Afuresertib

- Efficacy: PFS of 7.6 months for LAE002 (afuresertib) plus fulvestrant combination versus PFS of 2.0 months for placebo plus fulvestrant，HR=0.33 (p <0.0001) - Safety: treatment with oral, once-daily LAE002 was well tolerated, with very low rates of discontinuation due to adverse events - Plans to submit NDA to CDE in the near term. Laekna has entered into an exclusive licensing agreement with Qilu Pharma in China and is actively seeking partners to accelerate global development and commercialization of LAE002 in ex-China region. April 15, 2026 — Laekna (2105.HK) announced today that LAE002 (afuresertib) plus fulvestrant has demonstrated strong positive topline results in the phase III clinical trial (AFFIRM-205) in locally advanced or metastatic HR+/HER2- breast cancer (“LA/mBC”) patients with PIK3CA/AKT1/PTEN alterations, following recurrence or progression on or after endocrine therapy(-ies) (with or without a CDK4/6 inhibitor). This pivotal study successfully met its primary endpoint, achieving a highly statistically significant and clinically meaningful improvement of progression-free survival (“PFS”) versus control. 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 only two AKT inhibitors globally in late-stage development for breast and prostate cancer. AFFIRM-205 is a multi-center, randomized, double-blind, placebo-controlled pivotal study to assess the anti-tumor efficacy and safety of the combination therapy. A total of 261 subjects were enrolled and 70.5% of subjects were previously treated with CDK4/6 inhibitors. Efficacy • The study met its primary endpoint with a median PFS of 7.6 months for LAE002 plus fulvestrant combination versus PFS of 2.0 months for placebo plus fulvestrant, HR=0.33 (p <0.0001). Safety Profile • Treatment with oral, once-daily LAE002 was well tolerated, with very low rates of discontinuation due to adverse events. The overall safety profile was consistent with previous data evaluating this combination. The detailed study results of AFFIRM-205 will be presented at an upcoming international scientific conference. Based on the positive results from the phase III pivotal study, Laekna will work together with Qilu Pharmaceutical Company Limited (“Qilu Pharma”) to submit the new drug application (“NDA”) for LAE002 (afuresertib) to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration in the near term. Laekna and Qilu Pharma entered into an exclusive licensing agreement for the China region in November 2025. Under the License Agreement, Laekna is eligible to receive up to RMB2,045 million in total in upfront and milestone payments and is 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. “We are proud to share that the Phase III clinical trial of LAE002 (afuresertib) for breast cancer has met its primary endpoint. The treatment has brought significant and clinically meaningful improvements to patients, with the top-line results clearly demonstrating best-in-class efficacy and safety profile.” said Dr. Chris Lu, Chairman and CEO of Laekna. “In response to the high unmet medical needs, we are pursuing collaborations with partners to accelerate patient access to this novel therapy in global markets.” About Breast Cancer Breast cancer has become the leading cause of death for women globally, with approximately 2.29 million new cases diagnosed each year and around 666,000 lives lost to the disease. In China, breast cancer ranks the second most common cancer among women, with approximately 72% of the patients found to be HR+/HER2- (hormone receptor-positive/HER2-negative). Collectively, 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 a new treatment for drug-resistant patients with this subtype of breast cancer, AKT inhibitors offer new hope for them and their families. – End – Contact Us IR ir@laekna.com Corporate and Business Development BD@laekna.com About Laekna HKEK Stock Code: 2105.HK Patient needs in major disease areas—such as metabolic diseases, oncology, and liver fibrosis—remain the driving force behind our mission. Laekna, a science-driven biotechnology company, is committed to bringing novel therapeutics to patients around the world. Leveraging our tremendous experience and extensive know-how in disease biology, we have built a pipeline of over 20 internally discovered innovative drug candidates with proprietary intellectual property rights. We keep expanding our global reach through strategic partnerships, fostering collaborative success across regions. In oncology, we have completed subject enrollment for the Phase III clinical trial of LAE002 (afuresertib, an AKT inhibitor) for breast cancer (AFFIRM-205). We plan to submit NDA to the CDE in 2026, which will mark Laekna’s pivotal transition from clinical development to commercialization. Laekna has entered into an exclusive licensing agreement with Qilu Pharma to further accelerate the delivery of this novel therapeutic to patients across China. In metabolic diseases, building on our deep expertise and extensive knowhow in the ActRII pathway, we have established a globally competitive, differentiated portfolio comprising LAE102, LAE103, and LAE123. We are rapidly advancing the clinical development of LAE102 in both China and the United States. In the U.S., Laekna has successfully completed the Phase I SAD study, in collaboration with Eli Lilly, to accelerate the global development of this high-quality weight management therapy. From our laboratory in Zhangjiang Pharma Valley in Shanghai, to clinical trials conducted across China, the U.S., and Australia, our footprint spans the globe. Looking ahead, Laekna will continue to collaborate with international partners to accelerate delivery of novel therapeutics to patients worldwide. 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.

