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]

Core Insights - The performance of actively managed equity funds focused on humanoid robots is currently lagging behind, while funds heavily invested in innovative pharmaceuticals have emerged as top performers, with the Huatai-PineBridge Hong Kong Advantage Selected Mixed Fund (QDII) A achieving a year-to-date return of 64.44% as of April 27 [1][2] Fund Performance - As of April 27, the Huatai-PineBridge Hong Kong Advantage Selected Mixed Fund (QDII) A has a year-to-date return of 64.44%, making it the best-performing public fund this year [1] - The top ten holdings of this fund include Rongchang Biologics, Kelun-Botai Biologics-B, Innovent Biologics, and others, indicating a strong focus on leading pharmaceutical companies [1] - Several other pharmaceutical-themed funds have also shown significant returns, with funds like Changcheng Pharmaceutical Industry Selected Mixed Fund and Yongying Pharmaceutical Innovation Selected Mixed Fund exceeding 40% year-to-date returns [1] Market Trends - The pharmaceutical sector has seen a notable increase in stock prices, particularly in the innovative drug segment, with stocks like Rongchang Biologics and Innovent Biologics showing year-to-date increases of over 200% and nearly 50%, respectively [2] - Key breakthroughs in research and development have acted as catalysts for the pharmaceutical market, with recent approvals for innovative drugs such as the PD-1/VEGF bispecific antibody by Kangfang Biologics [2] Market Dynamics - The performance of Hong Kong-listed pharmaceutical stocks has shown greater elasticity compared to A-shares, attributed to the overall higher quality of Hong Kong's innovative drug companies and recent liquidity improvements in the market [3] - The current pharmaceutical market is characterized by a positive cycle of technological breakthroughs, policy support, and globalization, with significant growth in the number and value of overseas transactions by Chinese innovative drug companies [3][4] Future Outlook - The current innovative drug market is at a stage of heightened global competitiveness, with core stocks expected to maintain reasonable valuations without forming bubbles, allowing for potential earnings based on fundamental performance [4] - Key catalysts to watch for in 2025 include critical clinical data disclosures, overseas market authorizations for major products, performance realization of listed products, and new product negotiations with insurance [4]

2024 來凱醫藥環境、社會及管治報告 卓越治理，堅守責任使命 創新研發，不忘治癒初心 微光成炬，成就不凡人才 綠色經營，守護自然環境 行而不輟，播種善念於心 01 目录 | 關於本報告 | 02 | ESG 亮點績效 | | --- | --- | --- | | CEO 致辭 | 03 | 獎項與榮譽 | | 公司簡介 | 04 | | 卓越治理 堅守責任使命 | 合規經營與規範治理 | 08 | | --- | --- | | ESG 治理 | 12 | | 風險管理與內控 | 17 | | 商業道德與反貪污 | 18 | | 供應鏈管理 | 19 | 創新研發 不忘治癒初心 | 研發創新管理 | 22 | | --- | --- | | 推進臨床試驗與確保藥品安全 | 29 | | 信息安全與知識產權保護 | 34 | 微光成炬 成就不凡人才 | 來凱企業文化 | 38 | | --- | --- | | 員工雇傭 | 41 | | 員工培訓與發展 | 43 | | 職業健康與安全 | 45 | | 多元、平等與包容 | 48 | 行而不輟 播種善念於心 關鍵績效表 | | | | 廢棄物管理 | 6 ...

