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BioWorld - Saturday, February 7, 2026
Home » Topics » Regulatory » NMPA

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China flag and vial

Six drugs to watch in China for 2026

Jan. 16, 2026
By Tamra Sami
No Comments
As China emerges as a critical commercial market and a source of global innovation, the newly released 2026 edition of Clarivate’s Drugs to Watch report highlights six drugs to watch in the China market for the year ahead.
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Hutchmed plans China NDA filing of sovleplenib in rare anemia

Jan. 13, 2026
By Marian (YoonJee) Chu
No Comments
Hutchmed Ltd. plans to file a second NDA in China for sovleplenib, a novel spleen tyrosine kinase inhibitor, based on positive phase II/III findings in warm antibody autoimmune hemolytic anemia.
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Hutchmed plans China NDA filing of sovleplenib in rare anemia

Jan. 8, 2026
By Marian (YoonJee) Chu
No Comments
Hutchmed Ltd. plans to file a second NDA in China for sovleplenib, a novel spleen tyrosine kinase inhibitor, based on positive phase II/III findings in warm antibody autoimmune hemolytic anemia.
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Immune

Cansino’s PCV24 gains clinical trial clearance in China

Jan. 7, 2026
No Comments
Cansino Biologics Inc. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for the company’s 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (PCV24).
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3D map of China

NMPA aims to tamp down on online sales of med tech

Jan. 6, 2026
By Mark McCarty
China’s National Medical Products Administration (NMPA) has issued guidance governing online sales of medical devices with a focus on inspections of the products’ manufacturing facilities. The agency made it clear that the manufacturer will have to deal promptly with any deviations from the regulations or face enforcement action, signaling a new era of tighter scrutiny of online sales of these products.
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Illustration of cancer cell in crosshairs being destroyed
Immuno-oncology

Three Helius solid tumor candidates gain clinical trial clearance

Dec. 31, 2025
No Comments
Shanghai Henlius Biotech Inc. has announced acceptance of IND applications by China’s National Medical Products Administration (NMPA) for three differentiated candidates for the treatment of solid tumors.
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Liver illustration

China accepts Hutchmed fanregratinib NDA on single phase II trial

Dec. 30, 2025
By Tamra Sami
No Comments
Hutchmed (China) Ltd. has moved closer to establishing China’s first domestically developed FGFR-targeted therapy for intrahepatic cholangiocarcinoma, after the National Medical Products Administration (NMPA) accepted its NDA for fanregratinib (HMPL-453) and granted the drug priority review.
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Illustration of red and white blood cells in an artery
Endocrine/metabolic

CSPC cleared to advance SYH-2072 into clinic in China

Dec. 30, 2025
No Comments
CSPC Pharmaceutical Group Ltd. has obtained approval from the National Medical Products Administration (NMPA) in China to conduct clinical trials of SYH-2072 (tablets), a highly selective and potent aldosterone synthase inhibitor. It is being investigated as a potential treatment for uncontrolled hypertension and primary aldosteronism.
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Illustration of intestinal track

China approves Innovent’s ipilimumab for colon cancer

Dec. 30, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration approved Innovent Biologics Inc.’s NDA for Tabosun (ipilimumab N01, IBI-310) in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient colon cancer.
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Illustration of intestinal track

China approves Innovent’s ipilimumab for colon cancer

Dec. 29, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration approved Innovent Biologics Inc.’s NDA for Tabosun (ipilimumab N01, IBI-310) in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient colon cancer.
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