After the GLP-1 combination drug, does Hengrui have three more "Ace" cards up its sleeve?

Recently, Hengrui Pharma announced that the New Drug Application (NDA) for its independently developed Shudi Insulin Noiiglutide Injection (HR17031) has been formally accepted by the National Medical Products Administration (NMPA).

This is a fixed-ratio combination product consisting of a long-acting basal insulin analog and a glucagon-like peptide-1 receptor agonist (GLP-1 RA).

The proposed indication is for the improvement of glycemic control in adults with type 2 diabetes mellitus with inadequate glycemic control, to be used in combination with other oral antidiabetic drugs on the basis of diet and exercise.

The industry's immediate reaction was that Hengrui Pharma has once again made a strategic move in the diabetes space. Following the launches of retagliptin, henagliflozin, and metformin, Hengrui Pharma's metabolism franchise is poised to add another blockbuster drug.

However, the acceptance of this product appears to signal the beginning of a defensive battle rather than a charge forward.

Jin Chunlin, Director of the Shanghai Health Development Research Center, told VCBeat that, overall, Hengrui Pharma's strategic intent remains focused on defending its position in the metabolic disease space. This product is more likely to serve as a foundational asset, reinforcing Hengrui's presence in diabetes treatment. The fixed-ratio combination product currently under review can be seen as an "appetizer," while subsequent multi-target oral weight-loss products may represent the true main course.

"Although the challenges are significant, with its commitment to a comprehensive presence in metabolic diseases and its existing deep accumulation, Hengrui has the potential to become a strong competitor in the metabolic disease field both in China and globally," he said.

The value of HR17031 is reflected in the data from two pivotal Phase III clinical studies.

Professor Ji Linong from Peking University People's Hospital led the HR17031-301 study, while Professor Chen Liming from Tianjin Medical University Chu Hsien-I Memorial Hospital led the HR17031-302 study. These trials targeted two patient populations respectively: those with inadequate glycemic control on oral antidiabetic drugs, and those with inadequate glycemic control on basal insulin therapy.

The results showed that for the primary endpoints, HR17031 demonstrated statistically significant superiority over the trial control groups, with favorable long-term safety and tolerability.

It is understood that the mechanism of this product is quite straightforward: it combines two drugs with complementary mechanisms—a long-acting insulin and a GLP-1 receptor agonist—into a single formulation. Insulin effectively lowers blood glucose but carries risks of hypoglycemia and weight gain; GLP-1 receptor agonists help address these limitations while also providing additional glycemic benefits, achieving a therapeutic gain where "1+1>2."

In Jin Chunlin's view, the core value of such drugs lies in addressing a critical clinical need—combining two medications that would otherwise require separate daily injections into a single injection, reducing the injection frequency by one per day and thereby naturally improving patient adherence.

However, this is not an entirely new therapeutic category. Globally, similar products have already been on the market. Novo Nordisk's Xultophy (insulin degludec and liraglutide injection) and Sanofi's Soliqua (insulin glargine and lixisenatide injection) are examples. According to the EvaluatePharma database, the global sales of these two products reached approximately USD 1.018 billion in 2025.

In the Chinese market, data shows that Xultophy was approved in October 2021 and launched in 2022. According to Novo Nordisk, sales revenue for this product in China surged from RMB 45 million in 2022 to RMB 1.426 billion in 2024, representing a compound annual growth rate of 463%.

In January 2023, Sanofi's Soliqua was approved for marketing in China and has been included in multiple authoritative domestic and international guidelines and consensus statements, such as the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes.

Facing these two major players, domestic Chinese pharmaceutical companies have not been absent. In addition to Hengrui Pharma, according to data from Pharnexcloud, companies such as Tonghua Dongbao Pharmaceutical, The United Laboratories, CTTQ, Huisheng Biopharmaceuticals, HEC, and Hua Medicine are all developing diabetes combination products. Among them, Tonghua Dongbao and The United Laboratories have both entered Phase III clinical trials.

Competition appears poised to become increasingly intense. Jin Chunlin commented that although Hengrui Pharma already has a solid presence in the diabetes market, whether this product can reshape the market landscape requires careful consideration. The core competition in the GLP-1 space has now shifted toward weight-loss efficacy and multi-target innovative drugs, making the market highly crowded.

Hengrui's Shudi Insulin Noiiglutide Injection (HR17031) represents more of a combination optimization strategy, aimed at penetrating and replacing existing treatments by simplifying the treatment regimen, rather than creating an entirely new therapeutic category.

"This product is more likely to serve as a foundational asset, reinforcing Hengrui's defensive line in diabetes treatment and holding its ground to buy time for the subsequent development of more disruptive innovative drugs. Overall, its impact on the market landscape is likely to be limited, representing more of a defensive strategy," Jin Chunlin told VCBeat.

The true protagonists may lie deep within Hengrui Pharma's pipeline.

According to available information, Hengrui Pharma has already secured market approval for five products in the metabolic disease space, including henagliflozin and retagliptin. However, what has truly captured external attention are three innovative weight-loss drugs currently in late-stage development.

The first is Ribupatide (HRS9531), a GLP-1/GIP dual receptor agonist being developed in both once-weekly subcutaneous injection and once-daily oral tablet formulations for the treatment of obesity and overweight.

