공고 • 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). 공고 • 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. 공고 • 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 공고 • 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. 공고 • 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 공고 • 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