February 13, 2026
Source: drugdu
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On February 10, 2026, Hengrui Pharmaceutical and Kailera Therapeutics (US) jointly announced positive top-line results from a Phase II clinical trial (NCT06841445) of Remputeptide Tablets (HRS9531), their investigational GLP 1/GIP dual receptor agonist, in Chinese adults with obesity. Data showed that at Week 26, mean body weight reduction in the highest dose group reached 12.1%, with no weight loss plateau observed. Up to 38.6% of participants achieved at least 15% weight loss, while the incidence of gastrointestinal adverse events was maintained at a low level.
This breakthrough marks important progress in the global development of oral multi target weight loss drugs. With its convenient once daily oral administration and robust efficacy data, Remputeptide Tablets is expected to offer a new therapeutic option for patients with obesity that may surpass injectable formulations. It also adds a key competitive asset to Hengrui’s global strategic layout in metabolic diseases.
1 Remputeptide: Dual pathway Synergy, Oral and Injectable Formulations in Parallel Development
Remputeptide is a GLP 1 (glucagon like peptide 1) and GIP (glucose dependent insulinotropic polypeptide) dual receptor agonist independently discovered by Hengrui Pharmaceutical. It is being developed in two formulations: a once weekly subcutaneous injection and a once daily oral tablet. The GLP 1 pathway induces weight loss by promoting insulin secretion, inhibiting glucagon release, delaying gastric emptying, and centrally suppressing appetite. The GIP pathway plays a unique role in improving insulin sensitivity, promoting lipolysis, and enhancing energy metabolism.The synergistic activation of both incretin receptors theoretically delivers multiple benefits: glycemic control + weight reduction + metabolic improvement. Furthermore, the GIP component may mitigate GLP 1 related gastrointestinal adverse reactions and improve overall tolerability.
Compared with single GLP 1 receptor agonists, remputeptide’s dual target design offers potential advantages in weight loss magnitude and comprehensive metabolic improvement. Critically, the oral tablet overcomes the technical bottleneck of existing GLP 1 therapies that rely on injection. Although Novo Nordisk’s oral semaglutide (Rybelsus) is already marketed, its low bioavailability, fasting administration requirement, and dietary restrictions limit clinical convenience. Using innovative formulation technology, Remputeptide Tablets is expected to achieve superior oral bioavailability and patient compliance, providing an ideal alternative for injection averse patients or those seeking a convenient lifestyle.
2 12.1% Weight Loss at 26 Weeks with No Plateau Observed
This Phase II study (HRS9531 T 201) was a multicenter, randomized, double blind, placebo controlled trial enrolling 166 Chinese adults with obesity (BMI ≥ 28 kg/m²) without type 2 diabetes. Participants were randomly assigned in equal ratio to receive once daily oral Remputeptide Tablets 10 mg, 25 mg, 50 mg, or placebo. The primary endpoint was percentage change in body weight at Week 26.
In the estimand analysis based on the hypothetical strategy (assuming all participants completed treatment per protocol), mean weight reductions from baseline at Week 26 were 6.9%, 12.1%, and 12.1% in the 10 mg, 25 mg, and 50 mg groups, respectively, versus only 2.3% in the placebo group. All dose groups showed dose dependent efficacy, and no weight loss plateau was seen in the highest dose group, suggesting potential further weight reduction with longer treatment. Results from the treatment policy estimand (accounting for early discontinuation or use of other weight loss interventions) were consistent: reductions of 6.7%, 11.9%, and 11.4% in the three active groups, and 2.1% in the placebo group, confirming data robustness.
In terms of weight loss quality, at Week 26: 59.1% of participants in the 25 mg group achieved ≥ 10% weight loss, and 38.6% achieved ≥ 15%; 52.5% and 37.5% in the 50 mg group achieved ≥ 10% and ≥ 15% weight loss, respectively. These deep weight loss rates are outstanding among oral agents and approach the efficacy levels of some injectable formulations. These deep weight loss rates are outstanding among oral agents and approach the efficacy levels of some injectable formulations. Notably, Remputeptide Tablets uses a simplified dose titration scheme, helping patients build tolerance gradually and reducing discontinuations due to early gastrointestinal reactions.
