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Home » Topics » Regulatory » NMPA

NMPA
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China’s NMPA accepts Innocare’s zurletrectinib NDA for solid tumors

April 22, 2025
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted Innocare Pharma Ltd.’s NDA for its second-generation pan-tropomyosin receptor kinase inhibitor, zurletrectinib (ICP-723), for treating adults and adolescents with advanced solid tumors harboring neurotrophic tyrosine receptor kinase gene fusions.
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Hand holding elbow

Akeso scores China approval for ebdarokimab in plaque psoriasis

April 22, 2025
By Tamra Sami
China’s National Medical Products Administration has given the thumbs up to Akeso Pharmaceuticals Inc.’s ebdarokimab for treating moderate to severe plaque psoriasis in adults. An interleukin (IL)-12/IL-23 dual-targeted monoclonal antibody, ebdarokimab (also known as AK-101) is the company's first class 1 new drug approved for autoimmune diseases.
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China’s NMPA accepts Innocare’s zurletrectinib NDA for solid tumors

April 16, 2025
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted Innocare Pharma Ltd.’s NDA for its second-generation pan-tropomyosin receptor kinase inhibitor, zurletrectinib (ICP-723), for treating adults and adolescents with advanced solid tumors harboring neurotrophic tyrosine receptor kinase gene fusions.
Read More
3D representation of tumor
Cancer

Hansoh Pharma’s HS-10529 cleared to enter clinic in China for advanced solid tumors

April 16, 2025
Hansoh Pharmaceutical Group Co. Ltd. has obtained clinical trial clearance from China’s National Medical Products Administration (NMPA) for HS-10529 tablets.
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Telitacicept packaging

Remegen’s lupus drug surfaces with phase III myasthenia gravis data

April 15, 2025
By Marian (YoonJee) Chu
Remegen Co. Ltd. emerged as a surprise challenger in the generalized myasthenia gravis space, unveiling positive phase III data of its China-approved lupus drug, telitacicept (RCT-18; Tai’ai), in the rare autoimmune neuromuscular disorder at the 2025 American Academy of Neurology conference.
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Kelun Biotech rendering of sacituzumab tirumotecan

Kelun posts phase I/II data of China’s first TROP2 ADC for NSCLC

April 15, 2025
By Marian (YoonJee) Chu
Phase I/II trial results of sacituzumab tirumotecan (sac-TMT; Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.) published in Nature Medicine came a month after China’s National Medical Products Administration gave clearance to Kelun-Biotech’s supplemental NDA of sac-TMT to treat advanced non-small-cell lung cancer (NSCLC).
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Blood glucose chart and monitor, stethoscope, injector pen

Hightide’s HTD-1801 meets phase III endpoints in type 2 diabetes

April 15, 2025
By Tamra Sami
Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met primary and secondary endpoints in the Symphony 1 and Symphony 2 phase III trials in type 2 diabetes in Chinese patients. Based on the data, Shenzhen-based Hightide will submit an NDA to China’s National Medical Products Administration (NMPA) later this year.
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Illustration of antibodies targeting cancer cell
Immuno-oncology

China’s NMPA clears Simcere Zaiming’s FGFR2b-targeting ADC to enter clinic

April 15, 2025
Simcere Zaiming Pharmaceutical Co. Ltd. has received clinical trial approval from China’s National Medical Products Administration (NMPA) for the company’s antibody-drug conjugate (ADC), SIM-0686, for FGFR2b-positive, locally advanced or metastatic solid tumors.
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Heart illustration
Cardiovascular

CSPC’s SYH-2046 gains clinical trial clearance in China for heart failure

April 14, 2025
CSPC Pharmaceutical Group Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYH-2046 for heart failure after acute myocardial infarction.
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Telitacicept packaging

Remegen’s lupus drug surfaces with phase III myasthenia gravis data

April 9, 2025
By Marian (YoonJee) Chu
Remegen Co. Ltd. emerged as a surprise challenger in the generalized myasthenia gravis space, unveiling positive phase III data of its China-approved lupus drug, telitacicept (RCT-18; Tai’ai), in the rare autoimmune neuromuscular disorder at the 2025 American Academy of Neurology conference.
Read More
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