健康元药业集团 关于药品注册上市许可申请获受理的提示性公告 证券代码：600380 证券简称： 健康元 公告编号：临 2025-058 健康元药业集团股份有限公司 关于药品注册上市许可申请获受理的提示性公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，健康元药业集团股份有限公司（以下简称：本公司）控股子公司丽珠医 药集团股份有限公司（以下简称：丽珠集团）收到国家药品监督管理局（以下简称： 药监局）核准签发的《受理通知书》（受理号：CYHS2502991），丽珠集团申请的 JP-1366 片（以下简称：本品）的境内生产药品注册获药监局受理。现将有关详情公 告如下： 一、受理通知书的主要内容 药物名称：JP-1366 片 英文名/拉丁名：JP-1366 tablets 剂型：片剂 规格：20mg 适应症：反流性食管炎 申请事项：境内生产药品注册上市许可 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 二、药品研发及相关情况 JP-1366 片是一款创新钾离子竞争性酸阻滞剂（P-CAB ...

Core Viewpoint - Health元's subsidiary, Lijun Pharmaceutical Group, has received the acceptance notice from the National Medical Products Administration for the domestic production registration of JP-1366 tablets, an innovative potassium ion competitive acid blocker (P-CAB) [1] Group 1 - JP-1366 tablets work by competitively blocking the K(+) channel of H(+), K(+)-ATPase (proton pump), inhibiting the binding of K(+) to the proton pump, and suppressing gastric acid secretion [1] - The drug promotes esophageal mucosal healing and improves reflux symptoms [1] - JP-1366 tablets can rapidly increase gastric pH levels and maintain gastric pH above 4 for an extended period, effectively addressing nighttime acid breakthrough [1]

Core Viewpoint - China's innovative pharmaceuticals have transitioned from being followers to key players in global medical innovation, achieving significant breakthroughs in core treatment areas such as metabolic diseases and oncology, with a surge in new drug approvals and international progress [1][3]. Group 1: Market Trends - The attention of A-share investors towards innovative pharmaceuticals has significantly increased this year, with numerous companies actively disclosing their R&D and clinical progress [2]. - The total value of license-out transactions for innovative drugs in China is projected to exceed $60 billion by mid-2025, surpassing the total for 2024, with 16 transactions exceeding $1 billion each [3]. - The market size of China's innovative drugs reached 679 billion yuan in 2022, expected to exceed 1 trillion yuan by 2026 and reach 1.12 trillion yuan by 2027 [6]. Group 2: International Expansion - Chinese innovative drug companies are accelerating their international business, with 81 companies generating over 100 billion yuan in overseas revenue from 2022 to 2024, accounting for more than 14% of their total revenue [7]. - The proportion of China's innovative drug transactions in the global market has increased from 10.8% in 2015 to approximately 52.5% by August 2023 [6]. Group 3: Policy and Financial Support - The Chinese government has implemented policies to support the high-quality development of innovative drugs, significantly reducing the time from drug approval to inclusion in the medical insurance directory from about 5 years to approximately 1 year [8]. - From 2015 to 2024, the financing in China's innovative drug sector exceeded 1.23 trillion yuan, providing strong momentum for industry growth [9]. Group 4: R&D Investment - The number of companies in the pharmaceutical and biotechnology sector has increased from over 220 in 2015 to nearly 500 currently, with R&D investment in the sector exceeding 140 billion yuan in 2024, a fivefold increase since 2015 [9]. - Among the 81 innovative drug companies, R&D investment rose from approximately 8.8 billion yuan in 2015 to over 57.8 billion yuan in 2024, with R&D intensity increasing from 3.29% to 8.04% [9]. Group 5: Company Developments - Companies such as Betta Pharmaceuticals and Rundu Co. have reported significant advancements in their innovative drug pipelines, with Betta's drug expected to be approved by June 2025 and Rundu's drug completing phase III clinical trials [12]. - The stock performance of companies involved in innovative drugs has surged, with some companies experiencing average increases of over 50% since May 1, 2023 [13]. Group 6: Institutional Interest - 13 companies have received significant institutional interest this year, with some experiencing over 30% increase in financing, indicating strong market confidence in innovative drug investments [14]. - Companies like BeiGene and TaiGen Biotechnology are projected to see substantial profit growth in 2025 and 2026, with BeiGene potentially turning profitable this year [15].

Group 1 - The core viewpoint of the article highlights the recent research conducted by a well-known private equity firm, Hongchou Investment, on a listed company, focusing on its innovative transformation strategy and product pipeline [1] - The company, Jian Kang Yuan, is advancing its prescription drug segment, concentrating on key therapeutic areas such as respiratory, digestive, mental health, reproductive assistance, and pain relief, with over 20 first-class innovative drugs in development [1] - The company plans to submit the application for the Marpacisavir capsule for market approval in August 2024, and has received clinical trial approval for a pediatric dry suspension formulation [1] Group 2 - The company is conducting Phase II clinical trials for TSLP monoclonal antibodies targeting moderate to severe COPD in China, and has completed Phase I trials for PREP inhibitors and Nav1.8 inhibitors, moving towards Phase II trials [1] - A systematic innovation drug layout for COPD has been established, creating three pathways for solutions, including a pediatric formulation that enhances medication acceptance based on weight [1] - Internationalization is a key strategic direction, with the establishment of a new sales subsidiary, collaboration with Kalbe Group for factory construction, and acquisition of the Vietnamese pharmaceutical company IMP [1] Group 3 - Over the past five years, the company has completed share buybacks totaling 2.7 billion, and has introduced a new annual dividend plan with increased cash dividend efforts [1]

健康元(600380.SH)在投资者关系活动中透露，目前已布局超过20款1类创新药，并有10款以上进入II期 及以后关键研发阶段。在COPD治疗领域，公司已构建起系统性的COPD创新药布局，形成三条针对性 解决路径，包括靶向PDE4的吸入制剂、全球首创的口服PREP抑制剂以及新一代ICS吸入制剂。此外， 公司与腾盛博药合作的新型多粘菌素项目已正式落地。 ...

