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BioWorld - Sunday, April 19, 2026
Home » Topics » Regulatory » NMPA

NMPA
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Kim Dong-gun (DG), CEO, Elevar

Elevar gets new CEO, files NDAs for lirafugratinib, rivoceranib

Jan. 30, 2026
By Marian (YoonJee) Chu
No Comments
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
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Stomach cross section on abstract scientific background

Alphamab’s HER2 bispecific hits phase III gastric cancer endpoints

Jan. 27, 2026
By Tamra Sami
No Comments
Suzhou Alphamab Co. Ltd.’s HER2 bispecific antibody, anbenitamab (KN-026), combined with chemotherapy has the potential to become a new standard of care for patients with HER2-positive gastric cancer who failed at least one prior line of therapy, according to newly released phase III results that show the combo cut disease progression risk by 75%.
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Cancer

China’s NMPA clears clinical trial of Henlius’ HLX-701

Jan. 22, 2026
No Comments
China’s National Medical Products Administration (NMPA) has cleared Shanghai Henlius Biotech Inc. to initiate a phase Ib/II trial of HLX-701 in combination with cetuximab and chemotherapy for the treatment of patients with advanced RAS/BRAF wild-type colorectal cancer.
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China flag and vial

Six drugs to watch in China for 2026

Jan. 20, 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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China accepts Telix/Grand Pharma NDA for TLX-591-CDx

Jan. 20, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has accepted for review Grand Pharmaceutical Group Ltd./Telix Pharmaceuticals Ltd.’s NDA for TLX-591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate for diagnosing prostate cancer.
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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.
Read More

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.
Read More
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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