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The EU's Key Medicines Act has entered the implementation phase, requiring the establishment of minimum inventories for key medicines and an increase in the local production ratio of active pharmaceutical ingredients (APIs). The United States continues to support domestic biomanufacturing through tools such as the Defense Production Act.
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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.
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The application of AI in target discovery, molecular generation, and clinical trial design is transitioning from experimentation to scale, exemplified by collaborations such as the NVIDIA/Lilly AI drug discovery alliance and the commercialization of Google DeepMind's AlphaFold 3. The market anticipates that the first new drugs fully designed and optimized by AI will enter critical clinical stages within the next 2-3 years.

