Tillkännagivande • May 15
Laekna, Inc., Annual General Meeting, Jun 05, 2026 Laekna, Inc., Annual General Meeting, Jun 05, 2026, at 09:00 China Standard Time. Location: 5f, 987 cailun road, pudong, shanghai, china, Hong Kong Tillkännagivande • Mar 06
Laekna, Inc. to Report Fiscal Year 2025 Results on Mar 18, 2026 Laekna, Inc. announced that they will report fiscal year 2025 results at 4:00 PM, China Standard Time on Mar 18, 2026 Tillkännagivande • Jan 14
Laekna, Inc. Announces That the U.S. Food and Drug Administration Has Accepted Its Investigational New Drug Application for LAE118 The board of directors of Laekna, Inc. announced that the U.S. Food and Drug Administration has accepted its Investigational New Drug application for LAE118, a novel PI3K a pan-mutant selective inhibitor for the treatment of patients with PIK3CA-mutant solid tumors. The Company will work closely with the regulatory authorities to complete the application. Building on its proven track record in successfully developing and out-licensing LAE002 (afuresertib), the Company aims to bring this precision therapy to cancer patients who are in need of novel treatment options. Tillkännagivande • Jan 02
Laekna, Inc. Commences Study Recruitment in Phase I Single Ascending Dose Study of LAE103 The board of directors of Laekna, Inc. announced that the Group has commenced study recruitment in phase I single ascending dose study of LAE103, an internally discovered monoclonal antibody against ActRIIB, in Australia. As of the date of this announcement, first subject has been dosed. The SAD Study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LAE103, administered subcutaneously, in healthy overweight or obese participants. The Group targets to read out the topline data of this SAD study in the third quarter of 2026. The Group targets to bring this precision therapy to cardiovascular and metabolic diseases with high unmet medical needs, such as obesity, sarcopenia and heart failure. Tillkännagivande • Sep 18
Laekna, Inc. has completed a Follow-on Equity Offering in the amount of HKD 586.8 million. Laekna, Inc. has completed a Follow-on Equity Offering in the amount of HKD 586.8 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 36,000,000
Price\Range: HKD 16.3
Discount Per Security: HKD 0.26
Transaction Features: Subsequent Direct Listing Tillkännagivande • Sep 11
Laekna, Inc. has filed a Follow-on Equity Offering in the amount of HKD 586.8 million. Laekna, Inc. has filed a Follow-on Equity Offering in the amount of HKD 586.8 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 36,000,000
Price\Range: HKD 16.3
Discount Per Security: HKD 0.26
Transaction Features: Subsequent Direct Listing Tillkännagivande • Jul 29
Laekna, Inc. to Report First Half, 2025 Results on Aug 13, 2025 Laekna, Inc. announced that they will report first half, 2025 results on Aug 13, 2025 Tillkännagivande • Jun 30
Laekna, Inc. Submits Investigational New Drug Application to the U.S. Food and Drug Administration The board of directors of Laekna, Inc. announced that the Group has submitted an Investigational New Drug application to the U.S. Food and Drug Administration for LAE103, an internally discovered monoclonal antibody against ActRIIB for the treatment of patients with sarcopenic obesity and muscle related disease. The Company will work closely with the regulatory authorities to complete the application and targets to bring this precision therapy to metabolic patients who are in need of novel treatment options. The Group plans to separately evaluate the efficacy and safety of monoclonal antibodies targeting at ActRIIA and ActRIIB in humans. Tillkännagivande • Jun 24
Laekna Presents Clinical and Pre-clinical Studies Results of LAE102, LAE103 and LAE123 Laekna announced that the results of: i) the phase I SAD study of LAE102 (an ActRIIA-selective antibody) for the treatment of obesity; and ii) the pre-clinical study of LAE102, LAE103 (an ActRIIB-selective antibody) and LAE123 (an ActRIIA/IIB dual antagonistic monoclonal antibody) as therapeutics for muscle growth and fat reduction were presented at the 85th scientific sessions of the American Diabetes Association (ADA). ADA is one of the global leading conferences dedicated to diabetes research, care, and innovation and has taken place in Chicago, USA, from June 20 to 23 this year. Professor Xuening LI, Zhongshan Hospital affiliated to Fudan University,Principal Investigator of the Phase I Clinical Trial of LAE102 in China. At the ADA Scientific Sessions, Laekna showcased LAE102, LAE102, LAE 103, and LAE123 - an innovative portfolio targeting the ActRII pathway - highlighting team's extensive expertise and leadership in this field. Highlights: A total of 40 participants were enrolled in Part A (IV) and 24 participants in Part B (SC). All participants completed the study as designed. The mean age was 29.0 years and 31.2 years, with the mean BMI 23.32 kg/m2 and 23.08 kg/m2 in Part A and Part B, respectively. Tillkännagivande • Jun 23
