Policy and Capital Fuel Accelerated Breakthrough in China’s Innovative Drug Industry
Bolstered by dual drivers of policy support and capital influx, China’s innovative drug industry is rapidly advancing towards a golden era of high-quality development.
Innovative Drug Policy Support: Faster Clinical Trial Approval and Improved Payment Systems
The Comprehensive Department of the National Medical Products Administration (NMPA) has released a draft announcement.
Aimed at optimizing the clinical trial review and approval process for innovative drugs, introducing a “30-day rapid approval channel” to support clinical value-oriented drug R&D further.
- The draft policy prioritizes drugs of national strategic importance and encourages global synchronous early-stage development and international multi-center clinical trials.
- And it supports clinically urgent traditional Chinese medicines, chemical drugs, and Class 1 biological products.
- Eligible drugs can enter this special review pathway, cutting the timeline from 60 to 30 working days.
Support on the payment side is also intensifying.
Beyond the annual National Reimbursement Drug List (NRDL) negotiation, China will establish a commercial health insurance innovative drug directory to support broader market access for innovative drugs.
Capital Market: STAR Market Reforms Unblock Funding Bottlenecks
On June 18, the China Securities Regulatory Commission (CSRC) issued an opinion on enhancing the Sci-Tech Innovation Board (STAR Market).
Allowing companies that have yet to generate profits to restart listing applications under the fifth set of standards.
The biopharmaceutical sector has been a major beneficiary of this standard, with 20 companies previously listing via this route.
However, IPO processes stalled recently due to market adjustments.
“The restart of the fifth set of standards will open capital market channels for more companies in the critical R&D phase,” stated HKdengyuemed, noting it provides crucial support to break through the “pre-clinical funding bottleneck.”
Industry Achievements: From “Running Alongside” to “Taking the Lead”
From 2015 to 2024, the number of innovative drugs developed by Chinese companies grew explosively, reaching 3,575 active drugs by the end of 2024, ranking first globally.
China-originated drugs like Ivonescimab and Zanubrutinib have demonstrated superior efficacy in head-to-head trials against foreign-developed counterparts.
In 2024, Chinese pharma companies secured over 90 overseas licensing deals totaling over $50 billion. This progress has benefited patients, raising the five-year cancer survival rate from 33.3% to 43.7%.
Dengyue Pharma believes the next 3-5 years will be a critical window for China’s innovative drug sector to transition from “running alongside” to “taking the lead.”
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