Also known as: China's National Medical Products Administration, National Medical Products Administration of China, NMPA
China has become the dominant source of external drug innovation, with pharma licensing deals reaching $135.7 billion in 2025 and China developing 30% of the world's new innovative drugs. Meanwhile, India is expanding AI use in drug discovery and strengthening its CRDMO and IP infrastructure, though investment gaps persist.
Hengrui Medicine won NMPA clearance for a Phase II NSCLC trial combining SHR-A2009 ADC with adebrelimab or EGFR-TKI, and with partner Kailera reported up to 12.1% weight loss in a Phase II obesity study of oral ribupatide. SHR-A2009 monotherapy NDA is under review for NSCLC, and cumulative R&D on SHR-A2009 has reached RMB 330 million.
In 2025, China's NMPA approved 289 new drug applications, including traditional Chinese medicines. A study reveals critical methodological gaps in clinical trials of herbal therapies, while a review highlights the potential of nanoformulations for renal fibrosis.
FDA granted rolling review for Palvella's QTORIN rapamycin NDA. Also covered: global expedited approval pathways, accelerated approval scrutiny, and multi-regional CDx strategies.
China's pharma industry hit record clinical drug trials and out-licensing deal values in 2025 and H1 2026, with NMPA approvals surging. The growth has drawn US Senate scrutiny and new bipartisan oversight legislation.
A rare BTK A428D mutation causes resistance to all BTK-targeted therapies, finds a new study. China is reviewing the first CAR-T therapy for gastric cancer, and research reveals why BET inhibitors fail and targets AML's DNMT3A mutation.
Cornerstone Robotics will present at the 2nd Global Health Summit in August 2026, where its CEO will deliver a keynote on the evolution of surgical robotics. The company's Sentire surgical system has secured regulatory approvals in China, the EU, and Singapore, and is now used in hospitals across Asia-Pacific and Europe.
The U.S. Congress is advancing three legislative and regulatory measures to scrutinize and potentially restrict partnerships between American biopharma companies and Chinese biotech firms, citing national security concerns. These actions target the flow of U.S. capital and technology to China amid a surge in deals, with innovative drug out-licensing transactions exceeding $60 billion in the first quarter of 2026 alone.
Hansoh received EU approval for Aumolertinib for EGFR-mutated NSCLC, while China's NMPA granted Breakthrough Therapy status to HS-10504 for EGFR C797S-mutated NSCLC.
Research and Markets added two cell and gene therapy publications, including a tools and reagents market report forecasting growth from $12 billion in 2025 to $19.8 billion by 2030. The reports track approvals, financing, deals, and manufacturing developments.
