On June 24, Gensci Pharmaceutical announced that its Category 2.2 new drug, Triptorelin Acetate for Injection (II), has recently received approval from the NMPA for the treatment of central precocious puberty (CPP) in children weighing 20 kg and above.
Central precocious puberty is a condition caused by the premature activation of the hypothalamic-pituitary-gonadal axis, leading to increased gonadotropin-releasing hormone (GnRH) secretion, which in turn triggers gonadal development and sex hormone production. This condition can impair growth potential and adversely affect psychological health in children, with its incidence showing an upward trend. Gonadotropin-releasing hormone agonists (GnRHa) are the recommended treatment for CPP in both domestic and international guidelines and consensus statements.
Triptorelin Acetate for Injection (II), developed by Gensci Pharmaceutical, is a one-month sustained-release formulation and is classified as a Category 2.2 chemical drug. This approval is based on a multicenter, open-label, single-arm study conducted in children with CPP, in which the drug demonstrated favorable efficacy and safety. According to the press release, this product is the first one-month GnRHa sustained-release formulation to complete a prospective registrational study for CPP in China, providing a new treatment option for children with precocious puberty.
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