New state-of-the-art facility to develop immunotherapy assets to address unmet needs in cancer treatment
SINGAPORE – Media OutReach – 28 June 2023 – Biosyngen, an immuno-oncology company with technology targeting the unmet medical needs in solid tumour and lymphoma treatment, today announced the official opening of its latest Good Manufacturing Practice (GMP) facility in Singapore. The facility will support cell manufacturing for immunotherapies in Singapore and across the world, and create more than 200 jobs for the cell and gene therapy (CGT) industry in the next three to five years.
[From Left to Right] Dr Han Deping, Chief Medical Officer, Biosyngen; Dr Cheong Wei Yang, Deputy Secretary (Technology), Ministry of Health; Ms Joan Zhang, Chairman, Biosyngen; Mr Alvin Tan, Minister of State for the Ministry of Trade & Industry; Ms Lily Peng Yuemei, Deputy Party Secretary, Director, Knowledge City (Guangzhou) Investment Group and Dr Michelle Chen, Chief Operating Officer, Biosyngen
The new facility is the first and largest privately-owned, fully automatic, enclosed and integrated GMP cell manufacturing facility and Research & Development base in Singapore to date. The facility is compliant with the latest FDA (U.S. Food and Drug Administration) recommendation, enabling Biosyngen to run automatic and closed-system production – the preferred best practice in the CGT industry. Designed with containment within each production suite, this facility can support multiple clinical trials in parallel.
According to statistics from The Global Cancer Observatory (GCO), there were over five million deaths due to solid tumour cancers in Asia in 2020, accounting for 60% of the world’s mortality rate. Most solid tumours respond poorly to conventional cancer treatments such as chemotherapy. Biosyngen’s new GMP facility will leverage innovative capabilities to further the development of cutting-edge immunotherapies to improve treatment outcomes for such solid tumours.
“We started from humble beginnings in Singapore, renting a facility from Temasek Life Sciences Laboratory, and have now launched our new GMP facility. There is an urgency to increase speed in clinical trials for patients and build capacity for global needs, and Biosyngen is determined to take the lead in this space,” said Dr Michelle Chen, Chief Operating Officer, Biosyngen.
Through years of extensive research, Biosyngen’s first-in-class products targeting nasopharyngeal cancer (NPC) and EBV+ lymphoma were granted Investigative New Drug (IND) approval by the US FDA and China National Medical Products Administration (NMPA). Its product targeting NPC was also recently granted the status of Orphan Drug Designation (ODD). In June 2023, the company submitted IND applications for two other indications, lung cancer and liver cancer, to both the FDA and NMPA.
“Our facility in Singapore enables R&D in drug discovery and process development, and will also be able to accommodate more advanced processes or products that will be introduced in the future,” added Dr Cecilia Zhang, Chief Scientific Officer, Biosyngen.
In Guangzhou China, Biosyngen also has the largest GMP cell production base in South China. Biosyngen has become the only immuno-oncology company in Asia with dual headquarters, dual fully automatic and enclosed GMP, and dual R&D layout. Biosyngen has achieved the simultaneous global development of innovative drugs and cost reduction of CGT drugs to the largest extent.
“We are a company dedicated to giving cancer patients a new lease of life by developing first-in-class immunotherapies. We aim to achieve this through our Research & Development (R&D) and collaborations with key stakeholders in hospitals, the wider industry and governments.
Having two sites, one in Singapore and China, is a key global strategy for Biosyngen to advance the company’s product pipeline quicker, and drive R&D and GMP manufacturing from both sites,” said Isaac Chow, Chief Business Officer, Biosyngen.
Earlier this week, the company signed two key agreements to set up a China-Singapore Technology Innovation and Translational Medicine Centre for Tumour Prevention and Treatment as part of the Singapore-Guangdong Collaboration Council (SGCC), and a joint lab with Agency for Science, Technology and Research (A*STAR) to develop multi-specific antibodies targeting solid tumours as part of the Singapore Economic and Trade Cooperation Council.
Biosyngen is also working closely with stakeholders in the Singapore healthcare ecosystem, collaborating with the National Cancer Centre Singapore (NCCS) to conduct a basket of clinical trials for various cancer indications and biomarker discovery to enhance patient selection and effectiveness. In addition, the company has partnered with the Agency for Science, Technology and Research (A*STAR) to develop multi-specific antibodies targeting solid tumours. The company also works closely with the Advanced Cell Therapy and Research Institute (ACTRIS) to consult on GMP practices and process development.
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With R&D powered by scientists from Singapore, China, Germany, Australia, France, and America, Biosyngen is dedicated to give cancer patients a second chance by developing first-in-class innovative immunotherapies. Aiming for the global market with dual R&D centers and GMP facilities set in Singapore and China, Biosyngen owns a product portfolio with potential global market of more than 50 billion USD.
Biosyngen possesses exclusive licenses and patented therapies targeting multiple solid tumors and hematological malignancies including nasopharyngeal cancer, gastric cancer, lymphoma and posttransplant lymphoproliferative disorders. We collaborate closely with the world’s leading biomedical research and clinical institutes including A*STAR, Helmholtz Zentrum München, Hannover Medical School, Sun Yat-Sen University Cancer Center to advance our R&D process and conduct clinical trials in Singapore, Australia and China.
Utilizing our strong R&D capability and translational medicine platform, we have been able to engage the end-to-end cycle of drug development including lead identification, preclinical studies cell production and quality control, regulatory filing and clinical studies, thus integrating R&D, manufacturing and commercialization