- Topline results from Phase I studies of LAE102 (ActRIIA monoclonal antibody) in the U.S. and China demonstrated encouraging, dose-dependent trends in lean mass increase and fat mass reduction, as well as a well-tolerated safety profile

- Completed subject enrollment of the Phase III clinical trial of LAE002 (afuresertib) in breast cancer, targeting NDA submission in 2026. Entered into an exclusive licensing agreement with Qilu Pharma to accelerate the commercialization of LAE002 (afuresertib)

- Achieved first commercial revenue in 2025, marking a significant milestone in its transition to the commercial stage with a robust pipeline of internally discovered innovative drug candidates

Mar 19, 2026 — Laekna (2105.HK) announced the consolidated annual results for the year ended December 31, 2025. The company has achieved significant progress with respect to internal discovery, clinical development, commercialization and global collaboration.  

“In 2025, Laekna continued to accelerate its development upon a solid foundation, achieving a remarkable transition from a clinical-stage to a commercial-stage company,” said Dr. Chris Lu, Chairman & CEO of Laekna. He stated: “In oncology, our lead breast cancer drug candidate LAE002 (afuresertib) is poised for launch. Laekna has entered into an exclusive licensing agreement with Qilu Pharma to accelerate commercialization and expand patient access. In metabolic diseases, building on our deep expertise and extensive know-how in the ActRII pathway, we have established a globally competitive, differentiated portfolio that includes LAE102, LAE103, and LAE123, to develop next‑generation, high-quality weight management therapies. Together with Eli Lilly and other partners, Laekna is accelerating the global development of  its robust pipeline”.

Dr. Lu emphasized that Laekna achieved its first commercial revenue in 2025, with a robust pipeline of internally discovered innovative drug candidates. “We strive to continuously push the boundaries of novel drugs, enhance public access to medicines, actively embrace globalization, and create sustainable economic and social value”.

Key clinical progress

Metabolic diseases

• LAE102 (ActRIIA monoclonal antibody) in Obesity, Phase I 

- SAD study in China: Positive topline results announced in January 2025

First-in-Human study results presented at ADA in June 2025

- China MAD study: commenced by the end of March 2025

The preliminary results demonstrated encouraging trends toward increased lean body mass and reduced fat mass.

At week 5, the LAE102 6 mg/kg group exhibited a 1.7% increase in mean lean body mass and a 2.2% reduction in mean fat mass compared to the baseline. Adjusted from the placebo control group, the mean lean body mass is increased by 4.6%, whereas the mean fat mass is reduced by 3.6%. Consistent with the prior Phase I SAD Study of LAE102, the MAD Study demonstrated a well-tolerated safety profile.

Multiple Dose Expansion Study: completed subject enrollment in January 2026. This pre-planned study is designed to further evaluate the efficacy and safety profile of LAE102 over a longer treatment duration (6 months).

- U.S. SAD Study (in collaboration with Eli Lilly and Company): In March 2026, the Group announced positive results of the U.S. SAD study. It showed encouraging trends in body composition improvements following administration of a single dose and further demonstrated a well-tolerated safety profile, with no serious adverse events reported. In Week 4 following a single dose of LAE102, the group with the highest exposure exhibited a 5.06% increase in mean lean body mass from baseline (placebo group has 1.34% reduction from baseline) and a 0.12% decrease in mean fat mass from baseline (placebo group has 2.11% increase from baseline).

• LAE103 (ActRIIB monoclonal antibody) in Obesity, Phase I  

- Obtained IND approval from the U.S. FDA in July 2025

- Initiated the Phase I SAD Study of LAE103 in Australia and dosed the first subject in December 2025

Oncology

• LAE002 (afuresertib, a potent AKT inhibitor) + Fulvestrant in HR+/HER2- breast cancer, Phase III China

- Completed subject enrollment of Phase III clinical trial in December 2025

- In February 2026, an article titled “Afuresertib plus fulvestrant for pretreated HR-positive, HER2-negative, advanced breast cancer: a phase Ib trial” was published in Nature Communications, a leading international scientific journal. The findings indicate that this combination regimen demonstrates promising anti-tumor activity and a well-tolerated safety profile in this patient population.

