Core Viewpoints - The company showcased multiple early clinical products at the 2025 ADA conference, demonstrating excellent early data, particularly for LAE102, which showed good safety and pharmacokinetic properties [1][2] - The clinical and preclinical studies of LAE102, LAE103, and LAE123 indicate promising fat reduction and muscle gain effects, with LAE102 outperforming LAE103 [1][3] Events - On June 23, 2025, the company announced the clinical and preclinical research results of LAE102, LAE103, and LAE123 at the 2025 ADA conference [1] Safety and Efficacy - LAE102 demonstrated good safety with no serious adverse events (SAE) reported in both intravenous and subcutaneous administration groups, and no cases of diarrhea were noted [2] - Initial efficacy signals were observed for LAE102, with a significant increase in Actvin A levels correlating with drug dosage, indicating promising pharmacokinetic and pharmacodynamic effects [2] Clinical Pipeline - The company has a balanced pipeline focused on cancer and metabolic diseases, with several candidates in various stages of development, including LAE103 and LAE123, both in the IND application stage [3] - LAE001 and LAE005 are also in clinical trials, with LAE001 having completed Phase I trials and LAE005 showing potential in treating triple-negative breast cancer [3] Financial Projections - The company has a globalized and integrated approach to its cancer and metabolic drug development, with expectations for LAE102 to meet market demand upon commercialization [4] - Revenue projections for 2025, 2026, and 2027 are estimated at 0, 0, and 169 million respectively, with a target valuation of 16.85 billion HKD and a revised target price of 41.30 HKD [4]

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. 本公司董事（「董事」）會（「董事會」）宣佈：(i)用於治療肥胖症的LAE102（ 一種針對 Act RI IA 的 單 克 隆 抗 體 ）的 I 期 單 劑 量 遞 增 (SAD ) 研 究 結 果 ； 以 及 (ii) LAE102 、 LAE103（ 一種針對Act RIIB的單克隆抗體 ）及LAE123（ 一種針對Act RIIA / IIB雙靶點 的單克隆抗體 ）作為增肌減脂療法的臨床前研究結果，已於美國糖尿病協會(ADA) 第85屆科學年會上公佈。 相關海報詳情如下： 海報編號1 – 1 – 摘要編號： 2205 -LB 標題： LAE102在健康志願者中的首次人體研究：評估其安全性、耐受 性、藥代動力學及藥效學 時間： 202 ...

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 或任何部分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） 於2025年6月3日舉行的 股東週年大會投票結果 來凱醫藥有限公司（「本公司」）董事（「董事」）會（「董事會」）謹此宣佈，於2025年6 月3日舉行的股東週年大會（「股東週年大會」）上，日期為2025年5月12日的股東週 年大會通告所載於股東週年大會上提呈的所有決議案（「決議案」）已獲本公司股份 （「股份」）相關持有人（「股東」）以投票表決方式正式通過。除文義另有所指外，本 公告所用詞 彙與本公司日期為2025 年5月 12 日的通函（「通函」）所界 定者具有相同 涵義。股東週年大會投票結果如下： | | | 普 | 通 決 | 議 案 | 所 投 票 數（ 佔 所 投 總 票 數 比 的 概 約 百 分 ） 由 股 東 附 註 (a) ...

Group 1 - The stock of Lai Kai Pharmaceutical-B (02105) rose over 4%, reaching HKD 19.94 with a trading volume of HKD 133 million [1] - The phase II study results of Eli Lilly's ActRIIA/B antibody Bimagurmab (Bima) in combination with semaglutide will be announced at the ADA conference on June 23 [1] - The agenda for the 2025 ADA conference includes a 90-minute session on Bima, featuring five presentations and discussions, focusing on the efficacy and safety comparison between Bima combined with semaglutide and semaglutide alone [1] Group 2 - Lai Kai Pharmaceutical's LAE102 will present its first human clinical data at the 2025 ADA conference, showcasing its potential alongside Bima [2] - Eli Lilly plays a crucial role in both Bima and LAE102, having acquired Bima and collaborating with Lai Kai Pharmaceutical for LAE102's phase I clinical study in the U.S. for obesity treatment, which began in late May and is expected to complete the main study phase by September 2025 [2]

