Recently, CSPC Group announced that the marketing application for semaglutide injection developed by its subsidiary CSPC Baike has been formally accepted by the NMPA, with the indication for blood glucose control in adults with type 2 diabetes.
In addition, CSPC Group has also laid out other products in the GLP-1 field, including the long-acting semaglutide preparation SYH9017 (which is expected to achieve once-monthly administration), the innovative pipeline TG103, and the oral small-molecule GLP-1 receptor agonist SYH2086.
Currently, the popularity of the GLP-1 track continues to rise, and the hundred-billion-dollar market is ushering in fierce competition. Through multi-dimensional pipeline layout, CSPC Group has laid an important groundwork for seizing market opportunities.
Chemical synthesis opens up a new path
As a first-line drug for the treatment of type 2 diabetes and the largest single product in the weight loss field, semaglutide injection has broad market prospects. The original research company Novo Nordisk has built high barriers relying on DNA recombination technology, while CSPC Group's declared 2.2 class chemical modified new drug uses a complete chemical synthesis method to prepare semaglutide, marking a major breakthrough in the technical path of domestic innovative drugs.
This chemical synthesis route has significant advantages:
Through advanced synthesis and purification processes, not only is the raw material purity higher, but also immune substances such as host proteins introduced during biological fermentation can be avoided, and the impurity level is guaranteed to be no higher than that of semaglutide prepared by DNA recombination technology.
Impurity profile comparison studies show that its impurity level is lower than that of semaglutide injection prepared by DNA recombination technology, and no new impurities are generated under long-term storage conditions of 2~8℃, with excellent stability.
Preclinical studies have shown that this chemically synthesized product is similar to semaglutide injection prepared by DNA recombination technology in terms of in vitro biological activity and in vivo hypoglycemic effect, and also has consistent metabolic characteristics and safety in cynomolgus monkeys, confirming that the chemical synthesis method does not affect the drug efficacy.
This marketing application is based on a key phase III clinical trial. The results show that in patients with type 2 diabetes whose blood glucose is not well controlled after metformin treatment, the efficacy of this product is highly consistent with that of semaglutide developed by Novo Nordisk, and the incidence of gastrointestinal reactions is slightly lower.
Based on its comprehensive advantages in efficacy, safety, and formulation technology, in addition to promoting the indication of type 2 diabetes, CSPC Group is also actively carrying out phase III clinical trials of the product for obesity/overweight indications, in order to benefit a wider range of patient groups. Domestic competition heats up
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist and has become a blockbuster drug in the global diabetes treatment and weight loss fields.
Its core mechanism lies in simulating the naturally secreted GLP-1 in the human body, promoting insulin secretion, inhibiting glucagon release, delaying gastric emptying, and enhancing satiety. Compared with natural GLP-1, semaglutide has a longer half-life (about one week), enabling once-weekly administration and continuous regulation of metabolism.
Novo Nordisk's first-half 2025 financial report shows that the sales of the entire semaglutide product line reached 112.756 billion Danish kroner (approximately 16.6 billion U.S. dollars, calculated at the average exchange rate: 1 Danish krone = 0.1475 U.S. dollars), accounting for 73% of the company's total revenue. This figure has surpassed the performance of K drug in the same period (15.161 billion U.S. dollars), and semaglutide is expected to top the global innovative drug sales list in 2025.
The huge market potential has ignited the competition enthusiasm of domestic pharmaceutical companies. According to Yaozhi Data, with the addition of CSPC Group, the number of domestic enterprises submitting marketing applications for semaglutide has increased to 6, including Jiuyuan Gene, Livzon Group, Qilu Pharmaceutical, United Laboratories, Zhongmei Huadong, and CSPC Group. In addition to the above declared enterprises, semaglutide projects of pharmaceutical companies such as Sihuan Pharmaceutical, Zhengda Tianqing, and Chen'an Bio have also entered the phase III clinical stage, indicating that market competition will be more intense in the future.
The core component patent of semaglutide in China will expire in 2026. This means that domestic pharmaceutical companies need to complete the evaluation and approval process within about one year next to seize market opportunities.
It is expected that the price of domestic semaglutide after listing will be significantly lower than that of the original research drug, which will constitute a key advantage in markets with high price sensitivity (such as the environment of medical insurance cost control). With the potential differentiated advantages brought by its complete chemical synthesis technology (such as higher purity, better impurity profile, and potential cost advantages), CSPC Group is expected to shape unique competitiveness in the fierce competition.
Seize the opportunity
Pfizer predicted in its "Near-Term Launches High-Value Pipeline Day" report that the global GLP-1 receptor agonist (GLP-1RA) market size is expected to reach 100 billion U.S. dollars by 2030.
