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翰宇药业HY3003项目进入原料药中试阶段 三靶点减重新药加速推进
Zheng Quan Ri Bao· 2025-06-13 07:45
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]
翰宇药业:司美格鲁肽注射液项目已进入剂量维持期 预计2026年中国申报上市
news flash· 2025-06-12 11:52
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]
翰宇药业(300199) - 300199翰宇药业投资者关系管理信息20250612
2025-06-12 11:44
Group 1: Project Development and Strategy - The HY3003 project is a GLP-1R/GIPR/GCGR receptor agonist for weight loss, currently in the raw material drug pilot scale-up phase, laying the groundwork for IND application and clinical transformation [2][4]. - The company employs a multi-formulation parallel development strategy for HY3003, including weekly and ultra-long-acting monthly formulations, aiming to enhance patient compliance and reduce gastrointestinal side effects [3][4]. - The ultra-long-acting monthly formulation reduces injection frequency from weekly to monthly, alleviating patient burden and stabilizing drug concentration levels [4]. Group 2: Technology and Innovation - The AI peptide chip technology enables high-throughput screening of lead compounds, utilizing semiconductor processes to achieve rapid and accurate identification of active peptides [5][7]. - The collaboration with Carbon Cloud focuses on leveraging AI and peptide chip technology for drug development, aiming to create China's first multi-target peptide weight loss drug [7][8]. Group 3: Market Expansion and Product Pipeline - The company has authorized raw materials to over 20 countries and formulations to more than 90 countries, with ongoing negotiations for additional partnerships [9]. - The product pipeline includes innovative drugs such as the HY3000 nasal spray for coronavirus prevention, currently in phase III clinical trials, and ongoing exploration of CBD-based drugs [8][9]. - Upcoming products expected to launch include Glatiramer acetate injection and Acetate of Cetrorelix, targeting multiple sclerosis and assisted reproductive technology, respectively [11]. Group 4: Future Directions and Business Model - The company plans to introduce at least 20 new formulations over the next decade, including innovative and micro-innovative drugs [9]. - The CRDMO business model integrates research, development, and production services, enhancing collaboration and market expansion opportunities [11].
翰宇药业: 关于2025年度向金融机构申请综合授信及担保额度的进展公告
Zheng Quan Zhi Xing· 2025-06-12 09:27
Group 1 - The company plans to apply for a total credit and guarantee limit of up to 350 million yuan for the year 2025, which includes 50 million yuan for the company to provide guarantees for its subsidiaries and 300 million yuan for subsidiaries to provide guarantees for the company [1][2] - The company intends to apply for an additional fixed asset loan of 28 million yuan from Bohai Bank, secured by equipment from a fixed asset project, with its wholly-owned subsidiary providing joint liability guarantee [2][4] - As of the announcement date, the total external guarantee balance provided by the company and its subsidiaries is 727 million yuan, which accounts for 125.64% of the latest audited net assets [4] Group 2 - The company's total assets as of December 31, 2024, were approximately 3.01 billion yuan, while the total liabilities were approximately 2.41 billion yuan, resulting in net assets of approximately 578.63 million yuan [3] - The company's operating income for the year 2025 (unaudited) was approximately 309.97 million yuan, with a total profit of approximately 76.35 million yuan and a net profit of approximately 69.44 million yuan [3]
翰宇药业(300199) - 关于2025年度向金融机构申请综合授信及担保额度的进展公告
2025-06-12 08:45
证券代码:300199 证券简称:翰宇药业 公告编号:2025-030 深圳翰宇药业股份有限公司 关于2025年度向金融机构申请综合授信 一、授信及担保审议程序 深圳翰宇药业股份有限公司(以下简称"公司"或"翰宇药业")于2025年2月 28日召开第六届董事会第二次会议、2025年3月17日召开2025年第一次临时股东 大会,审议通过了《关于2025年度申请综合授信及担保额度的议案》,同意公司 及子公司2025年度向金融机构申请综合授信及担保额度总计不超过3.5亿元。其 中:公司为子公司、子公司之间提供综合授信及担保额度5,000万元;子公司为本 公司提供综合授信及担保额度不超过30,000万元。该授信自2025年3月17日起12 个月内有效,同时授权公司管理层实施具体相关事宜。具体内容详见公司披露于 中国证监会指定的创业板上市公司信息披露网站巨潮资讯网的相关公告。 二、授信及担保情况概述 为支持公司业务快速发展与战略布局,进一步拓展多元化融资渠道、优化融 资结构,公司拟向渤海银行股份有限公司深圳分行申请新增固定资产借款2,800 万元。本次贷款以该固贷项目的设备作为抵押物,由全资子公司翰宇药业(武汉) 有限 ...
