Hainan is beginning to turn one of Lecheng’s most distinctive regulatory advantages into something broader: a route that can take selected overseas drugs and medical devices from early clinical use in China through registration and, in some cases, into production on the island.
The idea is no longer confined to a single project. At a late-June press conference, Hainan’s drug regulator said three products had already reached local production through the wider effort to link Lecheng use, real-world research, domestic registration and manufacturing. The regulator did not identify all three at product level, but one case, Trilaciclib, can be followed publicly through every stage from first use in Lecheng to production in Haikou.
A second major drug, ruxolitinib phosphate cream, has now completed the Lecheng and national-approval stages while its Hainan production base is being built. Medical devices are also being brought into the same framework.
What began as cooperation between Lecheng and Haikou is therefore starting to look more like a province-wide industrial strategy.
Trilaciclib showed that the route could work
Trilaciclib, marketed in China as Cosela, provides the clearest example.
The drug was first used in China through Lecheng’s special-access policy in June 2021 and entered Hainan’s real-world-data pilot two months later. Simcere says the Lecheng study provided supporting evidence during the Chinese registration process. The National Medical Products Administration (NMPA) granted the drug conditional approval in July 2022, which was converted to regular approval in October 2023.
In December 2023, the NMPA approved a supplemental application transferring the product to domestic manufacture by Hainan Simcere Pharmaceutical, with the production site in Haikou. The first locally produced batch, about 20,000 vials, came off the production line in Haikou National High-tech Industrial Development Zone on April 1, 2024. The production line was designed for annual capacity of up to 2 million vials.
That sequence demonstrates the complete route in practice: early access in Lecheng, real-world research, national approval and production in Haikou.
It also gave Hainan something that policy alone could not provide, a working precedent.
Ruxolitinib is moving through the same route
Ruxolitinib phosphate cream is moving along the same path.
Developed by Incyte, the product entered special-access clinical use in Lecheng in August 2023 and was later included in Hainan’s real-world-data programme. A January 2026 HKEX filing from China Medical System said a Chinese real-world study produced results consistent with the product’s overseas pivotal trials. The licensing agreement covers mainland China, Hong Kong, Macau, Taiwan and 11 Southeast Asian countries.
The NMPA approved the product in January 2026 for patients aged 12 and above with non-segmental vitiligo involving the face. A second indication, for mild-to-moderate atopic dermatitis, was approved on September 2.
The manufacturing stage is not yet complete.
In January, Dermavon said it was preparing the application for local production while its Haikou factory and production line were under construction. Hainan Daily subsequently reported that local production was expected in 2027. In August, CMS said the main structure of Dermavon’s Hainan R&D and manufacturing base was about to be topped out.
Ruxolitinib is on course to become another product to move from Lecheng use into Hainan manufacturing.
The strategy has widened from Haikou to Hainan
The policy behind this model predates 2026.
Hainan’s 2025 Government Work Report called for the province to advance the “Lecheng research and application + Haikou production” model in innovative drugs and medical devices.
The wording changed significantly in the 2026 report.
Under its advanced-manufacturing programme, the 2026 Government Work Report called for deepening the “Lecheng research/use + Hainan production” model, accelerating pharmaceutical and medical-device R&D results and promoting local production of introduced drugs and devices.
The change from “Haikou production” to “Hainan production” is small linguistically but important industrially. The model is no longer being framed only as cooperation between one medical zone and one manufacturing park. It is being positioned as part of Hainan’s wider manufacturing strategy.
That was followed on May 27 by a dedicated set of measures from the Hainan Medical Products Administration covering imported innovative and improved drugs. The final document was approved by the regulator and issued for implementation that day.
The measures explicitly connect Lecheng’s special-access and real-world-data systems with production in Hainan. They encourage multinational pharmaceutical companies conducting clinical research in Lecheng to plan production lines at the same time in Haikou National High-tech Industrial Development Zone and other key parks. For products whose registration is supported by qualifying Lecheng real-world data and which are intended for Hainan production, the regulator provides early intervention and guidance on production facilities and GMP requirements.
That begins to change the commercial proposition. Instead of Hainan trying to attract manufacturing only after a product has completed the Chinese approval process, the province wants the production decision considered while the product is still moving through Lecheng.
Medical devices are part of the same plan
Medical devices are following a similar route.
Hainan introduced dedicated high-end medical-device measures in October 2025 and amended and reissued them in September 2026. The September amendment changed two provisions, while retaining the core localisation framework established in 2025.
The current measures encourage international innovative devices to enter use through Lecheng and support devices first used there in locating manufacturing operations in Hainan. The regulator describes the intended chain as “research/use — conversion — production — distribution”. The measures also provide registration support, land-approval coordination, infrastructure assistance and guidance on relevant Free Trade Port zero-tariff and processing value-added policies.
One device has already advanced part of the way through that process.
A polyester-collagen bone-repair material introduced from Switzerland by Hainan SuSheng Biotechnology was first used in Lecheng in 2023 and received NMPA approval in February 2025. Hainan’s drug and medical-device review centre described it as the first medical-device product cultivated under the “Lecheng research/use + Haikou production” model. The same official notice said the company intended to work with the overseas licence holder to achieve local production in Haikou.
It has not yet reached the manufacturing stage completed by trilaciclib, but it expands the model beyond pharmaceuticals.
The pipeline behind the first projects is growing
The number of products reaching manufacturing is still small compared with the number entering through Lecheng, but the pool from which future localisation projects could emerge is becoming larger.
At the late-June press conference, Hainan said 27 drug and medical-device products had gained accelerated approval with support from real-world evidence generated through Lecheng, while three products had reached local production.
A separate July meeting of the Hainan Medical Products Administration reported that 48 drug and medical-device products had entered Lecheng’s real-world-research programme and 28 had been approved for market. The focus is now shifting to the practical work of scaling the model. The regulator said it would explore asset-light routes including contract R&D, segmented production and shared manufacturing to help more products establish operations in Hainan.
That points to the next stage of the model.
Lecheng already gives Hainan a recognised entry point for international medical products. Haikou has demonstrated that at least one of those products can move from early use into domestic manufacturing. The province is now broadening that relationship across Hainan and building policies around keeping more of the value created after registration on the island.
The next test will be how many products follow trilaciclib through the entire chain.
If ruxolitinib reaches local production as planned, more medical devices move beyond registration into manufacturing, and the regulator’s existing pipeline continues to produce localisation projects, Lecheng’s role could become considerably larger than early access alone.
It could become the front end of a medical-manufacturing pipeline for the Hainan Free Trade Port.
Related article: How Hainan Is Turning Aircraft Maintenance Into a Free Trade Port Industry
