Hangzhou Kang Ming Information Technology Co., Ltd. (HKG: 9955), known as “ClouDr,” has officially launched dapagliflozin, its self-operated product with marketing rights. This drug serves as a generic version of AstraZeneca (NASDAQ: AZN)’s Forxiga, a leading treatment for type 2 diabetes. The approval for dapagliflozin was secured through Nanjing F&S Pharmatech Co., Ltd., receiving clearance from the National Medical Products Administration (NMPA).
Dapagliflozin functions as a sodium-glucose co-transporter protein 2 (SGLT-2) inhibitor, aimed at improving glycemic control in patients with type 2 diabetes. The original formulation was approved in China in 2017 and was included in the National Reimbursement Drug List (NDRL) in 2019. Notably, the patent for the molecule in China is set to expire this month.
F&S Pharmatech’s generic version gained marketing approval after successfully navigating a Category 4.2 challenge, indicating that it does not infringe on existing patents. Additionally, the firm has effectively contested the originator’s crystal form patent. F&S Pharmatech has partnered with ClouDr, enabling the latter to utilize its extensive hospital and pharmacy networks for the promotion and marketing of the product.- Flcube.com
