LAEKNA-B Shares Surge Over 5% in Morning Session as LAE002 Phase III Trial Hits Primary Endpoint, NDA Submission Imminent

LAEKNA-B (02105) rose more than 5% in morning trading. As of the time of writing, the stock was up 5.14% to HK$14.32, with a turnover of HK$13.01 million. The catalyst for the move is the announcement on April 15 that the Phase III clinical trial of the company's core product, the AKT inhibitor LAE002 (Afuresertib), for the treatment of breast cancer has reached its primary endpoint. According to the company's plan, it will collaborate with its partner, Qilu Pharmaceutical, to submit a New Drug Application (NDA) to the National Medical Products Administration in the near future. Qilu Pharmaceutical also announced on April 30 that it will advance the domestic NDA for the drug. Under the previously established license agreement, Qilu Pharmaceutical has obtained exclusive rights for the clinical research, drug development, production, and commercialization of LAE002 in China. LaeKNA is responsible for completing the Phase III clinical trial for HR+/HER2- breast cancer (AFFIRM-205). In return, if LAE002 secures its first indication approval in China, LaeKNA is entitled to receive a non-refundable upfront payment of RMB 530 million and up to a total of RMB 2.045 billion in milestone payments.