Hengrui Pharma (SHA: 600276, HKEX: 1276) disclosed Wednesday September 2, 2026 that China's National Medical Products Administration (NMPA) accepted the marketing authorization application for HRS-7535 (an oral once-daily small-molecule GLP-1 receptor agonist) for long-term weight management in adults with obesity or overweight, plus a separate marketing authorization application for HRS-7535 in type 2 diabetes based on the Phase 3 OUTSTAND-1 and OUTSTAND-2 trials. The Chinese Phase 3 obesity trial delivered mean weight loss of up to 10.9% at Week 44 (11.1% at Week 50 with continued treatment) versus 2.5% for placebo in the 180 mg group. If approved, HRS-7535 would become the first oral small-molecule GLP-1 receptor agonist marketed in China. HRS-7535 is licensed to Kailera Therapeutics (NASDAQ: KLRA) for global rights outside Greater China; the U.S. Phase 3 program is planned to initiate imminently. HRS-7535 would compete with Novo Nordisk's Wegovy pill (oral semaglutide) and Eli Lilly's Foundayo (orforglipron) in oral obesity therapeutics.
Following the August 22 Lancet Diabetes & Endocrinology publication of the full EECOH-2 Phase 3 trial results for Xianweida's ecnoglutide (XW003, a first-in-class cAMP-biased GLP-1 receptor agonist that preferentially activates the cAMP signaling pathway over β-arrestin recruitment), Chinese biotech peptide activity continued through end of August into September. Ecnoglutide received its Chinese NMPA approval for type 2 diabetes January 30, 2026, followed by the March 6, 2026 approval for weight management in adults with overweight or obesity; the Lancet publication supplies the peer-reviewed data package supporting global regulatory submissions. Ecnoglutide is licensed to Pfizer under the up-to-$495 million partnership announced in 2024 for ex-China commercialization. The biased-agonism concept (selective signaling pathway activation to separate efficacy from tolerability) is now being pursued by CSPC (SYH2069 GLP-1/GIP dual-biased agonist) and other Chinese biotech peptide developers.
TJ Biopharma and Biogen said China's National Medical Products Administration approved felzartamab for injection, branded Jingfei, on Thursday, August 13, 2026 for use with lenalidomide and dexamethasone in adults with multiple myeloma who have received at least one prior line of therapy. It is the anti-CD38 antibody's first approval anywhere; TJ Biopharma submitted the application in December 2024. In April 2026 Biogen agreed to pay $100 million upfront and up to $750 million in milestones for TJ Biopharma's Greater China rights, giving Biogen worldwide rights; Biogen handles commercialization in the region, and TJ Biopharma manufactures the drug at its Hangzhou facility. Outside China, Biogen is testing felzartamab in Phase 3 trials in antibody-mediated rejection after kidney transplant, IgA nephropathy, and primary membranous nephropathy.