NDA of the First Domestic Insulin Degludec is Accepted, Accelerate the Development of Diabetes Product Pipelines
Hong Kong, 18 July, 2022 - Sihuan Pharmaceutical Holdings Group Ltd. is pleased to announce that, the new drug application (the “NDA”) of the fourth-generation insulin analogue, the insulin degludec injection (the “Product”), developed by the Group’s non-wholly owned subsidiary, Jilin Huisheng Biopharmaceutical Co., Ltd. (“Huisheng Biopharmaceutical”), was accepted by the National Medical Products Administration (the “NMPA”). It is the first domestic fourth-generation insulin analogue, the insulin degludec, that has applied for and accepted an NDA in China after the original drug Tresiba®.
Insulin degludec is a new generation of long-acting basal insulin analogue with unique long-acting mechanism and excellent glucose-lowering effect, featuring stable blood glucose concentration, low risk of hypoglycaemia, high safety and long-lasting effect. With a half-life of approximately 25 hours and a duration of action of up to 42 hours, insulin degludec is more flexible in dosing time and have higher patient compliance thanks to its longer half-life and duration of action. It is the first insulin that allows patients with diabetes to inject at any time of the day (at 8-hour intervals). Clinical data show that the insulin degludec developed by Huisheng Biopharmaceutical has similar pharmacokinetics and pharmacodynamics to the original drug, and the phase III comparative study achieved the expected endpoint of the haemoglobin, which has similar clinical effect comparing to the original drug.
According to the IQVIA data, the insulin market size in China reached nearly RMB20 billion in 2021. Among them, sales of insulin degludec in China grew rapidly between 2018 and 2021, with a compound annual growth rate of 903.8%.
Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holding Group, said: “With insulin analogs further replacing the human insulin market and the continuous penetration of analog market, upon the launch of Huisheng Biopharmaceutical’s insulin degludec, it is expected that the sales volume will grow rapidly and the market share will be rapidly seized with great potential. At the same time, the Product can also form a combination of insulin degludec/insulin aspart and insulin degludec/lirglutide with other products in the product pipeline of Huisheng Biopharmaceutical. This will also help the Group to accelerate the development of its diabetes product pipelines, and is expected to further boost sales growth, enhance the Group’s comprehensive strength and significantly strengthen the Group’s core competitiveness.”
Huisheng Biopharmaceutical
Huisheng Biopharmaceutical is a biopharmaceutical company under Sihuan Pharmaceutical, a large domestic pharmaceutical and medical aesthetics group, focusing on the areas of diabetes and complications. 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 diabetes drug research and development. At present, it has nearly 40 products in the whole product pipeline of diabetes and complications, covering a full range of second-, third-, and fourth-generation insulin and analog product pipelines (covering basic, premixed and quick-acting products), innovative drugs with the latest mechanism, such as SGLT-2, GLP-1, DPP-4, and other hypoglycemic drugs and complication drugs of various mechanisms. Huisheng Biopharmaceutical is currently the only biopharmaceutical company in China that has achieved full product coverage in the field of diabetes and related complications, and integrated the whole industrial chain of R&D, production and sales. It is committed to providing full-process, all round integrated treatment solutions for diabetic patients, serving patients and making health easier.
Sihuan Pharmaceutical Holdings Group Ltd.
Founded in 2001 and listed on the Main Board of The Stock Exchange of Hong Kong Limited in
2010, Sihuan Pharmaceutical is an international medical aesthetic and pharmaceutical enterprise led by innovation, with an independent and leading research and development technology platform, a rich global product pipeline, strong product registration capability, a full dosage form production platform with high efficiency and low cost and a mature and excellent sales system. Adhering to the overall strategic goal for the “full promotion of a two-wheel drive strategy of its medical aesthetics and biopharmaceutical businesses”, Sihuan Pharmaceutical endeavors to build itself into a leading medical aesthetics and biopharmaceutical company in China.