来凯医药 20260319 摘要 LAE102(ActRIIA)中美一期数据亮眼：中国 MAD 组 4 周瘦体重增加 4.6%，脂肪减少 3.6%；美国 SAD 组瘦体重增加>5%，脂肪减少 >2%，安全性良好且无种族差异。 LAE102 研发提速：24 周单药 MAD 扩展试验 60 例受试者已于 2026 年 1 月入组，预计 Q3 读出数据；与 GLP-1 联用二期临床即将启动，旨 在实现增肌减脂高质量减重。 AKT 抑制剂 LAE002(Afuresertib)商业化在即：三期临床已完成入组， 预计 2026Q2 读出顶线数据并递交 NDA，目标 2027 年上市；齐鲁制 药负责大中华区销售。 LAE002 财务预期：与齐鲁协议总额 20.45 亿元，首个适应症获批前可 获 5.3 亿元；参考阿斯利康同类药，预计海外销售峰值可达 10-20 亿美 元，公司正寻求海外 BD。 管线梯队清晰：LAE103(ActRIIB)一期 SAD 预计 2026Q3 读出数据； 双抗 LAE123 计划 2026 年递交 IND；口服 GIPR 激动剂 LAE124 预计 2026 年完成 PCC。 Q&A 我是公司 ...

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 分 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。 Laekna, Inc. 來凱醫藥有限公司 （於開曼群島註冊成立之有限公司） （股份代號：2105） 截 至2025年12月31日 止 年 度 的 年 度 業 績 公 告 來 凱 醫 藥 有 限 公 司 董 事 會 欣 然 公 佈 本 集 團 截 至2025年12月31日 止 年 度 的 綜 合 年 度 業 績，連 同 截 至2024年12月31日 止 年 度 之 比 較 數 字，載 列 如 下。 於 本 公 告 內，「我 們」指 本 公 司 及（如 文 義 另 有 所 指）本 集 團。本 公 告 所 載 若 干 金 額 及 百 分 比 數 字 已 經 約 整，或 約 整 至 小 數 點 後 一 位 或 兩 位 數。本 公 ...

Investment Rating - The report maintains an "Increase" rating for the pharmaceutical and biotechnology sector [5]. Core Insights - The pharmaceutical and biotechnology sector experienced a slight decline of 0.22% this week, ranking 13th out of 31 sectors, and a year-to-date decline of 0.13%, ranking 23rd out of 31 sectors [8]. - A significant milestone was achieved with the approval of the first invasive brain-computer interface medical device by the National Medical Products Administration, marking a transition from technical exploration to clinical application [9]. - The launch of a national major science and technology project for innovative drugs targeting Alzheimer's disease indicates a strong governmental focus on drug development for critical diseases in the central nervous system [10]. Summary by Sections 1. Market Observation - The pharmaceutical and biotechnology sector has seen a decline of 0.22% this week and 0.13% year-to-date, indicating a market correction [8]. 2. Industry Dynamics 2.1 Brain-Computer Interface Milestone - The approval of the brain-computer interface system by the National Medical Products Administration represents the first global launch of an invasive medical device, aimed at assisting patients with cervical spinal cord injuries [9]. 2.2 Alzheimer's Disease Drug Development - The initiation of a national project for innovative Alzheimer's drugs highlights the importance of addressing urgent clinical needs in the central nervous system, potentially leading to technological breakthroughs and industrial advancements [10]. 3. Company Dynamics 3.1 Kanglong Chemical - Kanglong Chemical announced a strategic partnership with Eli Lilly for the commercialization of the oral GLP-1 drug Orforglipron, receiving a $200 million investment to enhance its technical capabilities [11]. 3.2 Laika Pharmaceutical - Laika Pharmaceutical successfully completed Phase I SAD studies for LAE102 in the U.S. and is planning Phase II trials, indicating accelerated global development [12]. 3.3 Hotgen Biotech - Hotgen Biotech's innovative drug SGC001 has completed its first administration in Phase II clinical trials for heart attack treatment, marking significant progress in its development [13]. 3.4 East China Pharmaceutical - East China Pharmaceutical's HDM2024 has received FDA approval for Phase I clinical trials, targeting advanced solid tumors, enhancing its competitive position in oncology [14]. 3.5 Kelun Pharmaceutical - Kelun Pharmaceutical's SKB575 has been approved for clinical trials targeting atopic dermatitis, showcasing its potential as a best-in-class treatment with a long dosing interval [15]. 4. Areas of Focus - The report suggests focusing on the innovative drug supply chain and the brain-computer interface sector for potential investment opportunities [16].

