公开资料显示，LAE002(Afuresertib)是来凯医药开发的一种AKT强效抑制剂。由徐兵河院士牵头的 LAE002联合氟维司群，针对治疗HR+/HER2-局部晚期或转移性乳腺癌(LA/mBC)伴随 PIK3CA/AKT1/PTEN通路改变患者的III期临床试验AFFIRM-205正顺利推进，2025年12月已经完成III期 入组，目标于今年上半年公布顶线数据，并计划今年年中向中国国家药品监督管理局药品审评中心提交 新药上市申请。2025年11月，来凯医药与齐鲁制药签订了中国地区独家许可协议，加速商业化 LAE002。 来凯医药(02105)午前涨超5%，截至发稿，涨4.82%，报12.82港元，成交额1253.32万港元。 消息面上，国际科学期刊《自然-通讯》(Nature Communications)2月6日在线发表了中国工程院院士、中 国医学科学院肿瘤医院徐兵河教授领衔的《Afuresertib联合氟维司群治疗经治HR+HER2-晚期乳腺癌： 一项Ib期试验》，表明该联合治疗方案在晚期乳腺癌患者中显示出令人鼓舞的抗肿瘤活性和良好的安全 性特征。 ...

智通财经APP获悉，来凯医药(02105)午前涨超5%，截至发稿，涨4.82%，报12.82港元，成交额1253.32 万港元。 公开资料显示，LAE002(Afuresertib)是来凯医药开发的一种AKT强效抑制剂。由徐兵河院士牵头的 LAE002联合氟维司群，针对治疗HR+/HER2-局部晚期或转移性乳腺癌（LA/mBC）伴随 PIK3CA/AKT1/PTEN通路改变患者的III期临床试验AFFIRM-205正顺利推进，2025年12月已经完成III期 入组，目标于今年上半年公布顶线数据，并计划今年年中向中国国家药品监督管理局药品审评中心提交 新药上市申请。2025年11月，来凯医药与齐鲁制药签订了中国地区独家许可协议，加速商业化 LAE002。 消息面上，国际科学期刊《自然-通讯》（Nature Communications）2月6日在线发表了中国工程院院 士、中国医学科学院肿瘤医院徐兵河教授领衔的《Afuresertib联合氟维司群治疗经治HR+HER2-晚期乳 腺癌：一项Ib期试验》，表明该联合治疗方案在晚期乳腺癌患者中显示出令人鼓舞的抗肿瘤活性和良好 的安全性特征。 ...

Core Viewpoint - The stock of Lai Kai Pharmaceutical-B (02105) opened over 4% higher following the announcement of an exclusive licensing agreement with Qilu Pharmaceutical for the commercialization of the breast cancer candidate drug LAE002 in China [1] Group 1: Licensing Agreement - Lai Kai Pharmaceutical has entered into an exclusive licensing agreement with Qilu Pharmaceutical to accelerate the commercialization of LAE002 (Afuresertib) for HR+/HER2- breast cancer in China [1] - The agreement includes a non-refundable upfront payment of up to RMB 530 million and milestone payments related to clinical development [1] - Additionally, Lai Kai is entitled to receive a tiered sales revenue share from future net sales in China, with the share percentage ranging from over ten percent to over twenty percent [1] Group 2: Clinical Trials - The Phase III clinical trial (AFFIRM-205) for LAE002 is currently progressing as planned, with patient recruitment ongoing [1]

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].