More internally discovered pre-clinical candidates

- LAE123（ActRIIA/IIB dual antagonistic monoclonal antibody）:

- Advancing through IND-enabling studies, targeting IND submission in 2026

- LAE124 (a small molecule dual amylin and calcitonin receptor agonist): expected to complete PCC declaration in 2026

- LAE118 (a novel PI3Kα pan-mutant selective inhibitor): obtained IND approval from the U.S. FDA in February 2026 for treatment of patients with PIK3CA-mutant solid tumors. A poster showcasing LAE118 was presented at the AACR in April 2025.

- LAE120 (a USP1inhibitor): obtained IND approval from the U.S. FDA in February 2025

Progress of commercialization

Laekna and Qilu Pharma have entered into an exclusive licensing agreement, Qilu Pharma is granted an exclusive license for research, development, and commercialization of LAE002 (afuresertib) in the China region.

Under the license agreement, Laekna is entitled to receive non-refundable upfront and clinical development milestone payments up to RMB530 million upon new drug application approval for the first indication in China. Laekna is eligible to receive up to RMB 2,045 million in total in upfront and milestone payments and is also entitled to receive tiered royalties on future net sales of LAE002 (afuresertib) in the Licensed Territory, at percentages ranging from the low teens to the low twenties.

The Group can leverage this opportunity to accelerate the regulatory approval and commercialization of LAE002 (afuresertib) in the Licensed Territory and maximize its commercial value.

Expected Upcoming Milestones in 2026

• About LAE102

- Report results from the Phase I MAD Expansion Study in China

- Initiate a Phase II clinical study in combination with a GLP-1 receptor agonist

• About AFFIRM-205

- Report results from the Phase III China trial (AFFIRM-205)

- Submit NDA to CDE

• About Other Metabolic Disease Drug Candidates

Report results from Phase I SAD of LAE103

IND submission for LAE123

Complete PCC declaration for LAE124

Sounding financial positions

Laekna adopts a disciplined funding and treasury policy, aiming to maintain an optimal financial position.

As of December 31, 2025, cash and bank balances and time deposits balances were RMB1,262.4 million.

Laekna achieved its first commercial revenue in 2025, derived from the out-licensing transaction of LAE002 (afuresertib) pursuant to the License Agreement the Group entered into with Qilu Pharma.

–  End –

Contact Us

IR  ir@laekna.com

Corporate and Business Development  BD@laekna.com

About Laekna

HKEK Stock Code: 2105.HK

Patient needs in major disease areas—such as metabolic diseases, oncology, and liver fibrosis—remain the driving force behind our mission. Laekna, a science-driven biotechnology company, is committed to bringing novel therapeutics to patients around the world.

Leveraging our tremendous experience and extensive know-how in disease biology, we have built a pipeline of over 20 internally discovered innovative drug candidates with proprietary intellectual property rights. We keep expanding our global reach through strategic partnerships, fostering collaborative success across regions.

In oncology, we have completed subject enrollment for the Phase III clinical trial of LAE002 (afuresertib, an AKT inhibitor) for breast cancer (AFFIRM-205). We plan to submit NDA to the CDE in 2026, which will mark Laekna’s pivotal transition from clinical development to commercialization. Laekna has entered into an exclusive licensing agreement with Qilu Pharma to further accelerate the delivery of this novel therapeutic to patients across China.

In metabolic diseases, building on our deep expertise and extensive knowhow in the ActRII pathway, we have established a globally competitive, differentiated portfolio comprising LAE102, LAE103, and LAE123. We are rapidly advancing the clinical development of LAE102 in both China and the United States. In the U.S., Laekna has successfully completed the Phase I SAD study, in collaboration with Eli Lilly, to accelerate the global development of this high-quality weight management therapy.

From our laboratory in Zhangjiang Pharma Valley in Shanghai, to clinical trials conducted across China, the U.S., and Australia, our footprint spans the globe. Looking ahead, Laekna will continue to collaborate with international partners to accelerate delivery of novel therapeutics to patients worldwide.

For more information, please visit: https://www.laekna.com/  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.