Investment Rating - The report maintains an "Increase" rating for the pharmaceutical and biotechnology sector [5]. Core Insights - The pharmaceutical and biotechnology sector experienced a slight decline of 0.22% this week, ranking 13th out of 31 sectors, and a year-to-date decline of 0.13%, ranking 23rd out of 31 sectors [8]. - A significant milestone was achieved with the approval of the first invasive brain-computer interface medical device by the National Medical Products Administration, marking a transition from technical exploration to clinical application, which opens commercial opportunities in the field of neuroregulation and implantable medical devices [9]. - The launch of a national major scientific research project for innovative drugs targeting Alzheimer's disease indicates the government's commitment to addressing urgent clinical needs in the central nervous system, potentially accelerating technological breakthroughs and industrialization in this area [10]. Company Dynamics - Kanglong Chemical announced a strategic partnership with Eli Lilly for the commercialization of the oral GLP-1 drug Orforglipron, receiving a $200 million investment to enhance its technical capabilities [11]. - Laika Pharmaceuticals successfully completed Phase I SAD studies for LAE102 in the U.S. and is planning Phase II trials, indicating progress in global development [12]. - Hotgen Biotech's innovative drug SGC001 has completed its first administration in Phase II clinical trials for treating acute myocardial infarction, marking a significant advancement in this therapeutic area [13]. - East China Pharmaceutical's self-developed dual-target ADC drug HDM2024 has received FDA approval for Phase I clinical trials in the U.S., enhancing its competitiveness in the oncology field [14]. - Kelun Biotech's SKB575 has been approved for clinical trials targeting atopic dermatitis, showcasing its potential as a best-in-class treatment with a long dosing interval [15]. Suggested Focus Areas - The report suggests focusing on the innovative drug supply chain and the brain-computer interface sector for potential investment opportunities [16].

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。 Laekna, Inc. 來凱醫藥有限公司 （於開曼群島註冊成立之有限公司） （股份代號：2105） 療效方面，美國SAD研究顯示：單次給藥後，受試者身體組成部分呈現令人鼓舞 的改善趨勢，觀察到與劑量相關的增肌減脂效果。LAE102單次給藥後的第29天， 最高暴露量的組別其平均瘦體重較基線增加5.06 %（ 安慰劑組較基線減少1.34 % ）， 平均 脂肪 量較 基線 減少0.12 %（ 安 慰劑 組較 基線 增加2.11 % ）。 單次給 藥LAE102 導 致啟動素A水準顯著且持續地上升，顯示出強有力的靶點結合。靶點結合的持續 時間與劑量水準相關。本集團計劃在即將召開的科學會議上公佈詳細研究結果。 – 1 – 上述積極結果進一步支持LAE102作為心血管代謝疾病治療的創新療法。本集團正 積 極 規 劃 II 期 臨 床 試 驗 ， 以 ...

來凱醫藥有限公司 （於開曼群島註冊成立之有限公司） （股份代號：2105） 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 或任何部分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。 Laekna, Inc. 承董事會命 來凱醫藥有限公司 主席 呂向陽博士 香港，2026年3月6日 於本公告日期，執行董事為呂向陽博士、謝玲女士及顧祥巨博士；非執行董事為 王國瑋博士及孫淵先生；獨立非執行董事為尹旭東博士、利民博士及周健先生。 董事會會議日期 來凱醫藥有限公司（「本公司」）董事（「董事」）會（「董事會」）宣佈，董事會會議將於 2026年3月18日（ 星期三 ）舉行，旨在（ 其中包括 ）考慮及批准本公司及其附屬公司 截至2025年12月31日止年度的全年業績及其刊發。 ...

