With an increasing number of hospitals focusing on clinical research being established in Lecheng, international pharmaceutical and medical device companies continuously introducing products targeting real-world studies there, and investment funds also arriving, Lecheng is drawing ever closer to achieving its BD (Business Development) objectives.

On November 24, the Boao Lecheng International Medical Tourism Pilot Zone in Hainan (hereinafter referred to as "Lecheng") held a BD conference aimed at facilitating transactions and transformations of innovative pharmaceuticals and medical devices. The conference also officially launched the Lecheng BD Center to provide one-stop services for enterprises interested in business development.

BD is a buzzword in the healthcare industry. Broadly, it signifies various business opportunities; narrowly, it refers to collaborations centered around the buying and selling of products. Lecheng's BD conference attracted 400 representatives from domestic and international pharmaceutical and medical device companies, investment institutions, and medical industry associations nationwide. Over 100 innovative biopharmaceuticals, medical devices, and special food-related products were released online, with nearly 30 innovative biopharmaceutical projects showcased in offline presentations that day.

Economic Observer Network has learned that four products from the first batch of projects were successfully transacted that day, including three products from overseas and one from China.

Lecheng's BD Ambitions

Jia Ning, Director of the Lecheng Administration, told the Economic Observer Network that Lecheng had been preparing for this BD conference for more than half a year.

After the end of the pandemic in 2023, Lecheng's team visited the United States, Israel, and numerous European countries. They discovered that many foreign small and medium-sized pharmaceutical and medical device companies wished to enter the Chinese market but lacked appropriate pathways and were unfamiliar with China's market access policies. Lecheng, with its policy advantages in granting special permission for the use of pharmaceuticals and medical devices within Lecheng and in conducting real-world studies, has a natural edge in introducing these products.

Jia Ning stated that Lecheng can help overseas innovative pharmaceuticals and medical devices—those in Phase II or III clinical trials or already on the market—find investors and partners in China to achieve industrialization and localization.

Additionally, some domestic small and medium-sized enterprises aim to bring promising medical products to international markets. Lecheng can assist Chinese innovative pharmaceutical and medical device companies with international aspirations to connect with capital, achieving mutual benefits for all parties involved.

At the BD conference, Li Jiaxuan, Head of Consumer Goods, Food, and Medical Industry at Business Finland in China, expressed great interest in Lecheng's BD initiatives. "(I hope) to use Hainan Lecheng as an incubator to quickly develop good projects and bring them to the Chinese market," she said.

According to data, as of now, Lecheng has introduced 442 innovative products for use exclusively in the "Medical Special Zone", including 164 drugs and 278 medical devices that are not yet registered in China. These products span fields such as oncology, ophthalmology, rehabilitation, and cardiovascular diseases.

From a commercial return perspective, Novartis's innovative cholesterol-lowering drug Inclisiran Sodium Injection, began its first administration in Lecheng in 2021 under special permission for use within the "Medical Special Zone", even before receiving approval for the broader Chinese market. During this period, it generated sales exceeding 100 million yuan (approximately 13.8 million dollars) within Lecheng. Similarly, an artificial cochlear implant and processor, permitted for use in Lecheng under the same policy, was used in over 700 cases and achieved sales surpassing 500 million yuan (approximately 68.97 million dollars) before gaining approval for nationwide marketing in China.

Zhang Ruohan, General Manager of Hainan Boao Lecheng Cooperative Development Company, commented, "These two sets of data demonstrate that the introduction of these products in Lecheng not only achieved early market entry but also swiftly realized commercial returns. This allows investors to observe the clinical application effects and market feedback of the products."

Each pharmaceutical or medical device introduced under permission to be used in Lecheng and subsequently approved in China with the aid of Lecheng's real-world data means that more patients in China no longer need to travel to Lecheng; they can receive diagnosis and treatment closer to home.

So, what can Lecheng do next? From an industry development perspective, Jia Ning believes that Lecheng is an open platform capable of serving as an incubator. Having already attracted international innovative pharmaceutical and medical device companies, Lecheng aims to draw in Chinese enterprises interested in business development and investment funds, thereby gradually perfecting the platform.

An example is the introduction of Cosela, a product of Simcere Pharmaceutical, which began official production in Haikou this April by adopting the "Lecheng Research and Use + Haikou Production" enclave economic model. This signifies that Lecheng's initial pathway as an incubator has been successfully established, and under this model, Lecheng can create more value for the Hainan Free Trade Port.

Yu Chengqiang, a partner at Beijing Goldensum Asset Management Co., Ltd. (hereinafter referred to as "Beijing Goldensum Asset"), is one of the investors attracted by Lecheng, having focused on the health sector for many years. On that day, Yu and multiple colleagues from Beijing Goldensum Asset attended the Lecheng BD conference; for the three major areas of pharmaceuticals, medical devices, and special foods, they had dedicated personnel assigned to follow up in each field.

Beijing Goldensum Asset manages the Goldensum Lecheng Health Fund, primarily investing in the introduction of international innovative pharmaceuticals and medical devices and equity investments in innovative enterprises within the health industry. Yu Chengqiang stated that the Goldensum Lecheng Fund can collaborate with international pharmaceutical and medical device companies and partners within China to establish Chinese project companies. These entities will undertake all tasks from introducing innovative products to clinical application and commercialization. Throughout this process, the fund provides financial support and business collaboration, working alongside international companies to complete product registrations and jointly develop the Chinese market.

Dual Policy Advantages

For Lecheng to intensify its BD efforts, it relies primarily on its core advantages: the use of pharmaceuticals and medical devices granted special permission within Lecheng and the real-world research policy. These two policies have been in place for many years and continue to attract pharmaceutical and medical device companies and hospitals.

On the same day as the Lecheng BD conference, West China Lecheng Hospital of Sichuan University (hereinafter referred to as "West China Lecheng Hospital") introduced Servier's new drug Vorasidenib, designed for specific types of brain gliomas, and issued China's first prescription for it. This also marked the "first use in Asia" of Vorasidenib, preceding its prescription in Europe.

Simultaneously, a real-world study evaluating the safety and efficacy of Vorasidenib in the Chinese population will be conducted in Boao Lecheng.

Real-world studies conducted within China's local medical environment are more closely aligned with the actual conditions of Chinese patients, making the results more representative and valuable. Such studies, with flexible inclusion criteria and innovative designs, can yield research results more rapidly.

Liu Yi, President of West China Lecheng Hospital, stated that it generally takes three to five years for a drug to reach the market through traditional clinical research. However, utilizing the real-world study pathway can accelerate approval from regulatory authorities. In his view, Vorasidenib is indicated for a rare disease; by administering it to Chinese patients and collecting more data, the future publication of these data could influence rare disease patients worldwide. Therefore, he hopes the drug can be marketed through real-world research.

On November 26, after nearly a year of trial operations, West China Lecheng Hospital officially opened. One of its significant objectives is to conduct internationally leading and innovative clinical medical research, promoting clinical innovation and the transformation of research achievements.

From this perspective, with more hospitals focusing on clinical research being established, international pharmaceutical and medical device companies continuously introducing products targeting real-world studies, and investment funds arriving, Lecheng is getting ever closer to realizing its BD goals.