On November 12, 2025, Laekna, Inc. (2105.HK) and Qilu Pharmaceutical Company Limited (Qilu Pharma) entered into an exclusive licensing agreement to accelerate the commercialization of LAE002 (afuresertib) for the treatment of breast cancer in China.
This collaboration represents a significant commercial milestone in the development of Laekna. Under the License Agreement, Laekna is eligible to receive non-refundable upfront and clinical development milestone payments up to RMB530 million upon NDA approval for the first indication in China and up to RMB2,045 million in total in upfront and milestone payments. Laekna is also entitled to receive tiered royalties on future net sales in the licensed territory, at percentages ranging from the low teens to the low twenties.
LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 (afuresertib) in patients with HR+/HER2- breast cancer. Study recruitment is on track and Laekna is responsible for completing this Phase III clinical trial (AFFIRM-205). The company targets to complete subject enrollment in the fourth quarter of 2025 and to submit NDA to CDE in 2026.
Breast cancer has now become the leading cause of death among women worldwide, estimated number of new cases every year reaches 2.29 million with 666,000 deaths. In China, breast cancer ranks the second most common cancer among women, with approximately 72% of the patients found to be HR+/HER2- (hormone receptor-positive/HER2-negative). Although most of patients with this subtype of breast cancer can initially benefit from first/second-line treatment by endocrine therapy + CDK4/6 inhibitors and/or chemotherapy, they may gradually develop drug resistance and result in treatment failure. Novel therapeutic options are urgently needed for patients after drug resistance. As a new treatment for drug-resistant patients with this subtype of breast cancer, AKT inhibitors offer new hope for them and their families.
Fangda Partners provided comprehensive legal services to Laekna in this transaction, including the design of the transaction structure and the drafting, negotiation, and revision of transaction documents. The Fangda team was led by partners Josh SHIN and Henry HE. Team members included Audrey LUO and Ethel WANG. The team’s efficient collaboration ensured the smooth progress of the transaction and provided effective legal support.
