From 'Blockbuster Drug' to 'Red Ocean': Semaglutide's Patent Wall Crumbles as Dozens of Chinese Firms Rush to Seize Market Share

Cailian Press, March 23 (Reporter Lufeng Lu)On March 20, the core compound patent of Semaglutide in China expired.

This heavy-hitter, dubbed the "king of drugs" by the market, has rapidly gained momentum over the past few years with dual indications for diabetes and weight loss. It has also propelled the GLP-1 field to become one of the most watched areas in the global pharmaceutical industry. As the patent protection period ends, the supply-side landscape in China begins to shift, with generic drug/biosimilar companies entering the market en masse.

"We were the first to report production and also the first company to receive acceptance. Currently, it is still under review, and we have not yet obtained the approval." Hangzhou Jiuyuan Gene Engineering Co., Ltd. (02566.HK) told reporters from Cailian Press who called in as an investor; The United Laboratories (03933.HK) also stated that its product "is waiting for the final evaluation and approval from the national authorities, and you can absolutely rest assured about the production capacity."Livzon Group(000513.SZ) stated that "the listing application has been submitted and is still under review, and the production line has been completed"; a person close to CSPC Pharmaceutical Group (01093.HK) also revealed that it is expected to be approved for listing in the first half of 2026, and the long-acting formulation of semaglutide is also being advanced simultaneously.

As of now, ten companies' semaglutide generic drugs/biosimilars marketing applications have been accepted, with some products entering the "pending approval" stage, and are expected to be launched for sale within this year.

Meanwhile, before the formal launch of semaglutide generics/biosimilars, terminal prices have already shown signs of weakening, and competition at the channel level has intensified in advance. In the view of several interviewees, from the expected increase in supply to the restructuring of the pricing system, the GLP-1 track is entering a reshaping window period triggered by patent expiration.

Multiple Listed Companies "Rush for the First Batch of Licenses"

Globally, semaglutide has rapidly become one of the fastest-growing and most commercially valuable innovative drugs in recent years, thanks to its dual indications for glycemic control and weight loss. According to Novo Nordisk's financial report, the combined sales of its related products reached over 25 billion US dollars in 2024, becoming the absolute core source of the company's revenue and ranking among the best-selling drugs globally in 2024, following Humira as the "global blockbuster drug."

In the Chinese market, constrained by patent protection, its supply has long been dominated by original research enterprises, with a relatively stable price system and channel structure.

However, as the core compound patents expire, this "single supply" structure began to loosen, with domestic companies accelerating their entry. Unlike traditional chemical drugs, the supply release of semaglutide did not proceed simultaneously but showed distinct phased progress.

According to the data from the Center for Drug Evaluation of the National Medical Products Administration,Huadong MedicineRepresentative companies such as Hangzhou Jiuyuan Gene Engineering Co., Ltd., Livzon Pharmaceutical Group Inc., and The United Laboratories International Holdings Ltd have completed technical reviews or entered the later stages of the review process, nearing the first batch of certification windows; Qilu Pharmaceutical Co., Ltd., Huisen Biologics, CSPC Pharmaceutical Group, Chengdu Bright Future, Fosun Pharma Wanbang, and Zhengda Tianqing under China Biologic Products Holdings (01177.HK) remain in the ongoing review phase; additionally, there areChina Resources Double-Crane、Hybio PharmaceuticalSeveral companies, including Hybio Pharmaceutical Co., Ltd., Hangzhou Jiuyuan Gene Engineering Co.,Ltd., Livzon Pharmaceutical Group Inc., China Resources Double-Crane Pharmaceutical Co.,Ltd., Qilu Pharmaceutical Co., Ltd., and The United Laboratories International Holdings Ltd, are still in the clinical or registration preparation stage, attempting to catch up in the subsequent window period.

The formation of this echelon structure is not the result of a short-term concentrated application after the patent expiration, but rather the outcome of enterprises strategically planning around the patent cycle years in advance.

From the statements made by companies, "securing the first batch of approvals" has become the core objective at this stage.

Hangzhou Jiuyuan Gene Engineering Co.,Ltd. told the reporter from Cailian Press who called as an investor, "We were the first to report production and also the first to receive acceptance," and currently, "it is still under review and we haven't obtained the approval document yet." In the industry's view, this kind of "time advantage" will be transformed into a market-first advantage in the first batch of market launches.

In terms of production preparation, Hangzhou Jiuyuan Gene Engineering Co., Ltd. further stated, "We already have a production line, and since we previously produced liraglutide for East China, the production line can be used with just some improvements and upgrades." They also mentioned that if the product is approved, "the production capacity can cover the sales scale for 1 to 2 years after the product launch."