Laekna, Inc. Announces Results of Phase I Sad Study of Lae102 Laekna, Inc. announced that the results of (i) phase I SAD study of LAE102 (an ActRIIA-selective antibody) for the treatment of obesity; and (ii) the pre-clinical study of LAE102, LAE103 (an ActRIIB-selective antibody) and LAE123 (an ActRIIA/IIB dual antagonistic monoclonal antibody) as therapeutics for muscle growth and fat reduction were presented at the 85th scientific sessions of the American Diabetes Association (ADA). Presentations details are as follows: Poster No.1. Abstract Number: 2205-LB, Title: First-in-Human Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LAE102 in Healthy volunteers, Time: Sunday, June 22, 2025, 12:30 p.m.-13:30 p.m. CST, Location: Poster Hall (Hall F1) McCormick Place Convention Center, Chicago, Illinois, the USA. Highlights: A total of 40 participants were enrolled in Part A (IV) and 24 participants in Part B (SC). All participants completed the study as designed. The mean age was 29.0 years and 31.2 years, with the mean BMI 23.32 kg/m2 and 23.08 kg/m2 in Part A and Part B, respectively. Baseline demographic and clinical characteristics were generally balanced across the intravenous (IV) and subcutaneous (SC) cohorts of the study. Overall, LAE102 was well tolerated following a single IV or SC dose. No serious adverse events or treatment emergent adverse events (TEAEs) leading to discontinuation of treatment were reported. The majority of the TEAEs were mild laboratory test abnormalities, which were asymptomatic and did not require medical intervention. There was no reported case of diarrhea. Activin A was significantly increased in 24 hours following a single intravenous or subcutaneous dose of LAE102. The duration of Activin A elevation was dose-dependent. The high-dose groups (8 mg/kg IV group, 16 mg/kg IV group, and 8 mg/kg SC group) maintained 2-to-3-fold increases above the baseline level through 28 days post-administration, indicating prolonged pathway blocking. In addition, they also inhibit activin E and GDF3, which promote lipid accumulation of adipose tissue. In mouse models, LAE102 alone significantly induced muscle growth and reduced fat mass, while LAE103 had less effect. Notably, a synergistic effect on muscle increase and fat loss was observed when combining LAE102 with LAE103, achieving the maximal effect comparable to the ActRIIA-IIB dual-specific antibody LAE123. This positions LAE102 as a promising drug candidate for achieving quality weight control. Tillkännagivande • May 13
Laekna, Inc., Annual General Meeting, Jun 03, 2025 Laekna, Inc., Annual General Meeting, Jun 03, 2025, at 09:00 China Standard Time. Location: 5f, 987 cailun road, pudong, shanghai China Tillkännagivande • Mar 26
Laekna, Inc. Commences Study Recruitment in Phase I Multiple Ascending Dose Study of Lae102 for the Treatment of Obity The board of directors of Laekna, Inc. announced that the Group has commenced study recruitment in phase I multiple ascending dose study of LAE102 in China for the treatment of obesity. As of the date of this announcement, the first visit for the first subject has been completed. The 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 Group aims to bring this precision therapy to overweight and obese patients who are in need of novel treatment options for achieving quality weight control. Tillkännagivande • Mar 10
Laekna, Inc. to Report Fiscal Year 2024 Results on Mar 24, 2025 Laekna, Inc. announced that they will report fiscal year 2024 results on Mar 24, 2025 Tillkännagivande • Jan 13
Laekna, Inc. Announces Completion of A Successful Phase I Single Ascending Dose Study of Lae102 for the Treatment of Obesity The board of directors of Laekna, Inc. announced that the Group has successfully completed the phase I single ascending dose study of LAE102 for the treatment of obesity. The SAD Study enrolled a total of 64 healthy subjects with an average BMI of 23.2+-2.2 kg/m2, including 5 intravenous cohorts and 3 subcutaneous cohorts. The positive outcomes of the SAD Study results have established a solid foundation for the coming phase I multiple ascending dose study in China as well as the phase I clinical study in collaboration with Eli Lilly & Company in the U.S. The SAD Study data of LAE102 analyzed to date demonstrated an encouraging safety and tolerability profile, with no serious adverse events and no discontinuations due to adverse events. All treatment emergent adverse events reported to date were very well tolerated, with the majority of them being reported as mild (grade 1) lab test abnormality without any clinical symptoms or signs. There is no reported case of diarrhea. Obvious target engagements and expected pharmacodynamic biomarker changes have been observed. Single doses of LAE102 resulted in significant and sustained increasing in activin A level, indicating a robust target engagement. The duration of target engagement correlated to the dose level. The detailed study results will be presented in a scientific conference as soon as possible. The positive SAD Study results support continuing the investigation of LAE102 for thetreatment of obesity. The Group plans to initiate the MAD Study in the first quarter of 2025 and to work closely with Lilly to commence the phase I clinical study in U.S. as soon as possible. The 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 Group aims to bring this precision therapy to overweight and obese patients who are in need of novel treatment options for achieving quality weight control.