Lai Kai Pharmaceutical-B announced that LAE002's new drug marketing application has been accepted by the Drug Evaluation Center of the China National Drug Administration for the treatment of patients with HR+/HER2-locally advanced or metastatic breast cancer with changes in PIK3CA/AKT1/PTEN after previous endocrine treatment. The application is based on the positive results of the phase III clinical trial, AFFIRM-205, which reached the primary end of progression-free survival. The company signed an exclusive license agreement with Qilu Pharmaceutical in November 2025, and is eligible to receive a total down payment and milestone payment of up to RMB 2,045 billion.

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