Investment Rating - The industry investment rating is "Outperform the Market," indicating an expected relative increase of over 10% in the industry index compared to the broader market within the next six months [5][8]. Core Insights - The National Medical Products Administration (NMPA) has reduced the review and approval time for clinical trial applications of eligible innovative drugs from 60 days to 30 days, aiming to accelerate the market entry of innovative drugs and shift domestic new drug development from "Fast-Follow" to "First-in-Class" [3]. - The focus of this policy includes pediatric drugs, rare diseases, and globally synchronized research products, with the NMPA encouraging the development of pediatric and rare disease medications through various incentives [3]. - Data from Yaozhi Network indicates that leukemia is the most common cancer among children, accounting for approximately 30% of all cases, while brain and spinal cord tumors account for about 25% [3]. - The overall trend shows that the domestic innovative drug review and approval policy has transitioned from "passive approval" to "active empowerment," enhancing the global competitiveness of domestic innovative drugs [3]. Summary by Sections Regulatory Changes - The draft proposal outlines that eligible innovative drugs must be either traditional Chinese medicine, chemical drugs, or biological products that meet specific criteria, including being supported by the state or included in special programs for children and rare diseases [2]. - Applications for eligible innovative drugs will be reviewed and approved within 30 working days [2]. Market Implications - The policy aims to facilitate early global synchronized research and international multi-center clinical trials for eligible innovative drugs [2]. - If a review cannot be completed within 30 days due to technical reasons, the NMPA will inform the applicant, and the subsequent timeline will follow a 60-day implied approval process [2]. Industry Performance - The report indicates that the pharmaceutical and biotechnology sector has shown a relative performance against the CSI 300 index, with a notable increase in the sector's attractiveness for investment [5][6].

Core Viewpoint - The National Medical Products Administration (NMPA) has proposed a draft to optimize the clinical trial review and approval process for innovative drugs, potentially reducing the approval timeline to 30 working days for core innovative drug varieties, which may reshape China's innovative drug development landscape [1][3][4]. Summary by Sections Clinical Trial Review and Approval Optimization - The draft aims to significantly enhance the efficiency of drug development, marking a key step towards establishing China as a global hub for innovative drug research [3][4]. - The 30-day review and approval channel will support national key research varieties and encourage early global synchronized research and international multi-center clinical trials [3][4]. Categories of Supported Drugs - The drugs eligible for the expedited review include: 1. Nationally supported key innovative drugs with significant clinical value. 2. Drugs included in the NMPA's Children's Drug Star Program and Rare Disease Care Program. 3. Globally synchronized research varieties, including Phase I, II clinical trials, and international multi-center clinical trials led by Chinese principal investigators [3][4][5]. Impact on Clinical Trial Efficiency - The reduction of the approval timeline from the conventional 60 working days to 30 days (and even 18 days in some regions) is expected to significantly enhance the initiation efficiency of clinical trials, thereby accelerating the pace of research and reducing costs and risks for companies [4][5]. - For instance, a typical oncology drug could see its Phase III multi-center clinical trial approval time reduced by 55 days, potentially allowing for market entry six months earlier [4][5]. Encouragement for Global Collaboration - The inclusion of global synchronized research in the priority channel is anticipated to increase China's attractiveness as a key site for international multi-center clinical trials, motivating multinational pharmaceutical companies to incorporate China into their early global plans [5][8]. Regulatory and Operational Requirements - The draft emphasizes the responsibility of applicants to engage with clinical trial institutions before submitting applications, ensuring that they have the capacity for risk assessment and management [8][9]. - A commitment to initiate clinical trials within 12 weeks post-approval is mandated, which aims to prevent resource idling and compel companies to enhance their clinical operational capabilities [10][12]. Focus on Rare Diseases and Children's Drugs - The draft specifically addresses the needs of "niche" diseases, highlighting the importance of children's drugs and rare disease medications, which have historically faced a lack of systematic policy support in China [10][11]. - The inclusion of these drugs in the fast-track channel is seen as a critical incentive to address the insufficient research motivation in these areas [10][11]. Challenges and Considerations - While the draft presents opportunities, it also raises the bar for companies, requiring them to establish robust risk management and drug safety systems to align with the accelerated timelines [12]. - The implementation of this draft will necessitate careful attention to regional disparities in institutional capabilities and the prevention of local protectionism in the regulatory process [12].

Core Viewpoint - The National Medical Products Administration (NMPA) has proposed a draft to optimize the clinical trial review and approval process for innovative drugs, potentially reducing the approval timeline to 30 working days, which could significantly enhance the efficiency of drug development in China [1][2]. Group 1: Approval Process Changes - The new draft aims to compress the clinical trial review and approval period for key innovative drugs to 30 working days, with some regions like Beijing potentially reducing it to 18 days [2]. - The draft supports the development of drugs that are classified as traditional Chinese medicine, chemical drugs, and biological products, specifically focusing on three categories: nationally supported innovative drugs, drugs for children and rare diseases, and globally synchronized research products [1][4]. Group 2: Impact on Drug Development - The reduction in approval time is expected to significantly improve the efficiency of clinical trial initiation, allowing companies to accelerate their research and capture global market opportunities [2]. - The new policy is anticipated to lower research and development costs and risks, reduce waiting times for companies, and ultimately enhance the international competitiveness of China's pharmaceutical industry [2][3]. Group 3: Focus on Rare Diseases and Children's Drugs - The draft emphasizes the inclusion of drugs for rare diseases and children's medications, addressing unmet clinical needs in these areas [6]. - Currently, only about 10% of the over 800 rare disease drugs available globally have been approved in China, indicating a substantial market opportunity for new drug development in this sector [6]. Group 4: Responsibilities and Compliance - The draft introduces a requirement for applicants to demonstrate their capability in risk assessment and management, ensuring that clinical trials can commence within 12 weeks post-approval [3][4]. - Companies must establish robust drug safety monitoring and risk control systems to align with the expedited review process, ensuring quality and safety standards are maintained [7][8]. Group 5: Global Collaboration and Market Positioning - The inclusion of global synchronized research in the priority review channel is expected to enhance China's attractiveness as a key site for international multi-center clinical trials [2][5]. - Domestic innovative pharmaceutical companies, such as BeiGene and Innovent Biologics, are likely to benefit from this new policy, as it allows them to expedite the development of their first-class new drugs that align with national support directions [5].