In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor.
CSPC Pharmaceutical Group Ltd.’s selective son of sevenless homolog 1 (SOS-1) inhibitor SYH-2038 has received clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials in China.
In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor.
The U.S. and China biotech Apollomics Inc. on Nov. 16 gained the NMPA’s conditional approval for its cellular mesenchymal-epithelial transcription inhibitor for lung cancer called vebreltinib (APL-1010) through its Beijing-based partner, Avistone Biotechnology Co. Ltd.
The U.S. and China biotech Apollomics Inc. on Nov. 16 gained the NMPA’s conditional approval for its cellular mesenchymal-epithelial transcription inhibitor for lung cancer called vebreltinib (APL-1010) through its Beijing-based partner, Avistone Biotechnology Co. Ltd.
Abbisko Therapeutics Co. Ltd. has received clearance from China's National Medical Products Administration (NMPA) to conduct clinical trials in China of ABSK-051, a novel small-molecule CD73 inhibitor, for advanced solid tumors.
CSPC Pharmaceutical Group Ltd.’s SYS-6011 has been cleared by China’s National Medical Products Administration (NMPA) to enter clinical trials in China for solid tumors.
Researchers from Shanghai Henlius Biotech Inc. presented the discovery and preclinical characterization of HLX-42, a next-generation EGFR-targeting antibody-drug conjugate (ADC) being developed for the treatment of cancer.
China’s National Medical Products Administration (NMPA) has largely completed its development of overarching regulations for medical devices and is now drilling down into more granular matter, such as a guidance on assessments of benefits and risks for medical devices. Grace Fu Palma, CEO of China Med Device LLC, told BioWorld that this new guidance is a much more detailed version of the 2019 edition, but added that China’s anticorruption efforts will be ramped up with an eye toward health care, just one of several current and impending developments of interest in this massive market.
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