国家药监局政策法规司司长张琪介绍，《药品管理法实施条例》是《药品管理法》的重要配套行政法 规。现行条例是2002年公布施行，曾3次修改过个别条款，这次修订是条例施行23年来的首次全面修 订。《药品管理法实施条例》的上位法《药品管理法》2019年全面修订，这次全面修订条例，修改条款 达到90%以上，除了第一条以《药品管理法》作为立法依据的条款没有修改外，其余条款均有调整或者 修改。 新修订的《中华人民共和国药品管理法实施条例》27日公布，5月15日起正式施行。国家药监局表示， 这是条例实施23年来首次全面修订。记者独家专访国家药监局相关负责人进行权威解读。 保护药品知识产权 此次条例修订的一大重点是系统加强对药品知识产权的保护，鼓励企业持续研发和创新。此次条例修 订，明确支持以临床价值为导向，研究和创制新药，并首次引入了儿童用药品、罕见病药品市场独占期 制度，推动药物研发，更好地服务患者临床用药需求。 其中规定： ■在数据保护期内，创新药企业获得合理收益，有助于持续研发创新；数据保护期之后，仿制药企业借 助原研药数据，简化上市申请，有助于降低药价，改进公众用药可及性和可负担性。 ■对符合条件的儿童用药品给予不超 ...

Core Viewpoint - Dongyang Sunshine Pharmaceutical has been awarded the "Annual Outstanding Biopharmaceutical Enterprise" at the "Technology Empowerment · Capital Breakthrough" sharing session, highlighting its achievements in innovation and research in the biopharmaceutical sector [1][3]. Company Overview - Dongyang Sunshine Pharmaceutical (06887.HK) is engaged in drug research, production, and commercialization, focusing on innovative drugs, including modified new drugs, generics, and biosimilars. The company emphasizes innovation, internationalization, and sustainability, driven by independent research and development [3]. - The company has established a comprehensive R&D system over 20 years, employing over 1,100 R&D personnel, including more than 20 foreign and returned experts. It has received the Guangdong Province Innovation Team title six times and holds over 2,500 patents [3][4]. Strategic Focus - The company adheres to "independent innovation" as its core strategy, deepening its "internationalization" efforts while focusing on three key therapeutic areas: infections, chronic diseases, and tumors. It employs diverse technologies, including small molecules, antibodies, small nucleic acids, ADC, and cell therapies [4]. - Dongyang Sunshine has launched three original innovative drugs and has 49 first-class innovative drugs in development, with one nearing market launch and ten in clinical phases II and III. Several pipeline products have "First in class" or "Best in class" potential [4]. Recent Achievements - In 2024, two candidate drugs are expected to achieve external cooperation and licensing agreements, with a total transaction value exceeding $1 billion [4]. - The company is addressing the global challenge of functional cure for hepatitis B with its small nucleic acid drugs and has the only complete independent intellectual property treatment plan for pan-genotype hepatitis C in China [4]. - Dongyang Sunshine's insulin product, Glargine, is set to be approved for sale in the U.S., making it the first Chinese company to market insulin in the U.S. Additionally, its new diabetes drug, Ologliptin, is also nearing approval [4].

Group 1: Investment and Financing Activities - Shanghai Zhishi Robotics completed A+ round financing of several tens of millions, exclusively invested by Yinfeng Capital, focusing on four-way shuttle robots for automated storage solutions [2] - Wuhan Jizhao Energy Technology announced the completion of several tens of millions in angel+ round financing led by Guanghe Venture Capital, aimed at supporting the delivery of the world's first MW-level liquid metal battery energy storage system [2] - Deep Intelligent Pharma announced nearly $50 million in D round financing led by Dinghui Baifu, with participation from existing shareholders, to enhance AI-driven drug development [4] - Deshengji Pharmaceutical completed $108 million in B round financing, with investors including IDG Capital and Sequoia China, focusing on precision therapeutic drug development [5] - Skild AI is in negotiations for over $1 billion investment from SoftBank and NVIDIA, potentially increasing its valuation to approximately $14 billion [6] - Pruy Benchmark completed over $10 million in new financing, focusing on AI-driven drug research and development [7] Group 2: Company Developments and Innovations - Zhishi Robotics aims to enhance storage density and efficiency in warehouses through innovative four-way shuttle technology [2] - Jizhao Energy is the first domestic supplier of liquid metal battery energy storage systems, with a pilot production line established for various battery products [2] - Shenzhen Zhaqi Xinzhi focuses on creating a high-throughput, low-cost protein detection platform using semiconductor technology [4] - Skild AI, founded by former Meta AI researchers, aims to develop general AI software systems for robotics, enhancing their perception and decision-making capabilities [6] - Pruy Benchmark leverages multi-omics and AI algorithms to support drug mechanism research and biomarker development [7]

