Shanghai Securities News China Securities Network News (reporter Han Yuanfei) Anke Bio announced at noon on December 30 that the company received the "Notice of Approval of Drug Supplement Application" issued by the State Drug Administration, and the company's supplementary application for growth disorders and idiopathic short stature indications for girls caused by hypogonadism (Turner syndrome) has been approved.
The company's injectable human growth hormone was approved in July 2021 and September 2021 respectively to add new indications for Turner syndrome and idiopathic short stature (English abbreviation: ISS), and on the basis of the approval of the company's human growth hormone indications for injection, the application for human growth hormone injection supplementation was added to the above two indications.
So far, the company's human growth hormone injection has been approved for 8 indications: 1) for children with endogenous growth hormone deficiency caused by slow growth; 2) for short stature caused by Nonan syndrome; 3) for short stature or growth disorders in children caused by SHOX gene defects; 4) for the treatment of severe burns; 5) for short stature caused by cartilage hypoplasia; and 6) for adult short bowel syndrome receiving nutritional support 7) for growth disorders in girls caused by hypogonadism (Turner syndrome); 8) for idiopathic short stature.