- Topline results from Phase I studies of LAE102 (ActRIIA monoclonal antibody) in the U.S. and China demonstrated encouraging, dose-dependent trends in lean mass increase and fat mass reduction, as well as a well-tolerated safety profile - Completed subject enrollment of the Phase III clinical trial of LAE002 (afuresertib) in breast cancer, targeting NDA submission in 2026. Entered into an exclusive licensing agreement with Qilu Pharma to accelerate the commercialization of LAE002 (afuresertib) - Achieved first commercial revenue in 2025, marking a significant milestone in its transition to the commercial stage with a robust pipeline of internally discovered innovative drug candidates Mar 19, 2026 — Laekna (2105.HK) announced the consolidated annual results for the year ended December 31, 2025. The company has achieved significant progress with respect to internal discovery, clinical development, commercialization and global collaboration. “In 2025, Laekna continued to accelerate its development upon a solid foundation, achieving a remarkable transition from a clinical-stage to a commercial-stage company,” said Dr. Chris Lu, Chairman & CEO of Laekna. He stated: “In oncology, our lead breast cancer drug candidate LAE002 (afuresertib) is poised for launch. Laekna has entered into an exclusive licensing agreement with Qilu Pharma to accelerate commercialization and expand patient access. In metabolic diseases, building on our deep expertise and extensive know-how in the ActRII pathway, we have established a globally competitive, differentiated portfolio that includes LAE102, LAE103, and LAE123, to develop next‑generation, high-quality weight management therapies. Together with Eli Lilly and other partners, Laekna is accelerating the global development of its robust pipeline”. Dr. Lu emphasized that Laekna achieved its first commercial revenue in 2025, with a robust pipeline of internally discovered innovative drug candidates. “We strive to continuously push the boundaries of novel drugs, enhance public access to medicines, actively embrace globalization, and create sustainable economic and social value”. Key clinical progress Metabolic diseases • LAE102 (ActRIIA monoclonal antibody) in Obesity, Phase I - SAD study in China: Positive topline results announced in January 2025 First-in-Human study results presented at ADA in June 2025 - China MAD study: commenced by the end of March 2025 The preliminary results demonstrated encouraging trends toward increased lean body mass and reduced fat mass. At week 5, the LAE102 6 mg/kg group exhibited a 1.7% increase in mean lean body mass and a 2.2% reduction in mean fat mass compared to the baseline. Adjusted from the placebo control group, the mean lean body mass is increased by 4.6%, whereas the mean fat mass is reduced by 3.6%. Consistent with the prior Phase I SAD Study of LAE102, the MAD Study demonstrated a well-tolerated safety profile. Multiple Dose Expansion Study: completed subject enrollment in January 2026. This pre-planned study is designed to further evaluate the efficacy and safety profile of LAE102 over a longer treatment duration (6 months). - U.S. SAD Study (in collaboration with Eli Lilly and Company): In March 2026, the Group announced positive results of the U.S. SAD study. It showed encouraging trends in body composition improvements following administration of a single dose and further demonstrated a well-tolerated safety profile, with no serious adverse events reported. In Week 4 following a single dose of LAE102, the group with the highest exposure exhibited a 5.06% increase in mean lean body mass from baseline (placebo group has 1.34% reduction from baseline) and a 0.12% decrease in mean fat mass from baseline (placebo group has 2.11% increase from baseline). • LAE103 (ActRIIB monoclonal antibody) in Obesity, Phase I - Obtained IND approval from the U.S. FDA in July 2025 - Initiated the Phase I SAD Study of LAE103 in Australia and dosed the first subject in December 2025 Oncology • LAE002 (afuresertib, a potent AKT inhibitor) + Fulvestrant in HR+/HER2- breast cancer, Phase III China - Completed subject enrollment of Phase III clinical trial in December 2025 - In February 2026, an article titled “Afuresertib plus fulvestrant for pretreated HR-positive, HER2-negative, advanced breast cancer: a phase Ib trial” was published in Nature Communications, a leading international