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BioWorld - Wednesday, February 11, 2026
Home » Topics » Regulatory » NMPA

NMPA
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Neurology/psychiatric

Luye advances dual agonist for schizophrenia, Alzheimer’s

Aug. 12, 2024
By Tamra Sami
China’s National Medical Products Administration has cleared Luye Pharma Group Ltd.’s new schizophrenia candidate LY-03020 to enter phase I trials in China. Independently developed by Shanghai-based Luye, the new chemical entity is a dual agonist that targets both the trace amine-associated receptor 1 and the 5-HT2C receptor and is intended to treat schizophrenia and Alzheimer’s disease psychosis.
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3D rendering of CAR T therapy in cell
Immune

BCMA-targeting CAR T cell cleared for clinic by China’s NMPA

Aug. 12, 2024
CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with its BCMA-targeting CAR T cell SYS-6020 for systemic lupus erythematosus (lupus) in China.
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Luye advances dual agonist for schizophrenia, Alzheimer’s

Aug. 8, 2024
By Tamra Sami
China’s National Medical Products Administration has cleared Luye Pharma Group Ltd.’s new schizophrenia candidate LY-03020 to enter phase I trials in China. Independently developed by Shanghai-based Luye, the new chemical entity is a dual agonist that targets both the trace amine-associated receptor 1 and the 5-HT2C receptor and is intended to treat schizophrenia and Alzheimer’s disease psychosis.
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3D map of China

China to deepen health care reforms to increase primary care capacity

Aug. 8, 2024
By Tamra Sami
China will deepen its health care reforms and will focus on enhancing its public health care capacity at the primary care level and at public hospitals, according to resolutions passed at the third plenary session of the 20th Central Committee of the Communist Party of China in July.
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Cancer

Westgene therapeutic vaccine cleared for clinic in US, China

Aug. 8, 2024
Chengdu Westgene Biopharma Co. Ltd. (Westgene) has received approval from both China's National Medical Products Administration (NMPA) and the FDA for its therapeutic cancer vaccine WGc-043 to enter first-in-human trials.
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Chinese flag and pills

China to deepen health care reforms, boost primary care capacity

Aug. 6, 2024
By Tamra Sami
China will deepen its health care reforms and will focus on enhancing its public health care capacity at the primary care level and at public hospitals, according to resolutions passed at the third plenary session of the 20th Central Committee of the Communist Party of China in July.
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Businessman and IPO virtual screen

Jiuyuan, Biokin, Transthera file for Hong Kong IPOs in July

July 30, 2024
By Marian (YoonJee) Chu
Three Chinese biopharmaceuticals have filed for IPOs on the Hong Kong exchange in July alone, highlighting a potential “newfound positivity” to strengthen the HKEX IPO market in the second half of 2024.
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Illustration of man with systemic lupus erythematosus showing rash on face and arms
Immune

Iaso Biotechnology cleared for clinical studies of IASO-782 in systemic lupus erythematosus

July 25, 2024
Iaso Biotechnology Co. Ltd. has announced that China’s National Medical Products Administration (NMPA) has approved the IND application for IASO-782 injection for a new indication – systemic lupus erythematosus.
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Tape measure wrapped around scale

Gan & Lee’s long-acting GLP-1 shows weight loss in phase IIb

July 23, 2024
By Tamra Sami
Gan & Lee Pharmaceuticals’ long-acting GLP-1 receptor agonist (GLP-1 RA), GZR-18, achieved as much as 17.29% weight loss in a phase IIb trial in obese and overweight Chinese patients. Developed independently by Shanghai-based Gan & Lee, GZR-18 is a once-weekly or potentially biweekly GLP-1 RA being developed to treat adults with type 2 diabetes and for weight management for obese or overweight patients.
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Red dart in center of red target

Innovent’s mazdutide hits phase III endpoints in type 2 diabetes

July 23, 2024
By Tamra Sami
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, mazdutide, met the primary endpoint and all key secondary endpoints in a phase III type 2 diabetes trial in Chinese adults. “Mazdutide is the first and fastest-developed GLP-1R/GCGR dual agonist in the world, and we are actively promoting the development of mazdutide for weight loss, T2D and other indications,” Lei Qian, Innovent’s vice president of clinical development, said.
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