[News] Centergene Receives Clinical Trial Approval for Recombinant Human Chorionic Gonadotropin Injection from the National Medical Products Administration

On May 17, 2024, Suzhou Centergene Pharmaceuticals Co., Ltd. (referred to as "Centergene"), a wholly-owned subsidiary of Shanghai Bao Pharmaceuticals Co., Ltd., received the Drug Clinical Trial Approval Notice from the National Medical Products Administration (NMPA) for its Recombinant Human Chorionic Gonadotropin Injection.

Recombinant Human Chorionic Gonadotropin Injection is a biosimilar to the originator imported drug 艾泽®, developed following the biosimilar drug development process. The drug is classified as a therapeutic biological product under Category 3.3.

In the field of assisted reproduction treatment, Recombinant Human Chorionic Gonadotropin Injection is the second drug developed by Centergene to receive clinical approval, following the approval of Recombinant Human Follicle-Stimulating Hormone-CTP Fusion Protein Injection.

 

About Chorionic Gonadotropin
Chorionic gonadotropin is a glycoprotein hormone secreted by the placenta that stimulates gonadal activity. In females of reproductive age, it promotes follicular maturation and ovulation, while converting the ruptured follicle into a corpus luteum to secrete progesterone. In males, it promotes seminiferous tubule function and the activity of interstitial cells in the testes to increase androgen production, induce testicular descent, and stimulate sperm production.

Chorionic gonadotropin is commonly used in assisted reproduction to accelerate follicular maturation and induce ovulation. It mimics the LH peak before ovulation, thereby accelerating follicular maturation and inducing ovulation. In addition, chorionic gonadotropin is also used to treat conditions such as cryptorchidi** in prepubertal males, male hypogonadi**, luteal phase insufficiency in females, and functional uterine bleeding.