Jinsai Pharmaceutical's recombinant human growth hormone plans to be included in the priority review for children with short stature, etc.

Text|Pharmaceutical Mission Hills

Today (October 12), the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that the recombinant human growth hormone injection submitted by Jinsai Pharmaceutical has been included in the priority review product and is to be developed for the treatment of child growth.

Screenshot source: CDE official website

Growth hormone (GH) is a peptide hormone secreted by the anterior pituitary gland of the human body, which can promote the growth of bones, internal organs and the whole body

According to the information published on the CDE official website, Jinsai Pharmaceutical’s recombinant human growth hormone injection is included in the proposed priority review for "new varieties, dosage forms and specifications of children’s drugs that meet the physiological characteristics of children".

①Used for slow growth of children caused by lack of endogenous growth hormone; ②Used for short stature in children caused by Noonan syndrome; ③Used for short stature or growth disorder in children caused by SHOX gene defect; ④Used For children with short stature caused by achondroplasia; ⑤for growth disorders in girls caused by gonadal hypoplasia (Turner syndrome); ⑥for Prader-Willi syndrome; ⑦for short bowel in adults receiving nutritional support Syndrome; ⑧ for the growth hormone deficiency caused by the established hypothalamic-pituitary disease and the significant deficiency of growth hormone confirmed by two different growth hormone stimulation tests; ⑨ for the treatment of severe burns

According to the report for the first half of 2021 issued by the parent company of Jinsai Pharmaceuticals Changchun High-tech, currently Jinsai Pharmaceuticals recombinant human growth hormone injection is still carrying out a number of phase 3 clinical trials, and the indications involved include small-to-gestational age infants (SGA ), plus idiopathic short stature (ISS), plus indications for childhood growth disorder caused by Prader-Willi syndrome (PWS), and indications for childhood growth disorder caused by chronic kidney disease (CKD) before kidney transplantation

Reference materials:

[1] Center for Drug Evaluation (CDE) of China National Medical Products Administration.