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1. With Two Home-Grown Insulin Products Approved for Marketing, It Leads the Development of The Domestic Insulin Market
On August 6th, Sihuan Pharmaceutical (00460.HK) announced that Insulin Degludec and Insulin Aspart Injection (trade name: Huiyoujia), developed by its subsidiary Huisheng Biopharmaceutical, was approved for marketing to treat adult type 2 diabetes. This marked the first domestic Insulin Degludec and Insulin Aspart Injection biosimilar drug to be approved for market, following the original drug company Novo Nordisk.
Shortly after that, Huisheng Biopharmaceutical achieved another breakthrough with its self-developed Insulin Degludec Injection (Huiyouda) on August 14th, also approved for marketing. This is the first domestically produced Insulin Degludec Injection biosimilar drug approved for marketing after the original drug.
Insulin Degludec is a new generation of long-acting basal insulin analogue, with a half-life of up to 25 hours and a duration of action of about 42 hours in the human body. Insulin Degludec Injection is classified as a Class B drug covered by the National Reimbursement Drug List, offering excellent glucose-lowering effects, ensuring stable control of blood sugar levels, lasting efficacy, and is known for its low risk of hypoglycemia and high safety. It is also the first long-acting insulin allows diabetic patients to inject at any time of the day (with an interval of 8 hours), providing greater flexibility in injection timing and higher patient compliance. Studies have shown that the use of Insulin Degludec Injection significantly reduces the risk of hypoglycemia in type 2 diabetes patients, especially the incidence of severe nocturnal hypoglycemia, which is reduced by 53% compared to Insulin Glargine.
The Insulin Degludec and Insulin Aspart Injection, composed of 70% Insulin Degludec and 30% Insulin Aspart, is the world's first soluble dual insulin formulation combining a long-acting and a rapid-acting insulin analogue, also classified as a Class B drug covered by National Reimbursement Drug List. The components of Insulin Degludec and Insulin Aspart in this product maintain their respective pharmacokinetic properties in the body, complementing each other and reducing the potential effect overlap of different components in traditional premixed insulin formulations, thereby more effectively reducing the risk of hypoglycemia. The Insulin Degludec and Insulin Aspart Injection does not require mixing before injection, greatly simplifying its usage and addressing issues of uneven medication distribution. Furthermore, the Insulin Degludec and Insulin Aspart Injection requires fewer injections, reducing treatment costs and psychological burden for patients, and offering better economic benefits.
Related Phase III clinical study data show that Huisheng Biopharmaceutical's approved products, Huiyouda and Huiyoujia, are comparable in clinical efficacy and safety to their respective original drugs, proving their reliability as treatment options.
Suffice to say, the approval for marketing of the two first domestic insulin products has reshaped the domestic insulin market landscape in less than ten days. This also sparks curiosity about the R&D strength behind Huisheng Biopharmaceutical—how such achievements were possible?
2. Integrating the Whole Industry Chain, A Nova Sparkles in the Domestic Diabetes Market
In this regard, Huisheng Biopharmaceutical has provided an excellent answer.
As a subsidiary of Sihuan Pharmaceutical, Huisheng Biopharmaceutical is one of the few domestic biopharmaceutical companies capable of achieving full product coverage in the diabetes and its complications domain, integrating R&D, production, and sales across the entire industry chain.
Firstly, lets take a look at the product pipeline. the company boasts a world-class research team with extensive experience in diabetes drug development. The pipeline includes over 30 products, covering the full range of second-generation and third-generation insulins, as well as new types of insulins represented by Insulin Degludec and Insulin Degludec and Insulin Aspart. Additionally, the company has ventured into new target products such as SGLT-2 inhibitors and GLP-1 receptor agonists, as well as other commonly used hypoglycemic and diabetes complication drugs.
On the basis of early-stage R&D, Huisheng Biopharmaceutical's products have now entered an intensive commercialization phase. In the first half of the year, five products were successfully launched for sale: Insulin Aspart Injection, Insulin Aspart 30 Injection, Insulin Aspart 50 Injection, Vildagliptin Tablets, and Methylcobalamin Tablets, marking the start of Huisheng Biopharmaceutical’s commercialization year. Moreover, Huisheng's self-developed Class I innovative drug SGLT-2 inhibitor, Janagliflozin tablet (Huiyoujing), also received approval from China’s National Medical Products Administration for marketing in January this year, and is expected to enter the market for sales in the second half of the year.
Secondly, in terms of production capacity, the company currently owns a diabetes biopharmaceutical production base with a capacity of 25 million units, planning to build a base with a capacity of over 100 million units in the future.
Lastly, in regard of commercial sales, with strong support and continuous empowerment from its parent company Sihuan Pharmaceutical, Huisheng Biopharmaceutical is rapidly establishing an efficient marketing network that combines direct sales and distribution, offline and online channels, providing solid support for the market expansion of various products.
This means that Huisheng Biopharmaceutical has become a company capable of efficiently integrating resources and optimizing processes from R&D innovation to production manufacturing, and then to marketing.
3. Globally-Oriented, It Seizes the Broad Opportunities in Southeast Asia and the Middle East Market
However, to ultimately garner considerable revenue from products, besides having an integrated system across the entire industry chain, a crucial point lies in accurately grasping the market. The market space not only determines the potential value of a company's products but also is a decisive factor in whether its intrinsic value can be fully unleashed.
