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National Medical Products Administration (NMPA)

National Medical Products Administration (NMPA)

Government regulatory agency

Appears in 4 stories

Stories

China approves first AI-assisted Class 1 innovative drug Mprosevir

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Approving authority for Mprosevir

Westlake University announced September 2 that China's drug regulator conditionally approved Mprosevir, a COVID-19 treatment. It is the country's first 'Class 1' innovative drug developed with AI assistance—the highest tier of China's drug registration system, for drugs never marketed before.

Updated 5 days ago

First CLDN18.2 antibody-drug conjugate reaches regulatory review for gastric cancer

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Reviewing the drug application

Advanced gastric cancer that returns after treatment usually kills within about six months. On June 4, 2026, Chinese biotech Innovent Biologics said its drug had slowed that clock in a late-stage trial.

Updated Jun 4

Tarlatamab rewrites treatment for small-cell lung cancer as approvals spread worldwide

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Approved tarlatamab through priority review pathway

For decades, patients with extensive-stage small-cell lung cancer who relapsed after chemotherapy had almost nowhere to turn — five-year survival rates sat around 3%. Now a drug that bridges the patient's immune cells to their tumor has won approval in both the United States and China.

Updated May 31

Hansoh's B7-H3 ADC wins China breakthrough status for esophageal cancer

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Granted HS-20093 breakthrough therapy designation

Patients with advanced esophageal squamous cell carcinoma who fail both chemotherapy and immunotherapy have almost no good options. On May 11, China's drug regulator granted breakthrough status to Hansoh Pharmaceutical's HS-20093, a targeted cancer drug built around a protein called B7-H3.

Updated May 11