Core Viewpoints - In 2024, the company's R&D expenses are projected to be 215 million RMB, remaining stable compared to 2023, indicating robust cost control and alignment with overall development expectations [1] - The company has approximately 800 million RMB in cash and cash equivalents, ensuring sufficient cash flow for future operations [1] - The Phase I SAD trial results for the core product LAE102 are promising, laying a solid foundation for the upcoming Phase I MAD trial, and collaboration with Eli Lilly enhances international influence [1][4] - The clinical trial for LAE002 is progressing, with the Phase III trial for breast cancer being particularly noteworthy [1] Financial Performance - The company reported a total loss of 254 million RMB for the year, a reduction of 31.05% year-on-year, indicating improved financial health [1] - Administrative expenses decreased by 2.4% year-on-year to 74 million RMB, reflecting effective management [1] Research and Development - The company has established a global R&D team of 61 employees, covering the entire drug discovery and development cycle, with innovation centers in Shanghai and New Jersey [2] - LAE102, a monoclonal antibody targeting ActRIIA, shows potential for effective weight management by promoting muscle gain and reducing fat [2] - The Phase I SAD clinical study for LAE102 began in June 2024, with 64 healthy participants recruited, demonstrating good safety and efficacy results [3] Clinical Trials and Collaborations - The collaboration with Eli Lilly involves conducting a Phase I trial for LAE102 in the U.S., expected to start in Q2 2025 [4] - The company is also advancing LAE002 in multiple cancer clinical trials, with significant results reported for various combinations [5][6] Pipeline and Future Prospects - The company maintains a balanced pipeline focused on cancer and metabolic diseases, with several candidates in various stages of development [7] - LAE002 has shown efficacy in multiple clinical trials, with ongoing efforts to expand its indications [6][7] - The company anticipates commercial potential for LAE102 and LAE002, with projected revenues of 0 million RMB in 2025 and 169 million RMB in 2027 [7]

Investment Rating - The report initiates coverage with a "Buy" rating for the company [4]. Core Insights - The company focuses on innovative therapies for cancer and metabolic diseases, with a strong emphasis on addressing unmet medical needs in obesity and tumor treatment [1][11]. - LAE102, a globally pioneering ActRIIA monoclonal antibody, aims to mitigate muscle loss associated with GLP-1 receptor agonist weight loss therapies, showing promising results in early clinical trials [2][38]. - Afuresertib (LAE002), a broad-spectrum AKT kinase inhibitor, is currently in late-stage clinical trials for HR+/HER2- breast cancer, demonstrating significant potential as a new treatment option for resistant cases [3]. Summary by Sections Company Overview - Laekna Therapeutics, established in 2016 and listed on the Hong Kong Stock Exchange in June 2023, is a biotechnology company dedicated to developing innovative therapies for cancer, metabolic diseases, and liver fibrosis [1][11]. LAE102 Development - LAE102 targets the ActRIIA receptor to counteract muscle loss caused by GLP-1 receptor agonists, with preclinical studies confirming its efficacy in promoting muscle growth and reducing fat accumulation [2]. - The drug has shown excellent safety and tolerability in Phase I trials, with no serious adverse events reported [38]. Afuresertib (LAE002) Development - Afuresertib is an oral, reversible, ATP-competitive AKT inhibitor that effectively suppresses tumor cell growth and metastasis by inhibiting the PI3K/AKT/mTOR signaling pathway [3]. - The drug is currently in Phase III clinical trials for HR+/HER2- breast cancer, with promising results in earlier phases indicating its potential as a new treatment for resistant breast cancer [3]. Financial Projections - The company anticipates revenues of 44 million, 50 million, and 76 million yuan for the years 2025, 2026, and 2027, respectively, with projected net losses of 271 million, 298 million, and 254 million yuan for the same years [4].

