41,000 New Enterprises Added, Cost of Medical Device Industry Export Drops by 30%, Haikou's First Spring After the Seal-Off Arrives!

The closure of Hainan Free Trade Port has brought unprecedented opportunities. As the core industrial cluster area of Hainan and the first承接地 for the island's capital, talent, industry, and policy resources after the closure, Haikou High-Tech Zone's pharmaceutical industry output value already accounts for 80% of Hainan Province. On March 7, Feng Fei, the Party Secretary of Hainan Province, announced that in just over two months since the operation of the closure, 51,000 new business entities were added, including 41,000 new enterprises, an increase of 43.6%. The number of newly established foreign-invested enterprises and registered foreign trade enterprises increased by 30% and 74%, respectively. According to public data, the EF account (multi-functional free trade account) surpassed 350 billion yuan in settlement scale after being online for more than a year, covering 91 countries and regions. The optimization of the ODI (Overseas Direct Investment) series of policies can help companies reduce overseas expansion costs by over 30%.

Nowadays, as the sealing-off policy enters the implementation phase, companies in the biopharmaceuticals and medical devices sectors are no longer concerned about "what policies are available," but rather about specifics such as "how much cost can be saved" and "how much faster processes can become." In response, enterprises within Haikou High-Tech Zone have provided concrete answers: Well Lead Medical Co., Ltd. has made a breakthrough on cost reduction through Hainan Free Trade Port's value-added processing policy, achieving immediate results in cutting costs and improving efficiency; SonoScape launched Hainan Free Trade Port's first bonded repair project for medical devices; and De Mei Pharmaceutical’s Ruxolitinib Phosphate Cream has taken advantage of the Lecheng pilot channel, with its industrialization successfully landing in Haikou High-Tech Zone.

These are not pilot cases, but replicable industrial pathways.On the afternoon of April 14, at the Marriott Hotel in Haikou, the "2026 Hainan Free Trade Port Global Industry Investment Conference – Biomedical Industry Session" will systematically break down these pathways.

This event was hosted by the Haikou Municipal Government, organized by the Hainan International Economic Development Bureau, Haikou National High-Tech Industrial Development Zone, and Haikou International Investment Promotion Bureau, with support from the Provincial Department of Industry and Information Technology, Provincial Department of Science and Technology, Provincial Health Commission, and Provincial Drug Administration.Haikou High-tech Zone and Hainan Provincial Drug Administration will focus on interpreting policy iterations post-sealing. Hainan Provincial Finance & Gold Group will release a government investment list. The Anti-Aging Research Institute of Shenyang Pharmaceutical University will sign for its establishment. Benchmark companies such as Well Lead Medical, SonoScape, Guochen Medical, and Well Lead Medical will share practical experiences. Institutions like Haikou Financial Control and Guangzhou Industrial Investment will participate in project roadshows. This is not a policy briefing but an "accounting meeting" and "matching session" – calculating the real costs of cross-border funds, taxation, and tariffs while connecting resources for industrial chain, capital, and service implementation.

The competitiveness of Haikou's biomedicine and medical device industry is supported by a multi-dimensional system of "tax incentives + institutional innovation + platform empowerment + convenient review," which exhibits stronger systematicness and certainty after the closure operation.

The value of "Zero Tariff, Low Tax Rate, Simplified Tax System" for pharmaceutical and medical device companies lies in the precise alignment of policies with industry characteristics. In the import process, the "zero tariff" list for self-use production equipment covers core pharmaceutical and medical device production equipment, allowing companies to import equipment without paying import tariffs, import VAT, or consumption taxes. The "30% value-added processing exemption from tariffs" policy encourages companies in key industries that produce goods with imported materials, which are processed in Hainan to increase their value by over 30% (inclusive), to enter the mainland without paying import tariffs.

As one of the first processing value-added pilot enterprises in Haikou National High-Tech Industrial Development Zone, Well Lead Medical Co., Ltd. sources its main product materials from Southeast Asia. Through the processing value-added policy, the company has significantly reduced production costs and greatly improved operational efficiency. Additionally, regarding corporate income tax, encouraged industry enterprises registered in Hainan are subject to a reduced tax rate of 15%, compared to the standard rate of 25% in mainland China. This means that a pharmaceutical or medical device company with an annual profit of 100 million yuan can save 10 million yuan in taxes each year. The benefits of the corporate income tax policy have a broad coverage, including not only biopharmaceutical research and development and pharmaceutical and medical device manufacturing enterprises but also pharmaceutical distribution companies and medical device supply chain enterprises, all of which are entitled to the same tax incentives. For enterprises, these cost savings will directly translate into net profits.

