格隆汇7月29日丨华润双鹤(600062.SH)公布，全资孙公司北京双鹤润创科技有限公司收到了美国 FDA(即"美国食品药品监督管理局")关于同意DC50292A片进行临床试验的函告。DC50292A片拟用于治 疗晚期实体瘤患者。 ...

Core Viewpoint - China Resources Double Crane announced that its wholly-owned subsidiary, Beijing Double Crane Run Chuang Technology Co., Ltd., received FDA approval for clinical trials of DC50292A tablets, which are intended for the treatment of advanced solid tumors [1] Summary by Categories Company Development - The cumulative R&D investment for the drug DC50292A amounts to RMB 41.66 million [1] - The drug is currently in the early stages of clinical development, indicating significant uncertainty [1] Industry Context - The approval from the FDA marks a critical step in the drug development process, potentially positioning the company within the competitive oncology market [1]

Core Viewpoint - The legal opinion letter issued by Beijing Zhonglun Law Firm confirms the compliance and authorization of China Resources Double Crane Pharmaceutical Co., Ltd.'s stock repurchase and cancellation plan for part of its restricted stock incentive program [1][2][3] Group 1: Approval and Authorization - The company has obtained necessary approvals and authorizations for the stock repurchase and cancellation, in accordance with relevant regulations and the incentive plan [4][5] - The legal opinion is based on a thorough review of the company's incentive plan and related documents, ensuring compliance with the Company Law and Securities Law [2][3] Group 2: Repurchase Plan Details - The repurchase is due to specific circumstances where certain incentive recipients no longer meet the conditions for holding restricted stock, resulting in a total of 79,013 shares to be repurchased [4][5] - The repurchase price for the shares is set at 6.125 yuan per share for certain recipients and 10.004 yuan per share for others, with adjustments based on market conditions and company performance [6][7] Group 3: Implementation Status - The company has followed the necessary procedures to notify creditors regarding the reduction of registered capital due to the stock repurchase [8] - The repurchase of the shares is expected to be completed by July 30, 2025, with subsequent legal and registration processes to be carried out [8]

证券代码：600062 证券简称：华润双鹤 公告编号：临 2025－062 华润双鹤药业股份有限公司 关于 2021 年限制性股票激励计划回购注销实施公告 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。 重要内容提示： 回购注销的原因：鉴于华润双鹤药业股份有限公司(以下简称 "公司")2021 年限制性股票激励计划中 7 名激励对象已不符合激励 条件，公司回购注销前述激励对象已获授但尚未解除限售的限制性 股票共计 79,013 股。 本次注销股份的有关情况： | 回购股份数量(股) | 注销股份数量(股) | 注销日期 | | --- | --- | --- | | 79,013 | 79,013 | 2025年7月30日 | 一、本次限制性股票回购注销的决策与信息披露 (一)公司于 2025 年 3 月 18 日召开第十届董事会第九次会议、第 十届监事会第八次会议审议通过《关于回购注销部分激励对象已获 授但尚未解除限售的限制性股票的议案》。具体内容详见公司于 2025 年 3 月 20 日披露的《关于公司 2021 年限制 ...

北京市中伦律师事务所 关于华润双鹤药业股份有限公司 2021年限制性股票激励计划 部分限制性股票回购注销实施的 法律意见书 法律意见书 ZHONG LUN 中 倫 律 師 事 務 所 法律意见书 目 录 | 一、本次回购注销的批准和授权 . | | --- | | 二、本次回购注销的方案 … | | 三、本次回购注销的实施情况 | | 四、结论 … | 2 法律意见书 二〇二五年七月 1 关于华润双鹤药业股份有限公司 致：华润双鹤药业股份有限公司 根据华润双鹤药业股份有限公司（以下简称"华润双鹤"、"公司"）与北京市 中伦律师事务所（以下简称"本所"）签订的《专项法律服务合同》的约定，本所作 为公司2021年限制性股票激励计划（以下简称"激励计划"或"本次激励计划"）相 关事宜的专项法律顾问，就本次股权激励计划部分限制性股票回购注销（以下简称 "本次回购注销"）实施涉及的相关事项出具本法律意见书。 为出具本法律意见书，本所律师审阅了《华润双鹤药业股份有限公司2021年限制 性股票激励计划（2022年12月修订稿）》（以下简称"《激励计划（2022年12月修订 稿）》"）、《华润双鹤药业股份有限公司2021年限 ...

Core Viewpoint - The announcement highlights that China Resources Double Crane Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Double Crane Limin Pharmaceutical (Jinan) Co., Ltd., has successfully passed the GMP compliance inspection, which is crucial for maintaining product quality and production capacity in the pharmaceutical market [1][6]. Group 1: GMP Inspection Information - The GMP compliance inspection was conducted from April 22 to April 25, 2025, at the new solid preparation workshop for tablet and hard capsule production [1]. - The investment for the new solid preparation workshop was approximately RMB 260 million (unaudited) [1]. Group 2: Product and Market Overview - The solid preparation workshop produces two key products: Nifedipine controlled-release tablets and Levofloxacin hydrochloride capsules [2][3]. - Nifedipine controlled-release tablets have a projected sales revenue of RMB 147 million for 2024, with a market share of 3.10% for Double Crane Limin among 28 approved manufacturers in China [5][6]. - Levofloxacin hydrochloride capsules are part of a competitive market with 62 approved manufacturers, and the total sales for 2024 are estimated at RMB 392 million [6]. Group 3: Impact on the Company - The successful GMP compliance inspection is expected to enhance the company's ability to maintain stable product quality and production capacity, thereby meeting market demand [6]. - The inspection results are not anticipated to have a significant impact on the company's overall performance [6].