In China, influenced by rapid economic growth over the past few decades, along with factors such as population aging, urbanization, and lifestyle changes, the prevalence of diabetes has continued to rise. Public data shows that about 30 years ago, the proportion of adults with diabetes in China was less than 1%, but today this figure has soared to around 12%.
This upward trend has significantly driven the increase in demand for diabetes treatment, thereby accelerating the expansion of the market size.
According to the "China Diabetes Market Report: 2024-2032" released by Research and Markets, the Chinese diabetes market reached $4.7 billion in 2023 and is expected to grow to $9.3 billion by 2032, with a compound annual growth rate of 7.9%.
However, the Chinese market is just a small part of the diabetes treatment market.
According to forecasts by the International Diabetes Federation, the global diabetes population is expected to increase from 425 million in 2017 to 629 million by 2045, an increase of 48%. A Frost & Sullivan report shows that the global diabetes medication market was close to $70 billion in 2020, and the global diabetes market is expected to exceed $90 billion by 2025, with hopes of approaching $110 billion by 2030.
The continuously growing number of diabetes patients worldwide and the expanding market space for diabetes medications point a direction for Huisheng Biopharmaceutical and other domestic innovative pharmaceutical companies: they should not be confined to the domestic market but should focus on a global layout.
Particularly in Southeast Asia and the Middle East, the demand for insulin and other diabetes treatment drugs is growing, with the market supply falling short of demand, leaving market demand vastly unsatiated.
Specifically, in Southeast Asia, the IDF report predicts that the number of diabetes patients will increase from 90 million in 2021 to 152 million by 2045, an increase of 68%, making it one of the most severe regions for diabetes globally. Public data shows that the current prevalence rates of diabetes in Malaysia, Indonesia, Thailand, and Vietnam are 19%, 10.6%, 9.7%, and 6.1%, respectively.
Middle East also shares the grimness, with eight Middle Eastern countries having the highest adult obesity rates globally, ranging from 27% to 40% of the population being chronically overweight. Take Saudi Arabia as an example, the local diabetes prevalence rate is as high as 18.7%, making it one of the top ten countries with the highest diabetes prevalence rates globally.
These figures not only highlight the urgency of diabetes treatment but also clearly indicate the growing demand for insulin and other diabetes treatment drugs in Southeast Asia, signaling huge market potential.
For leading Chinese biopharmaceutical companies like Huisheng Biopharmaceutical, which possess integrated capabilities in research, production, and sales, these demand trends represent not only tremendous business opportunities but also strategic chances to expand into international markets and enhance global brand influence.
4. Innovative Products and Rich Experience Enable It to Seize Overseas Market Opportunities
So, what enables Huisheng Biopharmaceutical to seize this overseas opportunity?
The writer believes there are two reasons:
On one hand, Huisheng Biopharmaceutical, with its comprehensive and significantly advantageous diabetes product pipeline, can fully meet the diverse needs of diabetes patients.
The company's products belong to a new generation, such as the newly approved Insulin Degludec and Insulin Aspart Injection (Huiyoujia) and Insulin Degludec Injection (Huiyouda). These products not only have significant advantages in terms of hypoglycemic effect, safety, and cost-effectiveness but also demonstrate their innovation and clinical value in the international market, highly aligning with the demand and development trend of the diabetes medication market in Southeast Asia and other regions.
On the other hand, Huisheng Biopharmaceutical relies on its mature international operational capabilities and cost control advantages to rapidly expand into overseas markets.
The parent company Sihuan Pharmaceutical, as an established HK-listed pharmaceutical company, provides a solid foundation for Huisheng Biopharmaceutical's international strategy with its rich international experience and business expansion expertise. This helps quickly establish and upgrade Huisheng's marketing network, forming a commercialization closed loop. Additionally, the cost control advantage of domestic biosimilar drugs also helps Huisheng Biopharmaceutical quickly open up overseas market entry points, ensuring the smooth progress of its overseas expansion plan.
It is not hard to tell that Huisheng Biopharmaceutical, with its innovative product pipeline and mature market strategy, is expected to meet the growing medical needs in Southeast Asia while achieving overseas growth and enhancing brand value, perfectly capturing the opportunities in Southeast Asia and other overseas markets.
5. Summary
Currently, with the launch of Insulin Degludec and Insulin Aspart Injection (Huiyoujia) and Insulin Degludec Injection (Huiyouda), both holding the title of "first domestic biosmilar in China," Huisheng Biopharmaceutical has firmly established its leading position in the domestic diabetes treatment field.
As more blockbuster drugs for diabetes and its complications from Huisheng Biopharmaceutical hit the market, its industry status is increasingly noteworthy. Meanwhile, with a competitive product pipeline and mature sales strategies, the company also possesses the capability to seize opportunities in overseas markets, expected to demonstrate greater competitive potential and commercial value on the international stage.
It is a safe bet that as Huisheng Biopharmaceutical continues to succeed in both domestic and international markets, its contribution to the parent company Sihuan Pharmaceutical will become increasingly significant. The market performance and brand influence of Huisheng Biopharmaceutical will further enhance Sihuan Pharmaceutical's industry status and overall value, bringing new development opportunities and valuation enhancement momentum.