Core Viewpoint - Hanyu Pharmaceutical (300199.SZ) is expected to turn a profit in the first half of 2025 after seven consecutive years of losses, primarily due to the approval and sales of its liraglutide injection in the U.S. market, along with growth in raw material exports and effective cost control [2][5]. Group 1: Financial Performance - The company forecasts a net profit of 142 million to 162 million yuan for the first half of 2025, a significant turnaround from a loss of 10.36 million yuan in the same period last year [2][5]. - The improvement in profitability is attributed to multiple factors, including the FDA approval of liraglutide, increased export of raw materials, and strict cost management [5][9]. Group 2: Product Development and Market Strategy - Liraglutide, a GLP-1 class drug for type 2 diabetes, has been pivotal for the company's recovery, with the FDA approval received on December 23, 2024, and nearly 1.4 million units shipped to the U.S. by January 2025 [2][9]. - The company has decided to withdraw its domestic application for liraglutide and terminate the project, fully impairing 52.99 million yuan, indicating a strategic shift to focus on international markets [2][11]. - Hanyu Pharmaceutical is also developing other GLP-1 products, including semaglutide, with a focus on overseas markets to avoid potential price wars in China [10][11]. Group 3: Market Context - The global market for GLP-1 drugs is expanding, with projections indicating that the market for diabetes and obesity treatments could reach 90 billion USD by 2030 [9]. - Hanyu Pharmaceutical's overseas revenue share is expected to increase significantly, from 11.25% in 2022 to 55.10% in 2024, reflecting the company's commitment to international growth [11].

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]