Public information shows that CSPC Pharmaceutical Group is accelerating the promotion of GLP-1 track layout. According to sources close to CSPC Pharmaceutical Group, its developed Semaglutide injection is expected to be approved for marketing in the first half of 2026. Relying on the existing production capacity system, it has complete production capabilities covering from research and development to industrialization.

From the perspective of the competitive landscape, there are currently more than 10 companies in China that have reported production of semaglutide. CSPC Pharmaceutical Group is in the first tier, and its product adopts a chemical technology route. Its weight-loss indication is one of the first batch of projects reported for production in China.

As multiple companies advance towards public listing, the market may gradually form parallel technical routes of biological and chemical methods. Among them, the biological method (i.e., biosimilars) aligns with the original research, while the chemical method (i.e., generic drugs) achieves equivalent efficacy to the biological method through process innovation, also holding certain advantages in impurity control.

In addition, CSPC Pharmaceutical Group's long-acting formulation of semaglutide is also advancing simultaneously. Public announcements from CSPC Pharmaceutical Group reveal that the company has initiated relevant clinical trials. This product is among the first batch of "monthly formulations" of semaglutide to enter the clinical stage in China, with the potential to further expand the advantages in dosing frequency and patient compliance.

The United Laboratories, on the other hand, sent a more direct signal from the perspective of industrialization capacity. Its Securities Department told reporters from the Caixin Media, who called as an investor, that the product "is waiting for the final review and approval from the national bureau," and "there are still some administrative procedures not yet completed." However, they emphasized that "you can absolutely rest assured about our production capacity," noting that the company has accumulated mature fermentation and large-scale production experience in products such as insulin and liraglutide.

In contrast, Livzon Pharmaceutical Group Inc. is still in the approval waiting stage. The company told a reporter from the Financial News Agency, who called as an investor, "The listing application has been submitted and is still under review," and the approval document has not been obtained yet. Meanwhile, the company emphasized that the production line "has been completed with sufficient capacity" and had finished the expansion preparation earlier.

This kind of "capacity first, approval later" strategy also reflects companies' early bets on future market expansion. However, despite thorough preparation on the corporate side, the actual release pace of supply is still subject to multiple constraints.

Liu Yuqi, Director of CIC灼识Consulting, told reporters that the expiration of the semaglutide patent does indeed lower the entry barrier, but more importantly, it is the "increase in potential participants" rather than the "immediate release of effective supply."

"Semaglutide belongs to complex peptides, and its manufacturing involves the selection of process routes. Different routes may even affect the registration classification and clinical requirements," Liu Yuqi pointed out. For instance, companies adopting a chemical synthesis route can, to a certain extent, shorten the time-to-market cycle; whereas those opting for a fermentation route similar to the original research must follow the biosimilar drug pathway for registration, facing higher clinical and review thresholds.

Moreover, the difficulty of peptide drugs in the industrialization phase is much higher than that of traditional chemical drugs. Zhao Heng, founder of Latitude Health, a medical strategy consulting firm, also told reporters that the complexity of peptide drugs determines that they cannot quickly enter into full competition like small molecule drugs after patent expiration. "In the short term, it is more likely that a few companies will take the lead in entering the market, gradually scaling up, rather than a comprehensive rollout."

The "Waist-Cut" Signal Has Appeared in the Off-Hospital Market

Unlike the "orderly queue" on the supply side, the competition on the price front has already substantially "kicked off".

Reporters from Cailian She have continuously tracked and found that in the past six months, the price center of Semaglutide in the off-hospital market has shown significant loosening, presenting a clear path of "gradual and channel-specific downward adjustment."

The earliest cracks appeared in the Internet medical and e-commerce channels. Since Q4 of last year, major platforms have taken the lead in pushing prices to their limits through billion-dollar subsidies and prescription flow承接 methods. The end-user成交 price of semaglutide has gradually retreated from a premium range close to 1,000 yuan to a core range of 500 to 600 yuan. Entering Q1 of this year, with the patent expiration date approaching, limited-time promotions on some platforms have even seen extreme low prices接近 "half off."

In the industry's view, this round of price changes is essentially an early market response to the "patent cliff."

Liu Yuqi, Director of CIC灼识Consulting, told the Caixin reporter that the current price adjustment can be understood as a process of "market value redistribution and pattern reshaping," and "its coreDriving Force"It is the gradual disappearance of monopoly profits, and the market expects that generic drugs will penetrate based on cost advantages."

