Boao Lecheng Introduces 151 Approved Special Medicines and Medical Devices, Including Novartis’ LEQVIQ (Inclisiran)

(By Yuan Yu) Recently, Novartis’ innovative lipid-lowering drug Leqvio (inclisiran) was administered for the first time in China at the Boao Lecheng International Medical Tourism Pilot Zone in the Hainan Free Trade Port (hereinafter referred to as the Lecheng Pilot Zone). This marks the introduction of another specially permitted global drug and medical device to the Lecheng Pilot Zone. According to the Lecheng Pilot Zone Administration, through integrated institutional innovation, Lecheng continues to accelerate the introduction of innovative drugs and medical devices. As of the end of June this year, 151 varieties of specially permitted drugs and medical devices have been approved for introduction in the pilot zone.

LEQVIQ (inclisiran) was approved in Europe in December 2020 for the treatment of hypercholesterolemia and mixed dyslipidemia in adults. However, as early as mid-2020, the Lecheng Pilot Zone Administration had already initiated efforts to introduce the drug. "After visiting the pharmaceutical company four times, we finally facilitated its market launch this year," said a relevant official from the Administration. To secure the drug's introduction, staff at all levels of the Administration worked diligently for nearly a year, ultimately winning over the pharmaceutical company with their utmost sincerity and the promising prospects of the Lecheng Pilot Zone.

According to reports, at the International Innovative Drug and Medical Device Exhibition in the Lecheng Pilot Zone, which opened in April this year, Novartis showcased multiple flagship products from its portfolio and held a launch ceremony for the first administration in China of Beovu, a novel therapeutic for fundus diseases. Bedian, President of Novartis China, stated at the exhibition that the Lecheng Pilot Zone is one of Novartis's key partners. Over the next five years, Novartis will have 50 new drugs approved and launched, which will be prioritized for use in the Boao Lecheng Pilot Zone.

This serves as a vivid snapshot of the deepening cooperation between international pharmaceutical and medical device companies and the Lecheng Pilot Zone. Through proactive integrated institutional innovation, the Pilot Zone has streamlined approval procedures, shortened approval timelines, established a traceability management platform to safeguard medication data security, hosted a permanent international exhibition for innovative drugs and medical devices, forged in-depth partnerships with multinational pharmaceutical and medical device enterprises, and built a premier hub for real-world research to accelerate the market entry of innovative pharmaceuticals and medical devices in China. Consequently, the Lecheng Pilot Zone has initially achieved synchronization with global developments in the pharmaceutical and medical device sector.

The Boston keratoprosthesis has restored sight to an elderly patient who had been blind for 58 years in Lecheng; cochlear implants have enabled over 500 children with hearing impairments to hear in Lecheng; melanoma patients who searched globally for treatments have been successfully treated in Lecheng; and patients with gastrointestinal stromal tumors have regained hope in Lecheng... The early gains from the construction of the Hainan Free Trade Port are enabling more Chinese citizens to enjoy the dividends of innovative medical technologies.

The official stated that the establishment and development of the Lecheng Pilot Zone means that, in the future, more patients will no longer need to travel overseas for medical treatment, as they can access the latest international drugs, medical devices, and therapeutic technologies right here in Lecheng. "With social and economic development, people have higher demands for health and well-being. This also inspires us to maintain our commitment to reform, continuously strive for excellence, and steadily enhance our market competitiveness."

It was reported that the Lecheng Pilot Zone Administration will also continuously deepen reforms to the existing policies on specially approved drugs and medical devices, steadily advancing towards greater convenience; coordinate with the Provincial Medical Products Administration, the Provincial Health Commission, and Haikou Customs on the overall workflow for specially approved drugs and medical devices to identify bottlenecks, address enterprises' pain points, and promote industrial development; and upgrade the existing traceability platform for specially approved drugs and medical devices to make regulatory oversight more intelligent, secure, and convenient.