Accelerate the Industrialization Development of Diabetes Product Pipelines, Further Enhance the Competitiveness and Comprehensive Strength
The new drug application (NDA) of Janagliflozin developed by Jilin Huisheng Biopharmaceutical Co., Ltd. (“Huisheng Biopharmaceutical”), a non-wholly owned subsidiary of the Group, has been accepted by the National Medical Products Administration (“NMPA”) of the People’s Republic of China (“China”). It is the second domestic SGLT-2 inhibitor, a Class 1 innovative drug, that has submitted a NDA in China and with the application having been accepted.
Janagliflozin is an inhibitor of the sodium-glucose transport protein subtype 2 (SGLT-2). It reduces the re-absorption of glucose by renal tubular via inhibiting SGLT-2 so that the excess glucose is excreted through urination, thus lowering overall glucose levels in the blood. SGLT-2 inhibitor is a new oral hypoglycemic drug which is highly recommended internationally for the treatment of patients with Type 2 Diabetes Mellitus.
The clinical data of Janagliflozin showed that it not only had significant anti-diabetic efficacy, with the decrease of glycosylated hemoglobin by -1.4% from baseline. Meanwhile, it has multiple benefits such as lowering blood pressure, reducing body weight and improving blood lipids with low risk of hypoglycemia and good overall safety. Through horizontal comparisons with phase III clinical data of marketed similar products, Janagliflozin showed similar and even better results.
According to the latest report from IDF, there are 537 million patients with diabetes in 2021 around the globe. SGLT-2 inhibitor, as a hypoglycemic drug with new mechanism of action, not only has good hypoglycemic effects, but also demonstrates cardiovascular and renal protective effects, positioning it in rapid development in clinical applications and markets. The SGLT-2 inhibitor products currently available in China include four imported original drugs and one domestic drug, namely, Ertugliflozin (Merck Sharp & Dohme), Empagliflozin (Boehringer Ingelheim), Canagliflozin (Johnson & Johnson), Dapagliflozin (AstraZeneca) and Henagliflozin (Hengrui Pharmaceutical), respectively. According to IQVIA data, the domestic sales generated from SGLT-2 inhibitor products amounted to RMB2,393 million in 2021, with a compound annual growth rate of 236.98% from 2018 to 2021, and continuously maintained rapid growth year on year.
As a Class 1 hypoglycemic innovative drug independently developed by the Group and reaching the Phase III clinical endpoints, Janagliflozin has global rights, including patents in China, the United States, Europe, Japan and Korea. The acceptance of the NDA for Janagliflozin marks a breakthrough of the Group in the field of original innovative drugs for diabetes treatment, fully demonstrating the Group’s strong independent research and development capability and strength of innovative drugs.
Dr. Che Fengsheng, chairman and executive director of Sihuan Pharmaceutical Holding Group, said: “With the increasing therapeutic status of SGLT-2 inhibitor hypoglycemic drugs and the continuous expansion of market application, as well as leveraging the Group’s outstanding marketing capabilities, it is expected that Huisheng Biopharmaceutical’s Janagliflozin has a great potential to achieve rapid increase in sales volume after its successful launch. This will also help the Group to accelerate the industrialization development of its diabetes product pipelines and further enhance the Group’s competitiveness and comprehensive strength.”
Huisheng Biopharmaceutical
Jilin Huisheng Biopharmceutical Co., Ltd. (the “Huisheng Biopharmceutical”) is a biopharmaceutical subsidiary, which focusing on diabetes and complications, of Sihuan Pharmaceutical, a large domestic pharmaceutical and medical aesthetic group. After 7 years of construction and development, the company currently has a world-class R&D team of more than 200 people, with rich experience in R&D of diabetes drug, and leveraging on the four innovative technology platforms to build a product pipeline with more than 40 products, covering the second, third, and fourth generation insulins (covering fast-acting, long-acting , and pre-mixed products), various oral hypoglycemic drugs, DPP-4, GLP-1, SGLT-2 and other new targets and complication drugs, etc. Huisheng Biopharmaceutical is currently the only company in China that achieves full product coverage in the field of diabetes and complications. Among, the marketing applications (NDA/BLA) of innovative drugs Japagliflozin, Insulin Aspart Injection, Insulin Aspart 30 Injection and Insulin Aspart 50 Injection have been officially accepted by the National Medical Products Administration ; the fourth-generation Insulin Degludec Injection, Insulin Degludec and Insulin Aspart Injection and other blockbuster pipeline are leading the industry in clinical progress, and are expected to become the first domestic product to be launched, innovative products continue to emerge. Huisheng Biopharmaceutical has a strong production advantage, with a production capacity of over 100 million units, the scale of which ranks among the top in China and can support an annual output value of 10 billion. It’s mass production capacity and high quality characteristics and assure the cost advantages in production. Leveraging on the strong sales resources of its parent company Sihuan Pharmaceutical, Huisheng Biopharmaceutical also has the ability to rapidly increase sales. With full coverage and multi-level product layout, a leading and heavyweight R&D pipelines, strong and comprehensive strategic resources, Huisheng Biopharmceutical is gradually becoming a biopharmaceutical leader in providing comprehensive solutions for diabetes and complications.