连续7年扣非净利润亏损的翰宇药业（300199.SZ），终在2025年上半年迎来转机。 6月30日晚，翰宇药业发布2025年半年度业绩预告，预计净利润1.42亿-1.62亿元，同比扭亏（去年同期亏损1035.88万元）。公司将此归因于利拉鲁肽注射液 在美国获批上市并放量销售、原料药出口增长及成本控制。 利拉鲁肽这款用于治疗2型糖尿病的GLP-1类药物，因兼具减重效果成为翰宇药业翻盘的关键。2024年12月，其利拉鲁肽注射液获FDA批准，随即在2025年1 月完成近140万支发货。截至去年年底，公司已收到美国合作方Hikma累计4639.63万美元订单。 但这款"救命药"的国内故事已画上句号。2023年6月，翰宇药业主动撤回利拉鲁肽国内上市申请，并于同年11月终止项目，全额计提减值5298.82万元。去 年，翰宇药业又将司美格鲁肽的国内权益转让给三生制药（01530.HK）旗下三生蔓迪。两个选择背后，是公司对国内GLP-1市场未来价格战的预判，同时也 吹响公司全力押注海外市场的号角。 翻盘全靠利拉鲁肽 公开资料显示，翰宇药业成立于2003年，2011年登陆深交所创业板，主营多肽制剂及原料药，主要产品包括多肽原料 ...

Core Insights - Hanyu Pharmaceutical (300199) has recently conducted investor research, discussing the progress of the HY3003 new drug project, its layout in the innovative drug field, and overseas market expansion [1][2] Group 1: HY3003 New Drug Project - The HY3003 project has completed preclinical candidate compound screening and raw material process development, officially entering the raw material pilot scale-up phase, which validates the producibility of the molecular structure for subsequent IND application and clinical transformation [1] - HY3003 is a GLP-1R/GIPR/GCGR receptor agonist developed using AI peptide chip technology, aimed at weight loss indications [1] - The project employs a multi-formulation parallel development strategy, including weekly, ultra-long-acting monthly, and oral formulations, with the ultra-long-acting formulation designed to reduce dosing frequency and improve medication adherence [1] Group 2: siRNA and Other Drug Developments - The company is also developing siRNA drugs such as Inclisiran and Zilebesiran for treating high cholesterol and hypertension, as well as Pegcetacoplan for treating geographic atrophy [1] Group 3: Overseas Market Expansion - Currently, the company's raw materials are sold to over 20 countries and regions, with formulations licensed in over 90 countries and regions [2] - The company has signed cooperation agreements for the semaglutide injection (weekly formulation) and oral tablets in markets including China, Brazil, Egypt, Mexico, Eurasian Union, GCC member countries, and North Africa [2] - The company has completed the enrollment of all participants in the Phase III clinical trial for semaglutide injection as of January this year, with plans to submit for approval in China by 2026, followed by the US and other global markets [2] Group 4: Future Pipeline - Hanyu Pharmaceutical has a rich pipeline of peptide and small nucleic acid formulations, planning to launch no less than 20 formulations over the next 10 years, including innovative drugs, micro-innovative drugs, and ANDA [2]

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]

Core Insights - Hanyu Pharmaceutical has entered the dosage maintenance phase for its Semaglutide injection project, with plans to apply for market approval in China by 2026 [1] Company Developments - The company is developing HY3003, a GLP-1R/GIPR/GCGR receptor agonist for weight loss, utilizing AI peptide chip technology for candidate selection [1] - Hanyu has completed preclinical candidate screening and raw material process development, now moving into the raw material pilot scale-up phase [1] - In addition to the weight loss drug, the company is also working on an innovative drug, HY3000 nasal spray, aimed at preventing coronavirus infections, which is currently in Phase III clinical trials [1] Collaborations and Innovations - Hanyu is collaborating with China National Pharmaceutical Group on the research and commercialization of Cannabidiol (CBD) innovative drugs, integrating peptide and small nucleic acid drug technologies [1] - The company has completed enrollment of all participants in the Phase III clinical trial for Semaglutide injection as of January this year and is currently in the follow-up phase [1]