China Updates National Essential Medicines List for First Time in Eight Years, Adding Semaglutide and 115 Other Drugs as Domestic Oral GLP-1 Treatments Show Progress

On July 9, 2026, China's National Health Commission added injectable semaglutide to the National Essential Medicines List for the first time in eight years, mandating all public hospitals to stock it effective September 1, 2026. The listing covers 116 new therapies, bringing the total catalog to 794 medicines, and is expected to accelerate access to generic semaglutide once approved. Concurrently, Gan & Lee's biweekly injectable bofanglutide showed glycemic and weight reductions at least as large as semaglutide in a Phase 2b trial, while Hengrui and Kailera's oral small-molecule GLP-1 drug HRS-7535 met its primary endpoint in the OUTSTAND-2 Phase 3 trial for type 2 diabetes.

HRS-7535 Phase 3 Trial Results (Hengrui / Kailera)

• ▪In the HARBOR-1 Phase 3 obesity trial, Hengrui and Kailera's oral GLP-1 drug HRS-7535 (180 mg) achieved mean weight loss of 9.8%–10.9% at Week 44 versus 2.4%–2.5% for placebo, meeting its primary endpoint.
• ▪HARBOR-1 safety data showed high gastrointestinal side effects: up to 68.6% of HRS-7535 recipients experienced vomiting and up to 36.9% experienced diarrhea, though most events were mild to moderate and no liver safety signal was observed.

Semaglutide NEDL Listing — Access, Patents and Generics

• ▪Semaglutide's core patent in China (CN101133082B) expired on March 20, 2026; more than ten Chinese drugmakers have submitted generic applications, but none had been approved as of July 2026 due to data protection under the China-Switzerland Free Trade Agreement running until April 2027.
• ▪The NEDL listing mandates all public hospitals to stock semaglutide, making it available even in remote rural hospitals across China — the country with the highest number of adults with diabetes in the world, per the International Diabetes Federation.
• ▪On July 9, 2026, China's National Health Commission updated the National Essential Medicines List for the first time in eight years, adding injectable semaglutide (Ozempic) as the second GLP-1 drug — after liraglutide — under the insulin and blood glucose-lowering medication category, effective September 1, 2026.
• ▪According to Justin Wang, partner at L.E.K. Consulting, the NEDL listing is expected to pave the way for generic semaglutide to be broadly listed in China once approved, and will make the drug "much more accessible across the country."

OUTSTAND-2 Phase 3 Trial Results (HRS-7535 in Type 2 Diabetes)

• ▪OUTSTAND-2 secondary outcomes included improvements in body weight, systolic blood pressure, lipid profiles, and urinary albumin-to-creatinine ratio (UACR) in T2D patients treated with HRS-7535
• ▪OUTSTAND-2: HRS-7535 (90 mg) reduced HbA1c by 1.68% at Week 32 versus 1.28% for dapagliflozin 10 mg, meeting primary non-inferiority endpoint across all dose levels in 810 adults with T2D on metformin
• ▪OUTSTAND-2 safety: most TEAEs were mild to moderate and gastrointestinal in nature; no Grade 3 hypoglycemic events and no liver safety signal were observed, consistent with prior HRS-7535 trial data