Suzhou Abogen Biosciences Co. Ltd.’s $700 million series C fundraising provides tailwinds for the development of its messenger ribonucleic acid (mRNA) platform. The company plans to accelerate its COVID-19 mRNA vaccine clinical trial, develop other vaccine candidates and oncology programs.
An update from China’s NMPA clarifying registration requirements and classification methods for drug-device combination products has been welcomed by industry as the regulator seeks to keep pace with fast-moving developments in the sector.
Innovent Biologics Inc.’s PCSK9 inhibitor, IBI-306, intended for the treatment of heterozygous familial hypercholesterolemia (HeFH), has met its primary endpoint in a phase III study in Chinese patients.
Inmagene Biopharmaceuticals Co. Ltd. has licensed rights from Kissei Pharmaceutical Co. Ltd. to develop and commercialize the spleen tyrosine kinase (Syk) inhibitor fostamatinib for all potential indications in China.
Following an interim analysis of phase III gastric cancer data, Innovent Biologics Inc. said it’s planning to seek an expanded label the company’s Eli Lilly and Co.-partnered PD-1 inhibitor, Tyvyt (sintilimab), in the indication. According to Innovent, a combination of the drug with chemotherapy met the primary endpoint of overall survival in the study, delivering a statistically significant improvement in the measure vs. placebo, also with chemotherapy.
China’s NMPA has given Belief Biomed Inc. the official go-ahead to start testing its investigational gene therapy, BBM-H901, for the potential treatment of hemophilia B in the country, marking the first time an I.V. gene therapy for a rare disease has been approved in China. The company plans to advance the phase I/II trial for the candidate shortly, it said.
Preliminary real-world data showed that Chinese inactivated vaccines are 63% protective against the COVID-19 Delta variant, China’s top epidemiologist Zhong Nanshan said at the 24th Respiratory Disease Academic Conference of Guangdong Medical Association in Guangzhou.
Akeso Inc. became the fifth company to score an approval for a homegrown PD-1 antibody in China, with penpulimab cleared for relapsed or refractory (r/r) classic Hodgkin’s lymphoma (cHL).
Burning Rock Biotech Ltd. has formed a global strategic partnership with Impact Therapeutics Inc. to develop companion diagnostics for a pipeline of drugs in the field of synthetic lethality.
Cell therapy company Zhuhai Grit Biotechnology Inc. completed a series A+ financing of undisclosed value to advance its lead tumor-infiltrating lymphocyte (TIL) program, GT-101 for advanced solid tumors, into the clinic by year end while also developing other TIL candidates in its pipeline.
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