Afuresertib

北京时间2025年12月22日——来凯医药（2105.HK）今天宣布：LAE102针对肥胖症治疗的中国I期临床试验实现重大进展——继I期多剂量递增研究（MAD研究）取得积极初步结果后，I期多剂量扩展研究受试者入组工作已按计划启动，并完成了首位受试者给药。 该I期多剂量扩展研究为： 一项随机、双盲、安慰剂对照研究 旨在评估LAE102（皮下注射）在超重/肥胖受试者中的安全性、耐受性、药代动力学及药效学特性 60名受试者将随机分配至LAE102组或安慰剂组，接受为期6个月的治疗 此前LAE102 I期MAD研究（每周皮下给药一次，持续5周）已展现出令人鼓舞的增肌减脂趋势、良好的耐受性和安全性，以及强有力的药代动力学。 (点击查看:公告 | 来凯LAE102 I期临床MAD研究取得积极初步结果) 在此基础上，本次多剂量扩展研究按预先规划，旨在进一步评估更长时间（6个月）持续治疗后的疗效与安全性特征。 — End — 关于LAE102 向上滑动预览 ActRIIA是在肌肉再生和脂肪代谢中发挥重要作用的受体。LAE102是来凯自主研发针对ActRIIA的单克隆抗体，在临床前模型中已显示出增加肌肉并减少脂肪的效果。LAE102与GLP-1受体激动剂联用可进一步减少脂肪并显著降低GLP -1受体激动剂导致的肌肉流失，使LAE102成为一种高质量体重控制候选药物。 关于来凯医药 向上滑动预览 股份代码：2105.HK 来凯医药是一家以科学为驱动、处于临床阶段的生物医药科技公司，致力于为全球代谢疾病、癌症及肝纤维化患者带来新型疗法。 截至2025年6月30日，来凯医药围绕LAE102、LAE002(afuresertib)等启动了七项临床试验，以解决肥胖症及癌症领域未被满足的医疗需求。 LAE102是来凯自主研发针对ActRIIA的单克隆抗体。阻断Activin-ActRII通路可促进肌肉再生和减少脂肪，这使LAE102有望成为一种实现高质量体重控制的候选药物，目前针对肥胖适应症的I期临床研究正在中美两国全速推进。2024年11月，来凯与礼来签订一项临床合作协议，旨在支持和加速LAE102针对肥胖症治疗的全球临床开发。 除LAE102，LAE103是我们自主研发的ActRIIB选择性抗体，LAE123是ActRIIA/IIB双重拮抗型单克隆抗体。来凯医药已建立全面的ActRII产品组合，并正积极推动上述候选药物作为肌肉类及其他疾病适应症的新型疗法进入临床研究。 在癌症领域，来凯已经建立全面的候选药物组合，包括LAE002(afuresertib)、LAE001及多种临床及临床前候选药物。LAE002(afuresertib)是一种AKT强效抑制剂，抑制所有三种AKT亚型（AKT1、AKT2及AKT3），也是全球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。目前来凯医药针对HR+/HER2-乳腺癌III期关键研究（AFFIRM-205）顺利推进中。 2023年6月29日,来凯医药在香港联合交易所有限公司（“香港交易所”）主板上市，股份代码：2105.HK。 如需了解更多公司信息，请访问http://www.laekna.com 前瞻性声明 向上滑动预览 本新闻稿有若干前瞻性陈述，该等前瞻性陈述并非历史事实，乃基于来凯医药的现有看法、假设和期待而对未来事件做出的预测，通常会使用“将”、“可能”、“期望”、“相信”、“计划”、“预估”、“预测“及其他类似词语进行表述。尽管本公司相信所做的预测合理，但是基于未来事件固有的不确定性，我们的实际未来业绩或表现可能与预测有重大差异。因此，您应注意，依赖任何前瞻性陈述可能导致已知及未知的重大风险和不确定性。本新闻稿载有的所有前瞻性陈述需参照本部分所列的提示声明。本新闻稿所载的所有信息仅以截至本新闻稿做出当日为准，且仅基于当日的假设，除法律有所规定外，本公司概不承担义务对该等前瞻性陈述更新。

Dec 22, 2025 —Laekna, Inc. (2105.HK) today announced that following the positive results observed in the Phase I MAD study, the company has commenced study recruitment in Phase I Multiple Dose Expansion study of LAE102 in China for the treatment of obesity and the first subject has been dosed. The Phase I Multiple Dose Expansion study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LAE102, administered subcutaneously, in 60 overweight/obese subjects. Enrolled subjects will be randomized into LAE102 or placebo for a 6-month treatment. The preliminary results of the Phase I MAD study of LAE102 (administered subcutaneously weekly for 5 weeks) demonstrated an encouraging trend towards lean body mass increase and fat mass reduction, a well-tolerated safety profile and robust PK/PD (Read more). The pre-planned study was initiated to further evaluate the efficacy and safety profile of LAE102 over a longer treatment duration (6 months). – End – Contact Us IR ir@laekna.com Corporate and Business Development BD@laekna.com About LAE102 LAE102 is an internally discovered monoclonal antibody selectively targeting ActRIIA, a receptor that plays an important role in muscle regeneration and lipid metabolism. In the pre-clinical models, LAE102 has been shown to increase lean mass and decrease fat mass. In combination with GLP1R agonist, LAE102 can further reduce fat mass and significantly regain the lean mass loss induced by GLP1R agonist. This positions LAE102 as a promising drug candidate for achieving quality weight control. About Laekna Stock Code: 2105.HK Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapeutics to patients with metabolic diseases, cancer and liver fibrosis around the world. As of June 30, 2025, Laekna has initiated seven clinical trials for LAE102, LAE002 (afuresertib) and other drug candidates to address unmet medical needs in obesity and cancers. LAE102 is our internally discovered antibody against ActRIIA. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass, this positions LAE102 as a promising drug candidate for achieving quality weight control. We are advancing the Phase I clinical trials for obesity indication in both China and the U.S. In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company to support and accelerate global clinical development of LAE102 for the treatment of obesity. In addition to LAE102, LAE103 is our internally discovered ActRIIB-selective antibody, LAE123 is an ActRIIA/IIB dual antagonistic monoclonal antibody. Laekna has established a comprehensive ActRII portfolio and is actively advancing these drug candidates to clinical studies as novel therapies for muscle and other disease indications. In the cancer area, Laekna has built a comprehensive portfolio of drug candidates including LAE002(afuresertib), LAE001 and other clinical and pre-clinical drug candidates. LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 in patients with HR+/HER2- breast cancer and the study recruitment is on track. Laekna, Inc. (2105.HK) was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023. For more information, please visit: https://www.laekna.com/ or https://www.linkedin.com/company/74110713/ Forward-Looking Statements This press release may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on Laekna’s current beliefs, assumptions and expectations, commonly identified by words such as "would", "may", "expects", "believes", "plans", "intends", "projects" and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law.