Immuno-oncology company Biosyngen opens new cell therapy GMP facility in Singapore

New state-of-the-art facility to develop immunotherapy assets to address unmet needs in cancer treatment

SINGAPORE,June 29,2023 --Biosyngen,an immune-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 GMP will support cell manufacturing for immunotherapies in Singapore and across the World for the cell and gene therapy (CGT) industry in the next three to five years for gobally.

[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 opening was officiated by Mr Alvin Tan,Minister of State for Trade and Industry,and executives from Biosyngen including Ms Joan Zhang,Chairman of Biosyngen,Dr Benjamin Seet,Board Member of Biosyngen,Dr Michelle Chen,Chief Operation Officer and Prof. Jean Paul Thiery,Chief Scientist of Biosyngen. The opening was also witnessed by distinguished guests from Ministry of Health,Enterprise Singapore,Economic Development Board,Singapore Exchange,The Agency for Science,Technology and Research and National Cancer Centre Singapore.

The new facility is the first and the largest privately owned fully automatic and enclosed integrated GMP cell manufacturing facility and R&D base in Singapore so far,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.

"In the Singapore 2030 plan,advanced manufacturing and BioPharm is a key component. The opening of Biosyngen's GMP Facility contributes directly to the 2030 plan. It is the first and so far the largest privately owned GMP manufacturing facility in Singapore. Government will continue to support the growth of this sector,"said Mr Alvin Tan,Minister of State for the Ministry of Trade & Industry.

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[1]. Most solid tumours respond poorly to conventional cancer treatments such as chemotherapy[2]. 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.

"Through years of effort by the Biosyngen team,our first-in-class products targeting nasopharyngenl carcinoma and EBV+ lymphoma were granted IND by US FDA and CN NMPA; and recently granted orphan drug designation status as well. Just this month,we submitted IND applications for two other indications,lung cancer and liver cancer,to both FDA and NMPA. From our humble beginning in Singapore,renting a facility from Temasek Lifesciences Lab,we're embarking on this new GMP Facility for patients worldwide. The urgency in increasing speed in clinical trials for patients and building capacity for global needs. Biosyngen is determined to become a leader in the CGT industry." Dr. Michelle Chen,COO Biosyngen.

In Guangzhou China Biosyngen also has the largest GMP cell production base in South China. Biosyngen has become the one and only cell and gene therapy biotech in Asia with dual headquarter,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 lifeby 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 site," said Isaac Chow,CBO Biosyngens.

"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,CSO Biosyngen.

Earlier this week,the company signed two important agreements to set up a China-Singapore Technology Innovation and Translational Medicine Centre for Tumor 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.

AboutBiosyngen

Biosyngen is a cell and gene therapy biotechnology company,focusing on R&D in immunotherapy and drug development; to achieve the best outcome for cancer patients.

The company's R&D team consists of multinationals from Singapore,China,Germany,Australia,France and the US,many of whom received their Phd. from renowned universities. Biosyngen's strategy of dual R&D centres and dual GMP facilities in Singapore and China,firmly anchors it as an Asian company towards a global ambition. The company's product pipeline potentially addresses an estimated value of 50 billion USD in the global oncology market.

Biosyngen possesses exclusive licenses and patented therapies targeting multiple solid tumors and hematological malignancies including nasopharyngeal cancer,gastric cancer,gastrointestinal cancer and EBV-positive hematological malignancies. The company's first-in-class product BRG01 was granted IND approval by US FDA and CN NMPA for Phase I/II clinical trial. BRG01 has also been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development (OOPD). Biosyngen is also one of a few biopharmaceutical companies that possess a portfolio consisting of CAR-T,TCR-T,TIL and multi-specific antibodies.

Based in Singapore and Guangzhou,Biosyngen 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 and a network of hospitals to advance R&D,develop products and conduct clinical trials in Singapore,Australia and China.

Through our R&D capability and translational medicine platform,Biosyngen have been able to engage the end-to-end cycle in drug development from lead identification,preclinical studies,cell production,quality control,regulatory filing,to clinical studies - integrating the entire chain of R&D,clinical trial,GMP manufacturing and commercialization.

Biosyngen contact email：info@biosg.com

[1]https://novotech-cro.com/sites/default/files/2022-07/Novotech_DiseaseReport_SOLIDTUMORS_APAC_CT_LANDSCAPE.pdf

[2]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5852245/