# NMPA
Latest news and articles about NMPA
Total: 10 articles found
From Outsourcing to Outpacing: China’s Biotech Leap Triggers Alarm in Washington
Pfizer’s multi-billion dollar partnership with Innovent Biologics underscores China’s rapid ascent from a pharmaceutical follower to a global innovation hub. As Chinese firms begin to outperform Western incumbents in clinical trials and regulatory speed, Washington is increasingly viewing the biotech sector through a lens of national security and competition.
CSPC Pharma Pivots to Next-Gen Cell Therapy with mRNA-Based CAR-T Clinical Approval
CSPC Pharmaceutical Group has received Chinese regulatory approval to begin clinical trials for SYS6063, a dual-target CAR-T therapy delivered via mRNA-LNP technology. This milestone reflects a strategic shift toward non-viral delivery systems that could make advanced cancer treatments more scalable and cost-effective.
Closing the Treatment Gap: Weiguang Biological Advances Hemophilia B Candidate in China
Weiguang Biological has received regulatory approval to begin clinical trials for Human Coagulation Factor IX, targeting Hemophilia B. This development marks a significant step in China's domestic rare disease treatment capabilities, though the company warns of the long-term risks inherent in drug development.
Protecting the Lab: China Solidifies Drug Data Protection in Historic Regulatory Overhaul
China has implemented a major revision to its drug administration laws, introducing a tiered system that protects clinical trial data for up to six years. This reform aims to incentivize high-end pharmaceutical innovation and align China's intellectual property regime with global standards.
Zhenghai Bio-tech Advances China’s Regenerative Frontier with Stem Cell Milestone
Zhenghai Bio-tech has reached the product validation phase for its human umbilical cord mesenchymal stem cell project. This milestone signifies a major step in the company's shift toward advanced cellular therapy and regenerative medicine.
Precision Oncology Gains Ground in China: AmoyDx Secures Regulatory Nod for c-Met Lung Cancer Diagnostic
Amoy Diagnostics has received NMPA approval for its c-Met gene amplification kit, a companion diagnostic for the lung cancer drug Savolitinib. This development marks a vital step in China's push for localized precision oncology and sophisticated personalized medicine tools.
Weiguang Bio Advances Patient-Centric Care with Subcutaneous Immunoglobulin Trial Approval
Weiguang Biological has received NMPA approval to begin clinical trials for a subcutaneous human immunoglobulin injection. The therapy targets primary immunodeficiency diseases and represents a shift toward home-based, patient-friendly administration in the Chinese plasma market.
How Shanghai Became the World’s First Hotbed for Clinical Brain‑Computer Interfaces
Shanghai has emerged as a global leader in bringing brain‑computer interfaces from the lab to the clinic after BoruiKang secured the world’s first Class‑III approval for an implantable BCI. The city’s dense industrial ecosystem, top hospitals and supportive policy are accelerating commercial launches, raising competitive, regulatory and ethical questions as China seeks to scale the nascent industry.
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.