- LAE118 is a novel allosteric inhibitor which demonstrated excellent potency and selectivity against various PI3Kα pan-mutant, with best-in-class potential

- Building on its proven track record in successfully developing and out-licensing LAE002 (afuresertib), Laekna is actively advancing LAE118 to clinical studies

Jan 14, 2026 — Laekna, Inc. (2105.HK) today announced that the U.S. Food and Drug Administration （FDA）has accepted its Investigational New Drug application for LAE118, a novel PI3Kα pan-mutant selective inhibitor for the treatment of patients with PIK3CA-mutant solid tumors.

PI3Kα mutations are common in multiple cancers including breast, colorectal, lung, endometrial. However, the currently approved PI3Kα inhibitors non-selectively target both wild-type and mutant PI3Kα, which leads to significant tolerability issues and high risk of resistance development.

Dr. Justin Gu, Chief Scientific Officer of Laekna, said: “LAE118 is an our internally discovered drug candidate for treatment of cancer and is advancing to clinical stage of development. LAE118 is a novel allosteric inhibitor that demonstrates excellent potency and selectivity against a board range of PI3Kα mutants. It has shown superior efficacy and a more favorable safety profile in the preclinical studies which demonstrated its best-in-class potential. The preclinical data of LAE118 were presented at the San Antonio Breast Cancer Symposium in December 2024”.

Mr. Keith Chau, Chief Financial Officer of Laekna, said: “We have completed patient enrollment in the phase III clinical trial AFFIRM-205 for LAE002 (afuresertib, an oral AKT inhibitor) in December 2025 and target to readout the topline data in the first half of 2026, followed by submission of NDA to CDE later in the year. The Group also entered into an exclusive licensing agreement with Qilu Pharma to accelerate the commercialization for LAE002 (afuresertib). Building on our proven track record in successfully developing and out-licensing LAE002 (afuresertib), we are actively advancing LAE118 to clinical studies and aim to bring this precision therapy to patients who are in need of novel treatment options”.

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Contact Us

IR  ir@laekna.com

Corporate and Business Development  BD@laekna.com

About LAE118

LAE118 is a novel PI3Kα pan-mutant selective inhibitor. The company is actively advancing this drug candidate to clinical studies as novel therapies for PIK3CA-mutant solid tumors.

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/

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.