“In the past two years, Lecheng Pioneer Zone has launched more than 100 licensed pharmaceutical devices through Ruijin Hainan Hospital. By 2025, it will basically achieve “three synchronizations” of pharmaceuticals, devices, and international technology, and by 2030, it will become a world-class medical tourism destination and medical science and technology innovation platform.” Dai Xiaolong, director of the Real Research and Transformation Department of the Hainan Lecheng Administration Bureau, said at a forum during the 7th China International Import Expo.

Some industry insiders pointed out that due to “policy green lights” and innovative models, Hainan Lecheng and the Guangdong-Hong Kong-Macao Greater Bay Area are becoming important platforms to promote a high level of collaboration and integration with global medical resources, attracting leading global pharmaceutical companies and high-quality domestic and international medical institutions.

Domestic patients can receive innovative treatment without going abroad under the “try first, first serve policy”

In May of this year, a giant liver cancer patient from Hainan came to Hainan Hospital of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, the only public hospital in the Hainan Boao Medical Special Medical Zone, and underwent surgery with yttrium-90 glass microspheres introduced through the “first try first” policy. The operation was carried out by a team of experts from the Radiological Interventional Department, Nuclear Medicine Department, and the Department of Interventional Medicine at Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine. After the operation was completed, the lesion was almost completely necrotic, and the effect was equivalent to radical surgical resection, and the patient ultimately benefited.

Yttrium-90 glass microsphere SIRT is an innovative treatment for liver cancer that uses beta rays released by the radioactive element Y90 to accurately kill cancer cells. Although this technology has been applied globally for more than 20 years, it is still at the cutting edge in China. Thanks to the Hainan Boao Lecheng Special Medical Zone's “Try First” policy, domestic patients can receive this treatment without going abroad.

There are many more stories like this in Lecheng, Hainan, a highland of health care innovation. Three years ago, the Hainan Hospital of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine was established in the Boao Lecheng Special Medical Zone. Mr. Gu Zhidong, Party Secretary and Director of Ruijin Hainan Hospital, shared the hospital's practices and experience in medical innovation over the past three years. At present, 168 licensed pharmaceutical devices have been successfully approved, 119 are being used, 77 are the first in the country, and 33 real-world data studies have been carried out, and a total of more than 10,000 patients across the country have been served.

The implementation of the first-to-test policy has also opened up a “fast track to market” for new global pharmaceutical products. Take Gilead as an example. As early as 2022, Gilead's antimycotic drug ambisol (amphotericin B liposome for injection) passed the advantages of a licensed pharmaceutical device import policy advantage in the Hainan Boao Lecheng International Medical Tourism Pilot Zone, and was the first to land in Lecheng, Hainan before it was officially approved domestically, successfully rescuing several patients with invasive fungal diseases.

In April of this year, Gilead established the Hainan branch and reached another strategic cooperation with the Hainan Boao Lecheng Pioneer Zone at the Expo. The two sides will continue to rely on the policy advantages of the Lecheng Pioneer Zone to accelerate the first-trial use of the long-term HIV treatment Lenacapavir for HIV prevention in Lecheng, so that more people in need can benefit from this cutting-edge drug earlier.

It is worth noting that in recent years, China's new health care reform policies have been introduced frequently. In 2023, the State Council approved the “Work Plan to Support Beijing's Deepening the Expansion and Opening of the National Service Industry and the Construction of a Comprehensive Demonstration Zone” to establish a pre-trial guarantee mechanism for rare disease drugs, clinically urgently needed drugs, and cell and gene therapy products in Beijing for clinical application without registration and approval, to further serve clinical drug use needs.

At this year's fair, Gilead first exhibited Seladelpar, an innovative drug for treating primary biliary cholangitis in China. The drug received accelerated approval from the US Food and Drug Administration (FDA) in August 2024, bringing new options for second-line treatment for patients with primary biliary cholangitis. To accelerate access to Seladelpar, an innovative drug in China, Gilead and Keyuan Xinhai (Beijing) Medical Products Trading Co., Ltd. signed a strategic cooperation. Relying on the Beijing Rare Disease Drug Guarantee Pilot Zone policy, the two sides will explore and promote Seladelpar's import and first trial to help patients with primary biliary cholangitis address unmet treatment needs.

Jin Fangqian, global vice president of Gilead Sciences and general manager of China, said, “Since starting operations in China seven years ago, Gilead has continued to promote innovative global therapies to accelerate the benefits of domestic patients, and has made improving the accessibility of innovative drugs one of the priorities of its development strategy in China.”

According to reports, at this fair, in order to continuously improve the accessibility of innovative drugs, Gilead also reached strategic cooperation with Sinopharm Holdings Co., Ltd., Shanghai Pharmaceutical Holdings Co., Ltd., and Meixin Health.

The “Hong Kong and Macau Drug Connect” policy promotes the integrated development of the healthcare industry in the Greater Bay Area

The “Hong Kong and Macau Pharmaceutical Device Connect” was implemented in 2021, opening up a channel for international advanced and innovative pharmaceutical devices to quickly enter clinical application, so that drugs already marketed in Hong Kong and Macau, as well as medical devices that have been purchased and used by Hong Kong and Macao public hospitals and have advanced clinical application, can be used in designated medical institutions within the Greater Bay Area when there is an urgent clinical need, bringing real convenience to residents of the Greater Bay Area for disease treatment.

According to data released by the Guangdong Drug Administration on October 9, by the end of September this year, the province had introduced 79 types of pharmaceutical devices (39 types of drugs and 40 types of devices) already marketed in Hong Kong and Macao, benefiting nearly 10,000 people in the Bay Area, covering 9 cities in the Greater Bay Area, and further attracting global multinational pharmaceutical companies to pay attention to Guangdong, creating a good atmosphere for the development of innovative pharmaceutical devices in the Greater Bay Area.

According to information, Boston Scientific, as the first multinational manufacturer to participate in the “Hong Kong and Macau Pharmaceutical Device Connect”, has so far obtained approval for four innovative products, including the EKOS ultrasound-assisted thrombolysis system, which can be used to treat pulmonary embolism. Just last month, EKOS was approved as the “Hong Kong and Macau Pharmaceutical Device Guide”. Soon, clinical treatment and real-world research will be carried out at several hospitals in the Greater Bay Area.

Zeng Zhiyu, senior director of Boston Scientific China's medical department, said, “The Hong Kong and Macau Pharmaceutical Exchange Policy provides an unprecedented opportunity to promote the integrated development of the healthcare industry in the Greater Bay Area. As a leading global medical device company, Boston Scientific is actively involved in this forward-looking enterprise, striving to improve the level of medical services in the Greater Bay Area and the whole country by introducing more cutting-edge technology and solutions.”