52周新高排行 | 股票名称 | 收盘价 | 最高价 | 创高率 | | --- | --- | --- | --- | | 景联集团(01751) | 0.510 | 0.840 | 40.00% | | 中国稀土(00769) | 0.680 | 0.690 | 23.21% | | 友谊时光(06820) | 1.180 | 1.180 | 22.92% | | 森浩集团(08285) | 0.035 | 0.038 | 22.58% | | 玮俊生物科技(00660) | 0.169 | 0.199 | 17.06% | | 中国白银集团(00815) | 0.510 | 0.540 | 16.13% | | 金斯瑞生物科技(01548) | 16.980 | 17.140 | 13.66% | | 帝王实业控股(01950) | 0.350 | 0.425 | 13.33% | | 布鲁可(00325) | 193.300 | 198.000 | 13.14% | | 诺诚健华(09969) | 13.160 | 13.720 | 12.64% | | 阿里影业(01060) | 1.060 | 1 ...

报道指出，从2025年美国糖尿病学大会(ADA)议程可以看到，关于Bima的专题研讨会时长有一个半小 时，包括5个主题演讲、问答和小组讨论。其中，备受市场期待的莫过于Bima联合司美格鲁肽的2期试 验数据读出，研究主要目的为对比Bima联合司美和司美单药的疗效和安全性，研究主要试验终点是48 周时的体重变化。次要试验终点包括腰围、体脂肪、内脏脂肪(VAT)、皮下脂肪(SAT)、躯干脂肪、瘦体 重、腰高比、安全性等。 在本次2025 ADA大会上，潜在Bic分子来凯医药LAE102首次公布人体临床数据。与Bima一起，两大分 子将向市场呈现各自的风采。值得注意的是，礼来无论是在Bima还是LAE102中都扮演着重要的角色， 一方面礼来大价钱收购Bima积极推动临床，另一方面又与来凯医药达成临床合作，负责LAE102在美国 针对肥胖症治疗的一项I期临床研究，5月下旬已完成首位受试者给药预计2025年9月完成主要研究阶 段。 智通财经APP获悉，来凯医药-B(02105)午前涨超4%，截至发稿，涨4.07%，报19.94港元，成交额1.33亿 港元。 消息面上，据瞪羚社报道，礼来的ActRIIA/B抗体Bimagu ...

2024 年，公司研发费用2.15 亿元，与2023 年相比保持稳定，费用管控稳健，2024 年整体发展符合预 期。同时公司现金及等价物在手约人民币8 亿元，充足现金流可保障未来运营。公司核心产品LAE102 的I 期SAD 试验结果可观，为I 期MAD 试验做良好铺垫，同时与礼来开展合作进一步提升国际影响力； LAE002 临床试验持续推进，针对乳腺癌的III 期临床试验值得关注。我们认为，公司研发布局全球一体 化，管线结构均衡，未来可期。 事件 2024 年11 月20 日，公司发布公告，与礼来就LAE102 针对肥胖症治疗在美国开展临床合作。 2025 年3 月26 日，公司发布公告，LAE102 肥胖症的I 期临床完成MAD 研究首例受试者访视。 2025 年3 月24 日，公司发布2024 年业绩公告。 简评 全年经营符合预期，费用管控稳健 机构：中信建投证券 研究员：贺菊颖/袁清慧 核心观点 2024 年11 月，公司与礼来签订临床合作协议，礼来将负责在美国执行一项I 期研究并承担相关费用， 美国I 期临床试验预计于2025 年第二季度开始。2025 年3 月，公司计划在中国启动I 期MAD 研究 ...

以科学驱动创新，专注癌症与代谢性疾病领域的全球化生物技术公司 港股公司报告 | 首次覆盖报告 来凯医药-B（02105） 证券研究报告 瞄准减重增肌新兴赛道，LAE102 未来可期 来凯医药成立于 2016 年，总部位于中国，致力于为全球癌症、代谢性 疾病及肝纤维化患者开发具有突破性的创新疗法。公司于 2023 年 6 月 在香港交易所成功上市，凭借其强大的科研能力和国际化布局迅速崭露 头角。来凯医药目前已启动包括 LAE102、LAE002（Afuresertib）、LAE001 和 LAE005 在内的七项临床试验，专注于解决肥胖和肿瘤治疗领域未被 满足的医疗需求。 全球首创 ActRIIA 单克隆抗体，助力减重领域突破肌肉流失困境 LAE102 是来凯医药自主研发的全球首创 ActRIIA 单克隆抗体，旨在解决 GLP-1 受体激动剂减重疗法中常见的肌肉流失问题。GLP-1 类药物在减 重领域展现出良好的效果，但其副作用之一是导致显著的肌肉流失，影 响患者的代谢健康和长期体重维持。LAE102 通过靶向 ActRIIA 受体，有 效抑制肌生成抑制素和 GDF11 的活性，从而促进肌肉生长、减少脂肪 堆积 ...