A股化学制药板块震荡回调,海辰药业、永安药业均跌超9%,一品红、哈三联、通化金马、翰宇药业、河化股份等均跌5%。
news flash· 2025-06-11 03:14
Group 1 - The A-share chemical pharmaceutical sector is experiencing a volatile correction, with companies such as Haichen Pharmaceutical and Yong'an Pharmaceutical both declining over 9% [1] - Other companies including Yipinhong, Hasanlian, Tonghua Jinma, Hanyu Pharmaceutical, and Hehua Co. have also seen declines of around 5% [1]
A股午后急挫,三大股指收跌:银行股逆市上涨,两市成交1.4万亿元
Xin Lang Cai Jing· 2025-06-10 07:25
Market Overview - The A-share market showed mixed performance on June 10, with the Shanghai Composite Index experiencing a decline of 0.44% to close at 3384.82 points, while the ChiNext Index fell by 1.17% to 2037.27 points [5][9] - The total trading volume in the Shanghai and Shenzhen markets reached 14,153 billion yuan, an increase of 1,289 billion yuan compared to the previous trading day [5] Sector Performance - Bank stocks performed strongly against the market trend, with several banks, including Nanjing Bank and Industrial Bank, reaching historical highs [7] - The pharmaceutical and biotechnology sectors continued to show strength, with multiple stocks hitting the daily limit or rising over 10% [7] - The TMT sector faced a broad adjustment, with significant declines in semiconductor, AI applications, and fintech stocks [3][8] Stock Movements - A total of 79 stocks saw an increase of over 9%, while 10 stocks experienced a decline of over 9% [6] - Notable declines were observed in the computer sector, with some stocks dropping over 30% [7][8] Market Sentiment and Outlook - Analysts predict a steady upward trend in the short term, supported by a loose monetary policy and potential fiscal measures [9][10] - The market is expected to remain in a wide-ranging fluctuation phase, with a focus on policy developments and external market conditions [10][11] - The investment focus is suggested to be on sectors that are decoupled from the macroeconomic cycle and have structural growth potential [10][12]
A股创新药板块持续活跃,众生药业、昂利康涨停,联化科技涨超9%,睿智医药、海辰药业、翰宇药业等高开。
news flash· 2025-06-10 01:34
A股创新药板块持续活跃,众生药业、昂利康涨停,联化科技涨超9%,睿智医药、海辰药业、翰宇药 业等高开。 订阅A股涨停捉妖队 +订阅 订阅A股市场资讯 +订阅 ...
翰宇药业减肥创新药项目取得关键进展 长效与口服制剂同步推进
Core Viewpoint - The collaboration between Hanyu Pharmaceutical and Carbon Cloud Peptide aims to develop innovative peptide drugs targeting metabolic diseases, marking a significant milestone in the HY3003 project [1][2]. Group 1: Project Development - The HY3003 project has successfully completed the screening of optimal candidate compounds and the development of raw material processes, now entering the raw material pilot scale-up phase [1][2]. - The project is advancing multiple dosage forms, including weekly, monthly, and oral formulations, with a focus on reducing administration frequency and improving patient compliance [2]. Group 2: Collaboration Details - Hanyu Pharmaceutical and Carbon Cloud Peptide signed a joint development agreement for the GLP-1R/GIPR/GCGR triple agonist, with Hanyu responsible for preclinical research, IND application, clinical trials, and product registration [1]. - Hanyu will pay up to 38 million yuan in milestone payments to Carbon Cloud Peptide, and will share revenue based on sales, with a maximum of 10% in North America and 3% in other global regions [1]. Group 3: Strategic Implications - This collaboration is expected to enhance Hanyu's innovation capabilities and product diversity in the treatment of metabolic diseases, laying a solid foundation for long-term development in the healthcare sector [2]. - The progress of HY3003 reflects Hanyu's technological advancements in the "AI + peptide" integration model, showcasing the company's expertise in peptide raw materials, formulation processes, and platform technologies [2].
翰宇药业(300199) - 董事会审计委员会关于续聘公司2025年度会计师事务所的审核意见
2025-06-06 11:01
深圳翰宇药业股份有限公司董事会审计委员会 关于续聘公司 2025 年度会计师事务所的审核意见 深圳翰宇药业股份有限公司审计委员会 2025 年 6 月 7 日 公司董事会审计委员会对立信会计师事务所的执业情况进行了充分的了解, 在查阅了其有关资格证照、相关信息和诚信记录后,一致认为立信会计师事务所 具有证券、期货等相关业务执业资格,具备为上市公司提供审计服务的经验与能 力,能够为公司提供公正、公允的审计服务,在 2024 年度执业过程中,立信会 计师事务所切实履行了审计机构应尽的职责,能够客观地评价公司的财务状况和 经营成果,较好地完成了 2024 年度报告的审计工作,具备足够的独立性、专业 胜任能力、投资者保护能力。因此,我们同意续聘立信会计师事务所为公司 2025 年度审计机构,并向董事会提议续聘立信会计师事务所作为公司 2025 年度审计 机构。 根据《中华人民共和国公司法》《深圳证券交易所创业板股票上市规则》《深 圳证券交易所上市公司自律监管指引第 2 号——创业板上市公司规范运作》《深 圳翰宇药业股份有限公司董事会审计委员会实施细则》以及《公司章程》等相关 规定,公司董事会审计委员会认真核查了拟聘任 ...