Novartis and Boao Reaffirm Collaboration to Advance Real-World Data Research, Drive Innovative Studies and Talent Development

SHANGHAI, Nov. 6, 2021 /PRNewswire/ -- At the 4th China International Import Expo, Novartis and the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration (hereinafter referred to as the "Boao Lecheng Administration") once again signed a strategic cooperation memorandum of understanding, aiming to initiate new cooperation and practices in the fields of translational medicine and real-world research. This collaboration will facilitate talent development and international exchanges, leverage real-world evidence to gather data on drug efficacy and safety, and thereby assist regulatory authorities in their decision-making for drug review and approval. These efforts will accelerate the approval and market launch of more Novartis innovative drugs in China, benefiting Chinese patients at the earliest possible opportunity. Lü Xiaolei, Deputy Director of the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration, Peter Bootsma, Senior International Affairs Officer of the Boao Lecheng Administration, and Bednian, President of Novartis China (Dan Brindle), Wang Xingli, Head of Novartis Global Drug Development (China), and other leaders from both sides attended and witnessed the signing ceremony.

Group Photo at the Signing Ceremony

The collaboration between Novartis and the Boao Lecheng Pilot Zone can be traced back to August 2018, when, upon its establishment, the Zone pioneered the introduction of Novartis’ strategic product, secukinumab, in China, enabling early access for patients in China.

During last year's China International Import Expo (CIIE), Novartis signed a strategic memorandum of understanding with the Boao Lecheng Administrative Bureau, aiming to accelerate the introduction of Novartis's portfolio of innovative products and solutions into the Lecheng Pilot Zone platform. This enables more Chinese patients to access the world's most advanced therapies domestically without traveling abroad. This year witnessed the pilot implementation of three of Novartis's blockbuster innovative medicines in the Lecheng Pilot Zone, which not only makes it possible for Chinese patients to access internationally advanced treatment regimens at the earliest opportunity, but also accelerates the market launch of Novartis's innovative products in China. Furthermore, the newly launched 2021 edition of the Lecheng Global Specialty Drug Insurance covers 100 specialty drugs. Among the 75 overseas specialty drugs included, eight innovative specialty drugs from Novartis were selected, ranking first among all participating companies in terms of product count.

The signing of the cooperation agreement at this China International Import Expo (CIIE) signifies that Novartis and the Boao Lecheng Administration will deepen and expand their strategic partnership, building upon collaborations from previous years. Both parties will jointly promote the clinical application of Novartis’s cutting-edge products. Based on the implementation of these products within the Pilot Zone, they will collaborate on clinical real-world data studies to foster innovative research and talent development, advance medical discipline construction and international exchange, and strengthen the optimization and management of real-world research platforms. This will facilitate the conversion of high-quality real-world data into real-world evidence, providing robust and reliable data support for the accelerated introduction of advanced medical technologies into China, ultimately contributing to the realization of the "Healthy China" initiative.

Remarks by Lyu Xiaolei, Deputy Director of the Boao Lecheng International Medical Tourism Pilot Zone Administration

Lü Xiaolei, Deputy Director of the Administrative Bureau of Boao Lecheng International Medical Tourism Pilot Zone, introduced that the Lecheng Pilot Zone is currently a pioneering testing ground in China for the clinical application of real-world data, enjoying policy advantages for pilot initiatives such as the dual “National Nine-Point Policies.” With the implementation of multiple landmark policies, the Boao Lecheng Pilot Zone will emerge as a new highland for medical innovation practices. “We will intensify efforts to advance the construction of a real-world data platform, transforming the Lecheng Pilot Zone into an international research platform for data and academic sharing. By integrating real-world evidence with clinical trial evidence completed overseas, we will establish a new fast-track channel for the domestic market launch of internationally innovative drugs and medical devices. This will further facilitate the deepening of reforms in China’s review and approval system, enabling patients in urgent need of treatment to access innovative products sooner and truly benefiting patients in China.”

Address by Bedan, President of Novartis Group (China)

Novartis Group (China) President Bert Bodmer (Dan Brindle) stated: "This strategic partnership represents version 2.0 of the collaboration between Novartis and the Boao Lecheng Administration. Through multi-level and multi-sector cooperation, both parties will jointly establish an advanced scientific research environment and platform, promote the advancement of translational medicine and real-world studies in Boao, better meet patients' medication needs while facilitating talent development, and jointly enhance research capabilities. The signing of this memorandum also stands as another testament to Novartis's proactive collaboration with diverse stakeholders across China's pharmaceutical ecosystem to jointly drive innovation."

The key areas of collaboration between Novartis and the Boao Lecheng Administrative Bureau include:

# Exploration of Innovative Models

Novartis will fully support real-world data studies for international innovative products in Boao. Through clinical research and scientific collaboration, it will drive the integration of "industry, academia, and research," providing a reference model for the collection, governance, and application of real-world data, thereby enabling platform optimization and management for real-world studies.

Facilitate International Exchange

Novartis will actively support the Hainan Annual Conference on Real-World Data Research. Through academic exchanges and expert symposia involving professionals both in China and internationally, it will promote the sharing of diagnostic and therapeutic expertise in the management of major diseases—including oncology, cardiovascular diseases, ophthalmology, hematology, transplantation, and rare diseases—thereby helping Hainan become a "world-leading practice base" for real-world research.

Joint Development of Research Capabilities

Novartis will strengthen collaboration and exchanges with renowned medical experts in China and specialists in real-world data (RWD) applications. Through initiatives including a series of lectures and training programs, practical training for master's and doctoral students, and support for the establishment of a dedicated journal on real-world research in Hainan, Novartis will foster talent development in related fields and develop the Lecheng Pilot Zone into a leading domestic and internationally influential research and practical training base for real-world data.

On Real-World Research

Real-world study refers to a research process that addresses clinical research questions by collecting, in a real-world setting, data related to the health status and/or diagnosis, treatment, and healthcare of study subjects (Real World Data, RWD) or aggregated data derived therefrom, and through analysis, generates clinical evidence regarding the value in use and potential benefit-risk profile of a drug (Real World Evidence, RWE).