Latest from Xu Hu
After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.
Chinese biopharma companies’ alliance strategies are transitioning from immediate cash needs to more strategic management of portfolios, as MNCs continue to hunt for derisked assets.
A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.
The main 2025 policy priorities for China's government as outlined in an annual report will include the strengthening of commercial insurance for innovative drugs and opening up cell and gene therapy and the hospital sector to foreign investment.
Multiple Chinese companies are progressing targeted protein degraders, with oncology the dominant indication and two assets already in Phase III for breast cancer.
Finding a balance between out-licensing, refocusing on internal strengths and addressing unmet needs were identified at a recent Shanghai conference as some of the key strategies for Chinese biopharma firms looking to truly globalize.