The island-wide customs clearance operation of Hainan Free Trade Port will bring positive impacts to enterprises in three aspects: innovation capability building, supply chain optimization, and international development. This was introduced by Shi Ruiwen, Vice President of SIMCERE PHARMA Group Co., Ltd. (hereinafter referred to as SIMCERE PHARMA). As a pharmaceutical company rapidly transforming toward innovation and R&D-driven development, SIMCERE PHARMA (02096) has continuously focused on core areas including neuroscience, oncology, autoimmune, and anti-infection in recent years, committed to drug research and development and production. The company has successfully launched 10 innovative drugs that are first-to-market globally or domestically, demonstrating strong R&D capabilities and outstanding market performance.
Taking this as an opportunity and leveraging the policy advantages of the free trade port, SIMCERE PHARMA plans to further increase investment in high-end pharmaceutical production in Hainan. Currently, its Hainan subsidiary, Hainan SIMCERE PHARMA Co., Ltd., has made the introduction of foreign marketed drugs and localized production one of its key development directions.
Shi Ruiwen further elaborated that the positive impacts brought by the island-wide customs clearance operation of Hainan Free Trade Port are mainly reflected in three aspects: First, in terms of innovation capability building, Hainan's preferential talent introduction policies will help enterprises attract more international high-end talents, injecting new momentum into innovative drug R&D. Meanwhile, the "zero tariff" policy helps reduce import costs of advanced equipment and raw materials, significantly enhancing enterprise hardware capabilities. Additionally, Hainan's pilot application of real-world data can significantly shorten new drug approval cycles, accelerate the domestic launch of innovative drugs already approved abroad, allowing patients to benefit earlier.
Second, in terms of production and supply chain optimization, the continued implementation of "zero tariff" and value-added processing tariff exemption policies after customs clearance will incentivize enterprises to increase their high-end pharmaceutical production layout in Hainan. The improvement of logistics and personnel flow convenience, combined with the free trade port's warehousing advantages, is expected to build a more efficient, resilient, and low-cost supply chain system, enhancing enterprise market competitiveness.
Third, Hainan Free Trade Port will significantly accelerate the enterprise's internationalization process. SIMCERE PHARMA plans to use Hainan as a "bridgehead" to establish an international business expansion base, strengthen international registration and market access capabilities, and promote self-developed innovative drugs into the global market, benefiting a broader patient population.
When discussing the optimization of Hainan's business environment, Shi Ruiwen stated that SIMCERE PHARMA has continuously received strong support from both provincial and municipal governments in Hainan in recent years. In 2023, Hainan SIMCERE PHARMA was successfully selected as a leading enterprise in Hainan Province's high-tech "Elite Action," and recently received 10 million yuan in economic high-quality development incentive funds for 2024. Particularly encouraging is the official release of the 2025 "Several Policy Measures of Hainan Province to Further Support High-Quality Development of the Biomedical Industry," which proposes a full-chain, differentiated industrial support model, bringing significant benefits to enterprises and filling SIMCERE PHARMA with confidence in its development prospects in Hainan.
SIMCERE PHARMA has three major expectations for future development: First, it hopes to further simplify and accelerate new drug evaluation and approval processes to help innovative drugs benefit domestic patients sooner. Second, it hopes Hainan will continue to improve the efficiency of special drug and device approvals and optimize the approval process for real-world research pilots, helping more innovative drugs already approved abroad accelerate their entry into the Chinese market. Third, it expects that after innovative drugs are approved, they can receive more efficient policy support in medical insurance payment and hospital access, clearing the "last mile" for innovative drug applications.
Shi Ruiwen specifically introduced the latest progress of Hainan SIMCERE PHARMA in introducing foreign marketed drugs and achieving localized production: In late August this year, the company's globally new-generation anti-insomnia drug Daridorexant (trade name: Quviviq®) imported from Switzerland has been successfully repackaged in Hainan, marking the formal transition of this innovative drug from the R&D stage to the domestic commercialization stage. On September 4, Quviviq® was officially launched on Alibaba Health, bringing new treatment options to Chinese insomnia patients.
To accelerate the commercialization process of this drug, SIMCERE PHARMA has submitted an application for localized production and expects to fully achieve local production by 2026, forming a complete industry chain closed loop. After localized production is achieved, the drug's time-to-market is expected to be shortened to about two weeks, which will not only significantly improve patient drug accessibility but also leverage Hainan Free Trade Port's preferential policies to reduce production costs, thereby further reducing the medication burden on patients.