2026.01. 30 本文字数：2393，阅读时长大约4分钟 作者 | 第一财经 吴斯旻 《药品管理法实施条例》（下称《条例》）实施23年，历经三次修订后，新版《条例》将于今年5月 15日起实施。 近年来，中国医药产业发展迅速，已进入全球药物研发第二梯队并稳居全球第二大医药市场。新修订 的《条例》回应了创新药行业发展需求。 一方面，《条例》通过完善和引入药品试验数据保护和市场独占期制度，平衡创新与仿制的关系，鼓 励儿童用药和罕见病用药研发；另一方面，将突破性治疗药物程序、特别审批程序上升到行政法规要 求的层面，缩短药品研制和注册进程；此外对于境外已上市药品获批前商业规模批次产品进口以及符 合条件的创新药分段生产予以支持并完善持有人责任。 国家药监局副局长徐景和30日发表署名文章，对于《条例》如何通过监管创新支持创新药发展进行 了详细解读，第一财经由此总结了四大亮点。 亮点一："数据保护"拓展至含有新型化学成分的药品 药品试验数据保护是与专利保护相并行，鼓励药物研发创新、推动仿创平衡的重要措施。 该制度对药品上市许可持有人（即MAH，下称"持有人"）自行取得且未披露的试验数据和其他数据 实施保护；待保护期限届 ...

国家药监局正积极推动制定《药品试验数据保护实施办法》 《药品管理法实施条例》（下称《条例》）实施23年，历经三次修订后，新版《条例》将于今年5月15 日起实施。 近年来，中国医药产业发展迅速，已进入全球药物研发第二梯队并稳居全球第二大医药市场。新修订的 《条例》回应了创新药行业发展需求。 一方面，《条例》通过完善和引入药品试验数据保护和市场独占期制度，平衡创新与仿制的关系，鼓励 儿童用药和罕见病用药研发；另一方面，将突破性治疗药物程序、特别审批程序上升到行政法规要求的 层面，缩短药品研制和注册进程；此外对于境外已上市药品获批前商业规模批次产品进口以及符合条件 的创新药分段生产予以支持并完善持有人责任。 国家药监局副局长徐景和30日发表署名文章，对于《条例》如何通过监管创新支持创新药发展进行了详 细解读，第一财经由此总结了四大亮点。 一年前，国家药监局已就《药品试验数据保护实施办法（试行，征求意见稿）》向社会公开征求意见。 不过彼时《条例》仍处于修订阶段。 随着新修订的《条例》正式"出炉"，徐景和表示，国家药监局积极推进《药品试验数据保护实施办法》 的制定，聚焦保护范围、保护期限、保护方式等核心要素进行深入论证 ...

《条例》提出，支持以临床价值为导向的药品研制和创新，鼓励研究和创制新药，支持新药临床推广和 使用。明确药物非临床安全性评价研究机构资格认定程序，细化药物临床试验管理要求。设立药品上市 注册加快程序，明确药品再注册程序，规定处方药、非处方药转换机制。对符合条件的儿童用药品、罕 见病治疗用药品给予市场独占期，对含有新型化学成分的药品等进行数据保护。细化药品上市许可持有 人的责任。 《条例》强调，加强药品生产管理。严格药品委托生产管理，压实委托生产时药品上市许可持有人的责 任，明确可以委托分段生产药品的情形。明确中药饮片、中药配方颗粒生产、销售的管理要求。 《条例》要求，完善药品网络销售管理制度，压实药品网络交易第三方平台提供者责任。加强医疗机构 药事管理，保障使用环节药品质量。明确医疗机构配制制剂审批流程，规定医疗机构制剂调剂使用条件 和程序，支持配制儿童用医疗机构制剂，满足儿童患者用药需求。 中证报中证网讯(记者傅苏颖)日前，新修订的《中华人民共和国药品管理法实施条例》(简称《条例》) 发布，自2026年5月15日起施行。 张伟表示，展望未来，随着《条例》的深入实施，将进一步提升我国药品审评审批的质量和效率，加 ...

