China Sets Sights on at Least Five USD1 Billion Drugs by 2030 as Developers Look Beyond Out-Licensing
Wu Simin
DATE:  11 hours ago
/ SOURCE:  Yicai
China Sets Sights on at Least Five USD1 Billion Drugs by 2030 as Developers Look Beyond Out-Licensing China Sets Sights on at Least Five USD1 Billion Drugs by 2030 as Developers Look Beyond Out-Licensing

(Yicai) Sept. 21 -- China aims to develop at least five drugs with annual global sales exceeding USD1 billion each by 2030, as the country seeks to strengthen its pharmaceutical innovation capabilities and help domestic drugmakers expand globally beyond out-licensing deals.

By 2030, China-developed first-in-class (FIC) drugs, which use novel mechanisms to treat diseases, should account for more than 25 percent of the global total, while the country's innovative drug industry should grow at an average annual rate of at least 20 percent over the next five years, according to the recent blueprint jointly released by China's industry ministry and nine other government departments.

The plan also aims to increase the number of Chinese pharmaceutical companies with annual revenue exceeding CNY10 billion (USD1.5 billion) to 50.

However, achieving those ambitions will require Chinese drugmakers to rely less on out-licensing, where they hand overseas development and sales rights to foreign partners, and build their own global capabilities, according to industry experts.

To reach its targets, China will focus on major disease areas including cancer, autoimmune and metabolic diseases, cardiovascular conditions, and neurological disorders, according to the plan. It will step up the research and development, production, and application of innovative drugs and medical devices to foster more blockbuster products and drive industry growth.

The country also intends to accelerate the use of emerging technologies in medicine, including artificial intelligence and quantum computing in drug R&D, as well as gene editing, precision molecular delivery, cell programming and regulation, and next-generation brain-computer interfaces.

Innovation Gains Momentum

China's pharmaceutical innovation pipeline is already expanding.

The country has approved 59 innovative drugs and 51 innovative medical devices for sale so far this year, including 13 FIC drugs based on new mechanisms and targets, according to data released by the National Medical Products Administration last week.

Chinese innovative drugs are also reaching overseas markets at a faster pace. The total value of out-licensing deals involving Chinese drugs has exceeded USD120 billion so far this year, up 36 percent from a year earlier, with upfront payments surpassing USD10 billion, according to the NMPA.

But out-licensing also means sharing the potential returns from successful drugs with overseas partners. Li Yan, deputy department director at the Development Research Center of the State Council, told Yicai that Chinese pharmaceutical companies still rely heavily on out-licensing deals for overseas expansion and have relatively limited capabilities in independently conducting global multicenter clinical trials, securing overseas drug registrations, building commercialization channels, and developing international brands.

Many promising innovative drugmakers in the early stages of development are also constrained by the high cost of global clinical trials, complex international compliance requirements, and restrictions on cross-border capital flows, Li added.

Beyond Out-Licensing Deals

The new national plan seeks to help Chinese drugmakers overcome these barriers.

It calls for deeper participation in global pharmaceutical innovation through joint R&D and commercialization, while encouraging companies to conduct international multicenter clinical trials, seek overseas drug registrations, and expand their R&D centers, production bases, and sales networks abroad.

Xu Ming, director of the Department of Global Health at Peking University's School of Public Health, suggested that over the next five years, China should encourage its innovative drug industry to move beyond out-licensing toward deeper partnerships involving joint development, joint ventures, and other structures that allow companies to share risks and benefits.

Editors: Dou Shicong, Emmi Laine

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Keywords:   Blockbuster Drug,Innovative Drug,License-Out,China,first-in-class medicine,innovation,out-licensing,global expansion,biomedicine,drug development,R&D