IND Accepted! Guangzhou Baiyunshan Enters the Heavily Contested GLP-1 Market, Potentially Reshaping the RMB 100 Billion Landscape

Apr 29, 2026 19:10 CST Updated 19:10

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Huadong Medicine

Large Comprehensive Pharmaceutical Product Developer

On April 29, 2026, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) showed that Guangzhou Baiyunshan Baidi Biopharmaceutical Co., Ltd. (hereinafter referred to as "Baiyunshan Baidi") submittedSemaglutide InjectionNew Drug Clinical Application (IND) Accepted by CDE: Two Acceptance Applications Announced (Acceptance Nos.: CXSL2600455, CXSL2600456). The drug category is therapeutic biologics, application type is new drug, registration classification 3.3 (biosimilar). Both applications were processed on April 29, 2026.

This acceptance information marks that Baiyun Mountain, the core listed platform under Guangyao Group, a leading domestic pharmaceutical company, has officially entered the GLP-1 track, which is already fiercely competitive in China, adding a significant player to this billion-dollar market competition.

From Blood Sugar Reduction to Weight Loss, Semaglutide Supports a Billion-Dollar Global Metabolic Market

As a benchmark product of GLP-1 receptor agonists, semaglutide injection is a phenomenal "super单品" developed by the original research company Novo Nordisk, and is also one of the most concerned varieties in the current global pharmaceutical market.

Since its debut, semaglutide has rapidly expanded its indications with core advantages such as long-acting dosing, significant glucose-lowering and weight-reducing effects, and good safety: It was first approved in the United States for type 2 diabetes in 2017, followed by approval for obesity/overweight in 2021, and subsequently expanded to multiple fields including non-alcoholic steatohepatitis (NASH) and cardiovascular risk reduction, transforming from a glucose-lowering drug into a blockbuster therapy covering the entire metabolic syndrome spectrum.

In terms of commercial performance, semaglutide continues to break the global sales record for pharmaceutical single products. Public data shows that in 2025, the global sales of Novo Nordisk's semaglutide for all indications have exceeded $30 billion, firmly ranking at the top of global pharmaceutical single-product sales. In the Chinese market, with the approval of the diabetes indication in 2021 and the obesity indication in 2023, coupled with the continuous rise in the prevalence of metabolic diseases and an explosive demand for weight loss, the market size of semaglutide has rapidly expanded. By 2025, the overall market size of GLP-1 class drugs in China has surpassed 30 billion yuan, of which semaglutide accounts for over 70% of the market share, making it the undisputed dominant player in the field.

More notably, the core compound patent for Semaglutide has officially expired in China as of January 2026. The arrival of the patent cliff has completely opened up space for Chinese manufacturers to enter the market, making the development and submission of Semaglutide biosimilars one of the most crowded fields in China's pharmaceutical industry.

30+ Companies Rush to Enter the Market, Why is Baiyun Mountain Entering this Red Ocean Track Now?

As of April 2026, more than 30 companies in China have submitted clinical applications for semaglutide injection. Among them, leading companies such as Qilu Pharmaceutical, Huadong Medicine, Livzon Pharmaceutical, and United Laboratories have already completed clinical research and submitted marketing applications. Some products have been approved for marketing after the patent expiration, turning the field from a blue ocean market into a highly competitive red ocean stage with homogenized competition.

At a time when the industry generally believes that "the first-mover advantage has been basically locked in," Guangyao Baiyunshan's decision to enter the market now may seem "a step behind," but in fact, there is a clear industrial logic and core confidence behind it.

As the leading enterprise that has ranked first in China's pharmaceutical industry for many years, Guangzhou Pharmaceutical Holdings Group (Guangyao Group) boasts the most complete industrial chain layout in China’s pharmaceutical sector, which is precisely Baiyunshan's core advantage in entering the GLP-1 field.

InTerminal ChannelOn the other hand, Guangzhou Pharmaceutical Group has been deeply involved in China's pharmaceutical market for decades. It owns a nationwide retail pharmacy network and grassroots medical channels, with unparalleled penetration in the OTC market and county-level healthcare market. The core consumer scenarios for semaglutide’s weight-loss indication have long expanded from hospital markets to retail terminals. Guangzhou Pharmaceutical’s channel advantages can help achieve full-channel coverage quickly after the product launch, enabling precise access to lower-tier markets. This is an insurmountable barrier for most innovative pharmaceutical companies and biotech enterprises.

