Core Viewpoint - The company has initiated a Phase I single ascending dose (SAD) study for LAE103, a self-developed ActRIIB monoclonal antibody, in Australia, with the first subject having completed dosing [1] Group 1: Study Details - The SAD study is a randomized, double-blind, placebo-controlled trial aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of LAE103 administered subcutaneously in healthy overweight or obese subjects [1] - The company aims to release the top-line data from this SAD study in the third quarter of 2026 [1] Group 2: Therapeutic Focus - The company is committed to introducing this precision therapy into areas of significant unmet medical needs in cardiovascular and metabolic diseases, such as obesity, sarcopenia, and heart failure [1]

Core Viewpoint - The company has initiated a Phase I single ascending dose (SAD) study for LAE103, a self-developed ActRIIB monoclonal antibody, in Australia, with the first subject having completed dosing [1] Group 1: Study Details - The SAD study is a randomized, double-blind, placebo-controlled trial aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of LAE103 administered subcutaneously in healthy overweight or obese subjects [1] - The company aims to release the top-line data from this SAD study in the third quarter of 2026 [1] Group 2: Therapeutic Focus - The company is committed to introducing this precision therapy into areas of significant unmet medical needs in cardiovascular and metabolic diseases, such as obesity, sarcopenia, and heart failure [1]

Group 1 - The company, Lai Kai Pharmaceutical-B (02105.HK), has initiated the enrollment of subjects for the Phase I single ascending dose (SAD) study of LAE103, a self-developed ActRIIB monoclonal antibody, in Australia [1] - The SAD study is a randomized, double-blind, placebo-controlled trial aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of LAE103 (subcutaneous injection) in healthy overweight or obese subjects [1] - The company aims to announce the top-line data from this SAD study in the third quarter of 2026, focusing on introducing this precision therapy into areas with significant unmet medical needs in cardiovascular and metabolic diseases, such as obesity, sarcopenia, and heart failure [1]

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。 （於開曼群島註冊成立之有限公司） （股份代號：2105） 來凱醫藥有限公司 Laekna, Inc. 自願公告 本 公 告 由 來 凱 醫 藥 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）自 願 作 出，以告知本公司股東及潛在投資者本集團最新業務進展。 – 1 – 本 公 司 董 事（「董 事」）會（「 董 事 會」）欣 然 宣 佈 ， 本 集 團 已 在 澳 大 利 亞 啟 動 LAE103 （ 一種自研的Act RIIB單克隆抗體 ）的I期單劑量遞增研究（「SAD研究」）的受試者入 組工作。截至本公告日，首位受試者已完成給藥。 該SAD研究為一項隨機、雙盲、安慰劑對照研究，旨在評估LAE103（ 皮下注射 ）在 健康的超重或肥胖症受試者中的安全性、耐受性、藥代動力學及藥效學特性。本 集團 ...

Core Insights - The article highlights the recognition of LaiKai Pharmaceutical (2105.HK) as a leading innovator in the biotech sector, winning the "Annual Investment Value Award" due to its robust R&D pipeline and strong growth potential [1][11] - The company is positioned to capitalize on the global shift towards true innovation in the pharmaceutical industry, particularly in the fields of metabolism and cancer treatment [1][11] Pipeline Breakthroughs and Commercialization - LaiKai Pharmaceutical has demonstrated differentiated competitive advantages in metabolism and cancer treatment, with a focus on the Activin-ActRII pathway [3] - The company's LAE102 monoclonal antibody for obesity has shown promising results in Phase I clinical trials, with a 4.6% increase in lean body mass and a 3.6% reduction in fat mass at a 6mg/kg dosage [3] - The FDA has approved the IND application for LAE103, targeting sarcopenic obesity and muscle-related diseases, while LAE123 is expected to enter clinical trials in 2026, enhancing the company's pipeline [3] Cancer Treatment Advancements - The AKT inhibitor LAE002 is in a critical stage of commercialization, with ongoing Phase III trials for HR+/HER2- breast cancer, expected to yield top-line data in mid-2026 [4] - The partnership with Qilu Pharmaceutical for LAE002's development and commercialization in China includes a potential total of 2.045 billion yuan in milestone payments, enhancing LaiKai's cash flow for future R&D [5] Policy and Capital Synergy - The Chinese innovative drug industry is experiencing a favorable development cycle, supported by policy, technology, and capital collaboration [7] - The average review time for innovative drug applications has been reduced to 225 working days, with a record 69 new drugs approved in 2025, facilitating faster market access [8] - The Chinese pharmaceutical industry is now the second largest globally, with a significant number of innovative drugs in development, indicating a growing recognition of Chinese innovation on the global stage [8] Conclusion - LaiKai Pharmaceutical is well-positioned to realize its value through its differentiated innovation, clear pipeline strategy, and efficient commercialization pathways, with the potential for sustainable returns for investors as products like LAE002 approach market approval [11]

