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BioWorld - Saturday, May 2, 2026
Home » Topics » Regulatory » NMPA

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Red and white blood cells

Ascentage moves BCL-2 inhibitor into fourth phase III

Aug. 14, 2024
By Tamra Sami
China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.
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Thyroid anatomy

Visen’s palopegteriparatide hits endpoints in hypoparathyroidism

Aug. 13, 2024
By Tamra Sami
Visen Pharmaceuticals Co. Ltd.’s palopegteriparatide met both primary and secondary endpoints in the phase III Pathway trial conducted in China in adults with chronic hypoparathyroidism, according to top-line data. In the 26-week randomized, double-blind, placebo-controlled Pathway trial, 77.6% of patients treated with palopegteriparatide achieved the primary multicomponent endpoint compared to 0% for placebo.
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Luye advances dual agonist for schizophrenia, Alzheimer’s

Aug. 13, 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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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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