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Hong Kong's First PIC/S GMP-Certified Stem Cell Production Facility Established at Science Park

Jumat, 31 Juli 2026 | 16:54
HKSTP hosted the HKSTP CGT Showcase 2026, bringing together local and overseas I&T enterprises, medical experts, researchers, investors and patient representatives to explore the clinical translation and broader development of cell and gene therapy.

HKSTP Hosts Showcase Featuring Clinical Progress from 10 Park Companies and Real-Life Patient Stories

HONG KONG SAR ' Media OutReach Newswire ' 31 July 2026 ' Hong Kong Science and Technology Parks Corporation (HKSTP) today hosted the HKSTP Cell and Gene Therapy (CGT) Showcase 2026 at the Charles K. Kao Auditorium, Hong Kong Science Park, with support from Invest Hong Kong. The event brought together more than 200 representatives from the healthcare, academic, investment and regulatory sectors, both locally and from overseas. A major milestone announced at the event was that HKSTP partner company Hong Kong Regen Medtech Limited (HKRM) has become the first facility in Hong Kong to be recognised by the Pharmacy and Poisons Board of Hong Kong (PPBHK) as an allogeneic mesenchymal stem cell (MSC) PIC/S GMP manufacturing facility, enabling the production of advanced therapy products for clinical trials.

Mr Terry Wong, CEO of HKSTP, said in his remarks: 'Cell and gene therapy is one of the fastest-growing fields in life and health tech. The establishment of Hong Kong's first stem cell production facility certified to PIC/S GMP standards at Hong Kong Science Park marks a significant milestone for the city's life and health tech ecosystem. The significance of this certification goes far beyond technology alone. It signifies not only that production has met the highest international safety standards, but also that patients and their families can choose locally manufactured cell therapy products with confidence and complete trust. This is a tangible achievement that will enable every Hong Kong citizen to benefit directly. As the orchestrator of Hong Kong's innovation and technology (I&T) ecosystem, HKSTP has been proactively connecting the life and health tech community with partners, investors and academia. Through a diverse range of incubation programmes, we provide our park companies with seed funding, innovation space, world-class infrastructure and regulatory support, helping them overcome challenges in the journey from laboratory research to clinical translation and turning scientific breakthroughs into real therapeutic outcomes for patients. We will continue to drive ecosystem development and fully support local I&T enterprises in bringing research achievements 'Made in Hong Kong' to the global stage.'

Hong Kong's First PIC/S GMP Stem Cell Production Facility Bridges a Critical Gap from Research to Clinical Application

One of the highlights of the event was HKRM, an HKSTP partner company, recently obtaining Hong Kong's first PIC/S GMP licence for stem cell production and operating the related manufacturing facility at Hong Kong Science Park, marking a key step in advancing the clinical translation of advanced therapies in Hong Kong. PIC/S GMP is internationally recognised as the gold standard for pharmaceutical manufacturing quality. Facilities must undergo rigorous international assessment to ensure that every batch is produced in a strictly controlled environment.

Mr Stanley Sy, HKRM Co-founder and CEO, said: 'HKRM's attainment of Hong Kong's first PIC/S GMP certification for stem cell production marks not only an important milestone in the company's development, but also signifies that Hong Kong now has the critical infrastructure needed to further support the clinical translation of advanced cell therapies. A stringent, internationally recognised manufacturing quality system helps ensure product consistency and traceability, while strengthening the confidence of medical and regulatory authorities in locally manufactured cell-based products. Based at Hong Kong Science Park, HKRM is grateful for the longstanding support of HKSTP. We also look forward to working with research and clinical partners in the Park to bring more promising therapeutic solutions from Hong Kong to the international stage.'

Patients, Families and Doctors Share First-hand Stories of the Journey from Cell Banking to Clinical Breakthroughs

The event also featured first-hand experiences from patients, their families and doctors on their treatment journeys. Park company Mononuclear Therapeutics (MonoTx) operates Hong Kong's first AABB-accredited public cord blood bank and haematopoietic stem cell apheresis facility at Hong Kong Science Park, with more than 2,000 cord blood units in storage.

Dr Wendy Cheng, Chief Operating Officer of MonoTx, joined Professor Leung Tak Yeung and Professor Ronald Wang of the Department of Obstetrics and Gynaecology at The Chinese University of Hong Kong (CUHK) to share research findings and patient cases with patient families.

Professor Leung Tak Yeung's team at CUHK is studying a treatment for foetuses with severe alpha-thalassaemia by processing the mother's stem cells through MonoTx and infusing them into the foetus, to investigate whether the foetus can develop immune tolerance to the mother's stem cells and thereby improve clinical outcomes.

Professor Ronald Wang's team is using cord blood to treat neonatal brain injury. Preliminary findings suggest that cord blood infusion within 48 hours of birth may help repair brain injury and improve the child's developmental outcomes later in life.

360 Life Sciences Companies Gather at Hong Kong Science Park, Reinforcing Hong Kong's Position as an International Health and Medical Innovation Hub

Hong Kong Science Park is home to more than 360 life sciences companies, while the number of cell and gene therapy (CGT) enterprises continues to grow, spanning frontier fields such as stem cells, gene editing, personalised cancer vaccines and CAR-T immunotherapy, and addressing diseases including cancer, heart failure and neurodegenerative disorders. HKSTP will continue to strengthen Hong Kong's position as an international health and medical innovation hub by accelerating the translation and application of more locally developed R&D outcomes for the benefit of patients, the industry and society. In doing so, it aims to make innovative therapies more accessible and enable Hong Kong to play an even greater role on the global life and health tech stage.


BERITA LAINNYA
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