Changchun High-Tech's subsidiary gains approval for growth hormone

Changchun High & New Technology Industry Group announced that its subsidiary, Jinsai Pharmaceutical, has received approval from the National Medical Products Administration for its supplemental application to add indications for its polyethylene glycol recombinant human growth hormone injection, branded as Jinsai Zeng. The approval covers two specifications of the drug: 54IU/9.0mg/1.0ml/bottle and 27IU/4.5mg/0.5ml/bottle. The 54IU/9.0mg/1.0ml specification is now approved for growth disorders in girls caused by gonadal dysgenesis (Turner syndrome) and for idiopathic short stature (ISS). The 27IU/4.5mg/0.5ml/bottle specification is approved for growth retardation in children caused by endogenous growth hormone deficiency. The company anticipates this approval will enhance market competitiveness and better meet clinical treatment needs.