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。 ...

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。消息面上，来凯医药公 布，旗下有望治疗PIK3CA类乳腺癌突变实体瘤的新药LAE118，已获美国药监局(FDA)受理临床试验申 请。据介绍，LAE118是一种新型PI3Kα泛突变选择性抑制剂，为针对PIK3CA突变实体瘤的新型疗法。 公司将与监管机构紧密合作以完成相关申请。凭借其在临床开发和对外授权LAE002(afuresertib)的良好 及已验证的实绩，公司致力于为需要新型治疗方案的癌症患者提供这种精准治疗。 ...

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]

消息面上，来凯医药公布，旗下有望治疗PIK3CA类乳腺癌突变实体瘤的新药LAE118，已获美国药监局 (FDA)受理临床试验申请。公司介绍指LAE118是一种新型PI3Kα泛突变选择性抑制剂，为针对PIK3CA 突变实体瘤的新型疗法。 来凯医药-B(02105)午后涨近5%，截至发稿，涨3.04%，报13.88港元，成交额1991.83万港元。 公告称，公司将与监管机构紧密合作以完成相关申请。凭借其在临床开发和对外授权 LAE002(afuresertib)的良好及已验证的实绩，公司致力于为需要新型治疗方案的癌症患者提供这种精准 治疗。 ...

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]

Company News - CITIC Securities (06030.HK) reported a revenue of RMB 74.83 billion for the fiscal year 2025, representing a year-on-year increase of 28.75%, and a net profit of RMB 30.05 billion, up 38.46% year-on-year [2] - CITIC Bank (00998.HK) announced a total revenue of RMB 212.48 billion for 2025, a slight decrease of 0.55% year-on-year, while net profit increased by 2.98% to RMB 70.62 billion [2] - Beijing North Star Industrial (00588.HK) expects to continue reporting losses for the fiscal year ending December 31, 2025 [3] - Yuexiu Property (00123.HK) reported a cumulative contract sales amount of approximately RMB 106.21 billion for 2025, a decline of about 7.3% year-on-year, achieving 88.1% of its sales target [3] - Jiao Ge Peng You Holdings (01450.HK) achieved a total GMV of approximately RMB 6.49 billion in Q4 2025, a year-on-year increase of about 4.34%, with a cumulative GMV of RMB 16.02 billion for the year, up 6.23% [3] - Sai Jing Technology (00580.HK) anticipates a revenue of approximately RMB 2.25 billion for 2025, reflecting a year-on-year increase of about 40% due to increased revenue from flexible transmission business [3] - China General Nuclear Power New Energy (01811.HK) reported a cumulative power generation of 19,000 GWh for 2025, a decrease of 0.8% year-on-year, with variations in different energy sources [3] - Morning News Technology (02000.HK) reported an unaudited revenue of HKD 397 million for 2025, a decrease of 7.4% year-on-year [3] Financing and Buyback Activities - Chow Tai Fook Enterprises (00659.HK) applied for the registration of debt financing instruments totaling no more than RMB 5 billion [7] - Tencent Holdings (00700.HK) repurchased 1.006 million shares at a cost of approximately HKD 636 million, with repurchase prices ranging from HKD 626 to HKD 638 [7] - Xiaomi Group-W (01810.HK) repurchased 4 million shares for approximately HKD 151 million, with repurchase prices between HKD 37.61 and HKD 42.50 [7] Research and Development - Hutchison China MediTech (00013.HK) announced the publication of SACHI III study results in The Lancet [4] - Laka Pharmaceuticals-B (02105.HK) had its clinical trial application for the new drug LAE118 accepted by the U.S. FDA [5] Other News - Yuanxu Technology (08637.HK) announced a short suspension of trading starting January 14, pending the release of insider information [6] - Haidilao (06862.HK) redeemed USD 600 million of its 2.150% notes due in 2026 [2]