# NMPA
Latest news and articles about NMPA
Total: 2 articles found
Merck’s PD‑1 Drug Pembrolizumab Wins China Approval as First‑Line Option for dMMR Advanced Endometrial Cancer
Merck’s pembrolizumab (KeRuida®) has been approved by China’s NMPA for first‑line use with carboplatin and paclitaxel, followed by pembrolizumab maintenance, in adults with dMMR advanced or recurrent endometrial cancer. The approval, based on phase III KEYNOTE‑868 (NRG‑GY018) data, shifts immunotherapy into the front line for this biomarker‑defined subgroup and raises issues of testing, reimbursement and market competition.
China’s TCM Clean‑Up: Regulatory Clock Ticks on ‘Unknown’ Safety Claims
China’s National Medical Products Administration is enforcing a rule that will bar re‑registration of traditional patent medicines whose package inserts still state key safety items as “not yet clear.” The measure aims to eliminate low‑use and poorly documented approvals, compel firms to supply safety data, and accelerate consolidation in an industry long criticised for uneven evidence on safety and efficacy.