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]

来凯医药-B（02105）盘初涨近7%，截至发稿，股价上涨5.95%，现报14.24港元，成交额1561.68万港 元。 1月14日， 来凯医药宣布，美国食品药品监督管理局（FDA）已经受理LAE118的新药临床试验申请 （IND）。LAE118是来凯自主研发的一种新型PI3Kα泛突变选择性抑制剂，用于治疗PIK3CA突变的实 体瘤患者。PI3Kα突变在乳腺癌、结直肠癌、肺癌、子宫内膜癌和其它癌症患者中较为常见。目前全球 已获批的PI3Kα抑制剂对突变型没有选择性， 因对野生型有很强的活性而耐受性较差，且易产生耐药 性。 热点栏目 自选股 数据中心 行情中心 资金流向 模拟交易 客户端 来凯医药-B（02105）盘初涨近7%，截至发稿，股价上涨5.95%，现报14.24港元，成交额1561.68万港 元。 1月14日， 来凯医药宣布，美国食品药品监督管理局（FDA）已经受理LAE118的新药临床试验申请 （IND）。LAE118是来凯自主研发的一种新型PI3Kα泛突变选择性抑制剂，用于治疗PIK3CA突变的实 体瘤患者。PI3Kα突变在乳腺癌、结直肠癌、肺癌、子宫内膜癌和其它癌症患者中较为常见。目前全球 已获 ...

消息面上，1月14日， 来凯医药宣布，美国食品药品监督管理局（FDA）已经受理LAE118的新药临床 试验申请（IND）。LAE118是来凯自主研发的一种新型PI3Kα泛突变选择性抑制剂，用于治疗PIK3CA 突变的实体瘤患者。PI3Kα突变在乳腺癌、结直肠癌、肺癌、子宫内膜癌和其它癌症患者中较为常见。 目前全球已获批的PI3Kα抑制剂对突变型没有选择性， 因对野生型有很强的活性而耐受性较差，且易产 生耐药性。 智通财经APP获悉，来凯医药-B(02105)早盘涨近7%，截至发稿，涨5.88%，报14.23港元，成交额934.24 万港元。 ...

Core Viewpoint - The stock of Lai Kai Pharmaceutical-B (02105) experienced a significant increase, rising nearly 7% in early trading, with a current price of 14.23 HKD and a trading volume of 9.34 million HKD, following the announcement of the acceptance of their new drug clinical trial application by the FDA for LAE118 [1] Group 1: Company Developments - Lai Kai Pharmaceutical announced that the FDA has accepted the Investigational New Drug (IND) application for LAE118 on January 14 [1] - LAE118 is a novel PI3Kα pan-mutant selective inhibitor developed by Lai Kai, aimed at treating patients with PIK3CA mutations in solid tumors [1] Group 2: Industry Context - PI3Kα mutations are commonly found in patients with breast cancer, colorectal cancer, lung cancer, endometrial cancer, and other cancers [1] - Currently approved PI3Kα inhibitors globally lack selectivity for mutant types, exhibiting strong activity against wild types, which leads to poor tolerability and a high likelihood of developing resistance [1]

Core Viewpoint - The announcement highlights that the U.S. Food and Drug Administration (FDA) has accepted the clinical trial application for LAE118, a novel PI3Kα pan-mutant selective inhibitor aimed at treating patients with PIK3CA-mutated solid tumors [1] Company Summary - The company is committed to collaborating closely with regulatory authorities to complete the relevant application for LAE118 [1] - The company has a proven track record in clinical development and licensing with LAE002 (afuresertib), reinforcing its dedication to providing precision treatments for cancer patients in need of new therapeutic options [1] Industry Summary - LAE118 represents a new therapeutic approach in the oncology sector, specifically targeting PIK3CA mutations, which are prevalent in various solid tumors [1]

LAE118是一种新型PI3Kα泛突变选择性抑制剂。作为针对PIK3CA突变实体瘤的新型疗法，集团正积极 推进此候选药物进入临床研究。 智通财经APP讯，来凯医药-B(02105)发布公告，美国食品药品监督管理局已经受理 LAE118的新药临床 试验申请。LAE118是一种新型PI3Kα泛突变选择性抑制剂，用于治疗PIK3CA突变的实体瘤患者。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。 ...

香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 的 內 容 概 不 負 責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部 或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 本 公 司 將 與 監 管 機 構 緊 密 合 作 以 完 成 相 關 申 請 。 憑 藉 其 在 臨 床 開 發 和 對 外 授 權 LAE 002 (afuresertib)的良好及已驗證的實績，本公司致力於為需要新型治療方案的 癌症患者提供這種精准治療。 關於LAE118 LAE118是一種新型PI3Kα泛突變選擇性抑制劑。作為針對PIK3CA突變實體瘤的新 型療法，本集團正積極推進此候選藥物進入臨床研究。 – 1 – 風險提示 LAE118最終不一定能夠成功開發及商業化。本公司股東及潛在投資者於買賣本公 司證券時務請審慎行事。 （於開曼群島註冊成立之有限公司） （股份代號：2105） 來凱醫藥有限公司 Laekna, Inc. 自願公告 美國食品藥品監督管理局受理LAE118新藥臨床試驗申請 本 公 告 由 來 凱 醫 藥 有 限 ...