Jiangsu Sinopep-Allsino Biopharmaceutical (SH:688076) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-07-31 23:13Core Viewpoint - Jiangsu Nuotai Aosaino Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of two drugs: Acetate Cetrorelix Injection and Agomelatine Tablets, marking a significant expansion into reproductive and mental health sectors [1][2][4]. Drug Registration Details - Acetate Cetrorelix Injection: - Formulation: Injection - Specification: 0.25mg - Registration Category: Class 4 chemical drug - Validity: 18 months - Approval Number: H20254895, valid until July 21, 2030 [1][3]. - Agomelatine Tablets: - Formulation: Tablet - Specification: 25mg - Registration Category: Class 4 chemical drug - Validity: 18 months - Approval Number: H20255026, valid until July 28, 2030 [2][3]. Clinical Advantages - Acetate Cetrorelix is a third-generation GnRH antagonist with clinical advantages over other similar drugs, including faster onset, better safety profile (prevention of OHSS), shorter treatment cycles, and improved patient tolerance [4]. - Agomelatine is a novel antidepressant with a unique dual mechanism of action, offering rapid sleep improvement without daytime functional impairment, low risk of sexual dysfunction, minimal weight impact, and good tolerance [4]. Strategic Impact - The approval of these drugs represents a strategic expansion for the company into reproductive and mental health, aligning with national policies on child-rearing subsidies and the inclusion of assisted reproduction in health insurance, thereby supporting high-quality population development [4].