Boston Scientific Partners with Boao Lecheng to Accelerate Market Access of Innovative Medical Devices in China

Hainan, January 21, 2020 /PRNewswire/ -- Today, Boston Scientific Corporation (NYSE: BSX) signed a strategic cooperation agreement with the Administration Bureau of Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the "Lecheng Administration Bureau") to conduct in-depth collaboration in the field of real-world data research on medical devices. Boston Scientific has become the first medical device enterprise partner of the Lecheng Pilot Zone in this field. Both parties will jointly promote the globalization of Chinese medical devices, bring benefits to more Chinese patients, and further support the Pilot Zone in achieving its goal of "three synchronizations" of medical technologies, equipment, and pharmaceuticals with international advanced standards.

In April 2019, the National Medical Products Administration (NMPA) released the Action Plan for Regulatory Science of Drugs in China, listing “methodological research on using real-world data for clinical evaluation of medical devices” as one of the first batch of research projects. In September 2019, the Implementation Plan for Supporting the Construction of the Boao Lecheng International Medical Tourism Pilot Zone, jointly issued by four departments—the National Development and Reform Commission, the National Health Commission, the National Administration of Traditional Chinese Medicine, and the NMPA—explicitly stated that eligible clinical use data from within the pilot zone could be used for registration applications of imported drugs and medical devices, thereby further accelerating the “pilot and trial” initiatives in the zone.

Amid the policy backdrop of promoting pilot programs for the application of real-world data (RWD) in the Boao Lecheng International Medical Tourism Pilot Zone, Boston Scientific has become the first medical device enterprise partner of the Lecheng Administrative Bureau in this field. According to the agreement, this collaboration will leverage the Lecheng Administrative Bureau’s advantages in policies, talent, and medical resources, while introducing Boston Scientific’s leading portfolio of minimally invasive interventional products and its global expertise in the regulatory application of real-world evidence (RWE). Together, the parties aim to provide new solutions for accelerating the market launch of global innovative products in China, assist the Pilot Zone in establishing a pilot RWD platform for medical devices, and further explore the feasibility of applying RWD to regulatory decision-making for medical devices.

At the signing ceremony, Jia Ning, Director of the Hainan Provincial Medical Products Administration, stated that research on real-world clinical data is a new endeavor, requiring collaborative efforts from the government, hospitals, pharmaceutical and medical device manufacturers, and experts. He welcomed all parties to bring their products and medical teams into the zone, affirming that the Provincial Medical Products Administration and relevant stakeholders would leverage the special policies of the Boao Lecheng International Medical Tourism Pilot Zone to provide support and facilitate the prompt initiation of real-world clinical data research.

Gu Gang, Director of the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration, stated, “The two parties completed the signing before the Spring Festival, demonstrating Boston Scientific’s strong eagerness to cooperate with the Lecheng Pilot Zone and its firm confidence in the development of the Free Trade Port. This is also a concrete measure taken by the Administration to implement the spirit of the Provincial Two Sessions.”。Gu GangAlsoIndicates：In the new year, the Administration will continue to adhere to a people-centered approach, accelerate the “pilot implementation” of imported medical devices, introduce more scientifically innovative products, and further enhance the level of medical services within the park. This will create a brand and demonstration effect with nationwide reach, making cutting-edge global medical solutions more accessible to the general public, and contributing Boao Lecheng’s strength to the construction of the Hainan Free Trade Port and the development of an international tourism and consumption center.

Academician Zheng Shusen of the Chinese Academy of Engineering likewise affirmed the importance of real-world studies and expressed his expectation for advancing international medical cooperation. He stated that with the deepened implementation of pilot programs for imported drugs and medical devices, and the continuous exploration of new pathways for import approval, patients in China with complex and refractory diseases will be able to access internationalized, one-stop, comprehensive healthcare services without leaving the country, thereby achieving truly “zero distance” and “zero time lag” with world-class medical resources.