对此，世界卫生组织独家回应《人民财讯》称，自2022年以来，世卫组织一直在针对不同年龄组制定一 套关于肥胖预防、护理和治疗的新指南。 有传闻称"世卫组织计划首次将减肥药纳入基本药物目录以治疗成人肥胖症"。 目前，关于使用GLP-1 RA和GLP-1 RA/GIP双受体激动剂治疗成年肥胖患者的指南，正按照指南审查委 员会的程序进行全面制定，预计在2025年8月或9月会出台最终方案。 该指南的目的在于明确GLP 1 RAs的临床适应症、应用以及规划方面的考量，包括这类药物如何以及在 何时能够作为包括临床干预和生活方式干预的慢性病管理模式的一部分加以应用。 另外，上述药物目前正由世界卫生组织基本药物选择与使用专家委员会进行评审。该专家委员会的评审 流程独立于指南制定程序，旨在评估多种药物是否应纳入《世界卫生组织基本药物标准清单》和《世界 卫生组织儿童基本药物标准清单》。 这两份清单为国家或地区采购机构提供指导，帮助其选择符合人群优先健康需求的药物。 中信证券研报认为，海外巨头的业绩持续超预期以及国内研发进展的加速，减肥药的产业趋势有望进一 步明确。预计后续海外巨头业绩预期指引&重磅药物销售数据超预期、海外GLP-1 ...

有业内人士表示，和过去相比，本轮创新药板块的行情更加理性。首先是产业趋势和政策导向更加明 晰，市场信心有所提升；其次，很多重点公司的核心品种已经上市或者已有关键临床数据验证，投资胜 率大幅提高；第三，部分龙头公司即将跨越盈亏平衡点，进入业绩兑现周期，估值稳定性显著提升。 医药主题基金走强 □本报记者 魏昭宇 今年一季度末，多只重仓人形机器人板块的主动权益类基金的业绩还"遥遥领先"，近期重仓创新药板块 的基金则脱颖而出。截至4月27日，基金经理张韡管理的汇添富香港优势精选混合（QDII）A以64.44% 的年内回报率，成为目前年内表现最好的公募产品。 医药行情的走强带动了医药主题基金的净值上涨，其中创新药赛道的涨势尤其明显。以汇添富香港优势 精选混合（QDII）为例，该基金前十大重仓股中，已经出现了多只牛股。比如，其第一大重仓股荣昌 生物近期股价一路走强，其港股股价今年以来的涨幅已经超过200%。再比如，信达生物今年以来的涨 幅接近50%。 研发方面的重要突破成为了医药行情的重要催化剂。4月25日，康方生物宣布，公司独立自主研发的全 球首创PD-1/VEGF双特异性抗体新药依达方（通用名：依沃西单抗注射液）单药 ...

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].

2025年4月，一则来自全球临床试验注册平台ClinicalTrials网站的信息显示，港股上市的Biotech公司来凯医药更新了其自研管线LAE102针 对肥胖症在美国的一项I期临床试验(NCT06908707)的相关信息。 一个引人注意的变化是：修订后的临床方案，出现了合作伙伴礼来的名字。 同时，来自ClinicalTrials网站的信息也显示，该研究计划于2025年4月底启动临床入组，预计在2025年8月结束。 LAE102是一款来凯医药自主研发的靶向激活素II型受体A(ActRIIA)的单克隆抗体，也是全球范围内除了礼来的Bimagrumab之外，为数不 多的已经进入临床试验阶段的靶向ActRII的在研管线。 目前来凯LAE102在中国的I期临床试验正全速推进：继单剂量递增部分(SAD研究)之后，2025年3月多剂量递增研究(MAD研究)已完成首 例受试者访视。 根据医药投资部落的数据库显示，去年11月，来凯医药与礼来公司签署了临床合作协议，礼来将负责在美国执行LAE102的一项I期临床试 验并承担相关费用，而来凯医药保留了LAE102的全球权益。 此次来凯医药向FDA提交的临床方案修订版，正是对应于 ...

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].

证券时报网讯，港股通标的中，来凯医药-B以14.55%的涨幅领跑市场，紧随其后的是康师傅控股和极 兔速递-W，分别录得9.42%和9.11%的涨幅。 此外，友宝在线和老铺黄金也表现不俗，涨幅分别为8.28%和6.98%。 百济神州、金山云、中国铝业和国泰航空的涨幅均在4%以上。 校对：冉燕青 金力永磁和鸿腾精密分别上涨6.94%和6.51%，中兴通讯和建滔积层板的涨幅也超过了6%，安踏体育和 东岳集团的涨幅分别为5.78%和5.95%，中芯国际和统一企业中国的涨幅分别为5.24%和5.12%。 ...