China’s NMPA has approved Carsgen Therapeutics Holdings Ltd.’s NDA for its B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy, zevorcabtagene autoleucel (CT-053, zevor-cel), for treating adults with relapsed or refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
China’s NMPA has approved Carsgen Therapeutics Holdings Ltd.’s NDA for its B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy, zevorcabtagene autoleucel (CT-053, zevor-cel), for treating adults with relapsed or refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
A China-based manufacturer of active pharmaceutical ingredients (API) suspended producing API for the U.S. market following an FDA inspection that found “significant deviations” from good manufacturing practices at the facility.
A China-based manufacturer of active pharmaceutical ingredients (API) suspended producing API for the U.S. market following an FDA inspection that found “significant deviations” from good manufacturing practices at the facility.
After Lianbio Co. Ltd. turned away a $465 million acquisition offer from Concentra Biosciences LLC, the China and U.S.-based biotech announced it was selling off its assets and shutting down the company.
Hong Kong’s Hutchmed (China) Ltd. reported mixed phase III results of fruquintinib as a second-line combination therapy for advanced gastric cancer on Feb. 6, with the oral vascular endothelial growth factor receptor inhibitor hitting just one co-primary endpoint.
Citing national security and intellectual property (IP) concerns, a bipartisan group of U.S. lawmakers is calling on three federal departments to investigate China’s Wuxi Apptec’s ties, and that of its subsidiary, Wuxi Biologics, to the Chinese Communist Party and the country’s People’s Liberation Army.
In a crowded thyroid eye disease (TED) space, Innovent Biologics Inc. reported positive late-stage findings for its TED therapy, IBI-311, spurring the Suzhou, China-based biopharma to file for regulatory approval in China.
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