Novartis Accelerates Innovation in China Amid Regulatory Reforms and R&D Breakthroughs

“Benefiting from China’s drug review and approval system reforms, Novartis had 24 new drug applications approved in China over the past two years, including nine new molecular entities. Between 2019 and 2023, Novartis expects to submit 50 new drug applications,” said Cai Zhenghua, Global Head of Drug Development and Chief Medical Officer at Novartis, in a recent interview with reporters in Shanghai.

In recent years, the field of life sciences has witnessed a series of breakthrough advancements globally. China is deepening reforms in its drug review and approval system, while Shanghai is striving to become a global hub for the biopharmaceutical industry. The advancement of pharmaceutical innovation not only facilitates the transition of growth drivers but also enhances the health and well-being of the general population.

“The reform of China’s drug review and approval system is highly significant, with one of its key manifestations being the acceleration of regulatory processes. For instance, the time required for clinical trial applications for drugs, which previously could take up to three years, has now been shortened to three months. This pace aligns with that of other major global markets, meaning that drug development in China is poised to keep step with global advancements,” said Cai Zhenghua. In response to diseases with high prevalence in China, such as liver cancer, gastric cancer, and nasopharyngeal carcinoma, Novartis is actively exploring new treatment options.

As a multinational pharmaceutical company deeply rooted in China, Novartis established its R&D center in China as early as 2006, creating an “end-to-end” R&D system that encompasses the entire architecture and model from early-stage drug research and translational medicine to drug development and even overall commercial operations. Currently, Novartis’ R&D center in Shanghai has 15 projects under development, primarily focusing on liver diseases and cancer, with early-stage R&D conducted in China.

Currently, a challenge facing new drug development is the escalating cost of research and development. A series of cutting-edge technologies in the digital domain, such as big data and artificial intelligence, hold promise for reducing these costs and transforming the pathways and landscape of pharmaceutical innovation. Many Chinese pharmaceutical companies are embracing digital technologies to accelerate the pace of new drug development.

“By 2018, Novartis had accumulated clinical data equivalent to that of 2 million patients. In-depth mining of these data can guide our clinical research and future R&D directions, thereby enabling more targeted screening of molecules and drugs effective against diseases,” said Cai Zhenghua.

In Cai Zhenghua’s view, drug development requires a long-term understanding of a disease, with a cycle that typically spans 10–12 years and cannot be rushed within just one or two years. Novartis China currently has approximately 700 scientists and looks forward to welcoming more outstanding researchers in the future, aiming to develop as many new medicines as possible to benefit a broad patient population.