Regulatory Agency
Appears in 10 stories · Last updated Nov 9, 2026
Will review Innovent's planned new-indication application
Innovent Biologics' tafolecimab cut LDL cholesterol by roughly 65% in a Phase 3 trial of patients who took no other lipid-lowering drug. The CREDIT-5 result is the first late-stage evidence that a Chinese-made PCSK9 antibody works as a stand-alone first-line treatment for high cholesterol.
Updated 3 days ago
Granted breakthrough therapy designation to NHWD-870 in May 2026
NUT carcinoma is rare, aggressive and has no approved targeted therapy. In a 40-patient Phase II trial reported at the European Society for Medical Oncology meeting in October 2026, Wenda Pharma's oral drug NHWD-870 shrank tumors in 30% of patients. Among 20 patients whose tumors started in the chest, 45% responded.
Updated Oct 29
Cleared AK0406 IND for influenza prevention in August 2026
Shanghai-based ArkBio won U.S. Food and Drug Administration (FDA) clearance to test its experimental flu prevention drug in a Phase II trial. The drug, AK0406, is a long-acting antiviral designed to prevent influenza for an extended period, not just treat it after infection.
Updated Oct 13
As of October 2026: 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
As of October 2026: 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
As of September 2026: 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
As of September 2026: 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
As of September 2026: 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
As of June 2026: 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
As of May 2026: 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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