scientific journal. The findings indicate that this combination regimen demonstrates promising anti-tumor activity and a well-tolerated safety profile in this patient population. More internally discovered pre-clinical candidates - LAE123（ActRIIA/IIB dual antagonistic monoclonal antibody）: - Advancing through IND-enabling studies, targeting IND submission in 2026 - LAE124 (a small molecule dual amylin and calcitonin receptor agonist): expected to complete PCC declaration in 2026 - LAE118 (a novel PI3Kα pan-mutant selective inhibitor): obtained IND approval from the U.S. FDA in February 2026 for treatment of patients with PIK3CA-mutant solid tumors. A poster showcasing LAE118 was presented at the AACR in April 2025. - LAE120 (a USP1inhibitor): obtained IND approval from the U.S. FDA in February 2025 Progress of commercialization Laekna and Qilu Pharma have entered into an exclusive licensing agreement, Qilu Pharma is granted an exclusive license for research, development, and commercialization of LAE002 (afuresertib) in the China region. Under the license agreement, Laekna is entitled to receive non-refundable upfront and clinical development milestone payments up to RMB530 million upon new drug application approval for the first indication in China. 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. The Group can leverage this opportunity to accelerate the regulatory approval and commercialization of LAE002 (afuresertib) in the Licensed Territory and maximize its commercial value. Expected Upcoming Milestones in 2026 • About LAE102 - Report results from the Phase I MAD Expansion Study in China - Initiate a Phase II clinical study in combination with a GLP-1 receptor agonist • About AFFIRM-205 - Report results from the Phase III China trial (AFFIRM-205) - Submit NDA to CDE • About Other Metabolic Disease Drug Candidates Report results from Phase I SAD of LAE103 IND submission for LAE123 Complete PCC declaration for LAE124 Sounding financial positions Laekna adopts a disciplined funding and treasury policy, aiming to maintain an optimal financial position. As of December 31, 2025, cash and bank balances and time deposits balances were RMB1,262.4 million. Laekna achieved its first commercial revenue in 2025, derived from the out-licensing transaction of LAE002 (afuresertib) pursuant to the License Agreement the Group entered into with Qilu Pharma. – End – Contact Us IR ir@laekna.com Corporate and Business Development BD@laekna.com About Laekna HKEK Stock Code: 2105.HK Patient needs in major disease areas—such as metabolic diseases, oncology, and liver fibrosis—remain the driving force behind our mission. Laekna, a science-driven biotechnology company, is committed to bringing novel therapeutics to patients around the world. Leveraging our tremendous experience and extensive know-how in disease biology, we have built a pipeline of over 20 internally discovered innovative drug candidates with proprietary intellectual property rights. We keep expanding our global reach through strategic partnerships, fostering collaborative success across regions. In oncology, we have completed subject enrollment for the Phase III clinical trial of LAE002 (afuresertib, an AKT inhibitor) for breast cancer (AFFIRM-205). We plan to submit NDA to the CDE in 2026, which will mark Laekna’s pivotal transition from clinical development to commercialization. Laekna has entered into an exclusive licensing agreement with Qilu Pharma to further accelerate the delivery of this novel therapeutic to patients across China. In metabolic diseases, building on our deep expertise and extensive knowhow in the ActRII pathway, we have established a globally competitive, differentiated portfolio comprising LAE102, LAE103, and LAE123. We are rapidly advancing the clinical development of LAE102 in both China and the United States. In the U.S., Laekna has successfully completed the Phase I SAD study, in collaboration with Eli Lilly, to accelerate the global development of this high-quality weight management therapy. From our laboratory in Zhangjiang Pharma Valley in Shanghai, to clinical trials conducted across China, the U.S., and Australia, our footprint spans the globe. Looking ahead, Laekna will continue to collaborate with international partners to accelerate delivery of novel therapeutics to patients worldwide. 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.