Core Viewpoint - The approval of injectable Acetate Cetrorelix and Agomelatine tablets by the National Medical Products Administration marks a significant advancement for the company in the reproductive and mental health sectors, aligning with national policies aimed at enhancing population quality and healthcare accessibility [1][2]. Group 1: Product Approvals - The injectable Acetate Cetrorelix is a third-generation GnRH antagonist that offers unique clinical advantages in assisted reproductive technology compared to other similar drugs, such as GnRH agonists and other antagonists like Ganirelix [1]. - Acetate Cetrorelix demonstrates superior onset speed, safety (prevention of OHSS), shorter treatment cycles, and better patient tolerance compared to GnRH agonists, and has milder injection reactions compared to other antagonists [1]. - Agomelatine is a novel antidepressant with a unique dual mechanism of action, distinguishing it from common antidepressants like SSRIs and SNRIs, and is the only antidepressant that improves sleep quickly without affecting daytime functioning [1]. Group 2: Market Position and Strategic Alignment - Agomelatine has a very low risk of sexual dysfunction, minimal impact on weight, good tolerance, and fewer withdrawal reactions, making it significant in the market for depression accompanied by insomnia [1]. - The successful approval of these products represents the company's strategic expansion into reproductive and mental health, complementing existing antiviral, cardiovascular, and immune regulation product lines [2]. - This expansion aligns with national policies on childcare subsidies and the inclusion of assisted reproduction in health insurance, providing strong support for patient services and contributing to the high-quality development of the national population [2].

Core 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].

Core Viewpoint - Jiangsu Nuotai Aosaino Biopharmaceutical Co., Ltd. has received drug registration certificates for Acetate Triptorelin Injection and Agomelatine Tablets, marking a significant expansion into reproductive and mental health sectors [1][2][3][4] Drug Registration Details - **Acetate Triptorelin 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 Triptorelin**: - Offers unique clinical advantages in assisted reproductive technology compared to other similar drugs, such as faster onset, better safety profile, shorter treatment cycles, and improved patient tolerance [3][4] - **Agomelatine**: - A novel antidepressant with a dual mechanism of action, it provides rapid sleep improvement without affecting daytime functioning, low risk of sexual dysfunction, minimal weight impact, and good tolerance [4] Strategic Impact - The approval of these products aligns with national policies on child-rearing subsidies and the inclusion of assisted reproduction in health insurance, enhancing the company's position in the reproductive and mental health markets [4]

Group 1 - The core viewpoint of the article highlights the collaboration between Shenzhen Hanyu Pharmaceutical Co., Ltd. and Zhuhai Carbon Cloud Peptide Pharmaceutical Technology Co., Ltd. on the HY3003 project, which has successfully completed preclinical candidate screening and raw material process development, entering the raw material pilot scale-up phase [2][3] - The HY3003 project is a GLP-1R/GIPR/GCGR tri-target receptor agonist for weight loss, utilizing AI peptide chip technology for high-throughput screening [2] - The project employs a parallel development strategy for multiple dosage forms, including weekly, ultra-long-acting monthly, and oral formulations [2] Group 2 - The management of Hanyu Pharmaceutical emphasizes the complementary strengths in technology and resources between the two companies, with Carbon Cloud Peptide possessing silicon-based peptide chip technology and AI algorithms, while Hanyu has extensive experience in peptide drug synthesis, purification, formulation development, and clinical translation [3] - A strategic cooperation was established in October 2024, followed by a joint development agreement in May 2025, aiming to incubate China's first tri-target peptide weight loss innovative drug [3] - Hanyu Pharmaceutical's Wuhan raw material production base passed FDA inspection with "zero defects" in November 2024, and the production line for Glatiramer Acetate Injection also successfully passed FDA inspection in 2025, with both products expected to launch in the U.S. market soon [3]