NMPA Research Base for Drug and Medical Device Regulatory Science Hainan Institute of Real World Data
/ EN
Trends

2.0 Edition of Cooperation between Lecheng and Novartis: Developing Real-world Study System and Spee

2022-02-25 291

Lecheng in the Import Expo

On November 6, at the 4th China International Import Expo, the Administration of Hainan Boao Lecheng International Medical Tourism Pilot Zone (Lecheng Administration) signed another memorandum of strategic cooperation with Novartis, with an aim to launch new cooperation and practice in the fields of translational medicine and real-world studies, boost talent cultivation and international exchange and obtain the drug effectiveness and safety information via real-world evidences, thereby helping the decision-making of regulators in drug evaluation and approval, and making more innovative drugs of Novartis approved in the market of China at a faster pace so as to benefit Chinese patients sooner.

undefined

Entrusted by Gu Gang, Party committee secretary and director of Boao Lecheng Administration, Lv Xiaolei, a Party committee member and deputy director, and Peter Bootsma, the senior international affairs officer of Boao Lecheng Pilot Zone Administration attended the event and witnessed the signing of contracts, while Dan Brindle, the president of Novartis Group (China) and Wang Xingli, the person in charge of Novartis Global Drug Development (China), etc. attended and witnessed the signing ceremony.

The cooperation between Novartis and Lecheng Pilot Zone could trace back to August 2018. When the Lecheng Pilot Zone was established, it had taken the initiative nationwide to introduce the strategic product of Novartis, Secukinumab Injection, to benefit Chinese patients.

undefined

On November 6, 2020, Novartis and Lecheng Pilot Zone Administration signed a memorandum of strategic cooperation

During China International Import Expo last year, Novartis and Lecheng Administration signed a memorandum of strategic cooperation, with an aim to introduce the innovative products and solutions of Novartis into the platform of Lecheng Pilot Zone at a faster speed and allow more Chinese patients to enjoy the world’s most advanced treatment without going to a foreign land. This year, three major innovative drugs of Novartis were piloted and experimented at Lecheng Pilot Zone, allowing Chinese patients to enjoy the world’s advanced treatment and speeding up the marketing of Novartis innovative products in China. Besides, the new products in the 2021 edition of Lecheng Global Special Drugs Insurance cover 100 special drugs. Of the 75 overseas special drugs, 8 special innovative drugs of Novartis were selected, making it ranked top among the involved enterprises.

The signing of the cooperation agreement at the China International Import Expo represented deeper and more comprehensive strategic cooperation between Novartis and Lecheng Administration on the basis of their cooperation in previous years. Both sides will promote the clinical application of Novartis innovative products and cooperate in real-world studies based on the application of products at Lecheng Pilot Zone, so as to promote the innovative researches, talent cultivation, discipline construction and international exchanges and cooperation, strengthen platform optimization and management for real-world studies, turn high-quality real-world data into real-world evidences, provide reliable data support for introducing advanced medical technologies into China sooner and gather strength for the realization of “Healthy China 2030”.

undefined

Lv Xiaolei, deputy director of Boao Lecheng Administration, said, “In today’s Import Expo, the cooperation between Lecheng and Novartis has reached a new level and expanded to more fields, from the accessibility of drugs to the affordability of drugs for patients. Novartis is also the enterprise that provides the most drug support in the catalogue of Lecheng special drugs insurance. The development strategy of Novartis is quite consistent with the philosophy of Lecheng. Lecheng Pilot Zone is committed to building a medical ecological platform so that international innovative medical product producers, medical institutions, expert teams and every market entity on the industrial chain can share the resources on the platform and promote the fulfillment of innovation schemes. Lecheng Administration will serve to help the medical product producers to promote the fulfillment of innovation schemes and make the medical innovation achievements benefit more patients.”

Lecheng Pilot Zone is currently a national test field for the application of real-world data, with the pioneering policy advantages such as double “Nine Policies of the Nation”. With the implementation of several major policies, Lecheng Pilot Zone will become a new highland of medical innovation practice. “We will step up our effort in promoting the construction of real-world data platforms and build Lecheng Pilot Zone into an international research platform of data and academic sharing. By combining real-world evidences and clinical trial evidences that have been completed abroad, we will create new channels for speeding up the marketing of international innovative drugs and medical devices in China, to deepen the reform of domestic approval system for medical products and let Chinese patients in urgent need of medical treatment use the innovative products sooner,” said Lv Xiaolei.

undefined

Dan Brindle, president of Novartis Group (China), said, “The strategic cooperation this time is 2.0 edition of the cooperation between Novartis and Lecheng Administration. Both sides will co-build advanced scientific research environment and platform through cooperation at different levels and in various fields, and promote the translational medicine and real-world studies in Boao. While better satisfying the demands of patients for drugs, we will boost talent cultivation and enhance our scientific research competence together. The signing of the memorandum is also another evidence of Novartis seeking active cooperation and promoting innovation with each party in the medical ecosphere of China.”

It’s reported that the cooperation between Lecheng Administration and Novartis this time covers fields such as innovation pattern exploration, international exchange promotion and scientific research competence co-building.

About Novartis

Novartis has maintained a relationship with China for over 135 years. The company’s Chinese name means “commitment to China”, that is, it will constantly improve Chinese people’s health and living quality with innovative products and services. Since 1987, Novartis has gained approval for over 80 innovative drugs in China. Its business in China includes Novartis Pharmaceutical (China), Novartis Tumors (China) and Sandoz China, with two major production bases in Beijing and Guangdong and R&D institutions in Beijing, Shanghai and Jiangsu. Novartis has about 9,000 employees in China.