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Home » Topics » Regulatory » NMPA

NMPA
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IPO, coins, financial chart

China pharma migration: Hengrui greenlighted for Hong Kong IPO

April 28, 2025
By Marian (YoonJee) Chu
Jiangsu Hengrui Pharmaceuticals Co. Ltd. is the latest mainland China pharmaceutical company to seek a capital raise on the Hong Kong stock exchange, winning clearance April 28 from the China Securities Regulatory Commission to float new H-shares.
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Blood pressure monitor
Cardiovascular

Chinese IND clearance for Rona′s AGT-targeting siRNA drug for hypertension

April 25, 2025
Rona Therapeutics Co. Ltd. has obtained IND clearance from China′s National Medical Products Administration (NMPA) for RN-1871, a small interfering RNA (siRNA) drug targeting angiotensinogen (AGT) for hypertension.
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Handshake with digital globe overlay

Chinabio 2025: Europe-China pharma deals rise as US markets shut

April 23, 2025
By Marian (YoonJee) Chu
Europe was a bigger counterpart to China in pharmaceutical dealmaking than the U.S. last year, speakers at Chinabio Partnering Forum said April 23, and the trend is likely to continue in 2025 with the shuttering of U.S. capital and volatility ailing global markets.
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China adds Ascentage's lisaftoclax, olverembatinib to guidelines

April 23, 2025
By Tamra Sami
Ascentage Pharma Group Corp. Ltd. said two of its novel candidates have been included in the 2025 Chinese Society of Clinical Oncology Guidelines, including its in-house developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which is under review in China and could be the first domestically approved Bcl-2 inhibitor and the second global approval.
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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.
Read More
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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