Ganirelix Acetate Injection Obtains Approval for Drug Registration

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Ganirelix Acetate Injection Obtains Approval for Drug Registration

CTTQ Pharma is pleased to announce that Ganirelix Acetate Injection (product name: Qingle®), has obtained approval for drug registration by China Food and Drug Administration of the People’s Republic of China, being the first generic drug of Ganirelix Acetate powder Injection in China.

Qingle® is a down-regulation drug in the field of assisted reproduction and is an analogue of gonadotropin-releasing hormone (“GnRH”). Its indications are for assisting women who apply assisted reproductive technology for controlling ovarian stimulation to prevent premature luteinizing hormone (LH) surge.

Qingle® is more efficient and safer than the GnRH agonist (Triptorelin). It has greater bioavailability, a more stable half-life and a more convenient dosage form than the third-generation GnRH antagonist (Cetrorelix). Compared with the brand drug, its preparation process has also been optimized. With delaying childbearing ages of China’s population and the liberalization of the second-child policy, the number of women who need assisted reproductive therapy will continuously increase. With the mission of providing “effective, safe and convenience-optimized” drugs to patients, the launch of Qingle® in 2 future will provide another medical choice for effective and quality treatment to patients with different ovarian responses (including normal and abnormal ovarian reactions) who apply assisted reproductive technology for controlling ovarian stimulation.