A medical revolution is taking place in the tropical island province of Hainan, with medicines not available anywhere else in China. Lecheng, an enclave covering 20 sq km on Hainan’s eastern coast, is no ordinary town. Dotted with over 30 state-of-the-art hospitals nestled amid lush foliage, it is China’s only “medical special zone”, where patients can access therapies still in clinical trials long before they hit the mainstream market. These can range from cutting-edge stem cell treatments to gene therapies. At West China Lecheng Hospital of Sichuan University, single-patient suites with floor-to-ceiling windows overlook tropical gardens, a far cry from the crowded, aging wards typical of mainland public hospitals. The zone’s groundbreaking policies, approved by national regulators in 2024, allow pioneering treatments to transition from lab benches to hospital beds under tightly controlled conditions. For patients, it is a lifeline. Many would otherwise face years on clinical trial wait-lists or exorbitant costs abroad. Likang Life Sciences’ LK101 injection, for instance, costs CNY150,000 per dose domestically – a fraction of the CNY7.2 million price tag for comparable Western therapies.
“It means a lot to patients who are desperate for new treatments,” said oncologist Dr. Wang Yongsheng. “In the past, patients could only access these breakthrough therapies by participating in clinical trials, which often have very strict eligibility criteria and limited enrollment.” Wang, Director of the Oncology Center at West China Hospital in Chengdu, is also responsible for the clinical research and evaluation of drugs at China’s National Medical Products Administration (NMPA). By collecting real-world data from willing patients, researchers gain insights to fast-track regulatory approval.
For China’s booming biotech sector, Lecheng has become a testing ground to rival global competitors. Yet beneath the optimism lies caution. Rigorous screening ensures only therapies with promising early trial data reach patients, and just two hospitals – staffed by elite medical teams – are authorized to administer them. Located in Boao town in Qionghai city, the Lecheng International Medical Tourism Pilot Zone is near the heart of the prestigious Boao Forum for Asia. The pilot zone has long been known for licensing drugs and medical devices that are marketed overseas but not yet approved in China. But now, as innovative therapies are being developed in China at an increasingly rapid pace, regulators are working to tighten regulation of the private sector. They are also seeking to establish new policy frameworks to promote home-grown medical innovation so that the country can stay ahead of international competition – and it is in this context that the zone is positioned as an experimental field.
In November of last year, the Hainan Provincial People’s Congress passed legislation enabling novel biomedical technologies, such as gene and cell therapies, to be offered as commercial services within the pilot zone. The law, which requires the registration and public disclosure of treatment pricing, came into effect in February. Consider, for example, emerging stem cell therapies. In December of last year, the U.S. Food and Drug Administration (FDA) approved mesenchymal stromal cell therapy, a type of stem cell treatment. Less than a month later, China’s drug regulator approved a home-grown therapy of this kind to treat a complication associated with bone marrow transplants. While both countries were marking their first officially approved stem cell therapies, six stem cell therapies for treating conditions including periodontal disease, heart failure, and arthritis were among the first 14 innovative therapies approved for early commercialization in Lecheng in February.
Since the zone’s establishment was formally approved in 2013, this policy has been an “unrealized dream of the past decade”, according to Chen Li, Founder of Likang. This unprecedented measure is seen as revolutionary by observers in the field. “Hainan’s new regulation covers almost the entire range of gene and cell therapy technologies, from precision cancer immunotherapy to stem cell therapy, and is of great significance in driving their overall advancement,” said an immunology researcher at a top university in Beijing who declined to be named. “If it succeeds, this regime will pave the way for the development of cell-based products in China and potentially worldwide.” The biologist said that for the hundreds of companies developing cell therapies in China, the very high R&D costs and long development time have dampened their enthusiasm for continued investment. Now, the latest initiative gives them the opportunity to reap financial rewards while investing in research and development (R&D).
Wang Xiaoyi, Vice President of West China Lecheng Hospital, told the South China Morning Post the original intention behind establishing the experimental zone was to quickly introduce international innovative drugs and medical devices. It was also aimed at accelerating the transformation and clinical application of new medical research achievements, including new biomedical technologies. Therefore, it was essential for Hainan province to issue legislation to oversee testing of investigative therapies. To ensure safety and minimize the risk of policy failure, of the dozens of hospitals in Lecheng, only West China Lecheng Hospital and a branch of Ruijin Hospital – a renowned university hospital affiliated with Shanghai Jiao Tong University – are currently qualified to carry out these treatments, the South China Morning Post reports.
