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]

Group 1 - The Hong Kong pharmaceutical stocks showed a strong performance, with notable gains in several companies [1] - Zai Lab (09688.HK) experienced a significant increase of 13.51% [1] - Other companies such as LianKe Pharma-B (02105.HK) and Kintor Pharmaceutical (02137.HK) also saw substantial rises of 10.34% and 6.17% respectively [1][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 LAE102針對肥胖症治療的IND臨床方案修訂版已遞交美國FDA LAE102是自主研發針對Act RIIA的單克隆抗體，Act RIIA是在肌肉再生和脂肪代謝 中發揮重要作用的受體。在臨床前模型中，LAE102已顯示出增加肌肉並減少脂肪 的效果。LAE102與GLP -1受體激動劑聯用可進一步減少脂肪並顯著降低GLP -1受 體激動劑導致的肌肉流失，使LAE102成為一種高質量體重控制候選藥物。 – 1 – 風險提示 LAE102最終不一定能夠成功開發及商業化。本公司股東及潛在投資者於買賣本公 司證券時務請審慎行事。 承董事會命 來凱醫藥有限公司 主席 本 公 告 由 來 凱 醫 藥 有 限 公 司（「 本 公 司 」， 連 ...

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） 自願公告 LAE102針對肥胖症治療的I期 多劑量遞增研究完成首例受試者訪視 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。 本公司董事（「董事」）會（「董事會」）欣然宣佈，本集團在中國開展的LAE102針對肥 胖症治療的I期多劑量遞增研究（「MAD研究」）已啟動受試者招募。截至本公告日 期，首例受試者完成了首次訪視。 MAD 研 究 是 一 項 隨 機 、 雙 盲 、 安 慰 劑 對照 研 究 ， 旨 在 評 估 皮 下 給 藥 的 LAE102 在 60名超重╱肥胖受試者中的安全性、耐受性、藥代 ...

