- Qilu Pharma is granted an exclusive license for research, development, and commercialization of LAE002 (afuresertib) in China

- Laekna is entitled to receive non-refundable upfront and clinical development milestone payments up to RMB 530 million upon NDA approval for the first indication in China

- Under the License Agreement, Laekna is eligible to receive up to RMB 2,045 million in total in upfront and milestone payments, and tiered royalties on future net sales in the licensed territory, at percentages ranging from the low teens to the low twenties

- The Phase III clinical trial for LAE002 (afuresertib) in patients with HR+/HER2- breast cancer is targeted to complete subject enrollment in Q4 of 2025 and to submit NDA to CDE in 2026

Nov 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.

“This strategic partnership marks the beginning of our commercial journey. It paves a way for our drug candidates in the rich pipeline and ushers a new era in the company’s development.”, said Dr. Chris Lu, Chairman and CEO of Laekna. “Qilu Pharma is a leading player in the pharmaceutical industry of China, consistently ranking among the Top 3 Chinese pharmaceutical companies in terms of sales revenue. It has established an extensive sales network, a highly efficient supply chain and a proven track record of commercialization. By leveraging the strong commercialization capabilities of Qilu Pharma, we are confident that LAE002 (afuresertib) will achieve rapid and widespread adoption among target patients and physicians to maximize its market potential and values for both companies.” 

“The licensing transaction of LAE002 (afuresertib) demonstrated our capabilities to monetize our drug candidate assets through strategic partnership. We are in active discussions with multiple potential partners and intend to pursue strategic partnerships to accelerate clinical development and commercialization of our drug candidate assets in the pipeline. Maintaining solid financial positions allows us to be selective in evaluating potential partnership structures that align the interests of all parties to maximize the global value of our R&D platform.”, Dr. Lu added. “Our collaboration with Qilu Pharma represents a positive step in our "Global R&D, Regional Partnership" strategy which serves as an effective model for integrating innovative R&D with local expertise. We are actively engaging with potential partners globally and remain open to exploring various business opportunities for our pipeline assets. We believe that continuous enhancement of our R&D capabilities, combined with a robust external collaboration ecosystem, is essential to efficiently unlock the value of our pipeline and generate sustainable returns for our patients and shareholders.

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.

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Contact Us

IR  ir@laekna.com

Corporate and Business Development  BD@laekna.com

About Laekna

Stock Code: 2105.HK

Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapeutics to patients with metabolic diseases, cancer and liver fibrosis around the world.

As of June 30, 2025, Laekna has initiated seven clinical trials for LAE102, LAE002 (afuresertib) and other drug candidates to address unmet medical needs in obesity and cancers.

LAE102 is our internally discovered antibody against ActRIIA. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass, this positions LAE102 as a promising drug candidate for achieving quality weight control. We are advancing the Phase I clinical trials for obesity indication in both China and the U.S. In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company to support and accelerate global clinical development of LAE102 for the treatment of obesity.

In addition to LAE102, LAE103 is our internally discovered ActRIIB-selective antibody, LAE123 is an ActRIIA/IIB dual antagonistic monoclonal antibody. Laekna has established a comprehensive ActRII portfolio and is actively advancing these drug candidates to clinical studies as novel therapies for muscle and other disease indications.

In the cancer area, Laekna has built a comprehensive portfolio of drug candidates including LAE002(afuresertib), LAE001 and other clinical and pre-clinical drug candidates. 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 in patients with HR+/HER2- breast cancer and the study recruitment is on track.

Laekna, Inc. (2105.HK) was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023.

For more information, please visit: http://www.np3h179.cn/  or https://www.linkedin.com/company/74110713/

About Qilu Pharma 

Qilu Pharmaceutical is now one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures and distributes both Finished Dosage Forms (FDFs) and Active Pharmaceutical Ingredients (APIs). Qilu currently has 12 subsidiaries, 11 domestic manufacturing sites and over 36,000 employees worldwide. Qilu ranks among Top 3 in Chinese pharmaceutical industry in 2024. Dedicated to offering high-quality & trustworthy medicines to the world and improving people‘s well-being, Qilu is vigorously exporting its products to over 100 countries and regions around the world. To date, Qilu has launched over 300 products with over 55 products “First-to-Launch” in China. The company has also fostered a robust pipeline including over 200 generic products, over 20 biosimilars and over 80 innovative products. Qilu Pharmaceutical is subsidiary of Qilu Pharmaceutical Group Co., Ltd.

Forward-Looking Statements

This press release may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on Laekna’s current beliefs, assumptions and expectations, commonly identified by words such as "would", "may", "expects", "believes", "plans", "intends", "projects" and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law.