Hansoh's Dual-Target Anti-Obesity Drug Olezypeptide Enters NDA Review, Highlighting Gastrointestinal Tolerability Advantage

(Source: Yao Cai She)

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Hansoh Pharma’s Olepatide Injection Has Officially Entered Marketing Approval Review, Adding Another Major Variable to China’s Weight-Loss Drug Sector.

This GLP-1/GIP dual-target agent is administered via once-weekly subcutaneous injection, targeting long-term weight management in adults with obesity or overweight.

Its 48-week weight loss data are comparable to those of the top-tier domestic competitors, and of greater concern is its gastrointestinal tolerability profile, which may become a key selling point in subsequent commercial competition.

01Orforglipron Enters Review Window

On June 4, Hansoh Pharma announced that the National Medical Products Administration had accepted its marketing authorization application for olepatide injection.

This drug is a GLP-1/GIP dual receptor agonist independently developed by Hansoh Pharma. It exerts glucose-lowering and weight-reducing effects by modulating pathways related to appetite control, glucose metabolism, and energy balance.

Previously disclosed Phase III data showed that after 48 weeks of treatment with olezarsen, the mean weight reduction from baseline in the 15 mg group was up to 19.3%, and the proportion of participants achieving a weight reduction of at least 5% was up to 97.2%.

In clinical trials of weight-loss drugs, a 5% reduction is generally considered the baseline threshold for clinical significance; however, in terms of market competition, it is the higher proportions of patients achieving 10%, 15%, and 20% weight loss that truly create a competitive edge.

Hansoh Pharma is currently highlighting its average price reduction and baseline target achievement rate; the subsequent disclosure of more comprehensive stratified data will help external parties assess its differentiation from comparable drugs.

Of particular note is the safety profile. Hansoh Pharma stated that in the olepatide treatment group, the incidence of nausea averaged less than 10%, and the incidence of vomiting averaged less than 5%; both the rate of gastrointestinal adverse events and the treatment discontinuation rate were lower than those reported in published phase III trials of similar agents.

For weight-loss medications intended for long-term use, the ability to ensure patient adherence is often as critical as efficacy.

If this advantage persists in the real world, the commercial selling point of Orforglipron will not be just greater weight loss, but easier adherence.

02Domestic Dual-Target Drugs Queue for Market Launch

From the perspective of application progress, domestically produced GLP-1/GIP dual-target weight-loss drugs have entered an intensive sprint phase.

Hengrui PharmaHRS9531 Injection was accepted by the NMPA in September 2025 for long-term weight management in adults.

Its Phase III study showed that the mean weight reduction at 48 weeks in the 6 mg group was 19.2%, with 44.4% of subjects achieving a weight loss of no less than 20%.

Hansoh Pharma’s olepatide application was accepted shortly thereafter. If calculated based on the narrow scope of GLP-1/GIP dual-target agents for weight loss indications, both drugs rank among the leading domestic innovative medicines.

However, the dual-target approach is not limited to the GLP-1/GIP pathway. Innovent Bio’s mazdutide, a dual GLP-1/GCGR agonist, was approved in June 2025 for long-term weight management.

In addition to weight loss, this mechanism also emphasizes its impact on indicators such as energy expenditure and hepatic lipid metabolism.

The follow-up cohorts are also being enrolled.Borui Pharma(Rights Protection)BGM0504 Injection Achieved Expected Targets in Phase III Trial for Weight Loss Indication in May 2026; Company Disclosed Nearly 19.3% Weight Reduction at 52 Weeks in the 15mg Group.

This means that in the next 1 to 2 years, multiple domestically produced dual-target drugs with weight loss effects approaching 20% may simultaneously emerge in the Chinese market. Doctors and patients will have more choices, but companies will also face more direct horizontal comparisons.

03Licensing to Regeneron Amplifies Overseas Value

Another key highlight of olepatide lies in its overseas licensing.

In June 2025, Hansoh Pharma and Regeneron Pharmaceuticals entered into a licensing agreement granting Regeneron exclusive global rights to develop, manufacture, and commercialize HS-20094 in all regions excluding mainland China, Hong Kong, and Macau.

The transaction includes an $80 million upfront payment, up to $1.93 billion in milestone payments, and double-digit percentage royalties on future product sales.

These transactions reflect a new pathway for innovative drugs in China.

Domestic companies are responsible for identifying and advancing early-, mid-, and late-stage clinical development, while overseas pharmaceutical or biotechnology companies take over global development and commercialization.

For Hansoh Pharma, licensing out enables upfront cash returns and reduces overseas registration and sales costs; for Regeneron, in-licensing a late-stage weight-loss asset helps bolster its obesity pipeline.

Hengrui Pharma has also adopted a similar approach.

Its rights to assets such as HRS9531 outside the Greater China region were previously licensed to Kailera, with a total transaction value of up to $6 billion, and equity stakes in the counterparty were acquired.

The vast global market for weight-loss drugs is pushing Chinese clinical assets onto the cross-border deal-making table.

Overseas buyers do not focus solely on individual data points; they place greater emphasis on the completeness of the pipeline, manufacturing capabilities, and the ability to reproduce efficacy in global multicenter clinical trials.

04Semaglutide Biosimilar Competition Nears

As Domestic Innovative Drugs Accelerate, Semaglutide Biosimilar Competition Looms.

The core compound patent for semaglutide in China expired on March 20, 2026, and the industry widely expects that domestically produced generic or biosimilar drugs will gradually enter the market.

However, as of one month after the patent expiration, media reports indicated that no domestically produced generic drugs had been approved, possibly due to factors involving data protection, review materials, and clinical pathways.

This suggests that around 2027, the domestic weight-loss drug market may develop along two main lines: one driven by low-cost semaglutide biosimilars improving accessibility, and the other characterized by innovative drugs such as orforglipron, HRS9531, BGM0504, and mazdutide competing for patients seeking highly effective treatment and metabolic benefits.

The former competes on price, supply, and distribution channels, while the latter competes on efficacy, tolerability, and brand recognition.

If medical insurance and commercial insurance fail to cover the primary weight-loss needs in a timely manner, out-of-pocket payment capacity will still impact the pace of volume growth.

This also means that companies cannot rely solely on R&D speed to gain a competitive edge; they must also prepare early for patient management, dose escalation education, and long-term follow-up evidence.

For Hansoh Pharma, the acceptance of olepatide’s application is merely the beginning. Its ability to secure a solid position among domestically produced dual-target agents will depend on approval timing, pricing strategy, production capacity, physician education, and real-world safety.

The weight-loss drug market is vast, but competition will quickly become crowded. The ultimate winner may not necessarily be the product with the most impressive clinical data, but rather the one that best balances efficacy, patient experience, and affordability.