格隆汇7月29日丨健康元(600380.SH)在互动平台表示，公司近年来持续加大在创新药领域的研发投入，当前已有多个1类创新药和具有全球差异化竞争力的创新药项目进入临床关键阶段截止现 ...

Core Viewpoint - Health元药业 Group has decided to extend the duration of its first phase of the long-term partner stockholding plan by 12 months until August 3, 2026, and to change the management method to self-management [1][8][12]. Group 1: Meeting and Resolutions - The 11th meeting of the 9th Board of Directors was held on July 25, 2025, where all nine directors participated, and the resolutions were passed without any objections [1][3]. - The first resolution approved was to extend the duration of the first phase of the stockholding plan by 12 months, allowing for early termination if all shares are sold before the new deadline [1][11]. - The second resolution approved was to change the management of the stockholding plan from Guosen Securities to self-management by the company [4][12]. Group 2: Voting Results - The voting results for the extension of the stockholding plan showed 6 votes in favor, with no votes against or abstentions [3][5]. - The second meeting of the stockholding plan holders also confirmed the extension with 100% approval from the participating holders [13][14]. Group 3: Background and Implementation - The first phase of the stockholding plan was initially approved at the second extraordinary general meeting of shareholders in 2021, with the plan's shares locked for 36 months from August 4, 2021, to August 3, 2024 [9][10]. - As of February 6, 2025, the plan held 2,430,800 shares, representing 0.13% of the company's total share capital [10].

健康元药业集团 第一期中长期事业合伙人持股计划延长存续期及调整管理方式的公告 证券代码：600380 证券简称：健康元 公告编号：临 2025-056 健康元药业集团股份有限公司关于 第一期中长期事业合伙人持股计划延长存续期及调整管理方式的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者 重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 健康元药业集团股份有限公司（以下简称：本公司）中长期事业合伙人持股计划 之第一期员工持股计划（以下简称"本期持股计划"）于 2025 年 7 月 25 日召开九届 董事会十一次会议审议通过《关于第一期中长期事业合伙人持股计划延长存续期的议 案》和《关于第一期中长期事业合伙人持股计划调整管理方式的议案》，同意将公司 本期持股计划的存续期延长 12 个月至 2026 年 8 月 3 日止，同意调整公司本期持股计 划管理方式，调整为自行管理。现将本期持股计划相关事项公告如下： 一、本期持股计划的基本情况 本公司于 2021 年 6 月 29 日召开 2021 年第二次临时股东大会，审议并通过《关于 公司<中长期事业合伙人持股计划之第一期持股计划 ...

健康元药业集团 第一期持股计划第二次持有人会议决议公告 证券代码：600380 证券简称：健康元 公告编号：临 2025-057 健康元药业集团股份有限公司 第一期持股计划第二次持有人会议决议公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者 重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 健康元药业集团股份有限公司（以下简称：公司）中长期事业合伙人第一期持股 计划（以下简称"第一期持股计划"）第二次持有人会议于 2025 年 7 月 25 日以通讯表 决方式召开。本次会议应出席持有人 41 人，实际出席持有人 37 人，代表第一期持股 计划份额 30,071,642 份，占公司第一期持股计划总份额的 96.89%。会议的召集、召开 和表决程序符合公司第一期持股计划的有关规定。会议以记名投票表决方式，审议通 过了以下议案： 审议并通过《关于第一期中长期事业合伙人持股计划延长存续期的议案》 本期持股计划存续期将于 2025 年 8 月 3 日届满，基于对公司未来发展的信心，会 议同意将公司本期持股计划的存续期延长 12 个月，至 2026 年 8 月 3 日止。存续期内 （ ...

健康元药业集团 九届董事会十一次会议 证券代码：600380 证券简称：健康元 公告编号：临 2025-055 健康元药业集团股份有限公司 九届董事会十一次会议决议公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者 重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 健康元药业集团股份有限公司（以下简称：本公司）九届董事会十一次会议于 2025 年 7 月 18 日（星期五）以电子邮件并电话确认的形式发出会议通知，并于 2025 年 7 月 25 日（星期五）以通讯表决形式召开。会议应参加董事九人，实际参加董事九人， 公司三名监事会成员、总裁清楚本次会议议案并无任何异议，符合《公司法》及《公 司章程》的规定。会议审议并通过如下议案： 1 / 2 健康元药业集团 九届董事会十一次会议 一、审议并通过《关于第一期中长期事业合伙人持股计划延长存续期的议案》 二、审议并通过《关于第一期中长期事业合伙人持股计划调整管理方式的议案》 公司第一期持股计划存续期将于 2025 年 8 月 3 日届满，基于对公司未来发展的信 心，同意将公司第一期持股计划的存续期延长 12 个月，至 2026 ...