Exclusive Summary

• - Best-in-Class Efficacy: A next-generation CDK2/4/6 inhibitor demonstrating a stellar 16.62-month mPFS (HR 0.36) in Phase III trials for ET-treated HR+/HER2- mBC, strictly outperforming marketed historical counterparts in ORR.
• - Conquers CDK4/6i Resistance: Strong concurrent inhibition of CDK2 directly addresses and overcomes both primary and acquired resistance to approved CDK4/6 inhibitors (e.g., Palbociclib) in validated models.
• - Unmatched Safety & Tolerability: Solves the class-wide toxicity bottleneck with a drastically lower Grade $\ge$ 3 neutropenia rate of 24.7% (vs. >60% for most peers) and a remarkable 0% AE-related discontinuation rate in Phase III.
• - Global Commercial Readiness: NDA currently under review by NMPA, fortified by robust Composition of Matter patents granted across major global markets (US, EU, JP, etc.) valid through 2036+.