“Riding on the further release of policy dividends from the ‘Nine National Measures’ and leveraging the ‘spillover effect’ of the Second China International Import Expo, Boao, Hainan has now become the premier destination for multinational corporations to implement innovative practices in China.” Ms. Zhang Jun, Vice President and General Manager of Greater China at Boston Scientific, stated: “Adhering to our original mission of ‘Innovating for Life,’ we aim to promote the transformation, upgrading, and coordinated development of the health industry through deep collaboration with the Boao Great Health Ecosystem. By taking a pioneering role in ‘pilot initiatives,’ we are committed to contributing substantively to the decisive decade for achieving the grand vision of ‘Healthy China.’”

Zhang Mingdong, Vice President of Medical Affairs and Health Economics for Boston Scientific’s Asia-Pacific region and Chief Medical Officer, stated, “The application of real-world clinical data, as a supplement and extension to traditional clinical trials, has become a major focus of medical research worldwide. We are honored to collaborate with the Boao Lecheng International Medical Tourism Pilot Zone Administration to support the implementation of pilot programs for the use of real-world clinical data, jointly creating a ‘fast track’ to connect Chinese patients with cutting-edge global medical resources.”

To further promote the pilot implementation of real-world data and accelerate the registration and market launch of breakthrough frontier products in China, Boston Scientific will also showcase its latest global products and technologies at the “Never-Ending” Exhibition of Specially Imported Drugs and Medical Devices, hosted by the Lecheng Administrative Bureau in late February 2020. The showcased innovations span cardiovascular intervention, structural heart disease, oncology intervention, peripheral vascular intervention, cardiac rhythm management and electrophysiology, endoscopic intervention, as well as urology and pelvic floor health. This initiative aims to expedite the alignment of local healthcare solutions with international standards and support the Pilot Zone in establishing a premier brand for the open development of the medical industry.

In the future, Boston Scientific will continue to collaborate with the Boao Greater Health Ecosystem for “co-creation and win-win outcomes,” introducing its full portfolio of innovative products to enhance local access to cutting-edge medical solutions. This effort will help the Pilot Zone further elevate its healthcare service standards, establish a brand and demonstration effect with nationwide reach, and ensure that patients across China benefit from the world’s most advanced medical solutions.

Regarding the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration

Boao Lecheng International Medical Tourism Pilot Zone Administration BureauApproved by the State Council, the Boao Lecheng International Medical Tourism Pilot Zone is the only national-level medical park in China that integrates medical rehabilitation and wellness, ecological conservation and energy-saving environmental protection, green international organizations, and leisure vacations. The zone pilots the “three synchronizations” of medical technologies, equipment, and pharmaceuticals with advanced international standards, aiming to establish itself as a key demonstration area and innovation hub within the Hainan Free Trade Zone (Port).

About Boston Scientific

Boston Scientific Corporation is committed to innovating for life. We are dedicated to developing innovative medical solutions that improve the lives of patients worldwide. For more than 40 years, Boston Scientific has been a leader in the global medical technology industry, offering a broad portfolio of high-performance medical solutions to meet the urgent therapeutic needs of patients and reduce healthcare costs. For more information, please visit our corporate website:www.bostonscientific.cn

About Boston Scientific Greater China

Boston Scientific established its China headquarters in Shanghai in 1997 and currently maintains branch offices in Beijing, Shanghai, Guangzhou, Chengdu, Hong Kong, and Taiwan. The company’s core business portfolio spans interventional cardiology, structural heart disease, cardiac rhythm management and electrophysiology, endoscopic interventions, peripheral and oncology interventions, urology and pelvic health, and respiratory products. Upholding its tradition as an innovation leader, Boston Scientific is committed to becoming a respected medical technology company that is responsive to the needs of patients and healthcare providers, driven by innovative vitality, and dedicated to delivering high-quality medical products and services for prevention, diagnosis, and treatment. For more information, please visit the company’s website:www.bostonscientific.cn