Kailera Therapeutics (NASDAQ: KLRA) is the U.S. biotech that holds rights outside Greater China to Hengrui Pharma's obesity portfolio under a May 2024 deal. Its lead drug, ribupatide, is a once-weekly GLP-1/GIP dual agonist, the same receptor pair as tirzepatide. In Hengrui's 48-week Chinese Phase 3, it produced mean weight loss of up to 17.7%. On September 30, 2026, Kailera said it had finished enrolling about 4,900 adults in its global KaiNETIC Phase 3 program, which includes a comparison with semaglutide 2.4 mg and reports in 2028. A once-daily oral form is slated for Phase 3 in the first half of 2027.
HRS-7535 (KAI-7535) is an oral small-molecule GLP-1 drug that completed the OUTSTAND-1 and OUTSTAND-2 Phase 3 trials in China, where Hengrui filed for approval in September 2026. KAI-4729, a GLP-1/GIP/glucagon triple agonist, is headed for Kailera's first Phase 1 in 2026. Kailera went public on Nasdaq in April 2026 at $16 a share, raising $625 million before the underwriters' option. See #ribupatide, #hrs-7535, and #hengrui-pharma.
Kailera Therapeutics (NASDAQ: KLRA) holds rights outside Greater China to several Hengrui Pharma obesity drugs. Ribupatide (KAI-9531), a once-weekly injectable GLP-1/GIP dual agonist, is in the three-trial global KaiNETIC Phase 3 program, which had enrolled more than 4,700 participants as of August 12, 2026, testing doses up to 10 mg over 76 weeks with data expected in 2028. KAI-7535 (HRS-7535) is a separate drug, a once-daily oral small-molecule GLP-1 receptor agonist, now in a roughly 320-person global Phase 2 trial in the U.S. and Australia with data expected in 2027; Kailera's GLP-1/GIP/glucagon triple agonist is a third drug, HRS-4729.
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.
Kailera Therapeutics (NASDAQ: KLRA) received sweeping positive analyst coverage following its August 12, 2026 Q2 2026 earnings report. Kailera confirmed an active Investigational New Drug (IND) application with the FDA for ribupatide oral (KAI-9531-T) and global Phase 3 obesity trials planned for H1 2027. Analyst response: according to 6 analysts, the average rating for KLRA stock is Strong Buy, with a 12-month average price target of $42.60 representing 82.83% upside from the $17.95-$19.50 trading range on August 13-14. Named ratings include TD Cowen at Buy with a $57 price target, Evercore ISI at Outperform, and William Blair at Outperform. The company holds cash, cash equivalents, and marketable securities expected to support execution of multiple clinical milestones with runway into mid-2028. Ribupatide mechanism: a once-weekly GLP-1/GIP dual agonist peptide (mechanistically similar to Eli Lilly's tirzepatide) with the ribupatide injection Phase 2 trial reaching 23.6% mean weight loss at 8 mg over 36 weeks, and the oral formulation reaching up to 12.1% weight loss with 38.6% of participants achieving at least 15% loss at Week 26 in Hengrui's Phase 2 trial. The Phase 2b high-dose injection trial in obesity is fully enrolled with data anticipated in mid-2027.
Kailera Therapeutics (NASDAQ: KLRA) reported August 12, 2026 Q2 2026 financial results and disclosed an active Investigational New Drug (IND) application with the US FDA for ribupatide oral (KAI-9531-T), a once-daily form of the GLP-1/GIP dual agonist peptide ribupatide for obesity, being co-developed with Hengrui Pharma. Global Phase 3 obesity trials are planned to initiate in H1 2027. Phase 2 data foundation: Hengrui's Phase 2 trial in adults with obesity documented up to 12.1% mean weight loss with no observed plateau at Week 26 and up to 38.6% of participants achieving at least 15% weight loss at the 25 mg and 50 mg once-daily oral doses. A ribupatide injection Phase 2b high-dose trial in obesity is fully enrolled with data anticipated in mid-2027. Ribupatide acts on the same two receptors as Eli Lilly's tirzepatide, and its weekly injectable form is already in Kailera's global Phase 3 KaiNETIC program. The oral formulation could compete with Lilly's orforglipron (oral small-molecule GLP-1 agonist, roughly 7.5-11.2% weight loss over 72 weeks) and Novo Nordisk's Wegovy pill (oral semaglutide 25 mg). Kailera holds US and ex-China commercial rights via a license from Hengrui.
Kailera Therapeutics and Hengrui Pharma reported positive topline Phase 3 data from a Chinese T2D trial of HRS-7535, an oral small-molecule GLP-1 receptor agonist licensed to Kailera. Most adverse events were mild-to-moderate GI, with no Grade 3 hypoglycemic events and no liver-safety signal. Hengrui plans to submit a Chinese NDA for HRS-7535 in T2D and will share detailed efficacy data at an upcoming scientific conference. The readout extends the China-led oral-GLP-1 pipeline alongside ribupatide and aleniglipron.