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BioWorld - Friday, May 1, 2026
Home » Topics » Regulatory » NMPA

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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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Red dart in center of red target

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

July 22, 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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Mabwell joins ADC breast cancer race as China clears phase II

July 16, 2024
By Marian (YoonJee) Chu
Mabwell Bioscience Co. gained clearance in China to start a phase II study of its novel Nectin4-targeting antibody drug conjugate (ADC), 9MW-2821, for metastatic triple-negative breast cancer.
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Needle syringe with a vaccine vial.
Immune

CSPC Pharmaceutical obtains Chinese approval to advance mRNA vaccine for RSV into clinic

July 12, 2024
CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with SYS-6016, the company’s mRNA respiratory syncytial virus (RSV) vaccine.
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Antibodies illustration

Tracon quits work on anti-PD-L1 envafolimab after phase III flop

July 2, 2024
By Tamra Sami
Tracon Pharmaceuticals Inc. is shuttering all development of its subcutaneous PD-L1 antibody, envafolimab, after the pivotal trial failed to meet the primary endpoint in soft tissue sarcoma.
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Red wooden approved stamp

China approves first cetuximab biosimilar

July 2, 2024
By Tamra Sami
China’s National Medical Products Administration authorized the country’s first cetuximab biosimilar with the approval of Simcere Zaiming’s Enlituo (CMAB-009, cetuximab beta injection) in combination with chemotherapy as first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer. The biosimilar references originator drug Erbitux (cetuximab, Eli Lilly and Co.).
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Multiple myeloma illustration
Immuno-oncology

CSPC’s mRNA-LNP-based CAR T-cell therapy cleared to enter clinic in China for multiple myeloma

June 26, 2024
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with the first mRNA-lipid nanoparticles (LNP)-based CAR T-cell injection, SYS-6020.
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Non-Hodgkin lymphoma cells in the blood flow

China’s NMPA clears Dizal’s golidocitinib in T-cell lymphoma

June 25, 2024
By Tamra Sami
China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
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