GenSci's Oncology Innovation: NDA Approval Secured for Prostate Cancer

GenSci's Leuprorelin Mesylate Injection (6M) has recently received NDA approval from the National Medical Products Administration(NMPA) for the treatment of advanced prostate cancer in patients requiring androgen deprivation therapy(ADT).

Prostate cancer is one of the most common malignancies of the male genitourinary system, particularly among older men. It ranks second in incidence and fifth in mortality among males, posing a growing burden on patients worldwide.

Leuprorelin Mesylate Injection (6M) is a long-acting formulation of a gonadotropin-releasing hormone agonist(GnRHa). Through sustained release of leuprorelin, it induces desensitization of pituitary GnRH receptors, suppresses the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and lowers testosterone, thereby achieving androgen deprivation.

The approval was supported by a Phase III, multicenter study conducted in China that enrolled 142 patients with advanced prostate cancer at 43 clinical sites. Results showed that Leuprorelin Mesylate Injection (6M) achieved rapid onset of action and sustained suppression of serum testosterone levels, with a favorable overall safety profile. The product has previously been approved for prostate cancer in the United States, the European Union, Canada, and the Taiwan region of China.

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