One of the differentiated advantages of Hainan Free Trade Port in the pharmaceuticals and medical devices field is the collaboration between Lecheng and Haikou High-Tech Zone: After innovative pharmaceuticals and medical devices complete the accumulation of real-world clinical data in Lecheng, enterprises in Haikou High-Tech Zone take over production, achieving an efficient transformation from "the latest globally" to "accessible in China." For enterprises, the full-cycle policy support under this model is particularly crucial. Haikou High-Tech Zone provides substantial policy incentives at key stages such as product registration, project implementation, and large-scale production, significantly amplifying enterprise benefits.

Taking the international innovative drug Ruxolitinib Phosphate Cream by De Mei Pharmaceuticals as an example, this drug was introduced to Lecheng in August 2023 through the policy for urgently needed imported drugs in clinical settings. It subsequently underwent real-world data-assisted approval and received full industrial chain support from Haikou High-Tech Zone, gaining CDE approval for market launch in January 2026. Another notable case is Cosela (Trilaciclib Hydrochloride for Injection) by Simcere Pharmaceutical, which took only 15 months from introduction to market approval, setting a speed benchmark for similar innovative drugs entering the Chinese market. More importantly, the industrialization of Trilaciclib has successfully landed in Haikou High-Tech Zone, achieving a seamless transition from "Lecheng entry" to "large-scale production in Haikou High-Tech Zone." For pharmaceutical and medical device products with limited patent periods, time value equals market value—every year of earlier market entry translates into hundreds of millions in exclusive market revenue. The policy boost from Haikou High-Tech Zone is precisely the core pivot enabling this value transformation.

Hainan Free Trade Port has multiple innovative policies supporting the efficiency of pharmaceutical and medical device review and approval, such as the "Implementation Plan for Deepening the Reform of Pharmaceutical, Medical Device, and Cosmetic Supervision in Hainan Province to Promote High-Quality Development of the Pharmaceutical Industry." In terms of the review of Class II medical devices, the time limit has been shortened by 55% compared to the statutory time limit. A green channel has been opened for innovative Class III medical devices, significantly reducing the review time. Meanwhile, the process of converting imported medical devices to domestically produced ones in China has been further accelerated, with a group of top international medical device companies achieving localized production in Haikou High-Tech Zone.

When it comes to specific cases, the impact is more visually convincing. In the past three years, thanks to the policy support of the Hainan Free Trade Port and the innovation in the review mechanism, SuSheng Bio has obtained approval for the market launch of 12 Class III medical devices and 6 Class II medical devices. For innovative pharmaceutical and device companies with fast product iteration, the efficiency of the review process directly determines their ability to seize the market window. Now, this efficiency is being redefined in the Hainan Free Trade Port.

In 2025, the number of China's innovative drug BD overseas licensing deals reached 157, with a total transaction value as high as $135.655 billion USD, setting new records in both scale and frequency. At the same time, the proportion of diversified cooperation models such as Newco and Co-Co has significantly increased, becoming a new trend in the industry. The arrival of this trend places higher demands on enterprises' cross-border capital scheduling capabilities, with compliance costs and time lags under the traditional foreign exchange control framework becoming limiting factors.

Hainan Free Trade Port's EF Account and ODI Policy Can Address the Above Pain Points. The EF account is equivalent to a multi-currency all-in-one card, allowing both RMB and foreign currencies to be managed within the same account, facilitating convenient and rapid fund flows between Hainan Free Trade Port and overseas, while effectively regulating fund transactions with mainland China. Relying on the EF account system, combined with the "first line liberalization, second line controlled permeability" policy and Haikou’s cross-border asset management pilot program, domestic and overseas fund circulation can be quickly established. By the end of 2025, a total of 11 banks in the province will have launched EF accounts, with 810 EF accounts opened, generating transactions equivalent to 350.9 billion RMB. Account holders have conducted fund transfers with 91 countries and regions.

Importantly, under the joint support of EF accounts and ODI policies, overseas profits repatriated by outbound enterprises are exempt from income tax. Combined with policy benefits such as the dual 15% tax rates on individual and corporate income taxes in free trade ports, this will directly optimize financial costs and significantly enhance operational and supply chain efficiency.

By the end of 2025, SonoScape's off-site bonded repair project for medical devices has been approved by the Ministry of Commerce, becoming the first off-site bonded repair project for medical devices approved in the Hainan Free Trade Port, as well as the first project allowing "both ends outside" bonded repair of medical devices after the whole island’s customs closure. Bonded repair allows companies to transport damaged medical devices from overseas to Haikou, complete the repairs under bonded status, and then export them, with the entire process exempt from tariffs and value-added tax at the import stage. For medical equipment that can cost hundreds of thousands of yuan per unit, the gross profit margin for repair services can reach 40%-60%.

