National Medical Products Administration– tag –
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Akeso’s EGFR/TROP2 Bispecific ADC AK158D1 Cleared for Phase I Clinical Trial in Advanced Solid Tumors by China’s NMPA
PR Newswire China Overview Akeso Inc., a Chinese biopharmaceutical company, announced that its EGFR and TROP2 bispecific antibody-drug conjugate (ADC) candidate, AK158D1, has received clearance from China's National Medical Products Admi... -
Gan & Lee’s First-in-Class AR PROTAC GLR2037 Receives NMPA Approval to Initiate Clinical Trials for Advanced Prostate Cancer
flcube.com China Overview Gan & Lee Pharmaceuticals announced that China's National Medical Products Administration (NMPA) has approved its first-in-class androgen receptor (AR) PROTAC, GLR2037, for clinical trials. This novel therap... -
China Approves Satri-Cel, World’s First CAR T-Cell Therapy for Claudin 18.2-Positive Gastric Cancer
PubMed China Overview China's National Medical Products Administration (NMPA) has approved satricabtagene autoleucel (satri-cel), a CAR T-cell therapy for Claudin 18.2-positive, HER2-negative advanced gastric or gastroesophageal junction... -
Xellsmart Secures FDA Fast Track Designation for Parkinson’s iPSC-Derived Cell Therapy, Accelerating CNS Pipeline
Longevity.Technology UK Overview Xellsmart announced its allogeneic, off-the-shelf iPSC-derived cell therapy for Parkinson's disease has received FDA Fast Track designation, expected to accelerate its development program. Specializing in... -
Porton Advanced Secures China NMPA Drug License to Expand CDMO Services to Commercial CGT Manufacturing
Porton Advanced China Overview Porton Advanced has been granted a Class C Drug Manufacturing License by China's NMPA, enabling it to undertake commercial contract manufacturing for Cell and Gene Therapy (CGT) products. This expands their... -
China’s First Approved MSC Therapy, Ruibosheng, Launched at Fraction of Global Price, Receives Conditional Approval for Severe GVHD
BioInformant China Overview China's first approved mesenchymal stem cell (MSC) therapy, Ruibosheng, has been launched at a fraction of global pricing, having received conditional approval from the NMPA on January 2, 2025. Approved for st... -
Porton Advanced Secures China NMPA Commercial Manufacturing License for CGT Products, Expanding CDMO Services from Process Development to Commercialization
Contract Pharma China Overview Porton Advanced has obtained a Class C drug manufacturing license from China's National Medical Products Administration (NMPA), enabling it to provide commercial contract manufacturing services for cell and... -
First Half 2026 Sees 24 New Small-Molecule Approvals: Pioneering PROTAC Vepdegestrant and Oral GLP-1 Orforglipron Enter Market
Chemexpress China Overview Twenty-four small-molecule drugs received their first global approval in the first half of 2026, with 95.8% being oral dosage forms. Key highlights include the approval of the first commercial PROTAC, vepdegest... -
China’s NMPA Grants World’s First Approval for Solid Tumor CAR T-Cell Therapy Satri-cel Targeting CLDN18.2 Positive Gastric Cancer
OncLive USA Overview OncLive's June 2026 GI oncology regulatory roundup highlights China's NMPA approval of CARsgen Therapeutics' satricabtagene autoleucel (satri-cel), the first solid tumor CAR T-cell therapy for Claudin18.2-positive ad... -
China Grants World’s First Solid Tumor CAR-T Approval for Satri-cel in Advanced Gastric Adenocarcinoma
Fierce Biotech USA Overview China's National Medical Products Administration (NMPA) has approved CARsgen Therapeutics' solid tumor CAR-T cell therapy, satri-cel, for HER2-negative, Claudin18.2-positive advanced gastric and gastroesophage...
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