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） 股 東 週 年 大 會 通 告 茲 通 告 來 凱 醫 藥 有 限 公 司（「本 公 司」）謹 訂 於2025年6月3日（星 期 二）上 午 九 時 正 假 座 中 國 上 海 浦 東 蔡 倫 路987號5層 舉 行 股 東 週 年 大 會，以 考 慮 及 酌 情 通 過 下 列 本 公 司 決 議 案（無 論 是 否 修 訂）（除 另 有 所 指 外，本 通 告 所 用 詞 彙 與 本 公 司 日 期 為2025年5月12日 的 通 函（「通 函」）所 界 定 者 具 有 相 同 涵 義）： 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 全部或任何部分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。 普 通 決 議 案 「動 議： (a) 在 本 決 議 案 下 列 條 款 的 規 限 下，一 ...

閣 下 如 對 本 通 函 任 何 方 面 或 應 採 取 的 行 動 有 任 何 疑 問，應 諮 詢 股 票 經 紀 或 其 他 註 冊 證 券 商、銀 行 經 理、律 師、專 業 會 計 師 或 其 他 專 業 顧 問。 Laekna, Inc. 此 乃 要 件 請 即 處 理 閣 下 如 已 出 售 或 轉 讓 名 下 的 所 有 來 凱 醫 藥 有 限 公 司 股 份，應 立 即 將 本 通 函 及 隨 附 代 表 委 任 表 格 送 交 買 主 或 承 讓 人 或 經 手 買 賣 或 轉 讓 的 銀 行、股 票 經 紀 或 其 他 代 理 商，以 便 轉 交 買 主 或 承 讓 人。 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 通 函 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 就 因 本 通 函 全部或任何部分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。 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） 建 議 授 出 發 ...

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 或任何部分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） 授出受限制股份單位 根據上市規則第17.06A、17.06B 及17.06C 條，董事會宣佈，於2025 年5月8日，根 據2024年股份獎勵計劃向承授人（ 包括三名執行董事 ）授出合共11,460,000份受限制 股份單位（ 相當於合共11,460,000股股份 ）。向包括呂博士、謝女士及顧博士在內的 三名執行董事授出受限制股份單位須待獨立股東在股東週年大會上批准後，方可 作實。 向承授人授出受限制股份單位的詳情如下： 授出日期 2025年5月8日 承授人 (i) 本集團的僱員參與者；及 (ii) 三名執行董事，包括呂博士、謝女士及顧博士 Laekna, Inc. 來凱醫藥有限公司 已授出受限制股份單位 的總數 11,460,000份受限制股份單位（ 相當於合共11,460,00 ...

Group 1 - The World Health Organization (WHO) is planning to include weight loss medications in its essential medicines list for the treatment of adult obesity, with guidelines expected to be finalized by August or September 2025 [1] - The guidelines will clarify the clinical indications, applications, and considerations for GLP-1 receptor agonists (RAs) as part of chronic disease management, including clinical and lifestyle interventions [1] - The WHO's expert committee is currently reviewing these medications independently to assess their inclusion in the essential medicines lists, which guide procurement agencies in selecting drugs that meet public health needs [1] Group 2 - Citic Securities reports that overseas giants are consistently exceeding performance expectations, and domestic R&D progress is accelerating, indicating a clearer trend for the weight loss drug industry [2] - Future catalysts for the weight loss drug sector include better-than-expected sales data from major drugs, disclosures of R&D results for overseas GLP-1 drugs in other indications, and successful approvals for domestic products [2] Group 3 - Gilead Sciences (01672) will present early research on its obesity candidate drug ASC47 at the 32nd European Congress on Obesity (ECO 2025) in Malaga, Spain [3] - LianKai Pharmaceuticals (02105) has reported smooth progress in its Phase I clinical trial for LAE102, a monoclonal antibody targeting overweight/obesity, with all 64 participants completing dosing [3] - LianKai has a clinical collaboration agreement with Eli Lilly for LAE102's Phase I study in the U.S., with Eli Lilly covering related costs [3] Group 4 - Innovent Biologics (01801) is at the forefront of domestic GLP-1 innovation with its dual agonist Mazdutide, which has received acceptance for two NDA applications in China targeting obesity and type 2 diabetes [4] - The weight loss indication for Mazdutide is expected to be approved in the first half of next year, with potential to replicate the success of Eli Lilly's weight loss drug in Western countries [4] - The dual-target product Mazdutide is in the application stage for market approval and is expected to be approved within the next two years [4]