In February 2026, the Phase II clinical trial of Ribupatide tablets in Chinese adults with obesity released top-line data: at week 26, participants achieved a mean body weight reduction of up to 12.1% from baseline, with no plateau observed, while the incidence of vomiting was no more than 11.4%. Currently, the once-daily oral Ribupatide tablet is about to enter Phase III trials, while the New Drug Application for Ribupatide injection has already been accepted by the National Medical Products Administration.

The second is HRS-7535, an oral small molecule GLP-1 receptor agonist. It is currently undergoing Phase III registrational clinical studies for both glucose-lowering and weight-loss indications, with results expected to be released sequentially in 2026.

The oral weight-loss drug market is currently gaining significant momentum. Goldman Sachs projects that the global weight-loss drug market could exceed USD 100 billion by 2030, with oral weight-loss drugs expected to account for 24% of the market by 2030 and 32% by 2035.

The third is HRS-4729, a GLP-1R/GIPR/GCGR triple receptor agonist. Compared with dual agonists, the activation of the GCGR target promotes energy expenditure and reduces blood lipids, thereby enhancing weight-loss efficacy.

This drug received clinical trial approval in December 2024 for the overweight/obesity indication and has now advanced to Phase I in China. In 2025, it received clinical approval for the indication of metabolic dysfunction-associated steatotic liver disease (MASLD) / metabolic dysfunction-associated steatohepatitis (MASH).

Currently, no product in this category has been approved for marketing in China or globally. Notably, however, Eli Lilly's triple-target drug Retatrutide is currently undergoing Phase III clinical trials for indications including obesity, type 2 diabetes, secondary prevention of cardiovascular events, and obstructive sleep apnea.

These three products constitute Hengrui's "main force" in the GLP-1 weight-loss space.

Jin Chunlin analyzed to VCBeat that Hengrui Pharma's strategy in the metabolic field reflects a clear approach: on one hand, it consolidates its market defenses through existing products; on the other, it actively invests in cutting-edge technologies to build a moat. Its product portfolio spans multiple formulations, from oral to injectable, and multiple mechanisms of action, from dual-target to triple-target, occupying various technological high grounds in the metabolic space.

"This broad-based strategy effectively diversifies the risk of failure in any single drug candidate, ensuring multiple growth drivers for the future. Through this approach, Hengrui aims to benchmark itself against international giants such as Novo Nordisk and Eli Lilly, constructing a comprehensive product matrix in the vast metabolic disease market that covers diabetes, obesity, and potential cardiovascular benefits, thereby enhancing the efficiency of bringing products to market," he said.

Meanwhile, a global strategy has already begun to take shape.

Hengrui Pharma has licensed the rights to its portfolio of GLP-1 innovative drugs, including Ribupatide, HRS-7535, and HRS-4729, to Kailera Therapeutics, a U.S.-based company, in a deal valued at up to USD 6 billion. Hengrui Pharma also received a 19.9% equity stake in Kailera.

Following the completion of the transaction, Kailera has secured two rounds of financing totaling USD 1 billion. The company is currently navigating a trajectory of "starting with clinical development in China—asset divestment—independent financing—global development."

From this perspective, Hengrui Pharma's intent is clear: to export its products, attract global capital, and expand its battlefield to the world.

For Hengrui Pharma, the road ahead in the metabolic weight-loss space appears far from smooth. By 2026, the weight-loss drug market has already become fiercely competitive.

Facing such a competitive landscape, Jin Chunlin told VCBeat that Hengrui's strengths and challenges are equally significant.

According to Jin Chunlin's analysis, Hengrui Pharma's core strengths first lie in its long-term accumulation in R&D and clinical development:

However, the challenges are equally formidable. In Jin Chunlin's view, on one hand, competition in the weight-loss arena has already reached a fever pitch. Giants such as Novo Nordisk and Eli Lilly have begun reducing prices, compounded by the impending patent expiration of semaglutide and the impact of numerous generic competitors in China. Once Hengrui's products hit the market, they may immediately face a landscape of significant price erosion and intense competition.

On the other hand, Novo Nordisk's semaglutide and Eli Lilly's tirzepatide have already established strong brand recognition and physician-patient education foundations globally, creating high brand barriers that make competition difficult.

"Furthermore, as a latecomer, Hengrui's weight-loss products will face challenging National Reimbursement Drug List (NRDL) negotiations, and market expectations will need to be adjusted accordingly. Pricing strategy will be critical to secure NRDL inclusion. Without clinical efficacy data demonstrating superiority over competitors, the pressure during NRDL negotiations will be immense," Jin Chunlin told VCBeat.

Hengrui's metabolic "defensive battle" is set to be a long game.

From this perspective, the acceptance of HR17031 may represent just one engagement in Hengrui's broader metabolic campaign. The true main forces—Ribupatide, HRS-7535, and HRS-4729—are still gathering strength behind the front lines.

Faced with encirclement by industry giants, pressure from generic competitors, and the challenges of NRDL negotiations, Hengrui's confidence stems from over two decades of deep cultivation in the metabolic space, its differentiated portfolio of multi-target pipelines, and its strategic vision demonstrated through global licensing deals.

The ultimate outcome of this defensive battle may not be an outright victory, but rather a steady hold of its ground—establishing Hengrui as a competitor that cannot be overlooked in the metabolic disease field, both in China and globally.