SCG Secures IND Approvals from China and Singapore for SCG101, Advancing Global Cell Therapy Strategy
SCG
Innovative Immunotherapy Developer
HSA
The Health Sciences Authority (HSA) is a statutory board under the Ministry of Health of the Singapore Government, formed by integrating five specialized agencies: the Centre for Drug Evaluation, the Institute of Science and Forensic Medicine, the National Pharmaceutical Administration, the Product Regulation Department, and the Singapore Blood Transfusion Service. The agency’s vision is to become a leading authority in safeguarding and promoting national health and safety.
SCG Cell Therapy
Innovative Immunotherapy Developer
On May 9, SCG (SCG Cell Therapy Pte. Ltd.) announced that its product SCG101—a novel TCR-T cell therapy for treating HBV-related hepatocellular carcinoma—has received IND approval from the Health Sciences Authority (HSA) of Singapore. Just in early March, SCG101 had obtained IND approval from the National Medical Products Administration (NMPA) of China, becoming the first TCR-T cell therapy product approved by the NMPA for the treatment of liver cancer.
Dr. Yong Wei Peng from the Cancer Institute of Singapore National University stated, "Liver cancer is one of the most common causes of cancer-related deaths, and there are significant challenges with existing treatment options in meeting patient needs. The IND approval of SCG101 is expected to provide a new treatment option for liver cancer patients in the Asia-Pacific region and even globally."
Professor Toh Han Chong, Chief Investigator at the National Cancer Centre Singapore, stated: "Cell therapy is one of the most promising and rapidly advancing treatments for life-threatening diseases such as cancer. SCG101 cell therapy, as the leading personalized cancer treatment solution, brings new hope to liver cancer patients in Singapore."
SCG CEO Wang Shuli stated that liver cancer is the second leading cause of cancer-related deaths globally, resulting in over 700,000 deaths annually. In terms of case distribution, four out of every five new liver cancer cases worldwide occur in the Asia-Pacific region, with China accounting for half of these cases. As the medical hub of Southeast Asia and a top global destination for medical tourism, Singapore's dual IND approval in China and Singapore will meet the needs of liver cancer patients in the Asia-Pacific region in the future. This aligns with the company’s expectations and represents a planned component of SCG's global cell therapy strategy.
For SCG, the IND approval obtained in Singapore this time was also expected. According to the official website of Singapore's Health Sciences Authority (HSA), as early as 2021, HSA announced that SCG had become its official partner. Together, they assessed and validated the manufacturing process of SCG’s cell therapy. The validation results fully supported the company's self-developed product, SCG101 TCR-T cell therapy IND application, demonstrating SCG’s prominence and leading position in cell therapy in Singapore.
Image source: Health Sciences Authority (HSA) official website, Singapore
As is known to all, Singapore incorporated the biopharmaceuticals industry into its national strategic planning at an early stage. From 2000 to 2019, Singapore's biopharmaceutical manufacturing industry achieved a compound annual growth rate of 9%. The world's top ten and most profitable multinational pharmaceutical giants such as GSK, Novartis, Roche, Sanofi, and Merck have established their Asia-Pacific headquarters, large-scale manufacturing plants, or research and development centers in Singapore. Since its inception, SCG has possessed an international "gene." The company’s global headquarters is located in Singapore, with research, translation, and clinical centers in Germany, Singapore, and China. The synchronized globalization layout of IND has become SCG's core competitive advantage, which will undoubtedly help SCG take another step forward on its path to becoming a leading biopharmaceutical enterprise in the Asia-Pacific region.