来源：经济观察网 经济观察网 根据公开信息，九源基因（02566.HK）在2026年有以下值得关注的事件： 行业政策与环境 资金动向 持续股份回购计划：公司自2026年1月以来多次进行股份回购，如2月5日回购85.40万股，耗资877.31万 港元，此类行动可能反映管理层对业务前景的态度，但需以公告为准。 以上内容基于公开资料整理，不构成投资建议。 司美格鲁肽专利到期及市场竞争变化：司美格鲁肽核心专利将于2026年3月后到期，预计国产司美格鲁 肽将进入市场竞争加剧的阶段，九源基因是申报该产品的企业之一。 产品研发进展 创新药JY54注射液临床试验进展：公司于2026年2月9日公告JY54注射液（长效胰淀素类似物）临床试 验申请获受理，计划用于肥胖或超重人群体重管理的Ⅰ期研究，后续临床试验的启动与数据披露值得关 注。 ...

Group 1 - The core viewpoint of the news is that Jiuyuan Gene has received acceptance for its clinical trial application for the innovative drug JY54 injection, aimed at weight management in Phase I studies [1] - JY54 injection is a next-generation weight loss therapy that operates through a mechanism similar to insulin, providing multiple metabolic regulation effects [1] - The product is positioned to complement existing GLP-1 products, highlighting the company's strategic extension in the field of metabolic diseases [1] Group 2 - In the recent stock performance, Jiuyuan Gene's share price experienced a fluctuation, reaching a high of 10.35 HKD on February 10 and a low of 9.40 HKD on February 13, with a total decline of 4.39% over the period [2] - Following the announcement, there was a significant increase in trading volume on February 10, with a turnover of 572.71 million HKD, but subsequent trading days saw a decrease in volume [2] - The company repurchased 26,000 shares at a cost of 255,300 HKD on February 12, indicating limited scale in its buyback activity [2]

Core Viewpoint - Jiuyuan Gene's self-developed innovative drug JY54 injection has received formal acceptance for clinical trial application by the National Medical Products Administration, marking a significant step in the company's focus on metabolic disease treatment [1][2] Group 1: Product Development - JY54 injection is a long-acting glucagon-like peptide-1 (GLP-1) analog aimed at weight management for overweight or obese individuals, with the first phase of clinical research planned to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics [1] - The drug's molecular design has undergone systematic optimization to enhance drug stability and pharmacokinetic characteristics, potentially supporting long-acting administration [1] Group 2: Strategic Positioning - Jiuyuan Gene is expanding into high-tech metabolic treatment areas, reflecting its ongoing investment in innovative drug development [1] - The company has established a clear gradient layout in its product pipeline, combining mature target products with innovative mechanisms to meet current market demands and explore future weight loss treatment directions [2]

Core Viewpoint - Jiuyuan Gene has submitted an IND application for its innovative drug JY54 injection, aimed at weight management for obese or overweight individuals, marking a significant advancement in the metabolic treatment field [2] Group 1: Product Development - JY54 injection is a long-acting insulin analog designed to manage weight, showcasing Jiuyuan Gene's commitment to innovation in metabolic diseases [2] - The product is a dual receptor agonist (DACRAs) that mimics natural insulin mechanisms, offering multiple actions such as inhibiting glucagon secretion, delaying gastric emptying, and reducing appetite [3] - Clinical pre-research indicates that JY54 injection has demonstrated excellent efficacy and safety, with significant potential for weight loss and metabolic improvement [6] Group 2: Market Positioning - The global obesity and metabolic disease prevalence is rising, making weight management therapies a highly active area for pharmaceutical innovation [3] - JY54 injection's mechanism is believed to have advantages over current GLP-1 drugs, potentially leading to better fat reduction while preserving muscle mass [3] - The product's unique molecular structure supports long-acting administration, enhancing patient compliance and laying the groundwork for future combination therapies with GLP-1 [5] Group 3: Strategic Direction - Jiuyuan Gene's pipeline includes both mature products and innovative therapies, creating a clear gradient layout that addresses current market needs while exploring future treatment advancements [6] - The combination of mature products and innovative pipelines is expected to build a resilient long-term development structure in the metabolic disease sector [6] - The acceptance of the IND application reflects Jiuyuan Gene's ongoing investment in innovative drug development and its ambition to enhance its global influence in the metabolic drug innovation field [6]

Core Viewpoint - Jiuyuan Gene (02566) has received formal acceptance from the National Medical Products Administration (NMPA) for the clinical trial application of its self-developed innovative drug JY54 injection, aimed at weight management in obese or overweight populations [1] Group 1: Drug Development - JY54 injection is a long-acting glucagon-like peptide-1 (GLP-1) analog developed by the company [1] - The drug mimics the action of natural glucagon-like peptide-1, binding to GLP-1 receptors to exert multiple biological effects, including inhibition of glucagon secretion, delayed gastric emptying, and appetite reduction [1] - Preclinical trial data indicates that JY54 injection has shown excellent performance across various pharmacodynamic and safety studies [1] Group 2: Clinical Research - The company plans to conduct Phase I clinical research to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JY54 injection in subjects [1] - JY54 injection has demonstrated significant drug synergy potential in studies involving combination with existing obesity treatment medications [1] Group 3: Market Potential - Based on its molecular design characteristics and mechanism of action, JY54 injection is expected to support long-acting dosing regimens and exhibit differentiated clinical application potential in the field of weight management [1]

Core Viewpoint - Jiuyuan Gene (02566) has received formal acceptance from the National Medical Products Administration (NMPA) for its IND application of the innovative chemical Class 1 drug JY54 injection, aimed at weight management in obese or overweight populations [1] Group 1: Clinical Development - The company plans to conduct Phase I clinical research to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JY54 injection [1] - JY54 injection is a long-acting glucagon-like peptide analog developed by the company, designed to mimic the action of natural glucagon-like peptide [1] Group 2: Mechanism of Action - The drug works by binding to glucagon-like peptide receptors, leading to multiple biological effects such as inhibiting glucagon secretion, delaying gastric emptying, and reducing appetite, which aids in blood sugar control and weight management [1] - Preclinical trial data indicate that JY54 injection has shown excellent performance across various pharmacodynamic and safety studies [1] Group 3: Competitive Advantage - In studies involving combination therapy with existing obesity treatment drugs, JY54 injection has demonstrated significant synergistic potential [1] - The molecular design and mechanism of action suggest that JY54 injection could support long-acting dosing regimens and exhibit differentiated clinical application potential in weight management [1]

（股 份 代 號：2566） 自願公告 JY54注射液 IND申請獲CDE正式受理 本公告乃由杭州九源基因生物醫藥股份有限公司（「本公司」，連 同 其 附 屬 公 司， 統 稱「本集團」）自 願 作 出，以 告 知 本 集 團 股 東（「股 東」）及潛在投資者有關本集團 之 最 新 業 務 發 展。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Hangzhou Jiuyuan Genetic Biopharmaceutical Co., Ltd. 杭州九源基因生物醫藥股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） 本公司董事（「董 事」）會（「董事會」）欣然宣佈，公司自主開發的化學1類創新藥JY54 注射液新藥臨床試驗（「IND」）申 請，已 獲 國 家 藥 品 監 督 管 理 局（「NMPA」）藥品審 評中心（「CDE」）正 式 受 理。本 公 ...