What Is HRS-7535?

1. Who Makes HRS-7535, and How Does It Work?

HRS-7535 is a small-molecule GLP-1 receptor agonist developed by Jiangsu Hengrui Pharmaceuticals, one of China’s largest drug companies. The class acts on appetite and fullness signaling to reduce food intake. Unlike the peptide semaglutide, it is a synthetic small molecule that can be made as an ordinary tablet. It targets GLP-1 alone; ribupatide, another Hengrui candidate, targets both GLP-1 and GIP (Hengrui development background).

The KAI-7535 name comes from Kailera Therapeutics, a U.S. company created in 2024 to take four Hengrui metabolic drugs to the rest of the world. In May 2024 Kailera licensed rights outside Greater China to HRS-7535, ribupatide and two other candidates for $110 million upfront, up to $200 million in development milestones, and up to $5.725 billion in sales milestones, with Hengrui keeping a 19.9% stake. The company launched publicly in October 2024 with $400 million from Atlas Venture, Bain Capital Life Sciences and RTW Investments (Kailera launch announcement). That split, Hengrui in China and Kailera elsewhere, is why the same tablet has two codes and two very different development stages.

2. What Happened in China?

China’s National Medical Products Administration accepted applications for adult type 2 diabetes and chronic weight management in September 2026, according to Hengrui. Acceptance means review, not approval. No confirmed approval or launch date was established in the sources checked September 7, 2026.

The diabetes filing draws on OUTSTAND-1 and OUTSTAND-2, which studied people inadequately controlled with diet and exercise or with metformin. HARBOR-1 supports the weight-management filing (Hengrui diabetes notice, weight-management notice).

OUTSTAND-2 is the diabetes trial with public numbers. It enrolled 810 adults with type 2 diabetes and a mean baseline HbA1c of 8.6%, and compared three HRS-7535 doses with dapagliflozin, an established SGLT2 inhibitor, rather than with placebo. All three doses met the non-inferiority target at week 32, and the 90 mg dose lowered HbA1c by 1.68 percentage points against 1.28 for dapagliflozin (Kailera July 2026 results). Beating an active comparator on blood sugar is a stronger result than beating placebo, and it is the basis for the diabetes filing.

3. Why Is the Global Program Still in Phase 2?

Kailera’s global Phase 2 study began in April 2026 in the United States and Australia. It aims to enroll approximately 320 adults and measures percentage weight change at Week 44. Researchers are testing a wider dose range and a more gradual escalation strategy to find a better balance between weight reduction and tolerability. Data are expected in 2027 (Kailera August development update).

Two things explain the gap between a Chinese filing and a Western Phase 2. Regulators in the United States and Europe generally want data from their own populations, and the Chinese trials enrolled lighter participants than a typical Western obesity trial: HARBOR-1’s average starting weight was 94 kg with a BMI of 34, against 107 kg and a BMI of 38 in AstraZeneca’s VISTA trial of elecoglipron. The second reason is tolerability. When the Phase 3 results were released on July 7, 2026, news coverage focused as much on the nausea and vomiting rates as on the weight loss, and Kailera’s shares fell on the day (Quartz). Kailera has framed its own trial as the chance to fix the dose ramp before Phase 3.

Development timeline

Sources: July results, August timeline, and Hengrui’s September notices above. Status checked September 7, 2026.

4. How Much Weight Loss Did HRS-7535 Produce?

People on the 180 mg dose in HARBOR-1 lost 9.8% of their body weight at 44 weeks, against 2.4% on placebo, counting everyone who was randomized. Among those who stayed on treatment, the figures were 10.9% and 2.5%. The first analysis, the treatment-policy estimand, was the trial’s primary one; the second is the supplementary efficacy analysis (Kailera HARBOR-1 results).

The gap between the two analyses is about a point, which tells you dropouts were not a major driver of the result. The separate 11.1% Week 50 headline uses an ad hoc efficacy analysis, not the primary Week 44 analysis.

The earlier China Phase 2 trial, published in Nature Communications, randomized 235 adults with obesity and no diabetes across 29 centers to 30, 60, 120 or 180 mg or placebo. At Week 26 the 180 mg group lost 9.36% versus 2.50% on placebo. Doses of 60 mg and above separated clearly from placebo, 30 mg did not, and the 180 mg effect held through Week 36. Put next to HARBOR-1, the two trials tell a consistent story: roughly 9 to 11% weight loss at the top dose, arriving mostly in the first six months.

For context, that is below the range reported for weekly injectables such as semaglutide and tirzepatide, and in the same neighborhood as other oral small molecules at the same stage. Whether a slower ramp can push the number higher is the open question Kailera’s global trial is meant to answer.

5. What Side Effects Were Reported?

Two in three people on the top dose vomited at some point. HARBOR-1 reported nausea in 70.0% and vomiting in 68.6% of the 180 mg group, versus 16.2% and 4.5% with placebo. The 120 mg group was no better, at 70.3% and 66.7%. Yet adverse events led to treatment discontinuation in only 3.1% of the 180 mg group and 4.1% of the 120 mg group, against 2.7% with placebo. Most events were gastrointestinal and mild or moderate (Phase 3 safety results).

That combination, very common symptoms but very few dropouts, is unusual and is the reason the dose ramp is being redesigned. It suggests the symptoms were tolerable enough to push through in a trial setting, but it is hard to imagine them being acceptable in routine use, and it is the main thing standing between this tablet and a competitive profile.

The peer-reviewed Phase 2 obesity paper likewise identified gastrointestinal events as the most frequent adverse effects, particularly during dose escalation.

6. How Does It Compare With Other Oral GLP-1 Tablets?

HRS-7535 could reach a market before its global rivals because of the China filing, but it will be a Chinese launch first. In the United States, orforglipron is already approved and aleniglipron and elecoglipron are ahead in the trial sequence. None of these tablets has been compared with another in a head-to-head trial, so the percentages on their pages cannot be ranked against each other.

7. HRS-7535 FAQ

• Is HRS-7535 approved in China?

  Not as of September 7, 2026. Hengrui's September announcements confirm that the National Medical Products Administration accepted marketing applications for review. Review in China typically takes many months, and no approval date has been announced.

• Why is KAI-7535 in Phase 2 if HRS-7535 has Phase 3 data?

  The programs are run by different companies in different regions. Hengrui completed China Phase 3 trials that support its Chinese filings. Kailera, which holds rights outside Greater China, is running its own Phase 2 study in the United States and Australia because regulators there expect data from their own populations and because it wants to test a gentler dose escalation before committing to Phase 3.

• How much weight did people lose on HRS-7535?

  In HARBOR-1, 9.8% at 44 weeks on the 180 mg dose versus 2.4% with placebo in the primary analysis, or 10.9% versus 2.5% among people who stayed on treatment. That is less than injectable GLP-1 medicines and in the same range as other oral small molecules at a similar stage.

• Why was nausea so common?

  HARBOR-1 escalated to 180 mg on a fixed schedule, and 70% of that group reported nausea. Kailera's global Phase 2 is built around this problem: it starts lower, climbs more slowly, and tests a wider dose range to see whether a gentler ramp keeps the weight loss with fewer side effects.

• Is there a KAI-7535 release date?

  No. Kailera expects global Phase 2 results in 2027, after which a Phase 3 program would still be needed for approval in the United States or Europe. A trial readout is not a release date.

8. Sources