As a basic therapy for diabetes and obesity, the GLP-1 receptor, due to its wide distribution in the whole body, enables the continuous expansion of indications for related drugs. Take semaglutide as an example; its applications have gone beyond the traditional treatment of type 2 diabetes and obesity, covering cardiovascular disease (CVD), atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), peripheral artery disease (PAD), non-alcoholic steatohepatitis (NASH), Alzheimer's disease (AD) and other fields.
According to a report by Ping An Securities, the global GLP-1 market size was approximately 52.83 billion U.S. dollars in 2024, a significant year-on-year increase of 46%. Among them, Novo Nordisk's semaglutide series (Ozempic accounting for 33%, Wegovy 16%, Rybelsus 6%) led with a 55% share; Eli Lilly's tirzepatide series (Mounjaro accounting for 22%, Zepbound 9%) followed closely with a 31% share, among which Zepbound is in a period of rapid growth due to its late approval.
In the Chinese market, the GLP-1 market size was approximately 6.6 billion yuan in 2024, with semaglutide injection accounting for 63% of the share, liraglutide and dulaglutide accounting for 18% and 11% respectively.
Currently, the domestic GLP-1 market is dominated by Novo Nordisk's semaglutide. However, the high annual treatment cost of the original research drug limits the accessibility of some patients, keeping some patients out.
Compared with the original research drug, in terms of pricing, it is expected that domestic semaglutide will be reduced in price, and reference can be made to the pricing strategy of liraglutide injection from Huadong Medicine. At that time, relying on the prominent price advantage, domestic semaglutide is expected to significantly improve the accessibility of primary markets and promote the growth of the overall drug penetration rate.
CSPC Group's semaglutide injection, relying on the potential cost advantage brought by chemical synthesis technology, may seize a larger market share. However, it should be noted that against the background of the global supply shortage of the original research drug, CSPC urgently needs to prove its large-scale mass production capacity to meet the potential market demand.
More than that, CSPC Group has built a multi-dimensional pipeline matrix in the GLP-1 field:
In the field of long-acting preparations, the long-acting semaglutide injection (SYH9017), which was approved for clinical use in December 2024, is the first domestic semaglutide preparation administered once a month. Relying on CSPC's long-acting delivery technology, it extends the administration cycle from once a week to once a month, significantly improving patient compliance. Preclinical studies have shown that its weight loss effect is equivalent to that of the original research drug, with good safety, and it also has the potential to treat type 2 diabetes and reduce the risk of cardiovascular diseases, laying a foundation for the subsequent development of multi-target GLP-1 drugs.
The innovative pipeline TG103 is a potential "star product" of CSPC. As a recombinant human GLP-1 Fc fusion protein developed based on the hyFc long-acting fusion protein platform technology, its molecular design can extend the in vivo half-life, enabling once-weekly or once-every-two-weeks subcutaneous administration, greatly improving patient compliance. Preclinical studies and German phase I clinical data have shown good safety. Currently, it is advancing clinical trials in indications such as type 2 diabetes, overweight/obesity, non-alcoholic steatohepatitis, and Alzheimer's disease. Among them, the overweight/obesity indication is in phase III clinical trial, and the phase II clinical trial for type 2 diabetes has been completed, and it is expected to be approved for marketing in 2026.
There are also significant progresses in the field of oral small molecules. SYH2086, a new oral small-molecule GLP-1 receptor agonist independently developed by CSPC, reached a global licensing agreement with Madrigal in July 2025, with a total transaction value of up to 2.075 billion U.S. dollars, setting a new record for the overseas export of early R&D achievements of Chinese innovative drugs. Preclinical data show that SYH2086 has shown excellent hypoglycemic and weight-loss activities and good safety in animal models, with no obvious gastrointestinal adverse reactions. This cooperation will accelerate its global layout in the field of metabolic diseases, and at the same time, through the development of a combination therapy with Madrigal's Rezdiffra, explore the synergistic effect of GLP-1 in the treatment of metabolic associated steatohepatitis (MASH).
With the continuous expansion of indications and the accelerated breakthrough of domestic drugs, the hundred-billion-dollar cake of the GLP-1 market is ushering in more intense competition, and CSPC Group's multi-pipeline layout has laid a solid foundation for its market competition in this field in advance.
Conclusion
The success of the chemical synthesis path has broken through the technical barriers that have long relied on biological fermentation processes in the GLP-1 field, opening up an innovative path for domestic pharmaceutical companies to "break through patent blockades and establish new process standards".
References:
References:
1. Yaozhi Data
2. Official website of CSPC Group
3. Ping An Securities, "GLP-1 Drugs Future Direction: Exploring the Tracks of Fat Reduction and Muscle Increase, Oral Dosage Forms, and Ultra-Long-Acting Preparations"