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 | 截至月份: | | --- | | 2026年2月28日 | | 狀態: | | 新提交 | 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 | 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： U ...

Core Insights - The anti-tumor drug industry is crucial for treating malignant tumors, with a shift from traditional chemotherapy to precision-targeted therapies driven by high cancer incidence globally and in China [1][2][5] Industry Overview - Anti-tumor drugs, also known as anti-cancer drugs, are designed to inhibit tumor cell growth and proliferation, playing a central role in systemic treatment for malignant tumors [2][3] - The industry is characterized by a transition towards innovative therapies such as immunotherapy and antibody-drug conjugates (ADCs), reflecting a global trend towards precision medicine [1][6] Development Background in China - China's cancer incidence and mortality rates are on the rise, with lung cancer, gastric cancer, and liver cancer being the most prevalent, creating a strong clinical demand [5][6] - The government has introduced various policies to support the development of the anti-tumor drug industry, including optimizing clinical trial approvals and enhancing drug accessibility through insurance [5][6] Current Market Analysis - The global anti-tumor drug market is projected to grow from $167 billion in 2020 to $295 billion by 2025, representing a cumulative growth of 76.7% [6][7] - In China, the anti-tumor drug market is expected to increase from 185.8 billion yuan in 2020 to 318.7 billion yuan by 2025, with a growth rate of 71.5% [8][9] Competitive Landscape - The Chinese anti-tumor drug industry features a competitive landscape where multinational companies lead in high-end markets while domestic firms are rapidly emerging [7][9] - Key domestic players like Heng Rui Medicine and BeiGene are making significant strides in core segments such as PD-1 inhibitors and small molecule targeted drugs [8][9] Future Trends - The industry is expected to focus on innovation, with a shift from generic drugs to original innovations and differentiated breakthroughs in areas like ADCs and cell therapies [10][11] - Domestic companies will continue to enhance their market share through policy support and cost advantages, while also working towards self-sufficiency in critical supply chains [11][12] - The regulatory environment will evolve to improve drug accessibility and quality, fostering a competitive ecosystem that prioritizes clinical value and patient affordability [12]

Core Viewpoint - The publication of the Phase 1b clinical study results for the AKT inhibitor Afuresertib (LAE002) in combination with Fulvestrant for HR+/HER2- advanced breast cancer demonstrates promising efficacy and safety, highlighting the potential for significant market opportunities in the treatment of this prevalent cancer subtype [1][3][18] Group 1: Clinical Study Insights - The Phase 1b study led by Academician Xu Binghe shows that Afuresertib combined with Fulvestrant exhibits potential efficacy and safety in patients with PIK3CA/AKT1/PTEN pathway alterations [1][5] - The ongoing Phase III study (AFFIRM-205) is expected to report data in the first half of 2026, with the Phase 1b results providing increased confidence for positive outcomes in the upcoming trial [1][15] - The Phase 1b study included a significant proportion of patients who had previously failed CDK4/6 inhibitor treatment, showcasing the potential of Afuresertib in this challenging patient population [7][8] Group 2: Market Potential - The global breast cancer drug market is projected to grow from approximately $38.2 billion in 2023 to $71.2 billion by 2032, with the HR+/HER2- subtype representing 60%-75% of breast cancer cases [3][16] - The market for second-line treatments for HR+/HER2- breast cancer, particularly those with PIK3CA/AKT1/PTEN alterations, is expected to be substantial, with estimates suggesting a market size of around 5 billion RMB [16] - Afuresertib's potential market share is estimated at 25%-30%, which could translate to sales peaks of approximately 1.5 billion RMB [16] Group 3: Competitive Landscape - Afuresertib's safety profile is highlighted as a competitive advantage over other AKT inhibitors like Capivasertib and Alpelisib, which have shown higher rates of adverse effects [11][12] - The Phase 1b study reported a 0% incidence of grade 3 hyperglycemia and a low rate of other adverse events, indicating a favorable safety profile that may enhance patient compliance [12][14] - The commercial success of Afuresertib is anticipated to be bolstered by its safety and efficacy, positioning it as a leading option in the AKT inhibitor market [11][14]

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。 ...