iRegene’s NouvSight001 Cleared for Retinitis Pigmentosa Trials in China and U.S.
iRegene Therapeutics has secured regulatory clearance in both China and the United States to move NouvSight001, its off-the-shelf photoreceptor cell therapy, into clinical development for retinitis pigmentosa (RP), giving the company another opportunity…
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…
LaNova Medicines’ Next-Generation Nectin-4 ADC LM-364 Wins China IND Clearance for Advanced Solid Tumors
LaNova Medicines has received clearance from China’s National Medical Products Administration (NMPA) to advance LM-364, its next-generation tumor microenvironment-responsive Nectin-4 antibody-drug conjugate (ADC), into clinical development for patients…
Leads Biolabs’ Opamtistomig NDA Accepted in China, Setting Up Potential World-First 4-1BB Therapy
Nanjing Leads Biolabs announced that China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for Opamtistomig (LBL-024), the company’s internally developed…
Innovent’s Once-Weekly Oral GLP-1 IBI3042 Gets NMPA IND Clearance for Obesity
Innovent Biologics has received clearance from China’s National Medical Products Administration (NMPA) to begin clinical development of IBI3042, a potentially first-in-class once-weekly oral small-molecule GLP-1 receptor agonist, marking another…
Hengrui Advances SHR-8203 Into Phase 1/2 Study in Advanced Solid Tumors, With Filing Hinting at Potential PD-1/VEGF/CTLA-4 Trispecific
Chinese pharmaceutical giant Hengrui Pharma has registered a new clinical study of SHR-8203 injection on China’s drug trial registration platform, moving the previously undisclosed biologic into a multicenter Phase 1/2 trial in patients with…