chief executive officer, Dr. Veerapol Khemarangsan, an experienced Obstetrics and Gynecology specialist, who brings deep clinical and commercial expertise. He continues to be personally involved in stem cell procedures, lending Medeze Group a rare combination of medical and operational leadership. He currently serves as the Director of Training Committee in Bangkok Metropolitan Endoscopic Center (BMEC).
Cordlife was incorporated in Singapore on 2 May 2001 and has been listed on the Mainboard of the Singapore Exchange Securities Trading Limited (“SGX-ST”) since 29 March 2012. The Offeree is a group company in the business of providing cord blood banking services such as the collection, processing, testing, cryopreservation and storage of umbilical cord blood at birth in countries including Singapore, Hong Kong, Macau, Indonesia, Thailand, India and the Philippines.
The directors of the Offeror (including any director who may have delegated detailed supervision of the preparation of this document) have taken all reasonable care to ensure that the facts stated and opinions expressed in this document are fair and accurate and that no material facts have been omitted from this document, and they jointly and severally accept responsibility accordingly.
Where any information has been extracted or reproduced from published or otherwise publicly available sources or obtained from the Offeree, the sole responsibility of the directors of the Offeror has been to ensure through reasonable enquiries that such information is accurately extracted from such sources or, as the case may be, reflected or reproduced in this document.
With six newly established, identical BSL-2 laboratories now operational, biologics CDMO Northway Biotech can conduct VCS programs for up to six clients simultaneously, significantly alleviating current market bottlenecks
Northway Biotech, a biopharmaceutical contract development and manufacturing organization (CDMO), today announced the expansion of its protein-based and gene therapy service offerings with the addition of Viral Clearance Studies (VCS) capabilities. This strategic growth follows the opening of Northway Biotech’s new Gene Therapy Center with dedicated cGMP facilities for virus-related projects.
With six newly established, identical BSL-2 laboratories now operational, Northway Biotech can conduct VCS programs for up to six clients simultaneously, significantly alleviating current market bottlenecks. Additionally, the company has expanded its capabilities to perform GMP-compliant manufacturing and testing under BSL-3 conditions, further strengthening its service offering across gene therapy and broader biologics development.
Viral Clearance Studies are now offered both as part of Northway Biotech’s integrated CDMO programs and as a standalone service. This flexibility allows external clients to access VCS expertise independently, without requiring a manufacturing agreement.
Accelerated Delivery Timelines – Over One Month Faster Than Industry Leveraging expanded infrastructure and integrated analytical capabilities, Northway Biotech is positioned to deliver Viral Clearance Studies substantially faster than the current industry standard. Comprehensive studies, assessing viral removal and inactivation, can now be completed with final regulatory-compliant reporting in under 10 weeks from initiation of project design when two model viruses are employed, and within 12 weeks when four model viruses are used.
“Our expansion into Viral Clearance Studies is a natural extension of our CDMO services, enabling us to manage these critical studies in-house and significantly reduce project timelines for our clients,” said Prof. Vladas Algirdas Bumelis, CEO of Northway Biotech. “By investing in state-of-the-art BSL-2 and BSL-3 facilities, expanding technical capabilities, and further strengthening our scientific teams, we are uniquely positioned to deliver high-quality VCS data faster – a key advantage for clients advancing through clinical development and regulatory approval.”
For more information on Northway Biotech’s Viral Clearance Study processes, service offerings, and delivery timelines, please complete the contact form to connect with the Northway Biotech team.
Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced and professional team executes projects at every stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company’s extensive expertise and vertically integrated service offering enables rapid execution of multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development, and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and operates locations in Vilnius, Lithuania; London, United Kingdom; and Waltham, MA, USA.
Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function announced positive interim results of an investigator-initiated proof of concept open-label study with low-dose IL-2 and CTLA4-Ig combination treatment in patients with Frontotemporal Dementia (FTD). The study is led by Dr. Alireza Faridar and Dr. Stanley Appel at the Houston Methodist Neurological Institute (Houston, TX) with funding from The Peggy and Gary Edwards Endowment Fund. Study patients received subcutaneously administered CTLA4-Ig, followed by a 5-day course of low-dose IL-2 every four weeks, for a total of 22 weeks of dosing and follow-up. The study aims to enroll up to 10 patients, and these interim results include data from the first 5 patients with mild to moderate FTD who have completed the full course of treatment.