1月27日，新修订的《中华人民共和国药品管理法实施条例》(以下简称《条例》)发布，将于2026年5月 15日正式实施。这是自2002年公布施行以来，该条例首次进行全面修订，旨在总结近年来药品监管改革 经验，细化药品管理法规定的制度措施，深化药品监管改革。《条例》明确国家支持儿童用药品、罕见 病治疗用药品的研制和创新，首次引入儿童用药品及罕见病药品市场独占期制度。 《条例》在药品研制和注册制度方面作出系统性完善，为医药创新提供了更为明确的政策支持。针对药 品产业创新发展需求，《条例》明确提出支持以临床价值为导向的药品研制和创新，鼓励研究和创制新 药，支持新药临床推广和使用。 国家药监局政策法规司司长张琪介绍，现行条例是2002年公布施行，曾有3次对个别条款进行修改，这 次修订是条例施行23年来的首次全面修订。 对含有新型化学成份的药品以及符合条件的其他药品的上市许可持有人提交的自行取得且未披露的试验 数据和其他数据实施保护，任何人不得对该未披露的试验数据和其他数据进行不正当的商业利用。 在业内人士看来，这些措施直接回应了创新药研发周期长、投入高的特点。 据介绍，与23年前相比，我国药品研制、生产、流通、使用各环 ...

Core Insights - China is enhancing support for innovative drugs with new mechanisms and targets across the entire chain of communication, clinical trials, registration, and review processes to facilitate "China's first launch" of innovative drugs [1][2] - By 2025, there is an expectation for a significant increase in the market launch of urgently needed clinical products in the pharmaceutical and medical device sectors [1] Group 1: Pharmaceutical Sector - In 2022, the National Medical Products Administration (NMPA) approved a total of 4,087 drug registration applications, including 76 innovative drugs, marking a historical high [1] - The time gap for domestic and international drug listings has been reduced, with 59 foreign new drugs receiving temporary import approval [1] - A total of 138 children's drugs were approved, and 48 rare disease drugs were granted temporary import approval, addressing medication gaps for special populations [1] Group 2: Medical Device Sector - The NMPA approved 3,402 medical device products in 2022, including 76 innovative medical devices, achieving a new record [1] - The medical device innovation ecosystem is continuously improving, supporting industry upgrades [1][2] - In 2026, the NMPA plans to expedite the market launch of high-end medical devices and allocate more review resources to urgently needed innovative devices and those for rare disease prevention [2] Group 3: Future Initiatives - The NMPA will implement a drug trial data protection system and establish market exclusivity for children's and rare disease medications [2] - There will be a focus on optimizing the review and approval measures for cell and gene therapy drugs [2] - The establishment of a national standardized technical working group for intelligent frontier medical devices is planned to advance standard formulation in key areas such as brain-machine interfaces [2]

Group 1: Market Performance - The Hang Seng Biotechnology Index (HSHKBIO) rose by 2.65% as of April 24, 2025, with notable increases in constituent stocks such as Rongchang Biopharmaceutical (09995) up 11.47%, Ascentage Pharma-B (06855) up 8.46%, and Innovent Biologics (01801) up 7.68% [1] - The Hang Seng Biotechnology ETF (513280) also increased by 2.62%, marking its fifth consecutive rise, with the latest price at 0.9 HKD [1] - Over the past week, the Hang Seng Biotechnology ETF has accumulated an 8.79% increase, ranking in the top third among comparable funds [1] - The ETF's liquidity was strong, with a turnover rate of 13.76% and a trading volume of 36.43 million HKD, indicating active market participation [1] - In the past month, the ETF's average daily trading volume was 82.80 million HKD, and it saw a significant increase of 7 million shares in the last month, placing it in the top third of comparable funds [1] Group 2: Company Developments - On April 23, 2025, CanSino Biologics announced that its bispecific antibody drug, Ivorisumab, successfully outperformed PD-1 in a head-to-head trial against BeiGene's Tislelizumab for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) [4] - The trial results were described as having strong positive outcomes, with statistical significance and major clinical benefits, leading to a surge in CanSino's stock price, which rose over 10% to reach a historical high of 100 HKD per share [4] - The National Medical Products Administration (NMPA) has proposed a six-year data protection period for innovative drug trial data, which is seen as a significant encouragement for drug research and development [4] Group 3: Industry Insights - Guosen Securities highlighted the importance of focusing on innovative drugs that are accelerating their international presence and benefiting from policy support [5] - Since the beginning of 2025, domestic innovative drug companies have completed numerous outbound licensing transactions, indicating a growing global competitive edge in research and clinical data [5] - The upstream pharmaceutical research and development sector is viewed as a critical component of China's self-sufficient industrial chain, with opportunities for quality companies to accelerate growth amid tariff impacts from the U.S. [5] Group 4: ETF Characteristics - The Hang Seng Biotechnology ETF (513280) is noted for having the lowest fees in the market for Hong Kong innovative drug products, with a management fee of only 0.15% per year and a custody fee of 0.05% per year, significantly lower than similar products [6] - As of December 2024, the ETF's index composition includes 66.4% innovative drugs, 15.4% CXO, and over 9% in pharmaceutical distribution and medical devices, indicating a balanced exposure across sectors [6]