InResearch and IndustrializationOn this level, the applicant Baiyunshan Baidi is a core biopharmaceutical research and industrialization platform under Guangyao Baiyunshan. It has been deeply engaged in the fields of recombinant protein drugs and biosimilars for many years, possessing a mature eukaryotic cell expression system, scaled biopharmaceutical production capabilities, and a comprehensive quality control system. It has established biopharmaceutical production lines that comply with the standards of China, the EU, and the FDA, providing full-chain technical support for the research, clinical development, and commercialization of the semaglutide biosimilar.

InBrand and ComplianceOn the other hand, Guangzhou Baiyunshan Pharmaceutical, as a century-old pharmaceutical enterprise, possesses strong brand credibility and consumer recognition. Having deeply engaged in the field of chronic disease management for many years, it has built a profound brand presence among patients with diabetes. Meanwhile, as a local state-owned enterprise, Baiyunshan has mature experience in compliance management, medical insurance integration, and response to centralized procurement, enabling it to better adapt to China's pharmaceutical policy environment and pave the way for the subsequent commercialization of its products.

Industry Insight: Breaking Through in a Crowded Market – The Path for Latecomers

"The competition in the GLP-1赛道 is no longer about 'whether it can be made,' but rather 'whether it can be sold after going to market and whether differentiation can be achieved,'" a senior analyst from China’s pharmaceutical industry stated in an interview. With the expiration of semaglutide's patent, a large number of domestically produced products are expected to hit the market soon, pushing the track into deeper waters of price wars and channel battles. Simple biosimilar replication will find it increasingly difficult to break through in such a highly homogenized competitive environment.

For a "latecomer" like Baiyun Mountain, to secure a place in the billion-dollar track, it must break away from the simple logic of generic drugs and find its own path of differentiated breakthrough.

From the perspective of industry trends and the company's own strengths, Baiyun Mountain's path to breakthrough has become clear.

One isChannel DifferentiationRelying on the retail terminals and grassroots medical network of Guangyao Group, it avoids the fierce competition in the in-hospital market, focusing on key areas such as the retail end, medical aesthetics institutions, and health management centers, which are core consumer scenarios for weight-loss indications. At the same time, it quickly penetrates into the county-level markets to capture incremental markets not yet fully covered by leading enterprises.

Secondly, it isIndications and Clinical Value DifferentiationIn addition to the two core indications of lowering blood sugar and weight loss, semaglutide has made positive progress in global clinical research for multiple indications such as NASH, Alzheimer's disease, and chronic kidney disease, continuously expanding its market potential. Baiyun Mountain can leverage its own clinical resources to simultaneously advance the clinical development of cutting-edge indications, achieving differentiated competition with other domestically produced products through the first-mover advantage in indications.

Third, it isCost and Industrial Chain Synergy AdvantagesGuangyao Group has a full industrial chain layout from active pharmaceutical ingredient (API) production to formulation manufacturing and end-market sales. Through large-scale production and supply chain management, the company is able to achieve optimal cost control. In the future, whether responding to national bulk procurement or creating cost-effective retail products, this cost advantage will become Baiyun Mountain's core competitiveness.

Fourth, it isLayout of Combination TherapyThe management of metabolic syndrome often requires multi-target and multi-drug combination interventions. Guangyao Group has a rich portfolio of chronic disease treatment drugs, traditional Chinese medicine products, and health products, which can be used to create a "semaglutide +" combination therapy and full-cycle health management plan around metabolic syndrome. This approach moves beyond the competition of single products to build systematic clinical and commercial value.

Conclusion

The entry of Guangyao Baiyunshan undoubtedly adds fuel to the already heated GLP-1 track. Although not among the first batch of players to enter, Baiyunshan still has the potential to reshape the market landscape with its whole industry chain barriers, profound brand accumulation, and strong terminal channel capabilities.

As more domestically produced semaglutide products enter the market, China's GLP-1 market is set to witness a comprehensive wave of localized substitution. Product prices are expected to drop significantly, allowing more patients access to cost-effective treatment options. For companies entering this field, the competition has only just begun. Only those who can break away from homogenization and identify true clinical and commercial value will emerge victorious in this multi-billion-dollar race.

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