China NMPA Clears Five Novel Drugs and Two New Indications in September Approval Wave
China’s National Medical Products Administration (NMPA) delivered another busy round of regulatory decisions in early September 2026, clearing a group of innovative therapies spanning oncology, infectious disease, cardiovascular medicine, hematology and…
Livzon/Kanova’s Lecankitug Gets China Approval After Beating Secukinumab in Phase 3 Psoriasis Trial
China’s National Medical Products Administration (NMPA) has approved lecankitug (LZM012/XKH004), an IL-17A/IL-17F-targeting monoclonal antibody jointly developed by Livzon Pharmaceutical Group and Beijing Kanova Biopharmaceutical, for the treatment of…
HUTCHMED’s Fanregratinib Wins China NMPA Approval for FGFR2+ Intrahepatic Cholangiocarcinoma (ICC)
HUTCHMED has secured conditional approval from China’s National Medical Products Administration (NMPA) for fanregratinib (HMPL-453), providing a new targeted treatment option for patients with FGFR2-altered intrahepatic cholangiocarcinoma (ICC). The NMPA…
TYK Medicines Wins China Approval for Asandeutertinib in EGFR-Mutant NSCLC With Brain Metastases
China’s NMPA has granted conditional approval to asandeutertinib (TY-9591), TYK Medicines’ brain-penetrant, deuterated EGFR inhibitor, for the first-line treatment of patients with EGFR-mutated non-small cell lung cancer with central nervous…
China’s NMPA Conditionally Approves GenrixBio’s Velinotamig for Heavily Pretreated Multiple Myeloma
China’s National Medical Products Administration (NMPA) has granted conditional approval to velinotamig (GR1803), a BCMA×CD3 bispecific antibody developed by Genrix Bio and partnered with Fosun Pharma’s YaoPharma, for adults with heavily pretreated…
Haisco’s class 1 small-molecule PNH drug has been approved for marketing in China
Today (July 23), the National Medical Products Administration (NMPA) of China announced that it has approved the marketing of Haisco Pharmaceutical‘s Class 1 innovative drug, Succinate Spocoman tablets (HSK39297), through the priority review and…