Entering the GLP-1 Race: High Stakes, High Risks for Chinese Biosimilar Players

Domestic GLP-1 drugs are attempting to encircle and suppress Novo Nordisk.

In early April, the official website of the Center for Drug Evaluation (CDE) indicated that the marketing application for “Jiuyoutai,” a semaglutide injection biosimilar developed by Jiuyuan Gene, had been accepted for review. The drug is indicated for glycemic control in adult patients with type 2 diabetes. This marks the first semaglutide biosimilar to file for market approval in China. Shortly before submitting the marketing application for Jiuyoutai, Jiuyuan Gene had just filed for an initial public offering (IPO) on the Hong Kong Stock Exchange. With already marketed GLP-1 drugs generating substantial revenue, Jiuyuan Gene’s intention to create a blockbuster product through its weight-loss medication to improve its operational performance is evident.

Biosimilars exhibit high structural and functional similarity to their reference innovator drugs, yet they can be priced significantly lower. In China, the initial listing prices of biosimilars are typically set at 80–90% of the reference product’s price. However, there have been notable precedents where prices were slashed to as low as half that of the innovator drug: Henlius’ rituximab biosimilar, Hanlikang, and Innovent’s biosimilar, Byvasda, were launched at 60% and 50% of the reference product’s price, respectively.

According to CIC Consulting, the market size of semaglutide in China is projected to increase from RMB 2.5 billion in 2022 to RMB 43.9 billion in 2032, with a compound annual growth rate (CAGR) of 33.0%. Given such substantial market potential, it is naturally impossible for the originator drug to capture the entire market.

In addition to Jiuyuan Gene, the semaglutide injection biosimilars developed by Livzon Group, United Laboratories, ChenAn Bio/BoWei Bio, Huadong Medicine (Zhongmei Huadong)/Chongqing Paijin, HuiSheng Bio/Sihuan Pharmaceutical, and ZhiTai Bio have all entered Phase III clinical trials.

Additionally, there are entrants in the market for biosimilars of Eli Lilly’s long-acting GLP-1 drug dulaglutide. Boan Biotech has announced that it has completed Phase III clinical trials for its dulaglutide biosimilar in China and is currently preparing for the Biologics License Application (BLA).

However, compared with oncology drugs, the originator semaglutide is not prohibitively expensive. Novo Nordisk’s injectable semaglutide for the treatment of diabetes was included in China’s National Reimbursement Drug List (NRDL) in the same year its indication was approved domestically, with prices of RMB 478 and RMB 890 for the 1.5 mL and 3 mL presentations, respectively. Although these prices were already far below overseas pricing, semaglutide underwent another round of price reductions at the beginning of this year. Currently, the selling prices per pen in public hospitals are RMB 421.34 for the 1.5 mL presentation and RMB 716.28 for the 3 mL presentation.

The Smoke of Competition Has Risen: With GLP-1, Will Chinese Companies Soar to New Heights or Become Cannon Fodder?

It’s Not Easy to Take a Bite Out of Originator Drugs

The biosimilar market is experiencing rapid growth, particularly in mature markets. According to IQVIA, the total sales of biosimilar products in the U.S. market currently amount to $38 billion, while the projected total sales for biosimilars either under development or approved but not yet launched are estimated to reach $96 billion. By 2027, biosimilars are expected to account for a significant share of the market.

The market launch and sales growth of biosimilars are closely linked to the expiration of patents on originator drugs.In 2023, a total of 13 biosimilars were approved for marketing in the United States, marking a record high in annual approvals. This surge was primarily attributed to the end of the Humira era, with adalimumab biosimilars accounting for 9 of the 13 newly approved drugs.

Biosimilars of semaglutide also face patent issues. The patent protection for the originator semaglutide in China is set to expire in 2026; however, Huadong Medicine has been challenging the patent rights of semaglutide through intellectual property measures since 2021.

In September 2022, the China National Intellectual Property Administration (CNIPA) declared all of Novo Nordisk’s compound patents for semaglutide invalid. The reason was that when Novo Nordisk initially filed the patent application for semaglutide, it did not disclose experimental data for any compound covered by the general formula; furthermore, the supplementary data submitted later failed to demonstrate the technical effects disclosed in the original application documents.

