Chinese drug regulatory agency
Appears in 7 stories
Reviewing olatorepatide new drug application for weight management
Hansoh Pharma presented full Phase III results for olatorepatide at the European Association for the Study of Diabetes meeting in Milan on October 2. Overweight and obese patients on the highest 15 mg dose lost 19.3% of their body weight on average by week 48, and the weight-loss curve had not flattened.
Updated Oct 2
Approved HRS-1596 for phase I clinical trials in China
Novo Nordisk will pay China's Hengrui Pharma $300 million upfront to license an experimental weight-loss pill designed for once-weekly use. The $2.6 billion total is a ceiling tied to development and sales milestones; the upfront is the only cash on signing, and it waits on US antitrust clearance.
Updated Oct 1
Cleared NouvSight001 for a Phase I/III trial in China
About 1.5 million people worldwide have retinitis pigmentosa, an inherited disease that destroys the retina's light-sensing cells and can end in blindness. The only approved treatment covers patients with a specific RPE65 gene mutation — a small fraction of the affected population.
Updated Sep 29
Granted HS-20093 breakthrough therapy designation
On September 2, 2026, China's drug regulator accepted the first marketing application for Hansoh Pharmaceutical's HS-20093, a targeted cancer drug built around the protein B7-H3. The filing covers small cell lung cancer after prior platinum-based chemotherapy and follows a July phase 3 win: the ARTEMIS-008 trial met its primary endpoint of overall survival, making HS-20093 the first B7-H3-directed antibody-drug conjugate to show a survival benefit in any tumor type.
Updated Sep 13
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 Sep 7
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
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
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