Financial Performance - Laekna, Inc. reported a revenue of $50 million for the fiscal year 2024, representing a 25% increase compared to the previous year[2]. - The company reported a significant increase in revenue, achieving a total of $500 million for the last quarter, representing a 25% year-over-year growth[1]. - The company anticipates a net profit margin of 10% for the fiscal year 2024, compared to a net loss of 5% in 2023[2]. - Other income increased by 128.7% from RMB 16.7 million in 2023 to RMB 38.2 million in 2024, primarily due to increased bank deposit interest income[50]. - Other losses decreased by 95.2% from RMB 6.3 million in 2023 to RMB 0.3 million in 2024, mainly due to a reduction in net foreign exchange losses[51]. - The company reported a net loss of RMB 254.3 million for the year, down from RMB 368.8 million in 2023[21]. - The total comprehensive loss for the year was RMB 242.9 million, compared to RMB 458.7 million in 2023[21]. Research and Development - The company has allocated $10 million for research and development of new oncology therapies in the upcoming fiscal year[4]. - The company plans to submit IND applications for LAE103 and LAE123 in Q2 and Q4 of 2025, respectively[15]. - The company is focused on strategic partnerships to accelerate the development and commercialization of its drug candidates to meet significant unmet medical needs[26]. - The company is actively expanding the indications for LAE002 (afuresertib) in other cancers, with ongoing clinical trials showing promising results in cervical and endometrial cancer patients[43]. - The company has established a comprehensive ActRII product portfolio, focusing on maximizing the development value of targeted ActRII receptor therapies[73]. Clinical Trials and Product Development - The company has initiated clinical trials for its new drug Afuresertib, targeting a market with an estimated value of $1 billion[5]. - LAE102, a monoclonal antibody targeting ActRIIA, is being developed for obesity treatment, with a Phase I SAD study completed in China involving 64 healthy participants[13]. - The Phase I SAD study showed encouraging safety and tolerability for LAE102, with no serious adverse events reported and most treatment-related adverse events being mild[13]. - The Phase III clinical trial AFFIRM-205 for LAE002 (afuresertib) commenced in China in May 2024, targeting HR+/HER2–LA/mBC patients[17]. - The company aims to complete subject recruitment for the AFFIRM-205 trial by Q4 2025 and submit a New Drug Application (NDA) to the CDE in H1 2026[17]. - The company plans to initiate a Phase I MAD study in March 2025 in China, involving 60 overweight/obese participants to further assess LAE102's safety and pharmacokinetics[14]. Market Expansion and Strategy - Laekna, Inc. plans to expand its market presence in Asia, aiming for a 30% increase in market share by 2025[6]. - The company is considering strategic acquisitions to bolster its market position, with a budget of $200 million allocated for potential deals[7]. - The company is exploring potential combination therapy opportunities between existing approved drugs and traditional therapies[74]. - The global obesity patient population is expected to exceed 1.21 billion by 2030, highlighting significant market opportunities in obesity and cancer treatment[27]. Financial Management and Corporate Governance - The company has a disciplined financial strategy to maintain a healthy financial status and stable cash flow amid a challenging macroeconomic environment[70]. - The board consists of three executive directors, two non-executive directors, and three independent non-executive directors, ensuring a balanced governance structure[194]. - The company is committed to maintaining high standards of corporate governance, as evidenced by the qualifications of its board members[103]. - The company has adopted a board diversity policy to enhance competitive advantage and ensure a balanced composition of the board[200]. Employee and Management - The company has a strong management team with members holding various qualifications, including CPA and CFA certifications[99]. - The company has been expanding its leadership team with experienced professionals from reputable financial institutions[95][96]. - The group has 86 employees, emphasizing the importance of personal development and stable employee relations without any significant labor disputes[169]. Shareholder and Equity Information - The total number of issued shares is 407,736,350, with Dr. Lu holding 33,739,390 shares, representing 8.27% of the company's equity[130]. - Major shareholders include OrbiMed Asia Partners III, L.P. with 49,148,000 shares, accounting for 12.05% of the company's equity[134]. - The company has not issued any stock options under the pre-IPO or post-IPO stock option plans during the reporting period[162].

Core Insights - The article highlights the collaboration between Lai Kai Pharmaceutical and Eli Lilly for the LAE102 clinical trial targeting obesity in the U.S. [1][2] - Lai Kai's LAE102 is a monoclonal antibody targeting ActRIIA, entering clinical trials alongside Eli Lilly's Bimagrumab, indicating a competitive landscape in the obesity treatment sector [1][3][9] - Eli Lilly is intensifying its focus on ActRII targets, launching multiple clinical trials for Bimagrumab in a short timeframe, reflecting confidence in its potential [3][6] Company Developments - Lai Kai Pharmaceutical has updated its clinical trial protocol for LAE102, which is set to begin patient enrollment by the end of April 2025 [1][2] - The partnership with Eli Lilly allows Lai Kai to retain global rights for LAE102 while Eli Lilly manages the trial in the U.S. [1] - Lai Kai's ongoing Phase I trials in China have shown promising safety and tolerability results, with no severe adverse events reported [12] Industry Trends - Eli Lilly's strategy to combine Bimagrumab with other treatments aims to address the muscle loss associated with GLP-1 weight loss drugs, positioning it as a leading player in the metabolic drug market [4][6] - The ActRII target is gaining traction as a promising area for drug development, with both Lai Kai and Eli Lilly actively pursuing research in this space [8][13] - The competitive landscape is evolving, with Lai Kai's differentiated approach to targeting ActRIIA potentially offering advantages over Eli Lilly's dual-target Bimagrumab [9][11] Market Potential - The article suggests that Lai Kai Pharmaceutical, with a market capitalization of 5 billion HKD, has significant growth potential in the metabolic drug sector as it advances its clinical pipeline [15] - The increasing focus on ActRII as a target for obesity treatment reflects broader industry trends towards innovative solutions for weight management [4][14]