Core Viewpoint - The Hong Kong Special Administrative Region (HKSAR) government has officially launched the "Guangdong-Hong Kong-Macao Greater Bay Area Clinical Trial Collaboration Platform," aimed at integrating clinical trial resources in the Greater Bay Area to provide a one-stop service for global biopharmaceutical companies and researchers focusing on advanced therapies such as rare disease drugs, high-end oncology drugs, and cell and gene therapies [1][2] Group 1 - The "Guangdong-Hong Kong-Macao Greater Bay Area Clinical Trial Collaboration Platform" is established as a unified service portal to enhance clinical trial resources [1] - The platform will support the registration applications of innovative drugs and medical devices in Hong Kong, mainland China, and overseas by utilizing real-world data generated under the "Hong Kong-Macao Drug and Device Access" policy [1] - As of December 10, 2023, 71 designated mainland medical institutions have introduced 140 types of drugs and medical devices that are already listed in Hong Kong and Macao, benefiting over 17,000 patients [1] Group 2 - The clinical trial institution aims to leverage the complete biopharmaceutical technology R&D and industrial chain in the Greater Bay Area, utilizing special policies that benefit Hong Kong [2] - The initiative is expected to accelerate patient access to advanced treatments in the Greater Bay Area and develop new productive forces [2]

Summary of Conference Call on Hainan Free Trade Port's Impact on the Pharmaceutical Industry Industry Overview - The conference call discusses the impact of the Hainan Free Trade Port (FTP) on the pharmaceutical industry, highlighting the benefits of zero tariffs, low tax rates, and value-added tax exemptions for pharmaceutical companies operating in the region [1][2]. Key Points and Arguments 1. Cost Reduction and Profitability - The zero tariff policy and 30% value-added tax exemption in Hainan significantly reduce operational costs for pharmaceutical companies, enhancing their gross margins. For instance, Weili Medical in Haikou High-tech Zone benefits from these policies by utilizing imported latex for processing [3][5]. 2. Accelerated Drug Approval Processes - The establishment of real-world data research in the Lecheng Pilot Zone has expedited the approval process for innovative drugs and medical devices, saving companies substantial costs in clinical trials and shortening the cash flow recovery period [3][4]. 3. Investment Fund Expansion - The Hainan Free Trade Port Construction Investment Fund is set to expand from 10 billion to 20 billion yuan, focusing on supporting innovation in the biopharmaceutical sector and cross-border mergers and acquisitions [1][5][6]. 4. Growth in Haikou High-tech Zone - The Haikou High-tech Zone accounts for approximately 70%-80% of Hainan's pharmaceutical output, with a reported output of 420 million yuan as of August 2025, and an expected growth of 20%-30% in 2023 [4][5]. 5. Tax Incentives and Internationalization - The corporate income tax rate in Hainan is 15%, positioning it as a potential offshore center for Chinese pharmaceutical companies, attracting international capital and enhancing local industry competitiveness [5][9]. 6. Medical Device Maintenance and Repair - The combination of zero tariffs and a bonded maintenance model allows foreign equipment to be repaired in Hainan before being re-exported, reducing maintenance costs and improving customs efficiency [5][9]. 7. Patient Access and Drug Availability - The establishment of medical alliances with hospitals across provinces has improved patient access to special medications, with an anticipated patient flow conversion rate of 70% [2][14][15]. 8. Regulatory Adjustments Post-Closure - Post-closure, the regulatory framework in the Lecheng Pilot Zone will focus on balancing safety and convenience, including measures for drug traceability and online follow-up services [16]. 9. Fund Focus for 2025 - The investment strategy for the Hainan Free Trade Port Fund in 2025 will emphasize licensing in and medical technology transformation, leveraging unique policy advantages for biopharmaceutical development [17]. 10. Cross-Border Financial Advantages - The unique EF account system in Hainan facilitates seamless cross-border capital flow, exempting new foreign direct investments from corporate income tax, which attracts large pharmaceutical companies to establish operations in the region [18]. Additional Important Insights - The Haikou High-tech Zone is actively attracting companies in the stem cell and cell therapy sectors, although economic benefits from these new entrants have yet to materialize [7]. - The real-world data research pathway has led to the approval of numerous products, with a goal of reaching 1,000 approved products to enhance international competitiveness [7][12]. - Successful case studies, such as SuSheng Bio and Huaxi Bio, illustrate the potential for rapid growth and operational success in Hainan due to favorable policies [10]. This summary encapsulates the critical insights from the conference call regarding the Hainan Free Trade Port's influence on the pharmaceutical industry, emphasizing the strategic advantages and growth opportunities presented by the region's policies.

Core Insights - The Hainan Boao Lecheng International Medical Tourism Pilot Zone has achieved significant progress in its special drug and medical device policy, with 476 imported special drugs and devices as of April 30, 2025, including 175 drugs and 301 devices [1] Group 1: Policy Advantages - The Lecheng Pilot Zone has four core policy advantages: special drug and device policy, real-world research policy for drugs and devices, real-world research policy for medical insurance, and special operation policy for public hospitals [1] - The special drug and device policy allows the import and use of new drugs and devices that have not yet been approved in China, enabling patients to access the latest global medical innovations more quickly and conveniently [1] Group 2: Future Plans - The Lecheng Medical Supervision Bureau plans to focus on "medical" as the core and actively serve the introduction of special drugs and devices through a traceability platform, transitioning from passive approval to proactive service [2] - The zone aims to introduce a full range of special drugs and devices related to specific diseases and specialties, creating a comprehensive multidisciplinary center for disease management [2] - The plan includes expanding the entire industrial chain of special drugs and devices through real-world data research and medical-engineering transformation, positioning Lecheng as a new highland for drug and device research and development [2] Group 3: Regulatory Commitment - The special drug and device policy is regarded as Lecheng's "golden signboard," with a commitment to maintaining medical safety, ethical safety, and policy safety [3] - The Lecheng Medical Supervision Bureau will continue to support the application of special drugs and devices and real-world data research while strengthening regulation to ensure medical safety [3]