Announcement #Changchun Gaoxin: Recombinant Human Growth Hormone Injection Approved to Add Five New Indications

Shanghai Securities News China Securities Network News (reporter Han Yuanfei) Changchun High-tech announced at noon on December 31 that the company's holding subsidiary Kinsey Pharmaceutical received the "Notice of Approval of Drug Supplement Application" approved and issued by the State Food and Drug Administration, and the company's application for recombinant human growth hormone injection met the relevant requirements of drug registration, and approved the supplementary application for increasing the approved indications of the same variety in China. Specifically, it includes: 1, for short stature in children caused by Noonan syndrome; 2, for children with short stature or growth disorders caused by SHOX gene defects; 3, for short stature in children caused by cartilage hypoplasia; 4, for growth disorders in girls caused by hypogonadism (Turner syndrome); 5, for adult short bowel syndrome receiving nutritional support.

Changchun Gaoxin said that this batch is the approval notice of the State Food and Drug Administration agreeing to the indications for the increase in dosage forms related to Kinsey Pharmaceutical's recombinant human growth hormone injection. The company will actively promote the marketing of new indications for the product.