Novo Nordisk stated that the semaglutide compound is breakthroughly innovative, and that patents in the same family have been granted in multiple countries. The company has filed an appeal with the Beijing Intellectual Property Court. “The compound patent for semaglutide will expire in 2026. The invalidation case concerning the semaglutide compound patent has not yet reached a final conclusion and is still under review by the court (the Intellectual Property Tribunal of the Supreme People’s Court).”

Jiuyuan Gene’s latest prospectus also mentioned that the patent for semaglutide has been declared invalid; however, the originator company is contesting the invalidation decision in the relevant court, and the court has not yet announced its ruling.

This means that even if Jiuyuan Gene’s semaglutide biosimilar ultimately receives approval, it cannot be commercialized until the patent invalidation case is fully resolved. Industry insiders believe that “the official market launch and sales of domestic semaglutide biosimilars in China will likely have to wait until 2026.”

Compared with generic small-molecule drugs, the development and commercialization of biosimilars involve significantly longer timelines and face higher R&D barriers, with the investment for a single biosimilar product often exceeding $100 million. The development of biosimilars is characterized by greater complexity and uncertainty than that of small-molecule generics, requiring Phase I trials and large-scale Phase III clinical trials to provide sufficient data demonstrating similarity to the reference product in terms of pharmacokinetics (PK) and efficacy.

High barriers to entry and intense competition have not diminished the profit appeal of biosimilars. For instance, last September, Tonghua Dongbao partnered with Jianyou Pharmaceutical to jointly advance the U.S. regulatory registration of insulin biosimilars, including insulin glargine, insulin aspart, and insulin lispro, thereby generating corresponding technical service revenue and contributing to performance growth. According to Tonghua Dongbao’s annual report, the company recorded RMB 107 million in technical service revenue in 2023.

However, domestic companies will need to wait a bit longer if they hope to carve out a share of the long-acting GLP-1 market by challenging the originator drug.Similar to AbbVie’s “protection” of Humira, Novo Nordisk has filed a large number of patents for semaglutide, covering not only the active ingredient but also various “secondary” patents surrounding the product, such as delivery devices and administration methods. The company has filed up to 227 patents across 28 countries worldwide. Through this patent thicket, even after the expiration of the active ingredient patent, the product can continue to be protected by leveraging other patents. Until then, the market remains dominated by the originator semaglutide.

Who Will Capture the New GLP-1 Market?

This year, China’s GLP-1 market is poised for significant changes. In March, Novo Nordisk disclosed that semaglutide’s weight-loss indication is expected to gain regulatory approval and launch in China this year. Initially, the product will primarily target self-paying patients, with supply quotas in place.

Eli Lilly’s domestic portfolio for weight-loss indications is also expected to catch up this year. Last July, Eli Lilly submitted and gained acceptance for a new indication marketing application in China for tirzepatide injection: for long-term weight management in adults with obesity or overweight with at least one weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity.

This signifies that long-acting GLP-1 products have officially entered the weight-loss sector, unlocking a market worth tens of billions. According to projections, by 2032, half of domestic semaglutide sales will come from indications other than type 2 diabetes.

But however enticing the GLP-1 market may be, domestic pharmaceutical companies must possess the requisite capabilities to capture a share of it.

Either seize the golden opportunity to enter early and profit during a period of rapidly rising demand.For example, Huadong Medicine first captured market share with its liraglutide biosimilar, “Liluping.” Although liraglutide injection requires once-daily administration, Liluping gained a first-mover advantage as the first GLP-1RA weight-loss drug approved in China. According to forecasts by Zheshang Securities, annual sales of Huadong Medicine’s liraglutide product are expected to peak at RMB 680 million in 2029.

Huadong Medicine has long maintained a robust marketing strategy, with its marketing expenses accounting for an increasingly larger proportion of revenue in recent years—a critical factor for chronic disease medications. The company stated that it expects to complete the hospital listing of liraglutide in over 1,000 hospitals by the first quarter of this year. It also highlighted that the out-of-hospital market serves as a sales channel for the weight-loss indication, and is actively expanding its presence across online platforms, offline pharmacies, and medical aesthetic institutions.

Although the approval of liraglutide for weight loss indications will not grant Huadong Medicine a dominant position in the weight-loss drug market, it is sufficient to secure a competitive advantage in the ensuing GLP-1 market rivalry, paving the way for its subsequent products such as biosimilar semaglutide injections.

