- The company has established a comprehensive ActRII portfolio and is in discussions with potential partners for strategic cooperations to accelerate development and commercialization of the ActRII portfolio

- First-in-human study of LAE102(ActRIIA mAb) demonstrated encouraging safety and efficacy profile, preliminary results of Phase I MAD study in China and U.S. Phase 1 clinical trial expected in H2 2025

- To complete subject enrollment of Phase III clinical trial in breast cancer for LAE002(afuresertib) in Q4 2025, NDA submission to CDE expected in H1 2026 

Aug 14, 2025 — Laekna, Inc. (2105.HK), a clinical-stage biotechnology company, announced the unaudited condensed consolidated interim results for the six months ended June 30, 2025, highlighting its significant progress in the research and development of metabolic diseases and cancer assets, as well as its global collaborations with strategic partners.

“At the 85th scientific sessions of the American Diabetes Association (ADA), the Phase II clinical data of Bimagrumab and the preclinical study results of our ActRII portfolio strongly validated the druggability of the ActRII pathway in muscle regeneration and fat mass reduction”, said Dr. Chris Lu, Chairman and CEO of Laekna. “In the second half of 2025, the anticipated data readout of Phase I MAD study in China and U.S. Phase I clinical trial of LAE102 (ActRIIA monoclonal antibody), combined with the initiation of human study for LAE103 (ActRIIB monoclonal antibody), we expect to achieve more validations of the individual and synergistic mechanisms of action of these two receptor subtypes (ActRIIA/B). This represents a key focus area for the entire industry, particularly among global leaders in the weight-loss therapeutics area.”

Dr. Chris Lu  further highlighted the potential of Laekna’s oncology assets: “We target to complete subject enrollment of our Phase III clinical trial of LAE002 (afuresertib) for breast cancer in Q4 2025. This poises LAE002 (afuresertib) to be the first domestically developed AKT inhibitor in China. We are fully committed to accelerating the NDA submission and commercialization of LAE002(afuresertib) to bring this precision therapy to patients who are in need of novel treatment options.”

He emphasized that, during the first half of 2025, a remarkable new wave of upswing is upfolding in China’s innovative pharmaceutical sector, and Laekna will actively engage in the global wave of innovation with ambition, resilience, and solid execution to further demonstrate our value.

Metabolic diseases: established a comprehensive ActRII portfolio, LAE102 in-human study demonstrated encouraging safety and efficacy profile 

Blocking Activin-ActRII pathway could promote muscle regeneration and fat mass reduction. This positions LAE102, our internally discovered monoclonal antibody against ActRIIA, as a promising drug candidate for achieving muscle preserving weight control.

In addition to LAE102, LAE103 is an 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. The pre-clinical study results of our ActRII portfolio were presented at the 85th scientific sessions of ADA. The findings indicate that ActRIIA is a major regulator of muscle growth and fat loss. The company is in discussions with potential partners for strategic cooperations to accelerate development and commercialization of the ActRII portfolio.

• LAE102(ActRIIA monoclonal antibody) in Obesity, Phase I, China and U.S.

By the end of December 2024, Laekna successfully completed the single ascending dose part of the Phase I clinical study (SAD Study) of LAE102 in China for the treatment of obesity. The first-in-human study results presented at the 85th scientific sessions of the ADA in June 2025 demonstrated that LAE102 has a favorable safety profile as well as robust and prolonged target engagement in both IV and SC injection groups.

The first subject of the Phase I multiple ascending dose study (MAD Study) of LAE102 in China was enrolled and dosed at the end of March 2025.

In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company. Lilly would be responsible for the execution and funding of a Phase I study in the U.S. Laekna retains global rights for LAE102. The first subject of the Phase I trial in the U.S was dosed in May 2025.

• LAE103 (an ActRIIB-selective antibody)

Laekna obtained IND approval for LAE103 from FDA in July 2025. We target to initiate phase I clinical studies of LAE103 in the second half of 2025.

• LAE123 (an ActRIIA/IIB dual antagonistic monoclonal antibody)

LAE123 is currently at IND-enabling stage. We target to advance it to phase I clinical studies in 2026.

Cancer: study recruitment on track, potential first commercial launch ahead

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

Laekna commenced the Phase III clinical trial AFFIRM-205 in China for LAE002 plus fulvestrant in patients with PIK3CA/AKT1/PTEN alterations and HR+/HER2- locally advanced or metastatic breast cancer (LA/mBC) in May 2024. Study recruitment is on track. We target to complete subject enrollment in the fourth quarter of 2025 and to submit new drug application to CDE in the first half of 2026.

Laekna is in discussions with potential partners for strategic cooperations to accelerate regulatory approval and commercialization of LAE002 (afuresertib).

 Pre-clinical candidates (PCC): fully demonstrated our innovation capabilities 

In addition to our ActRII portfolio progress, we’ve also made achievements with the following oncology assets:

LAE120(an USP1 inhibitor): received SMP (Study May Proceed) from FDA in February 2025

LAE118(a PI3Kαmutant-selective inhibitor): advanced to IND-enabling study in 2024

LAE122(a WRN mutant-selective inhibitor): PCC declaration completed in March 2025

Expected upcoming milestones in second half of 2025

• About LAE102

Preliminary results of Phase I MAD Study in China

Preliminary results of U.S. Phase 1 Clinical Trial

• About AFFIRM-205

To complete subject enrollment of AFFIRM-205 Phase III China trial

• Other Targeting ActRII Receptors

To initiate phase I clinical study of LAE103

Solid financial positions

Laekna adopts a prudent funding and treasury policy to maintain an optimal financial position.

As of June 30, 2025, our cash and bank balances (including cash and cash equivalents and time deposits) were RMB743.8 million.

–  End –

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/

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.