The implementation of SonoScape's project marks that Haikou has the capability to undertake global medical device after-sales services, which is a crucial step in the extension of the industry ecosystem from "manufacturing" to "service." Additionally, a number of enterprises such as Guochen Medical, Shantou Ultrasound, and Anhui Tuofan have successively settled. With the continuous release of bonded repair policy benefits and the ongoing establishment of various medical devices across regions, Haikou High-tech Zone is accelerating the formation of a medical device after-sales service cluster covering multiple niche fields, further consolidating its pivotal position in the global medical device industry chain.

If you need to further understand and interpret the policies of the Hainan Free Trade Port, you can scan the QR code above to directly download the PDF document.

(Left: Haikou City Supportive Policies for the Biopharmaceutical Industry; Right: Hainan Free Trade Port Biopharmaceutical 100 Questions and Answers)

The ultimate value of a policy lies in verifiable business outcomes, and the validated value requires an accessible conversion pathway. However, policy decoding demands professional insight, pathway replication needs practical guidance, and resource alignment calls for precise platforms. How to transform the "Haikou Experience" into a universally applicable corporate strategy? This is the core proposition that this event seeks to address.This event will help companies understand the new opportunities in customs-cleared operations and achieve a strategic leap in global development from the full-chain dimensions of policy decoding, practical sharing, capital docking, service implementation, and ecological investigation.

Haikou High-Tech Zone to Interpret Policy Iterations Post-Free Trade Port's Closing, Break Down the Applicable Scenarios of the "Zero Tariff, Low Tax Rate, Processing Value-Added" Combo in the Pharmaceutical and Device Fields. Additionally, Haikou High-Tech Zone will conduct thematic promotion on industrial cooperation and implementation pathways, specifying the full-process service nodes and liaison windows from project signing, registration approval, factory construction to production operation, allowing enterprises to clearly understand the time and administrative costs at each stage.

Hainan Provincial Finance and Gold Group will release a government investment list, detailing the scale of funds, investment stages, and application conditions focused on the biopharmaceutical industry, providing enterprises with a capital connection entry point. The provincial Drug Administration will interpret the advantages of medical device review and approval, explaining the operational procedures of new regulations and how the real-world data research channel can accelerate product launches.

Four Interpretations Point to "Accounting" – Clarifying the Real Financial Benefits of Tariff Savings, Tax Incentives, Capital Costs, and Evaluation Timeliness, Rather Than Staying at the Level of Policy Descriptions.

Well Lead Medical will showcase how to undertake international CDMO orders through the Haikou High-Tech Zone platform, achieving a transformation from single-product exports to the export of technical standards. SonoScape/Guochen Medical will provide a detailed explanation of the qualification application process, customs supervision requirements, profit model of repair services, and how to transform after-sales service from a cost center to a profit center as the first enterprise in China to implement a bonded repair project for medical devices. Well Lead Medical will elaborate on the entire chain operation from raw material imports, production processing, to domestic sales of finished products, as well as the key points and common pitfalls in policy applications.

These real-life cases are replicable "workbooks." Benchmark companies provide detailed explanations on policy application timelines, cost comparison data, and department liaison windows, enabling participating companies to arrive with questions and leave with solutions.

At the same time, this event also features booths set up outside the venue by investment institutions such as Haikou Financial Control and Guangzhou Industrial Investment. These institutions will participate on-site, focusing on sub-sectors like innovative drugs, high-end medical devices, and CRO/CDMO services, allowing companies to engage in face-to-face in-depth discussions with investors directly at the venue. The event also offers two immersive ecosystem exploration routes: High-Tech Zone Pharmaceutical Valley Planning Exhibition Hall – Simcere Pharmaceutical, and High-Tech Zone Meian Management Center – Well Lead Medical. Participants can transform policy texts into spatial awareness and convert data indicators into on-site experiences, achieving multi-dimensional cognitive enhancement.

For biopharmaceutical and medical device companies, the first year of the customs closure operation is the best window period to establish a presence in Hainan. The policy framework has been finalized, the industrial ecosystem has taken shape, the benchmark path has been successfully tested, and the first-mover advantage has not yet solidified.On the afternoon of April 14, Haikou Marriott Hotel, 2026 Hainan Free Trade Port Global Industry Investment Promotion Conference – Biomedical Industry Session, sincerely invites representatives from all links in the industry chain to attend the event. No empty slogans, only detailed calculations; no abstract concepts, only practical implementation.