2月6日，《自然-通讯》杂志发表了一项徐兵河院士领衔、来凯医药AKT抑制剂Afuresertib（LAE002）联合氟维司群治疗经治HR+/HER2-晚期乳腺癌1b期临 床研究结果，该联合疗法在携带PIK3CA/AKT1/PTEN通路改变乳腺癌患者中展现出潜力的疗效、安全性结果。 该刊文的发表，不仅展现了该临床研究在设计严谨性、过程透明度、结果质量等达到了国际水平；徐院士在论文结尾强调了研究验证了Afuresertib （LAE002）组合的疗效前景和良好安全性表现，同时也一定程度揭示了齐鲁制药为何在即将到来的三期揭盲前就率先以不菲的交易金额先拿下来凯医药的 大中华区权益。 目前，来凯医药Afuresertib关键III期（AFFIRM-205）临床进行中，并有望在2026上半年读出数据并递交国内一类新药申请（NDA）。最新刊登的1b结果展 示了不少增量信心，给未来三期大概率阳性结果的读出注入了一剂强心剂。 01 开放性探索研究：AKT抑制剂的精准疗效 来凯医药Afuresertib的1b期及III期（AFFIRM-205）研究均针对HR+/HER2-乳腺癌患者，是乳腺癌领域最大的细分市场；HR+/HER2- ...

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。 ...

《自然-通讯》发布全文DOI：https://doi.org/10.1038/s41467-026-69225-2 在伴有PIK3CA/AKT1/PTEN通路改变的患者中，研究者评估的确认客观缓解率（confirmed ORR）为 33.3% 在ESR1突变并伴随PIK3CA/AKT1/PTEN通路改变人群中，确认客观缓解率（confirmed ORR）达42.9% 徐兵河院士团队在文章结论中表示，此次Ib研究证实，对于经治的HR+/HER2-晚期乳腺癌患者， LAE002（afuresertib）联合氟维司群治疗方案展现出有前景的疗效和良好的安全性。其疗效在 PIK3CA/AKT1/PTEN通路改变患者中尤为突出。LAE002（afuresertib）良好的安全性特征，以及便捷的 每日一次口服的给药方式，使其成为该患者群体一个颇具吸引力的治疗选择。这些数据有力地支持了 LAE002（afuresertib）在晚期乳腺癌治疗领域的进一步开发和应用。 目前，由徐兵河院士牵头的LAE002（afuresertib）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/A ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | | | 致：香港交易及結算所有限公司 公司名稱: 來凱醫藥有限公司 呈交日期: 2026年2月5日 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02105 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 5,000,000,000 | USD | | 0.00001 USD | | 50,000 | 本月底法定/註冊股本總額： USD 50,000 FF301 第 1 頁 共 10 頁 v 1.2.0 FF301 II ...

本文源自：金融界AI电报 来凯医药(2105.HK)放量大涨超18%，最高触及16.72港元，创逾一个月新高。 ...

Core Viewpoint - Lai Kai Pharmaceutical (2105.HK) experienced a significant increase of over 18%, reaching a peak of 16.72 HKD, marking a new high in over a month following the announcement of its new drug LAE118, which has been accepted for clinical trial application by the FDA [1] Group 1 - The new drug LAE118 is designed to treat PIK3CA mutation-related solid tumors, representing a novel therapy in this area [1] - LAE118 is characterized as a novel PI3Kα pan-mutant selective inhibitor, targeting PIK3CA mutated solid tumors [1] - The company plans to work closely with regulatory authorities to complete the relevant application process for LAE118 [1] Group 2 - The company has a proven track record in clinical development and licensing with LAE002 (afuresertib), which enhances its credibility in providing new treatment options [1] - Lai Kai Pharmaceutical is committed to offering precision treatments for cancer patients in need of new therapeutic solutions [1]

Group 1 - The stock of Kai Medical-B (02105.HK) experienced a significant increase, rising nearly 5% in the afternoon trading session, and is currently up by 3.04% at HKD 13.88 [1] - The trading volume reached HKD 19.9183 million, indicating active market participation [1]

Core Viewpoint - The stock of Lai Kai Pharmaceutical-B (02105) rose nearly 5% in the afternoon, currently up 3.04% at HKD 13.88, with a trading volume of HKD 19.9183 million. The company announced that its new drug LAE118, aimed at treating PIK3CA-mutated solid tumors, has received acceptance for clinical trial application by the FDA [1]. Group 1 - Lai Kai Pharmaceutical's LAE118 is a novel PI3Kα pan-mutant selective inhibitor designed for PIK3CA mutated solid tumors [1]. - The company plans to work closely with regulatory authorities to complete the relevant application process [1]. - The company aims to provide this precision therapy to cancer patients in need of new treatment options, leveraging its proven track record in clinical development and licensing of LAE002 (afuresertib) [1].

Core Viewpoint - The stock of Lai Kai Pharmaceutical-B (02105) rose nearly 5% in the afternoon trading session after the U.S. FDA accepted the clinical trial application for its new drug LAE118, which targets PIK3CA mutation solid tumors [1] Company Summary - Lai Kai Pharmaceutical announced that its new drug LAE118, designed to treat PIK3CA mutation solid tumors, has been accepted by the U.S. FDA for clinical trial application [1] - LAE118 is described as a novel PI3Kα pan-mutant selective inhibitor, representing a new therapeutic approach for PIK3CA mutated solid tumors [1] - The company plans to work closely with regulatory authorities to complete the relevant application process [1] - Lai Kai Pharmaceutical aims to provide this precision treatment for cancer patients in need of new therapeutic options, leveraging its successful track record in clinical development and licensing of LAE002 (afuresertib) [1]