医药行业观点更新&来凯医药深度汇报 20250709 莱凯医药 L1A102 在激活素受体通路上选择性更强，安全性更优，可皮 下给药。一期临床数据显示安全性良好，多剂量递增研究正在进行中， 预计 2023 年三季度读出数据（注：原文时间，需更新）。 AKT 抑制剂是癌症治疗的重要手段，AZ 公司的 Kapi 已获 FDA 批准上 市，2024 年销售额达 4.3 亿美元。莱凯医药的 AKT 抑制剂正进行乳腺 癌三期临床，计划明年上半年申报上市，早期数据显示 PFS 与 AZ 数据 相当。 创新药泡沫化问题以及中国与美国 FDA 之间的差距如何影响未来发展？ 创新药目前尚未达到真正泡沫化阶段，与几年前中国疫苗产业相比仍有较大差 距。此外，中国临床及研发效益不断提升，但与美国 FDA 之间仍未完全接轨， 这意味着中国创新药改革仍有空间和余地。临床前研发效率提升空间依然存在， 美国市场对中国产品认可度和开放程度也支撑了创新药发展的底层逻辑。因此， 布局创新药仍是值得关注的方向。 摘要 创新药市场情绪回暖，下半年 BD 事件或将增多，与 2018 年医药行业 景气度回升相似，中国创新药和药政改革成果逐步显现，但尚未达 ...

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]

公司简介 来 凯 医 药（ 2105.HK ） 成⽴于 2016 年 ， 是⼀家 临 床 阶 段的⽣物技 术 公司 。 公司⽬前 拥 有 19 个 产 品候 选 , 多款 产 品 处 于 临 床 阶 段或 IND 批准状 态，产品包括 LAE002 （ 是全球仅有的两种处于晚期 临 床开 发阶 段的 针对 乳腺癌及前列腺 癌 的 AKT 抑制 剂 之⼀ ）和 LAE102 （ 全球第⼀个进⼊ 肥胖症治疗 临床阶段的 ActRIIA 特异性抗体 ）等等。产品应⽤ 覆盖 癌症（如卵巢癌，前列腺癌），代谢（肥胖症）和肝纤维化 等重⼤未 满 ⾜医 疗 需求 领 域。 CEO 兼 创 始⼈ 吕 向阳博⼠（持股 约 13% ） ： 拥 有超 20 年全球新 药 研 发 和企 业 管理 经验 ， 曾在 诺华 （ Novartis: 全球 TOP5 ⼤型制药公司）美国 总 部担任副 总 裁 ， 具 备 极 强 的管 线 判断⼒与 BD （商 业 开 发 ） 执 ⾏⼒。 管理层中， CSO 顾 祥巨博⼠ 同 样 来⾃ 诺华 ，⽽研发副总裁团队成员多数具 备辉 瑞、默沙 东 等欧美⼀ 线药 企背景， 拥 有 从 PCC （ 临 ...

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]

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 ...