The research and production of dual insulin formulations, with their unique technical challenges, have long allowed original drugs to dominate the domestic market for five years. However, this situation is set to change with the rise of the first domestic challenger. Sihuan Pharmaceutical Holdings Group Ltd. (0460.HK), a company listed on the Hong Kong Stock Exchange, recently announced that its incubated enterprise specializing in the treatment of diabetes and its complications, Huisheng Biopharmaceutical, has developed a Insulin Degludec and Insulin Aspart Injection (trade name: Huiyoujia) and has obtained drug registration approval from the National Medical Products Administration (the “NMPA”). This marks the debut appearance of a domestic biosimilar of Insulin Degludec and Insulin Aspart Injection.

 

This milestone event is of profound significance. It not only enriches the arsenal of treatments available to diabetes patients but also signals a major shift in the insulin market landscape. It demonstrates Huisheng Biopharmaceutical's forward-thinking strategy, well-established capabilities, and innovative prowess in the biopharmaceutical field, formulating a solid competitive barrier for the company.

 

Against this backdrop, the multiple leading products in Huisheng Biopharmaceutical's pipeline are once again drawing market attention. The company's brand credibility and market influence are set to increase, ushering in a golden period of rapid development.

 

Securing the First Domestic Biosimilar, Reshaping Market Dynamics

 

On August 6th, Sihuan Pharmaceutical announced that its non-wholly owned subsidiary, Huisheng Biopharmaceutical, had received approval from the National Medical Products Administration to market its Insulin Degludec and Insulin Aspart Injection (trade name: Huiyoujia) for the treatment of adult type 2 diabetes.

 

This is the first domestic biosimilar of Insulin Degludec and Insulin Aspart Injection approved for marketing following the original drugs from Novo Nordisk.

 

Known for its "dual-action drive," Insulin Degludec and Insulin Aspart Injection is designed to optimize blood sugar management comprehensively.

 

According to public data, the product combines basal insulin and mealtime insulin in one injection, meeting both needs simultaneously. It can quickly control fasting and postprandial blood sugar levels and better reduce glycated hemoglobin. As a non-co-crystallized compound formulation, it can be used without mixing, improving convenience and avoiding the risks associated with mixed injections. Compared to basal-bolus insulin therapy, it also reduces the number of injections, thereby helping to improve patient compliance. Pharmacoeconomic research confirms that Insulin Degludec and Insulin Aspart Injection offers a cost-effective advantage.

 

Consequently, Insulin Degludec and Insulin Aspart Injection is favored by guidelines and has received recommendations, recognition, and high praise from a large number of domestic and international guidelines/consensus. It can be used throughout the entire treatment process for type 2 diabetes.

 

Industry insiders believe that the value of Insulin Degludec and Insulin Aspart Injection is undeniable. Backed by years of accumulated real-world research data, this solid evidence provides strong support for its quality and efficacy. As a milestone for the country's first biosimilar, the approval of Huisheng Biopharmaceutical's Huiyoujia not only signifies its entry into a market with boundless potential but also is expected to lead a revolution and reshaping of the market landscape, breaking the "monopoly" on this drug.

 

So, what is the market potential and growth prospect for this product? Insights can be gleaned from last year's sales performance, where Insulin Degludec and Insulin Aspart Injection stood out among many insulin preparations.

 

According to Novo Nordisk's annual report, in 2023, the company's revenue from Insulin Degludec and Insulin Aspart Injection in the Greater China region was approximately $288 million, a 61.3% increase year-on-year. Data from Sinohealth CHIS shows that despite the decline in sales of many insulins in China in 2023, Insulin Degludec and Insulin Aspart Injection grew by 57.8% in sales, ranking third in the national-level hospital insulin market.

 

Moreover, according to IQVIA forecasts, the sales of Insulin Degludec and Insulin Aspart Injection  in China are growing rapidly, with the market expected to reach 3 billion yuan by 2025.

 

Building Competitive Business Barrier, Potential is Promising

 

After securing the crown of the first domestic biosimilar, Huisheng Biopharmaceutical faces challenges in production capacity, sales, and subsequent product reserves.

 

Huisheng Biopharmaceutical's "answer sheet" is well-prepared: the company already has a rich product pipeline and a solid foundation in insulin products, having established its own research, production, and sales system. Furthermore, backed by Sihuan Pharmaceutical, sales are expected to receive an auxiliary upgrade.

 

Huisheng Biopharmaceutical, as a subsidiary of the large pharmaceutical and medical aesthetics group Sihuan Pharmaceutical, focuses on the field of diabetes and complications. After ten years of establishment and development, Huisheng Biopharmaceutical has become one of the few full industry chain biopharmaceutical companies in China that can cover all products in the field of diabetes and its complications, integrating research, production, and sales.

 

In terms of research and development, the company has an internationally top-ranking R&D team with rich experience in diabetes drug development, with core members having worked in leading international enterprises such as Novo Nordisk and Bayer. The R&D product pipeline includes more than 30 products, covering the full range of second-generation, third-generation, and innovative insulin (including basal, premixed, and rapid-acting types), SGLT-2 inhibitors, GLP-1 receptor agonists, and other latest mechanism products, as well as various common hypoglycemic and complication treatment drugs. Specifically, the phase III clinical trials for the diabetes indication of Semaglutide injection have been completed, and the IND application for the weight loss indication has been accepted by the regulatory authority.

 

In terms of production capacity, Huisheng Biopharmaceutical has also planned ahead. The company has high-standard production facilities designed, constructed, and operated to international standards. Currently, it has a production base with a capacity of 25 million insulin units and plans to build a base capable of producing over 100 million insulin units in the future.

 

In terms of sales channels, Huisheng Biopharmaceutical has inherent advantages and strong competitiveness. Relying on the powerful sales resources of its parent company, Sihuan Pharmaceutical, Huisheng Biopharmaceutical can quickly establish and upgrade its marketing network, forming closed-loop marketing and paving the way towards BioPharma.

 

Against this backdrop, the vast space of the diabetes market cultivated by Huisheng Biopharmaceutical will bring abundant growth momentum to the company in the future.

 

According to a Frost & Sullivan report, the global diabetes drug market was close to $70 billion in 2020, and the global diabetes market is expected to exceed $90 billion by 2025 and approach $110 billion by 2030.

 

It is evident that, with the company's strong R&D strength verified, Huisheng Biopharmaceutical's well-planned and prepared production capacity and marketing channels are expected to accumulate experience and reputation through the in-depth cultivation of core products. This will bring synergistic effects to the realization of a rich pipeline and accelerate the transformation of new products and in-depth coverage of the product line, ultimately taking it a firm step forward towards BioPharma.