Beigene Ltd. has received approval from China’s NMPA to market Sylvant (siltuximab) for the treatment of patients with multicentric Castleman disease, including HIV-negative and human herpes virus-8-negative disease. The green light comes at a good time as the Beijing-headquartered company is preparing for a $3.5 billion listing on Shanghai’s STAR Market, its third listing. The monoclonal antibody siltuximab previously received regulatory approval in the U.S. and Europe.
Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
Ascentage Pharma Group International’s olverembatinib has received marketing approval from China’s NMPA for the treatment of patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CMP-AP) harboring a T315I mutation. The Suzhou, China-based firm said the decision marks the country’s first approved third-generation BCR-ABL inhibitor for the treatment of TKI-resistant CML.
SK Biopharmaceuticals Co. Ltd. has launched a central nervous system-focused biotech company called Ignis Therapeutics Ltd. with a $180 million series A round led by 6 Dimensions Capital L.P. The financing of the new Shanghai-based company represents the largest series A investment in China’s biopharma industry in 2021, according to the two founding companies. KB Investment Co. Ltd, WTT investment Ltd., HBM Healthcare Investments AG and Goldman Sachs Group Inc. also participated in the round.
Ascletis Pharma Inc. has obtained the global development and commercialization right for ASC-22 (envafolimab) outside greater China from Suzhou-based Alphamab Oncology Co. Ltd. to treat viral diseases including hepatitis B.
Shouti Inc. raised $100 million in a series B round led by BVF Partners LP to advance its discovery platform for designing oral medicines and to speed up the development of its candidates. The Shanghai and California-based company has secured a total of $158 million in funding so far.
China’s Center for Drug Evaluation (CDE) released a draft guide on clinical trials of drugs for rare disease as part of an ongoing push to encourage new drug development and nudge developers to focus on biomarkers, pharmacometrics and patient-reported outcomes. Both are needed to continue moving China’s R&D capabilities up the value chain and closer to being on par with the capabilities of other countries that are at the forefront of new drug development.
A pan-cancer liquid biopsy solution that was developed by Twist Bioscience Corp. and Anchordx Medical Co. Ltd. has been launched globally. The companies will market the Twist Alliance Pan-Cancer Methylation Panel (Pan-Cancer Panel) jointly. The Pan-Cancer Panel is a solution for pan-cancer study including DNA methylation library preparation and targeted enrichment for next-generation sequencing (NGS).
Cell therapy developer Cellular Biomedicine Group Inc. (CBMG) completed a $120 million series A financing, its first since becoming a private company. The funds will benefit the U.S. and China-based firm’s CAR T pipeline.
Cstone Pharmaceuticals Co. Ltd. released positive data from the phase III trial, Gemstone-302, of sugemalimab plus chemotherapy for the first-line treatment of patients with stage IV squamous and non-squamous non-small cell lung cancer.
