Gene therapy faces complexities in delivering treatments due to persistent safety concerns and daunting immune responses, but Next Generation Gene Therapeutics Inc. has found a way around this issue using dual-functional vectors to simultaneously remove harmful, mutated genes and replace them with normal, healthy genes to restore cellular function.
Drug regulators around the world have a unique opportunity – and, in some cases, a legal mandate – to remove the taint of forced labor from the biopharma supply chain. But some of them, including the U.S. FDA and Japan’s PMDA, may be turning a blind eye to those responsibilities, according to a recent report from the nonprofit Centers for Advanced Defense Studies.
Astrazeneca plc’s China president, Leon Wang, is under investigation in mainland China, the company said in an Oct. 30 statement. Although details are scant, Astrazeneca said Wang is “cooperating with an ongoing investigation by Chinese authorities,” and the company’s China operations will continue under the leadership of the current general manager of Astrazeneca China.
After raising $42 million in a series C1 round, Lanova Medicines Ltd. is advancing its lead phase III antibody-drug conjugate LM-302 that targets Claudin 18.2, as well as LM-299, an anti-PD-1/VEGF bispecific antibody, and LM-108, an anti-CCR8 monoclonal antibody. “Proceeds from this financing will allow us to expedite the development of our late-stage clinical programs, LM-302 and LM-108, moving us closer to market approval. We will also accelerate the clinical development of LM-299, which is currently in phase I clinical trials with best-in-class potential,” Lanova founder and CEO Crystal Qin said.
Innocare Pharma Ltd.’s tyrosine kinase 2 (TYK2) inhibitor, ICP-488, met the primary endpoint in a phase II trial in Chinese patients with moderate to severe plaque psoriasis, and the results clear the way to accelerate clinical development in psoriasis and other autoimmune diseases.
China’s National Medical Products Administration has given the thumbs up to Junshi Biosciences Co. Ltd.’s NDA for ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, marking the third PCSK9 inhibitor to be cleared in China.
Akeso Pharmaceuticals Inc. raised $250 million via a public offering that will allow the company to accelerate clinical development of its internally developed drugs in both China and international markets. The offering consists of 31.7 million shares priced at HKD$61.28 (US$7.88) per share and marks the second successful placement in 2024 for Guangdong, China-based Akeso. Following the offering, the company's cash on hand is expected to be $1.064 billion.
Wuhan YZY Biopharma Co. Ltd. is out-licensing lead candidate M-701, a CD3/EpCAM bispecific antibody, to Chia Tai Tianqing Pharmaceutical Group Co. Ltd. (CTTQ) for China rights in a deal worth up to $143 million. Under the deal, Sino Biopharmaceutical Ltd. subsidiary CTTQ is granted an exclusive license to develop, register, manufacture and commercialize M-701 within mainland China.
China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rivastigmine transdermal patch to treat mild to moderate Alzheimer’s disease. Developed by Sino Biopharm, the patch is the first domestically produced rivastigmine transdermal patch approved for marketing. Rivastigmine is a cholinesterase inhibitor used for the treatment of Alzheimer’s disease.
China’s National Medical Products Administration (NMPA) has accepted NDAs for Innovent Biologics Inc.’s IL-23p19 antibody picankibart to treat moderate to severe plaque psoriasis, and Lepu Biopharma’s antibody-drug conjugate MRG-003, to treat recurrent or metastatic nasopharyngeal cancer.
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