Qilu Pharmaceutical Inks $2.9 Billion Deal to Acquire Exclusive Rights to LAE002 (Afuresertib), a Potent AKT Inhibitor from Laekna Therapeutics

On November 12, Laekna Therapeutics announced that it had entered into an exclusive licensing agreement with Qilu Pharmaceutical.

Under the terms and conditions of the license agreement, Qilu Pharmaceutical has been granted an exclusive license to research, develop, and commercialize LAE002 (afuresertib) in the China region (including mainland China, the Hong Kong Special Administrative Region, the Macao Special Administrative Region, and the Taiwan region). Laekna Therapeutics will be responsible for completing the Phase III clinical trial (AFFIRM-205) for HR+/HER2- breast cancer.

In return, until the first indication receives new drug application approval in China, Laekna Therapeutics is entitled to receive up to a total of RMBRMB 530 million in non-refundable upfront and clinical development milestone payments、An upfront payment and milestone payments totaling up to RMB 2.045 billionEntitled to receive tiered sales royalties on future net sales of LAE002 (afuresertib) in the licensed territory, with royalty rates ranging from over ten percentage points to over twenty percentage points.

LAE002 (afuresertib) is a potent AKT inhibitor that can simultaneously inhibit all three AKT subtypes (AKT1, AKT2, and AKT3). It is also one of only two AKT inhibitors globally in late-stage clinical development for breast cancer and prostate cancer.

Laekna Therapeutics has initiated the Phase III clinical trial (AFFIRM-205) for LAE002 (afuresertib) in HR+/HER2- breast cancer. The trial recruitment is currently proceeding as planned. Laekna Therapeutics will be responsible for completing this Phase III clinical trial (AFFIRM-205), with plans to finish participant enrollment by the fourth quarter of 2025 and submit a new drug application to the Center for Drug Evaluation of the National Medical Products Administration in China by 2026.

The Board believes that entering into the licensing agreement is in the overall best interests of the Company and its shareholders. The Group can leverage this opportunity to accelerate the regulatory approval and commercialization process of LAE002 (afuresertib) within the licensed territory, and maximize its commercial value. The upfront payment and milestone payments mentioned above will strengthen the Group's financial position to support future development.

Currently, the Group is actively in discussions with multiple potential partners, planning to accelerate the clinical development and commercialization of candidate drug assets through the establishment of strategic partnerships. The Group maintains a robust financial position, allowing it to be selective in evaluating potential collaboration structures, ensuring alignment of interests to maximize the global potential of the Group's assets.

       Title: Heavyweight! Qilu Pharmaceutical Spends 2.045 Billion Yuan to Acquire Laekna Therapeutics' AKT Inhibitor LAE002