Core Viewpoint - The "Golden Award" annual outstanding company selection by Gelonghui highlights ten companies recognized for their investment value in the small and mid-cap category, emphasizing their revenue and net profit growth, as well as their overall business capabilities [1][2]. Group 1: Award Winners - Ten companies received the "Annual Investment Value Award (Small and Mid-Cap)" including: - Baiao Family Interaction (02100.HK) - Honghua Smart Energy (01083.HK) - Guichuang Tongqiao (02190.HK) - Laikai Pharmaceutical-B (02105.HK) - Longpan Technology (603906.SH/02465.HK) - Shoucheng Holdings (00697.HK) - Tiangong International (00826.HK) - Tuhu-W (09690.HK) - Yaoshibang (09885.HK) - Youran Agriculture (09858.HK) - The ranking is in alphabetical order and does not imply any priority [1]. Group 2: Evaluation Criteria - The award focuses on evaluating listed companies based on revenue and net profit growth, considering factors such as company size, business model, management capability, and innovation ability [1]. - The selection process involved quantitative data analysis and an expert review panel to determine the final results [1]. Group 3: Event Purpose - Gelonghui aims to create a reference value ranking for listed companies and unicorns with a global perspective on investing in China, covering all listed companies on major exchanges including HKEX, SSE, SZSE, NYSE, and NASDAQ [2].

Group 1 - The core point of the article is that Laekna Therapeutics has initiated a Phase I multi-dose expansion study for LAE102, aimed at treating obesity in China, and has completed the dosing of the first subject [1] Group 2 - The study is part of the company's efforts to advance its pipeline in the obesity treatment sector [1] - The announcement was made on December 22, indicating the company's ongoing commitment to research and development in the pharmaceutical industry [1] - The initiation of this study may present potential investment opportunities in the healthcare sector, particularly in obesity treatments [1]

Core Viewpoint - The company, 来凯医药-B (02105), has initiated a Phase I multi-dose expansion study for LAE102, aimed at treating obesity, with the first subject having been dosed [1] Group 1: Study Details - The Phase I multi-dose expansion study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of LAE102 in 60 overweight/obese subjects [1] - Subjects will be randomly assigned to either the LAE102 group or the placebo group, receiving treatment for a duration of 6 months [1] - The study is based on previously observed positive one-month treatment results from an earlier MAD study, aiming to further assess the efficacy and safety characteristics after prolonged treatment [1] Group 2: Company Commitment - The company is dedicated to providing precision treatment options for patients suffering from obesity or metabolic diseases who require new therapeutic alternatives [1]

Group 1 - The company, Lai Kai Pharmaceutical-B (02105), has initiated the enrollment of subjects for a Phase I multi-dose expansion study of LAE102 for the treatment of obesity in China [1] - The Phase I study is a randomized, double-blind, placebo-controlled trial aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of LAE102 (subcutaneous injection) in 60 overweight/obese subjects [1] - Subjects will be randomly assigned to either the LAE102 group or the placebo group, receiving treatment for a duration of 6 months [1] Group 2 - The multi-dose expansion study is designed to further assess the efficacy and safety characteristics of LAE102 after longer-term treatment, building on positive one-month treatment results observed in a previous MAD study [1] - The company is committed to providing this precision treatment for patients with obesity or metabolic diseases who require new therapeutic options [1]

Core Viewpoint - The company has initiated a Phase I multi-dose expansion study for LAE102, targeting obesity treatment in China, with the first subject having been dosed [1] Group 1: Study Details - The Phase I multi-dose expansion study is a randomized, double-blind, placebo-controlled trial [1] - The study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of LAE102 in 60 overweight/obese subjects [1] - Subjects will be randomly assigned to either the LAE102 group or the placebo group for a treatment duration of 6 months [1] Group 2: Previous Research and Future Goals - The expansion study is based on positive one-month treatment results observed in a previous MAD study [1] - The goal of the planned multi-dose expansion study is to further assess the efficacy and safety characteristics after longer-term treatment [1] - The company is committed to providing precision treatment options for patients with obesity or metabolic diseases [1]