证券代码：600062 证券简称：华润双鹤 公告编号：临 2025－061 华润双鹤药业股份有限公司 生产车间和生产线：固体制剂六车间(片剂、硬胶囊剂生产线) 检查时间：2025 年 4 月 22 日—4 月 25 日 结论：经药品 GMP 符合性检查，符合《药品生产质量管理规范》 (2010 年版)的要求 本次检查为新建固体制剂六车间(片剂、硬胶囊剂生产线)药品 GMP 符合性检查，该车间新建的投入为人民币 2.60 亿元(未经审计)。 关于全资子公司华润双鹤利民药业(济南)有限公司 通过GMP符合性检查的公告 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。 近日，华润双鹤药业股份有限公司(以下简称"公司")全资子公司 华润双鹤利民药业(济南)有限公司(以下简称"双鹤利民")收到山东 省药品监督管理局颁发的《药品 GMP 符合性检查告知书》(编号： GMP2025164)，现将相关情况公告如下： 一、GMP 检查相关信息 被检查单位名称：华润双鹤利民药业(济南)有限公司 检查地址：山东省济南市章丘区明水街道利民路 1 号 ...

Core Viewpoint - China Resources Double Crane (600062) announced that its wholly-owned subsidiary, China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd., passed the GMP compliance inspection conducted by the Shandong Provincial Drug Administration, covering the production workshops for tablets and hard capsules [1] Group 1: Company Developments - The GMP inspection included the production lines for tablets and hard capsules in the newly established solid preparation workshop No. 6 [1] - The investment for the new solid preparation workshop No. 6 amounted to 260 million yuan [1] Group 2: Financial Performance - The projected sales revenue for the company's Nifedipine sustained-release tablets in 2024 is 147 million yuan [1] - The sales revenue for Levofloxacin hydrochloride capsules is estimated to be 23.3137 million yuan [1]

Core Viewpoint - The establishment of a 1 billion yuan investment fund by companies under China Resources, in collaboration with Shanghai Fosun Pharmaceutical and Chengdu state-owned enterprises, aims to focus on the pharmaceutical and health sectors, particularly in innovative drug development and strategic emerging industries [2][4]. Group 1: Fund Structure and Partners - The fund, named China Resources Pharmaceutical (Chengdu) Innovation Investment Fund, has a total capital of 100 million yuan, with various partners contributing different amounts [3]. - The general partner (GP) is China Resources Pharmaceutical (Chengdu) Enterprise Management Partnership (Limited Partnership), while limited partners (LPs) include several pharmaceutical companies and investment funds [2][3]. - The fund's lifespan is set for 7 years, with a 3-year investment period and a 4-year exit period, extendable by 1 year upon partner approval [3]. Group 2: Investment Focus - The fund will concentrate on the pharmaceutical health sector and strategic emerging industries, targeting areas such as chemical innovative drugs, biological drugs (including vaccines), high-end medical devices, and traditional Chinese medicine [4]. - The involvement of the Chengdu Bio-City Jingchuang Equity Investment Fund indicates a strong potential for project implementation within the Chengdu Tianfu International Bio-City [4]. Group 3: Historical Context - An earlier fund, the China Resources Pharmaceutical (Shantou) Industry Investment Fund, was established 8 years ago but did not perform as expected, failing to reach its initial target of 2.5 billion yuan [4][6]. - The Shantou fund entered a liquidation phase in December 2024, having not achieved the anticipated scale, which affected the contributions of its partners [5][6].

Core Viewpoint - China Resources Double Crane plans to invest in a new fund aimed at optimizing its strategic layout and enhancing innovation transformation while securing investment returns [1][2] Group 1: Fund Establishment - The company will collaborate with ten limited partners to establish the China Resources Medicine (Chengdu) Innovation Investment Fund with a target fundraising scale of 1 billion yuan [1] - China Resources Double Crane will contribute 40 million yuan, representing 4% of the total fund [1][2] - The fund will be managed by Shenzhen China Resources Capital Equity Investment Co., Ltd [1] Group 2: Strategic Intent - The investment aims to improve the company's ability to acquire and allocate quality resources, supporting long-term sustainable development and profitability [1] - The transaction is classified as a related party transaction due to the common control by China Resources [1][2] Group 3: Historical Context - The company previously established a similar fund in October 2017 with a total scale of 2.5 billion yuan, contributing 50 million yuan as a limited partner [2] - The first fund successfully identified and invested in projects that provided synergistic value, such as the acquisition of Tiandong Pharmaceutical, which laid a foundation for a biopharmaceutical platform [3]