Coherus Biosciences Inc. and partner Shanghai Junshi Biosciences Co. Ltd. continued to build their case for the anti-PD-1 antibody toripalimab, popping the lid off positive interim data from the pivotal, combination phase III study called Choice-01 in first-line advanced squamous or non-squamous non-small-cell lung cancer (NSCLC).
Adlai Nortye Biopharma Co. Ltd.’s $100 million series D financing in July threw new light on the enticing prospect of targeting EP4 in prostaglandin (PGE2)-driven cancers, and a number of players are lined up in the space.
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.
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.
Astrazeneca plc and Daiichi Sankyo Co. Ltd. are pushing forward with a challenge to Roche Holding AG with breast cancer drug Enhertu (trastuzumab deruxtecan) after it demonstrated superiority over the Swiss firm’s Kadcyla (trastuzumab emtansine) in a head-to-head trial.
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.
SK Bioscience Ltd. has won approval from the South Korean Ministry of Food and Drug Safety (MFDS) to begin a phase III trial for its COVID-19 vaccine candidate GBP-510, making the recombinant protein antigen vaccine the first domestically developed candidate to make it to late-stage testing. “We aim to begin the phase III trials within August and to have the data ready by early 2022,” a company spokesman told BioWorld.
Shionogi & Co. Ltd. started a phase I trial in Japan for S-217622, its orally administered 3CL protease inhibitor for treating COVID-19. Should the drug be approved by Japanese regulators, it would be the first Japanese-developed COVID-19 treatment to be approved in the country.
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