Anuncio • Aug 19
Laekna, Inc. Provides Consolidated Earnings Guidance for the Six Months Ended 30 June 2026 Laekna, Inc. provided consolidated earnings guidance for the six months ended 30 June 2026. for the six months, the Group is expected to record revenue in the range of approximately RMB 145 million to RMB 155 million for the Reporting Period, as compared to nil for the six months ended 30 June 2025 and a consolidated net loss of no more than RMB 5 million for the Reporting Period as compared to a consolidated net loss of approximately RMB 130 million for the Corresponding Period, representing a significant decrease in loss of approximately 96% year-on-year. The anticipated increase in revenue and significant decrease in consolidated net loss during the Reporting Period were mainly attributable to the revenue recognized under the exclusive license agreements which the Group entered into with Vasque Bio, Inc. with respect to LAE118, and Qilu Pharmaceutical Company Limited with respect to LAE002 (afuresertib). Anuncio • Aug 12
Laekna, Inc. New Drug Application for LAE002 (Afuresertib) Is Accepted by China's National Medical Products Administration Laekna, Inc. announced that the New Drug Application (NDA) for LAE002 (afuresertib) has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer (LA/mBC) with PIK3CA/AKT1/PTEN alterations, following recurrence or progression on or after endocrine therapy(-ies) (with or without a CDK4/6 inhibitor). The NDA is supported by positive results from the Phase III Clinical Trial (AFFIRM-205) conducted in the aforementioned patient population. This pivotal study successfully met its primary endpoint of progression-free survival (PFS), demonstrating a highly statistically significant and clinically meaningful improvement over the control arm. LAE002 (afuresertib) also showed a favorable safety and tolerability profile. The detailed study results will be presented at an upcoming international scientific conference. Laekna is collaborating with its strategic partner, Qilu Pharmaceutical, to expedite the regulatory approval and commercialization of LAE002 (afuresertib) in China. As a potential Class I novel drug for breast cancer and the first domestically developed AKT inhibitor in China, the clinical results of LAE002 (afuresertib) have demonstrated a best-in-class efficacy and safety profile. Beyond breast cancer, the clinical development of LAE002 (afuresertib) for prostate cancer is also advancing rapidly. Laekna is actively pursuing strategic partnerships in ex-China regions to accelerate development and commercialization of LAE002 (afuresertib) in international markets. LAE002 (afuresertib) marks the first breakthrough of Laekna's innovative pipeline, as well as a significant milestone in its transition to the commercial stage. Laekna and Qilu Pharmaceutical entered into an exclusive licensing agreement for the China region in November 2025. Under the License Agreement, 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. Laekna plans to pursue strategic partnerships in ex-China regions to accelerate development and commercialization of LAE002 (afuresertib) in international markets. Capivasertib (Truqap) was the first approved AKT inhibitor from AstraZeneca, which was approved by the U.S. FDA for HR+/HER2- breast cancer in November 2023. In June 2026, the U.S. FDA further approved capivasertib (Truqap) in combination with abiraterone and prednisone for the treatment of PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). This approval significantly broadens the therapeutic scope of AKT inhibition and highlights its potential to address unmet needs across multiple tumor types. LAE002 (afuresertib) is a potent AKT inhibitor internally developed by Laekna that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3). It is one of the two most advanced AKT inhibitors globally in development for breast and prostate cancer. The Phase III clinical trial (AFFIRM-205), a multi-center, randomized, double-blind, placebo-controlled pivotal study, has met its primary endpoint of progression-free survival. It showed statistically significant and clinically meaningful benefits to patients with HR+/HER2- breast cancer and demonstrated a best-in-class efficacy and safety profile. Breast cancer has become the leading cause of death for women globally, with approximately 2,430,000 new cases diagnosed each year and around 694,000 lives lost to the disease. In China, breast cancer ranks the second most common cancer among women, with approximately 70% of the patients found to be HR+/HER2-. Collectively, genetic alterations in PIK3CA, AKT1 and PTEN affect approximately 50% of patients with breast cancer. Although most patients with this subtype of breast cancer can initially benefit from first/second-line treatment by endocrine therapy + CDK4/6 inhibitors and/or chemotherapy, they may gradually develop drug resistance and result in treatment failure. Novel therapeutic options are urgently needed for patients after drug resistance. As an innovative therapy for drug-resistant patients with this subtype of breast cancer, AKT inhibitors offer new hope for them and their families. Anuncio • Aug 08
Laekna, Inc. to Report First Half, 2026 Results on Aug 25, 2026 Laekna, Inc. announced that they will report first half, 2026 results on Aug 25, 2026 Anuncio • Jul 11
Laekna, Inc. (SEHK:2105) commences an Equity Buyback Plan for 44,933,135 shares, representing 10% of its issued share capital, under the authorization approved on June 5, 2026. Laekna, Inc. (SEHK:2105) commences share repurchases on July 9, 2026, under the program mandated by the shareholders in the Annual General Meeting held on June 5, 2026. As per the mandate, the company is authorized to repurchase up to 44,933,135 units, representing 10% of its issued share capital. The purpose for the buyback is to enhance the net asset value per share and/or earnings per share. The repurchases will be made out of the funds legally available for such purpose in accordance with trust deed and applicable laws of, and regulations in Hong Kong. The shares repurchased will be cancelled. The authority shall expire at the earliest of the next Annual General Meeting, the date on which the next Annual General Meeting is required to be held or the date on which the authority is carried out to the full extent, unless varied or revoked in a General Meeting. As of May 14, 2026, the company had 449,331,350 shares in issue.
On July 2, 2026, the company announces a Share Repurchase Program. Under the program, the company will repurchase up to HKD 56 million worth of its shares. The share share repurchase will be funded by the Company’s existing available cash resources. Anuncio • 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 Anuncio • 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 Anuncio • 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. Anuncio • 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. Anuncio • 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 Anuncio • 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 Anuncio • 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 Anuncio • 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. Anuncio • 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. Anuncio • 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. Anuncio • 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 Anuncio • 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. Anuncio • 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 Anuncio • 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.