Clinical Development - LAE102, a monoclonal antibody targeting ActRIIA for obesity treatment, received IND approval in Q2 2024 and initiated Phase I clinical trials in China ahead of schedule [3]. - The Phase I SAD study for LAE102 enrolled 64 healthy participants, demonstrating encouraging safety and tolerability with no severe adverse events reported [5]. - The company plans to initiate the Phase I MAD study for LAE102 in China in March 2025, focusing on 60 overweight/obese participants [6]. - The Phase III clinical trial AFFIRM-205 for LAE002 (afuresertib) in combination with fulvestrant for HR+/HER2- breast cancer is ongoing, with patient recruitment expected to complete by Q4 2025 [11]. - In the Ib study for LAE002, a confirmed objective response rate of 33.3% was observed among 18 patients with PIK3CA/AKT1/PTEN mutations [10]. - The collaboration with Eli Lilly aims to accelerate global clinical development of LAE102, with the US Phase I trial expected to start in Q2 2025 [4]. - The Phase I SAD study results indicated a significant and sustained increase in Activin A levels, demonstrating robust target inhibition [5]. - The company initiated a Phase II clinical trial for LAE002 (afuresertib) combined with LAE001 in mCRPC patients, showing a median rPFS of 8.1 months, significantly improved compared to 2-4 months in historical data [12]. - The company started a Phase II trial (PROFECTA-II) for LAE002 combined with paclitaxel in 150 platinum-resistant ovarian cancer patients, with a PFS of 5.4 months in the biomarker-positive subgroup [15]. - The company has initiated seven clinical trials targeting LAE102, LAE002 (afuresertib), LAE001, and LAE005 to address unmet medical needs in obesity and oncology [56]. Financial Performance - The company reported a net loss of RMB 254.3 million for the year, down from RMB 368.8 million in the previous year [19]. - The total comprehensive loss for the year was RMB 242.9 million, compared to RMB 458.7 million in the prior year [19]. - Total revenue for 2024 reached RMB 38,169 million, a significant increase from RMB 16,742 million in 2023, representing a growth of 128.3% [22]. - The company reported a basic and diluted loss per share of RMB 0.71 for 2024, an improvement from RMB 1.68 in 2023 [22]. - The company’s financial cost increased to RMB 3,024 million in 2024 from RMB 1,727 million in 2023, representing a rise of 75.1% [22]. - The company’s total liabilities decreased slightly to RMB 811,564 million in 2024 from RMB 812,541 million in 2023, a reduction of 0.1% [23]. - The company reported a total revenue of RMB 99,010 thousand from bank loan income in 2024, which is an increase of 82.1% compared to RMB 54,400 thousand in 2023 [24]. - Other income increased by RMB 21.5 million or 128.7% in 2024, reaching RMB 38.2 million, primarily due to increased bank deposit interest income [93]. - The company incurred interest expenses on bank loans amounting to RMB (2,732) thousand in 2024, up from RMB (1,359) thousand in 2023, reflecting a rise of 100.5% [24]. Research and Development - The company reported significant progress in clinical and preclinical development of drug candidates targeting muscle and other disease indications [7]. - Research for LAE103 and LAE123 IND-enabling studies has commenced, with IND applications planned for Q2 and Q4 of 2025 [16]. - R&D expenses decreased by RMB 15.4 million or 6.7% from RMB 230.5 million in 2023 to RMB 215.1 million in 2024, focusing on priority clinical projects [19]. - The company aims to present Phase I SAD data for LAE102 at a scientific conference in 2025 [18]. - The company is actively expanding the indications for LAE002 (afuresertib) through other clinical trials, including a phase I study in combination with sintilimab for solid tumor patients previously treated with PD-1/PD-L1 therapy [86]. Strategic Partnerships - The company plans to seek strategic partners to support the further development of LAE002 and LAE001 [15]. - The company plans to seek strategic partnerships to accelerate the development and commercialization of its candidate drugs to meet significant unmet medical needs [61]. - A clinical collaboration agreement has been established with Eli Lilly to support and accelerate the global clinical development of LAE102 for obesity treatment [123]. Market and Product Development - The global obesity patient population is expected to exceed 1.2 billion by 2030, highlighting the urgent need for effective treatments [62]. - Significant unmet medical needs exist in cancer treatment, particularly for HR+/HER2- metastatic breast cancer, mCRPC, PROC, and triple-negative breast cancer (TNBC) due to limited efficacy of standard of care (SOC) options [63]. - The company has made substantial progress in its pipeline and business operations, achieving key milestones and accomplishments as of December 31, 2024 [67]. - The company has established a comprehensive ActRII product portfolio to maximize the development value of targeting ActRII receptors [121]. - The company plans to advance multiple innovative drug candidates, aiming to introduce one candidate into clinical stages each year [122]. Corporate Governance and Financial Management - The audit committee has reviewed the accounting principles and policies adopted by the group and discussed internal controls and financial reporting matters [134]. - The company has adopted corporate governance principles and has complied with all relevant rules during the reporting period [126]. - The board will continue to review the effectiveness of the corporate governance structure to assess the need for separating the roles of chairman and CEO [127]. - The group has adopted a prudent financial policy to maintain optimal financial conditions and minimize financial risks [103].

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。 香港，2025年3月10日 來凱醫藥有限公司 Laekna, Inc. 於本公告日期，執行董事為呂向陽博士、謝玲女士及顧祥巨博士；非執行董事為 王國瑋博士及孫淵先生；獨立非執行董事為尹旭東博士、利民博士及周健先生。 來凱醫藥有限公司（「本公司」）董事（「董事」）會（「董事會」）宣佈，董事會會議將於 2025年3月24日（ 星期一 ）舉行，旨在（ 其中包括 ）考慮及批准本公司及其附屬公司 截至2024年12月31日止年度的全年業績及其刊發。 承董事會命 來凱醫藥有限公司 主席 呂向陽博士 （於開曼群島註冊成立之有限公司） （股份代號：2105） 董事會會議日期 ...

來凱醫藥有限公司 Laekna, Inc. 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。 – 1 – 60名超重╱肥胖受試者中的安全性、耐受性、藥代動力學和藥效動力學。本集團 致力於將這種精準治療帶給那些需要新型治療選擇以實現高質量體重控制的超重 和肥胖症患者。 關於LAE102 LAE102是自主研發針對Act RIIA的單克隆抗體，Act RIIA是在肌肉再生和脂肪代謝 中發揮重要作用的受體。在臨床前模型中，LAE102已顯示出增加肌肉並減少脂肪 的效果。LAE102與GLP -1受體激動劑聯用可進一步減少脂肪並顯著降低GLP -1受 體激動劑導致的肌肉流失，使LAE102成為一種高質量體重控制候選藥物。 （於開曼群島註冊成立之有限公司） （股份代號：2105） 自願公告 LAE102針對肥胖症治療的I期 單劑量遞增研究（SAD研究）已成功完成 本 公 告 由 來 凱 醫 藥 有 ...