- Completed the SAD study of LAE102 in China for the treatment of obesity, will commence the MAD study in China and the Phase I study in the U.S soon

- Pursuing global collaboration, 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

- Expected to complete the subject enrollment of the Phase III Clinical Trial of LAE002(afuresertib) in breast cancer in Q4 2025, targeting to submit NDA to CDE in H1 2026

- Sounding financial position with cash and bank balances of approximately RMB800.0 million

March 25, 2025 — Laekna (2105.HK), a science-driven, clinical-stage biotechnology company, announced the consolidated annual results for the year ended December 31, 2024. The company has made significant progress with respect to the development of clinical and pre-clinical candidates and global collaboration.

“Recently, China announced to launch of a ’3-year initiative for weight management’, providing significant guidance for enhancing public health and significant opportunities for the development of next-generation weight-management therapies”, said Dr. Chris Lu, Chairman of Laekna. "Laekna is advancing the clinical trials for LAE102, a promising drug candidate for promoting muscle regeneration and decreasing fat mass, in both China and the U.S. Our clinical collaboration with Eli Lilly further validates the international competitiveness of LAE102. We are developing, in addition to LAE102, more drugs candidates to maximize the value of targeting ActRII receptors. LAE103 (ActRIIB -selective antibody) and LAE123 (dual inhibitor against ActRIIA/IIB) are our internally discovered antibodies. Both candidates target to submit IND applications in 2025." he added.

Dr. Lu stated: “In 2025, we target to complete the subject enrollment of the Phase III Clinical Trial AFFIRM-205 in breast cancer in the fourth quarter of 2025 and submit NDA to CDE in the first half of 2026. This marks a significant milestone in the company's development. I take great pride in Laekna’s innovation-driven approach to drug discovery, which has enabled us to achieve significant progress in the areas of metabolic diseases and cancer etc. Innovation is an ongoing journey, and we are committed to pursuing global collaborations and exploring more possibilities for future”.

2024: Developed an innovative drug candidate portfolio and entered into a clinical collaboration with Eli Lilly

- LAE102(mAb against ActRIIA) in Obesity, Phase I

LAE102 is our internally discovered monoclonal 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. It is estimated that the number of obesity patients worldwide will exceed 1.2 billion by 2030.

In the first quarter of 2024, Laekna submitted IND applications to both CDE and FDA for LAE102 in obesity indication and obtained approvals of the same in the second quarter of 2024.

In June 2024, Laekna commenced the Phase I clinical trial of LAE102 in China which was ahead of our planned schedule.

In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company (NYSE: LLY) to support and accelerate global clinical development of LAE102 for the treatment of obesity. Lilly will be responsible for the execution and funding of a phase I study in the U.S. Laekna retains global rights for LAE102.

By the end of December 2024, Laekna completed the single ascending dose part of the Phase I clinical study (the SAD study) of LAE102 in China for the treatment of obesity. The positive outcomes of the SAD Study results have established a solid foundation for the Phase I multiple ascending dose study (the MAD study).

Laekna team has accumulated tremendous experience and extensive knowhow in the specific field of targeting ActRII receptors and is developing, in addition to LAE102, more drug candidates to maximize the value of the target. LAE103 is an ActRIIB-selective antibody and LAE123 is a dual inhibitor against ActRIIA/IIB. Both are our internally discovered antibodies for muscle and other disease indications.

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

LAE002(afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the two AKT inhibitors in late-stage development for breast and prostate cancer globally.

The results of the Phase Ib trial in China and the U.S. for the treatment of HR+/HER2-LA/mBC with LAE002 in a combination of a SOC treatment fulvestrant have shown promising anti-cancer efficacy with a well-tolerated safety profile. 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-LA/mBC in May 2024, which was ahead of our planned schedule. Study recruitment is on track.

In addition to the treatment of breast cancer, Laekna has completed the Phase II multi-regional clinical trial of the study of LAE002 (afuresertib) plus LAE001 (CYP17A1/CYP11B2 dual inhibitor) in patients with metastatic castration-resistant prostate cancer(mCRPC) following SOC treatment in the U.S. and South Korea respectively. The study demonstrated promising treatment benefit for mCRPC patients and was generally tolerable.

In May 2024, Laekna obtained approval from FDA for the protocol of the Phase III clinical trial. We plan to pursue strategic partnerships to accelerate the development and commercialization of LAE002(afuresertib) and LAE001.

- From 0 to 1, Achievements of Internal Discovery

As of December 31, 2024, four of Laekna’s internally discovered drug candidates have advanced to IND-enabling studies. These include LAE103 and LAE123, both are targeting ActRII receptors, as well as LAE118(PI3Kαmutant-selective inhibitor) and LAE120(USP1 inhibitor), in the field of cancer.

Laekna obtained IND approval from FDA for LAE120 in February 2025.

PCC declaration for LAE122, a WRN mutant-selective inhibitor, was completed in March 2025.

2025: To announce Phase I study data of the Next-generation weight-control drug, and complete patient enrollment for the Phase III trial of novel cancer therapy

Laekna is expected to achieve the following milestones by 2025:

- LAE102

Laekna plans to initiate the MAD Study in March 2025 in China. The phase I MAD Study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LAE102, administered subcutaneously, in 60 overweight/obese subjects.

The Phase I clinical trial of LAE102 in the U.S is expected to be commenced in the second quarter of 2025. 

The detailed study results of the SAD study of LAE102 will be presented at an international scientific conference in 2025.

- AFFIRM-205

The subject enrollment of the Phase III Clinical Trial AFFIRM-205 in China for LAE002(afuresertib) plus fulvestrant in patients with PIK3CA/AKT1/PTEN alterations and HR+/HER2-LA/mBC is expected to be completed in the fourth quarter of 2025.

Laekna targets to submit NDA to CDE in the first half of 2026.

- Other Targeting ActRII Receptors

Laekna plans to submit IND applications for LAE103(ActRIIB-selective antibody) and LAE123(dual inhibitor against ActRIIA/IIB) in the second quarter and the fourth quarter of 2025 respectively.

Sounding financial positions

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

In 2024, the net cash used in operating activities was RMB278.3 million. As of December 31, 2024, cash and bank balances (including cash and cash equivalents and time deposits) were RMB800.0 million.

-  End –

Contact Us

IR  ir@laekna.com

Media  communication@laekna.com

Corporate and Business Development  BD@laekna.com​​​​​​​

About Laekna

Stock Code: 2105.HK

Founded in 2016, 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 December 31, 2024, Laekna has initiated seven clinical trials for LAE102, LAE002 (afuresertib), LAE001 and LAE005 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’ve obtained IND approvals from the FDA and the CDE for LAE102 in obesity indication and are advancing the Phase I clinical trial in China. 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.

Laekna team has accumulated tremendous experiences and deep know-how in the specific field of targeting ActRII receptors and is developing more drug candidates (LAE103 and LAE123), in addition to LAE102, to maximize the value of the target. LAE103 is an ActRIIB-selective antibody and LAE123 is a dual inhibitor against ActRIIA/IIB. Both are our internally discovered antibodies 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 seven 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: 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.