Dr. Arun Swaminathan, Coya’s Chief Executive Officer followed: “The results thus far are consistent with previously published encouraging data from an open-label investigator-initiated study of patients with ALS treated with low-dose IL-2/CTLA4-Ig. This interim data in FTD provides us further confidence of our approach to target and enhance Treg biology to address devastating neurodegenerative diseases including ALS and FTD”.
Previous biomarker data presented by the Company demonstrated that FTD patients exhibit a compromised immunosuppressive function of regulatory T cells (Tregs), along with increased peripheral levels of inflammatory cytokines and chemokines, dysregulation of monocytes, and systemic activation of the inflammatory cascade, supporting the critical role of the immune system in the pathophysiology of FTD.
One previous study showed that a cohort of 68 patients with FTD worsened by an average of 3.57 points over a 12-month period per the Clinical Dementia Rating – Frontotemporal Lobar Degeneration (CDR‐FTLD) scale (Knopman et al. Brain 2008; 131(11): 2957-2968). In addition, patients with FTD typically have shorter survival times and more rapid rates of cognitive and functional decline compared to patients with Alzheimer’s disease (Rascovsky et al. Neurology 2005; 65(3): 397-403).
Dr. Fred Grossman, Coya’s Chief Medical Officer stated: “We are excited with the results observed in this initial group of patients with this proof-of-concept study. We believe that the increase in Treg numbers and suppressive function, with subsequent anti-inflammatory biological activity still to be evaluated, underscores the potential for this low-dose IL-2/CTLA4-Ig combination to be further studied as a therapy for FTD, for which there are no currently approved treatments.”
Summary of Interim Study Results
Overall, treatment with low-dose IL-2 and CTLA4-Ig was well tolerated. All 5 patients enrolled in the first cohort completed the study and received the investigational treatment as planned. The most common adverse events were mild injection site reactions. No serious adverse events were reported.
Treg numbers and suppressive function increased after the first treatment cycle (p < 0.01 and p < 0.05, respectively, and remained at higher significant levels throughout the treatment period.
Clinical functional assessments were performed in all patients at pre-specified timepoints over the course of the study using validated tools, including the Clinical Dementia Rating – Frontotemporal Lobar Degeneration (CDR‐FTLD) scale, the Montreal Cognitive Assessment (MoCA) scale, and the Progressive Aphasia Severity Scale (PASS). Results of the functional tests show that, on average, these five FTD patients treated with low-dose IL-2 and CTLA4-Ig combination exhibited minimal to no cognitive decline over the course of the study, compared to pre-treatment values.
The Company intends to publish and/or present more comprehensive data in a future peer-reviewed meeting and/or publication.
About Frontotemporal Dementia
Frontotemporal dementia (FTD) refers to a group of neurodegenerative disorders characterized by altered behavior and language, with a progressive decline in executive function.1 FTD affects an estimated 30,000 Americans.2 FTD is categorized clinically into various subtypes; the main three include behavioral-variant frontotemporal dementia and two language variants, semantic dementia (also known as semantic variant primary progressive aphasia) and progressive non-fluent aphasia (also known as non-fluent variant primary progressive aphasia). It’s a presenile dementia, meaning it can occur in younger individuals, often between the ages of 45 and 64. The average age of onset is 58, with an average survival time of 7.5 years.1,2
References 1. Knopman et al. Development of methodology for conducting clinical trials in frontotemporal lobar degeneration. Brain 2008; 131(11): 2957-2968
2. Rascovsky et al. Rate of progression differs in frontotemporal dementia and Alzheimer disease. Neurology 2005; 65(3): 397-403
About Coya Therapeutics, Inc.
Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system.
Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.
COYA 302 is a combination treatment comprised of low-dose IL-2 and CTLA4-Ig is an investigational therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of Tregs and suppress the inflammation produced by activated monocytes and macrophages. Coya is developing COYA 302 for the treatment of fatal neurogenerative diseases characterized by chronic inflammation and Treg dysfunction.
This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements.
Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; ; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