Either possess sufficiently profound expertise in the disease area and biological insights to develop best-in-class products.For example, mazdutide, a dual GLP-1R/GCGR agonist co-developed by Innovent Biologics and Eli Lilly, has demonstrated superior weight loss efficacy compared to both semaglutide and tirzepatide. In the 9 mg mazdutide group, patients achieved a mean weight reduction of 17.8 kg over 48 weeks, representing a robust 18.6% greater weight loss relative to placebo. In addition to promoting insulin secretion, lowering blood glucose, and reducing body weight through GLP-1R agonism, mazdutide enhances weight loss efficacy and improves hepatic lipid metabolism by activating GCGR to increase energy expenditure.

Mazdutide has demonstrated the greatest weight reduction compared with placebo among GLP-1 receptor agonists currently available for the obese population in China. In February this year, the marketing application for mazdutide injection was accepted for review, with weight management as the indicated indication. Innovent Biologics anticipates that mazdutide will be officially launched this year or next.

GLP-1: Beware of Getting "Buried"

There are over 100 GLP-1 drugs currently in global clinical trials, with nearly half originating from Chinese pharmaceutical companies.If these products continue to reach the market, not only will patients and consumers be inundated with GLP-1 offerings, but the companies rushing into the fray will also become mired in this intense competition, with many of their products inevitably ending up as casualties.

Most GLP-1 pipelines of domestic pharmaceutical companies are not innovative drugs; multiple companies have already obtained marketing approval or are in clinical trials for the same biosimilar products, which will inevitably lead to an oversupply in the GLP-1 market and intensify homogeneous competition. Furthermore, with the implementation of medical insurance cost-containment measures and the inclusion of biosimilars in centralized procurement, various GLP-1 products will face fierce price-cutting competition, further squeezing profit margins.

Moreover, the chronic disease sectors targeted by GLP-1 are areas many entering companies have never previously ventured into. Whether for diabetes or weight-loss indications, they must first confront pressure from foreign pharmaceutical companies.

“Research into diabetes targets has a history spanning several decades, with foreign companies holding a first-mover advantage, while domestic enterprises have primarily entered the market through generic drugs. As a chronic disease, the promotion of diabetes medications is not limited to hospital-based specialists but must also cover patient populations across different types and regions. Therefore, building sales and promotional teams for diabetes drugs requires substantial investment in both manpower and financial resources, an area where foreign companies possess more abundant resource advantages,” stated an industry professional with experience in promoting chronic disease medications at both multinational corporations (MNCs) and local pharmaceutical firms to VCBeat.

Secondly, the competition over GLP-1 drugs places considerable demands on pharmaceutical companies’ comprehensive capabilities.This differs significantly from the previous saturation in the PD-1 market or the current intense competition in the ADC sector. On one hand, oncology drug marketing focuses primarily on highlighting efficacy advantages and increasing physicians’ prescribing willingness, with relatively straightforward channel strategies and regulatory policies. In contrast, chronic disease drug marketing requires an integrated approach encompassing brand building, patient education, and adherence management, necessitating substantial marketing expenditures under a high-profile strategy. On the other hand, capacity planning for GLP-1 drugs is intricate, requiring comprehensive consideration of sales forecasts, cash flow, and competitors’ responses. Early entrants can gain market share by appropriately overbuilding capacity, while latecomers must proceed with greater caution.

Compared with oncology drugs that have clearer clinical value and benefits, GLP-1 drugs are backed by evidence-based medicine and resemble consumer goods more closely. Companies with insufficient cognitive and operational capabilities may fail to maintain their early-mover advantage, while those with precise positioning and effective strategies may well achieve success despite entering the market later. Moreover, even leading enterprises can instantly lose their competitive edge if strategic missteps occur or if competitors exploit compliance loopholes in their marketing practices.

Although the race to develop GLP-1 therapies has long been described as a matter of “time is money,” competition in this class of drugs resembles more of a marathon, requiring deep insights into the disease landscape, biology, and the future commercial ecosystem. Several newly launched GLP-1 pipelines, and even robust Phase 3 clinical data, remain merely “appealing on paper” until their commercial outcomes are realized.

Corporate strategy, product portfolio layout, and lifecycle management capabilities are all indispensable. Only in this way can one achieve ultimate victory in the long-term GLP-1 race.