Laekna Therapeutics grants Qilu Pharma exclusive license for LAE002 (afuresertib) in Greater China

On November 12, 2025, Laekna Therapeutics (02105.HK) announced that the company entered into an exclusive licensing agreement with Qilu Pharmaceutical. Under the agreement, Qilu Pharma has obtained exclusive rights to research, develop, and commercialize LAE002 (afuresertib) in Greater China, including China's mainland, Hong Kong SAR, Macau SAR, and Taiwan. Laekna will remain responsible for completing the Phase III clinical trial (AFFIRM-205) for HR+/HER2- breast cancer.

In return, Laekna is eligible to receive up to RMB 530 million in non-refundable payments, comprising an upfront payment and clinical development milestones tied to progress prior to the first NDA approval in China. Based on the licensing agreement, Laekna is eligible to receive total potential payments of up to RMB 2.045 billion, which include the aforementioned upfront and clinical milestones, plus additional regulatory and commercial milestone payments. Additionally, Laekna is entitled to receive tiered royalties on future net sales of LAE002 (afuresertib) in the licensed territory, with royalty rates ranging from the low teens to the low-twenty percent range.

LAE002 (afuresertib) is a potent AKT inhibitor that simultaneously targets all three AKT isoforms (AKT1, AKT2, and AKT3). It is one of only two AKT inhibitors globally in Phase III development for breast and prostate cancers. Laekna has initiated a Phase III clinical trial (AFFIRM-205) of LAE002 in patients with HR+/HER2- breast cancer, and patient recruitment is currently progressing as planned. The company remains responsible for the completion of this Phase III trial. Laekna aims to complete patient enrollment by the fourth quarter of 2025 and plans to submit a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in 2026.

The Board of Laekna considers that entering into this licensing agreement aligns with the overall best interests of the Company and its shareholders. This partnership enables the Group to accelerate the regulatory approval and commercialization of LAE002 (afuresertib) in the licensed territory, thereby maximizing its commercial value. The aforementioned upfront and milestone payments will strengthen the Group's financial position to support its future development.

Laekna is actively engaged in discussions with multiple potential partners and plans to establish strategic collaborations to accelerate the clinical development and commercialization of its pipeline assets. The Group's robust financial standing allows it to maintain selectivity when evaluating potential partnership structures, ensuring alignment of interests among all parties and maximizing the global potential of its assets.