Core Insights - Yiling Pharmaceutical was awarded the title of "Outstanding Drug R&D Innovation Enterprise of the Year" for its continuous innovation and strong R&D capabilities [1] - The company has maintained a high level of R&D investment, with R&D expenses reaching 544 million yuan in the first three quarters of 2025, accounting for 9.27% of its revenue [1] - Yiling Pharmaceutical has cumulatively invested over 5 billion yuan in R&D from 2019 to 2024, leading the industry in R&D spending [1] R&D Achievements - The company has successfully launched its patented traditional Chinese medicine "Qifang Nasal Congestion Tablets" in early 2025, becoming the first registered innovative traditional Chinese medicine in Macau [1] - Yiling Pharmaceutical has a target of producing five new drugs every five years, currently holding 17 innovative traditional Chinese medicine varieties covering eight major disease areas [1] - Among these, 11 varieties are included in the national medical insurance catalog, and 5 are in the national essential drug catalog, indicating broad market and clinical recognition [1] Pipeline and Future Prospects - The company has a rich pipeline with three new traditional Chinese medicine products, including Qigui Luobitong Tablets and Children's Lianhua Qingwen Granules, having submitted applications for market approval [2] - Additionally, five innovative traditional Chinese medicines are in various clinical stages, and one class 1 new chemical drug, Benanilofen Injection, has also submitted for market approval [2] - The company demonstrates a forward-looking layout in diverse drug development, with three class 1 innovative chemical drugs, including XY0206 tablets for solid tumors and leukemia, currently in clinical trials [2] Industry Recognition - The "21st Century Health Industry Competitiveness Research 'Sunshine' Case" aims to discover and promote outstanding enterprises and cutting-edge technologies in the health industry [2] - This year's event focused on seven dimensions, including innovation R&D, business development achievements, innovative drugs and devices, ESG practices, emerging enterprises, digital applications, and corporate health management, showcasing the industry's innovative vitality and exemplary practices [2]

Core Insights - The company reported a stable revenue growth of 4.14% year-on-year, achieving a total revenue of 897 million yuan in 2024, with a net profit of 219 million yuan, reflecting a slight increase of 0.11% [1] - The company continues to prioritize shareholder returns, proposing a cash dividend of 2.6 yuan per 10 shares, indicating confidence in future growth [1][7] - The company aims for sustainable growth in 2025 through a "quality improvement and efficiency enhancement" action plan, focusing on core business optimization, R&D innovation, and efficiency improvements [1][6] Financial Performance - In 2024, the company generated a net cash flow from operating activities of 215 million yuan, marking a significant increase of 34.98% [1] - The core product, Likujun tablets, contributed approximately 652 million yuan to revenue, accounting for 72.7% of total revenue [2] - The second core product, Niqunluo tablets, saw a revenue increase of 41.46% year-on-year, reaching 127 million yuan [2] Operational Efficiency - The company reduced its total employee count by 8.17% to 1,327, while increasing revenue per employee by 13.4% to approximately 675,600 yuan [3] - Accounts receivable decreased by 18.53%, indicating improved cash flow management [3] R&D Investment - The company invested 70.41 million yuan in R&D in 2024, an increase of 26.25% year-on-year [4] - The company is advancing multiple new drug candidates, including JJH201501 for depression and JJH201601 for cancer, with ongoing clinical trials [4][5] Future Strategy - The company plans to enhance its core product market positions and expand its sales scale in 2025, focusing on the promotion of Likujun tablets and Niqunluo tablets [6] - The company aims to improve operational efficiency through refined management practices and resource optimization [6] - The company has a history of consistent cash dividends, with a total of 1.55 billion yuan in dividends proposed for 2024, representing 70.58% of net profit [7][8]