From a structural perspective, this round of price adjustment shows obvious stratified characteristics. Semaglutide covers both the diabetes and weight-loss markets in China. The diabetes indication has been included in the medical insurance system, with prices constrained by payment policies, remaining relatively stable overall; however, the weight-loss indication is not covered by medical insurance and mainly relies on out-of-pocket payments. Its price is more directly affected by supply-demand relations and competitive expectations, making it the core area of this round of price reductions.

Wang Heng, General Manager of Beijing Bestrategy Marketing Planning Co., Ltd., told reporters that before the patent expiration, the original research enterprises proactively adjusted prices through promotional methods. On one hand, this was to "lock in the user base and enhance patient loyalty," and on the other hand, it was related to product sales rhythm and market competition expectations. "Essentially, the market is pre-pricing the future competitive landscape, rather than simply conducting phased promotions."

However, from the current situation, there is still a "bottom line" for price drops.

Zhao Heng judged that the mainstream price of weight-loss drugs will remain above 200 yuan in the next one to two years, a level that is related to production costs and also reflects that the current competition has not yet entered a fully unleashed stage.

Wang Hengyi believes that even if the subsequent generic/biosimilar drugs of Simotin gradually increase in volume, their prices are likely to remain at around 70% to 80% of the original product, rather than quickly entering a low-price competition zone. This means that before supply is fully released, the pricing system is more likely to show an "orderly decline" rather than a "disorderly collapse."

From "Who Can Get Approved" to "Who Can Stay in the Game"

As the first batch of generic drugs/biosimilars are approaching the realization phase within the year, the industry's focus is rapidly shifting from "who can get approved" to "who can truly achieve scaled-up production and remain in the game long-term."

Behind this shift lies the competitive logic determined by the inherent attributes of GLP-1 drugs – unlike traditional specialty medications, they possess both the continuity characteristic of chronic disease treatments and the consumer healthcare attribute driven by weight-loss demand. Once prices reach an accessible range, demand elasticity will be quickly unleashed, placing higher demands on supply capacity.

Liu Yuqi judged that the market would not immediately enter into full competition after the first batch of generic drugs/biosimilars hit the market, but instead, there would be a "limited competition window period." The formation of this window period is due to the limited number of companies initially approved, as well as being closely related to the pace of market access.

"The original research drugs have already built strong doctor awareness and patient loyalty. Related products need time to complete entering hospitals, doctor education, and channel establishment, and cannot be replaced in a short period of time," it said.

But this "buffer period" will not change the direction of accelerating convergence in competition.

From the perspective of the industrial chain structure, the cost of peptide drugs represented by semaglutide is not solely determined by raw materials but is jointly constituted by process pathways, scale-up capabilities, and supply chain efficiency. It is widely believed in the industry that within GLP-1-based products, as scale expands, there is significant room for the cost curve to decline. This also means that once leading companies achieve scale production, they will quickly widen the cost gap with latecomers.

"The competition in the future will not be about a single element, but a comprehensive capability system." Liu Yuqi pointed out that this system is based on cost, while also covering production capacity, quality, and compliance advancement capabilities.

In terms of production capacity, the competition among GLP-1 drugs is essentially a "scale competition." On one hand, the demand in the weight-loss market is rapidly increasing, with the growth rate of a single product far exceeding that of traditional chronic disease medications; on the other hand, the supply side must achieve large-scale stable production while ensuring consistent quality.

At the same time, channel capability began to become a key variable in determining the efficiency of volume expansion.

From the perspective of the current market structure, GLP-1类产品 have formed a dual-driven pattern of "hospital + non-hospital channels." Among them, diabetes indications are still mainly based on hospital channels, while the weight loss market relies more on retail pharmacies, DTP channels, and internet healthcare platforms. There are significant differences in pricing systems, patient demographics, and promotional models across different channels, which also means that companies face more complex operational requirements during the commercialization phase.

Against this backdrop, the market structure has started to show a layered characteristic. Zhao Heng judged that, in the short term, the structure will remain dominated by the original research enterprises, such as Novo Nordisk, with generic drugs/biosimilars gradually supplementing. Original research enterprises still have an advantage in the mid-to-high-end market due to their long-term accumulated clinical data, brand recognition, and channel systems, while generic drugs/biosimilars are more likely to achieve breakthroughs first in price-sensitive markets.

"Generic drugs/biosimilars will increasingly enter the mid-to-low price market, serving patient groups sensitive to pricing." It pointed out that in the future, a layered competitive structure with "originator drugs + generic drugs/biosimilars" coexisting may form.

From the perspective of the price evolution path, Wang Heng believes that as more companies complete their capacity ramp-up and enter the market, price competition is likely to accelerate in the mid-term, "not remaining温和 for a long time," but its pace will depend on the speed of supply release and channel penetration progress.