三是提质增效，畅通沟通服务渠道。根据创新药申报进度，提前对接属地检查分局及审评核查分中心， 优化检查安排，对创新药相关检查需求第一时间响应，选派资深检查员组成检查组，确保检查效率和检 查质量。 一是前端介入，构建"一对一"服务机制。对每家创新药申报企业，组建专属对接服务小组，聚焦共线生 产风险、动态生产计划制定、检查申报路径等关键环节开展"面对面"辅导，助力企业一次性完成顶层设 计。 二是合并检查，实现"一次检查、多项覆盖"。主动加强与国家药监局核查中心的对接，将注册现场核查 与GMP符合性检查合并实施，减少企业迎检频数，做到"数据多跑路、企业少跑腿"，切实为企业减 负。 近期，由省内生产企业研发的化学1类创新药玛硒洛沙韦片、利沙托克拉片、盐酸司美那非片、盐酸妥 诺达非片，以及中药1.1类创新药参蒲颗粒相继获批上市，为患者提供了新的治疗选择。省药监局核查 中心以贯彻落实省药监局加快创新药研发上市专题推进会部署为契机，持续发力、全程服务，在把牢药 品质量安全关的同时，助推江苏省创新药上市驶入"快车道"。 下一步，江苏省药监局核查中心将继续落实省药监局相关部署，以更高标准、更优服务、更实举措，助 力江苏省更多创新 ...

Group 1: Industry Achievements - In 2024, Jiangsu approved 352 new drugs, including 13 innovative drugs, accounting for 27.08% of the national total, and 490 Class III medical devices, leading the nation [1] - Jiangsu's innovative drugs and medical devices are rapidly gaining approval, with five innovative drugs approved in May 2025, four of which are related to cancer [1][2] - The first domestically approved BCL-2 inhibitor and a potential best-in-class treatment for erectile dysfunction were launched by Suzhou-based companies [2] Group 2: Regulatory Support and Initiatives - Jiangsu's regulatory agencies are focused on creating a "policy highland" to support the rapid approval of innovative drugs and devices, including a "face-to-face" service initiative that addresses companies' needs directly [4][5] - The province has established a comprehensive service mechanism that includes a dedicated team for each innovative product, ensuring personalized and efficient support throughout the development and approval process [6][5] - Jiangsu is a national leader in implementing pilot programs for drug approval reforms and has established a "white list" system for importing research materials, facilitating faster access for companies [7][9] Group 3: Innovative Products and Market Expansion - Jiangsu's innovative medical devices include a new type of laparoscopic "hand-controlled robotic arm," which enhances surgical efficiency and precision [3] - The province has successfully facilitated the entry of local innovative drugs into international markets, with a Chinese drug approved in the U.S. for a specific type of lung cancer [2] - Jiangsu's first segmented production pilot for ADC drugs has been approved, allowing companies to streamline production processes and reduce costs [8]

Investment Rating - The report indicates a positive outlook for the pharmaceutical and biotechnology sector, with a focus on innovative drug companies [2][3]. Core Insights - The pharmaceutical and biotechnology sector saw a weekly increase of 1.82%, outperforming the CSI 300 index (0.82%) and the Wind All A index (1.71%). The market is currently focused on the expectations surrounding semi-annual reports and business development (BD) activities [8][9]. - The launch of the 2025 National Basic Medical Insurance and Commercial Health Insurance innovative drug directory is a significant development. This directory will include high-innovation drugs that provide substantial clinical value and patient benefits, which are not covered by basic medical insurance but recommended for commercial health insurance [3][13]. - The report highlights the importance of the commercial health insurance sector in the payment for innovative drugs, suggesting that the accessibility of high-priced innovative drugs is expected to improve, particularly in the areas of cell and gene therapy [3][13]. Market Weekly Review - The medical research outsourcing sector led the gains with a 9.29% increase, primarily driven by WuXi AppTec's positive semi-annual report announcement. Conversely, offline pharmacies and other biological products experienced declines of -1.29% and -1.55%, respectively [8][9]. - Notable stock performances included Frontier Biotech-U (41.4%), Mediso (38.9%), and Lianhuan Pharmaceutical (38.6%) leading the gains, while ST Unimed (-18.5%), Shenzhou Cell-U (-13.4%), and Shutai Shen (-11.6%) faced significant losses [11][12]. Industry News and Key Company Announcements - The report outlines several key industry events, including the approval of innovative drugs and strategic partnerships among major pharmaceutical companies, which are expected to enhance their market positions and product offerings [13][16][17]. - The report also mentions significant financial forecasts from various companies, indicating strong growth potential in the sector, with some companies projecting net profit increases of over 100% year-on-year [17][18].

Investment Rating - The report maintains a "Buy" rating for the pharmaceutical and biotechnology sector, specifically recommending stocks such as WuXi AppTec and AopuMai [1]. Core Insights - The CXO and research service sectors are experiencing a recovery in market sentiment, with significant performance improvements noted in companies like WuXi AppTec and BoTeng [1][4]. - The A-share pharmaceutical index has shown a year-to-date increase of 12%, outperforming the CSI 300 index by 10% [4][9]. - The report highlights a notable performance in the CXO and research service sectors, driven by a significant uptick in orders and positive earnings forecasts for Q2 [15][22]. Summary by Sections Industry Trends - The report indicates a positive trend in the investment climate for innovative drugs, with a notable increase in the number of new drug development pipelines in China, surpassing global averages [15][16]. - The easing of U.S. monetary policy is expected to enhance the financing environment for pharmaceutical investments, contributing to a recovery in the sector [15][16]. Performance Metrics - The report details that WuXi AppTec's order backlog grew by 47.1% year-on-year, indicating strong demand and operational stability [21]. - Other companies like KaiLong and BoTeng also reported significant increases in their order volumes, with KaiLong's new orders growing by over 20% [21][22]. Stock Recommendations - The report ranks sub-sectors in the following order of preference: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10]. - Specific stock recommendations include WuXi AppTec, AopuMai, and BaiPuSaiSi for their strong growth potential and market positioning [10][11].