In safety, Remputeptide Tablets demonstrated a favorable tolerability profile. Most treatment emergent adverse events were mild to moderate, mainly gastrointestinal reactions, but at relatively low rates:vomiting: 2.4%, 11.4%, 7.5% in 10 mg, 25 mg, 50 mg groups; nausea: 11.9%, 22.7%, 20.0% in 10 mg, 25 mg, 50 mg groups. No permanent discontinuations or dose reductions due to gastrointestinal events were reported. This safety advantage is critical for long term compliance with oral therapy.
3 Injectable Formulation Supports Efficacy:
23.6% Weight Loss at 36 Weeks Sets a Benchmark
Development of Remputeptide Tablets is not standalone. Its injectable formulation (once weekly subcutaneous injection) has already demonstrated breakthrough efficacy in earlier studies, providing strong support for the mechanistic validity of the oral formulation.Previous clinical trials in China showed that, after 36 weeks of treatment, the 8 mg remputeptide injection group achieved a mean weight reduction of 23.6% from baseline (vs. only 1.8% in the placebo group), with no plateau observed. Safety and tolerability were consistent with other GLP 1 therapies.This magnitude of weight loss exceeds that of semaglutide (~15–21%) and tirzepatide (~20.2%), establishing remputeptide’s potential as a best in class dual target agonist.
The marketing application for Remputeptide Injection for long term weight management in adults was accepted by the National Medical Products Administration (NMPA) in 2025, and it is currently being evaluated in the global Phase III KaiNETIC clinical program. Hengrui’s parallel development of oral tablets and injectable formulations allows coverage of diverse patient preferences and clinical scenarios, building a complete remputeptide product portfolio.
4 Global Competitive Landscape: Fierce Competition in the Oral GLP-1 Race
The global weight-loss drug market is undergoing explosive growth and is projected to surpass USD 100 billion by 2030. Currently, the market is dominated by Novo Nordisk’s semaglutide (Wegovy/Ozempic) and Eli Lilly’s tirzepatide (Zepbound/Mounjaro), both of which are injectable formulations. Oral preparations have thus become a key direction for differentiated competition.
In the oral GLP-1 sector, Novo Nordisk’s oral semaglutide (Wegovy) was approved by the FDA for weight management in December 2025. Lilly’s orforglipron, a small molecule GLP 1 receptor agonist, has completed Phase III trials, delivering an average weight reduction of approximately 15% with food independent administration. Regarded as a strong competitor in the oral field, it is expected to be approved in 2026. In addition, multinational pharmaceutical companies including Pfizer, Amgen, and AstraZeneca are all developing oral small molecule GLP 1 or GLP 1/GIP dual target agents, making competition increasingly intense.
Among local Chinese companies, Hengrui Pharmaceutical leads the progress with Remputeptide Tablets. Beyond remputeptide, Hengrui is also developing HRS 7535, an oral small molecule GLP 1 agonist, and HRS 4729, a GLP 1/GIP/GCG triple target agonist, forming an in depth layout in metabolic diseases.Innovent Biologics’ mazdutide (GLP 1/GCGR dual agonist) has been approved as an injectable formulation, with its oral version in early stage development. Huadong Medicine, Brightgene, and other companies are also advancing oral GLP 1 therapies.With its dual target mechanism and 12.1% weight loss at Week 26, Remputeptide Tablets has established technological leadership among domestic competitors.
Conlusion
The positive Phase II clinical results of Hengrui Pharmaceutical’s Remputeptide Tablets mark an important milestone in the R&D of oral weight loss drugs in China. Its combined advantages — the GLP 1/GIP dual target mechanism, 12.1% weight loss at Week 26, sustained efficacy without reaching a plateau, and manageable gastrointestinal safety — together form differentiated advantages over existing therapies. The convenience of oral tablets will open up entirely new patient populations and clinical application scenarios in the injectable dominated weight loss market.
As Hengrui rapidly advances Phase III trials in China and Kailera Therapeutics initiates the global Phase II study in 2026, Remputeptide Tablets is accelerating its journey from the laboratory to the clinic, and from China to the world.This innovative achievement will not only benefit hundreds of millions of obese patients but also enhance the innovative voice of Chinese pharmaceutical companies in the global metabolic disease field.
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