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.
Sinovac Biotech Ltd. said booster shots of its Coronavac vaccine against SARS-CoV-2 induce strong immune responses in adult and elderly populations following a considerable loss of antibodies six to eight months after completing the current two-dose regimen.
Jiangsu Gdk Biotechnology Co. Ltd. will further develop its vaccine pipeline after it started trading on the Shanghai Stock Exchange Star Market on Aug. 2, where it raised ¥1.21 billion ($187 million) through an initial public offering of 22 million shares. The company plans to use the proceeds from the listing to establish a manufacturing plant to produce its quadrivalent influenza vaccine and invest in R&D for other vaccine candidates, as well as replenish working capital and repay bank loans.
China’s National Health Commission has just released a new set of regulations to evaluate the clinical value of both approved drugs and those still in trials as part of its efforts to improve the market standards.
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