香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 的 內 容 概 不 負 責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部 或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Laekna, Inc. 來凱醫藥有限公司 （於開曼群島註冊成立之有限公司） （股份代號：2105） 療效方面，美國SAD研究顯示：單次給藥後，受試者身體組成部分呈現令人鼓舞 的改善趨勢，觀察到與劑量相關的增肌減脂效果。LAE102單次給藥後的第29天， 最高暴露量的組別其平均瘦體重較基線增加5.06 %（ 安慰劑組較基線減少1.34 % ）， 平均 脂肪 量較 基線 減少0.12 %（ 安 慰劑 組較 基線 增加2.11 % ）。 單次給 藥LAE102 導 致啟動素A水準顯著且持續地上升，顯示出強有力的靶點結合。靶點結合的持續 時間與劑量水準相關。本集團計劃在即將召開的科學會議上公佈詳細研究結果。 – 1 – 上述積極結果進一步支持LAE102作為心血管代謝疾病治療的創新療法。本集團正 積 極 規 劃 II 期 臨 床 試 驗 ， 以 ...

Core Insights - The clinical trial HARMONY for HTD1801 in Type 2 Diabetes Mellitus (T2DM) patients has shown positive results, achieving its primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] - HTD1801 targets the root causes of T2DM, providing comprehensive cardiovascular metabolic benefits [1] Summary by Sections Clinical Trial Results - HARMONY is a randomized, double-blind, positive drug-controlled Phase III clinical study involving 369 participants, assessing the efficacy and safety of HTD1801 compared to Dapagliflozin in adults with T2DM who have inadequate blood sugar control after Metformin treatment [1] - The primary endpoint was the change in HbA1c from baseline after 24 weeks of treatment, with HTD1801 showing a least squares (LS) mean change of -1.12% compared to -0.93% for Dapagliflozin (LS mean difference: -0.20%; 95% CI: -0.37 to -0.03; P < 0.001) [1] - HTD1801 also achieved multiple secondary endpoints, demonstrating superior reductions in LDL-C and non-HDL-C compared to Dapagliflozin, with a significantly lower proportion of patients requiring additional or intensified statin therapy [1] Safety and Tolerability - HTD1801 exhibited good safety and tolerability, with a serious adverse event rate of 3.8% (compared to 4.4% in the Dapagliflozin group) [2] - The most common adverse events in the HTD1801 group were mild to moderate gastrointestinal issues, with no severe hypoglycemic events reported [2] Future Prospects - HTD1801's ability to simultaneously regulate metabolic and inflammatory pathways positions it as a promising foundational treatment for chronic kidney and metabolic diseases (CKM) [2] - Following the positive outcomes of the SYMPHONY-1 and SYMPHONY-2 trials, HARMONY marks the third successful Phase III trial for HTD1801, reinforcing its potential [2] - The company plans to initiate a New Drug Application (NDA) for HTD1801 within the year [2]

Core Viewpoint - Cheng Yi Bio Cayman Limited has submitted a listing application to the Hong Kong Stock Exchange, with Jefferies, BofA Securities, and CICC as joint sponsors [1] Company Overview - Cheng Yi Bio is a clinical-stage global biotechnology company focused on developing next-generation oral small molecule drugs to address significant unmet medical needs in cardiovascular metabolic diseases and inflammatory diseases [4] - The company utilizes its proprietary TRANDD platform to create a product pipeline aimed at single-agent treatments and combination therapies for weight management (obesity/overweight), Metabolic Associated Steatotic Liver Disease (MASH), osteoarthritis (OA) pain, and other cardiovascular metabolic diseases [4] Product Pipeline - The company has developed an oral small molecule GLP-1 receptor agonist (GLP-1RA) ECC5004, which is expected to be a best-in-class therapy and the second oral small molecule GLP-1 receptor agonist to be launched globally [4] - ECC4703, an oral liver-targeting thyroid hormone receptor β (THR-β) full agonist, aims to be a best-in-class treatment for MASH and a first-in-class liver-targeting selective THR-β full agonist for weight management [4] - ECC0509, an oral small molecule inhibitor of SSAO (also known as VAP1), can be used in combination with GLP-1 receptor agonists to maximize its therapeutic potential [4] Competitive Landscape - The company faces potential competition from multinational pharmaceutical companies and other biotechnology or specialty pharmaceutical companies that are actively developing or have commercialized therapies targeting similar indications, including GLP-1 receptor agonists and THR-β agonists [5] - The company does not guarantee the successful development and commercialization of its core products or any pipeline products [5] Financial Overview - For the fiscal years 2023, 2024, and the first half of 2025, the company's revenues are projected to be approximately $36.06 million, $221.29 million, and $0.557 million, respectively [7] - The net losses for the same periods are estimated at approximately $52.23 million, $138.84 million, and $20.11 million, respectively [7] - The company has no internal production facilities as of September 30, 2025, and all production activities are conducted through partners, including contract development and manufacturing organizations (CDMOs) [5]