New Developments in Global Regulation and Geopolitics
1. Europe and the U.S. Strengthen Supply Chain "De-risking"
The EU's Critical Medicines Act has entered the implementation phase, requiring minimum stockpiles of critical medicines and increasing the proportion of active pharmaceutical ingredient (API) production locally. The U.S. continues to support domestic biomanufacturing through tools like the Defense Production Act.
2. FDA Accelerates Approvals and Adopts Real-World Evidence
The FDA has issued further guidance on the approval pathways for AI-driven medical products. The use of real-world data (RWD) to support regulatory decisions—particularly for supplementing clinical trials or supporting expanded indications—has become a routine practice.
3. The GLP-1 Storm Sweeps the Globe, Fueling Derivative R&D
GLP-1 drugs from Novo Nordisk and Lilly continue to release data on weight loss and cardiovascular/renal benefits, driving sustained market expansion. The entire industry is engaged in fierce competition around GLP-1 combination therapies (with other metabolic drugs), oral formulations, and managing side effects such as muscle loss.
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22-24th.April.2025 -
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In vivo gene editing therapies from companies like Intellia/Regeneron and Verve Therapeutics (targeting conditions such as ATTR amyloidosis and hypercholesterolemia) have released longer-term positive data, validating the safety and efficacy of the technology and offering hope for "one-time cures" for common diseases. Related therapies from domestic companies like Boya Jiyin have also entered Phase II clinical trials.
