III期临床试验AFFIRM-205为一项多中心、随机、双盲、安慰剂对照的关键性研究，旨在评估该联合疗 法的抗肿瘤疗效及安全性。集团目标于2026年上半年公布此项III期关键研究的顶线数据，并于同年稍晚 时间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。集团与齐鲁制药有限公司已于2025年 11月12日签订独家许可协议。根据许可协议的条款及条件，齐鲁制药获得在中国地区(包括中国内地、 香港特别行政区、澳门特别行政区及台湾地区)进行LAE002(afuresertib)的研究、开发及商业化的独家许 可。 来凯医药-B(02105)发布公告，集团已完成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/AKT1/PTEN基因改变患者的III期临床试验AFFIRM-205入 组。 ...

III期临床试验AFFIRM-205为一项多中心、随机、双盲、安慰剂对照的关键性研究，旨在评估该联合疗 法的抗肿瘤疗效及安全性。集团目标于2026年上半年公布此项III期关键研究的顶线数据，并于同年稍晚 时间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。集团与齐鲁制药有限公司("齐鲁制 药")已于2025年11月12日签订独家许可协议。根据许可协议的条款及条件，齐鲁制药获得在中国地区 (包括中国内地、中国香港、中国澳门及中国台湾)进行LAE 002 (afuresertib)的研究、开发及商业化的独 家许可。 格隆汇12月15日丨来凯医药-B(02105.HK)发布公告，集团已完成LAE 002(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/AKT1/PTEN基因改变患者的III期临 床试验AFFIRM-205("III期临床试验AFFIRM-205")入组。 ...

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。 （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 LAE 002 (AFURESERTIB)針對HR + / HER2 -局部晚期或轉移性乳腺癌 之III期臨床試驗(AFFIRM -205)已完成入組 本 公 告 由 來 凱 醫 藥 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）自 願 作 出，以告知本公司股東及潛在投資者本集團最新業務進展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，本集團已完成LAE 002 (afuresertib)聯 合 氟 維 司 群 針 對 治 療 HR + / HER2 - 局 部 晚 期 或 轉 移 性 乳 腺 癌（「 LA / m BC 」）伴 隨 PIK3CA / AKT1 / PTEN基因 ...

除本次获批的二线治疗适应症外，库莫西利联合氟维司群用于一线HR+/HER2-乳腺癌适应症已于2025 年7月向NMPA递交上市申请，其辅助治疗适应症的Ⅲ期临床试验已完成全部患者入组，有望在未来两 年逐步获批上市。 在关键III期临床试验(TQB3616-III-01)中，库莫西利联合氟维司群方案展现出令人鼓舞的疗效。研究结 果显示，库莫西利联合氟维司群组的主要终点中位无进展生存期(mPFS)达16.62个月，较氟维司群组 (7.46个月)显着延长9.16个月，疾病进展或死亡风险降低64%(HR=0.36，p<0.0001)。客观缓解率(ORR)显 着提高(40.21%vs12.12%，p<0.0001)。在安全性方面，最常见的治疗相关不良事件(TRAEs)多为1-2级， 易于管理;≥3级骨髓抑制等血液学毒性小;未发生导致治疗终止或死亡的TRAEs，总体安全可耐受。 中国生物制药(01177)公布，集团自主研发的国家1类创新药库莫西利胶囊(商品名：赛坦欣)已获得中国 国家药品监督管理局(NMPA)的上市批准，用于与氟维司群联合治疗既往接受内分泌治疗后出现疾病进 展的激素受体(HR)阳性、人表皮生长因子受体2(H ...

Core Viewpoint - China Biologic Products (01177.HK) has received approval from the National Medical Products Administration (NMPA) for its self-developed innovative drug, Kumosily, for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer patients who have experienced disease progression after endocrine therapy [1][2]. Group 1: Drug Approval and Mechanism - Kumosily is a globally first-in-class triple inhibitor targeting CDK2/4/6, showing selective inhibition of CDK4 kinase, which helps delay resistance to CDK4/6 inhibitors and reduces the risk of bone marrow suppression [1]. - The drug has been approved for use in combination with Fulvestrant for second-line treatment [1]. Group 2: Clinical Trial Results - In the pivotal Phase III clinical trial (TQB3616-III-01), the combination of Kumosily and Fulvestrant demonstrated a median progression-free survival (mPFS) of 16.62 months, significantly extending the mPFS by 9.16 months compared to the Fulvestrant group (7.46 months) [2]. - The risk of disease progression or death was reduced by 64% (HR=0.36, p<0.0001), and the objective response rate (ORR) increased significantly to 40.21% compared to 12.12% (p<0.0001) [2]. - Most treatment-related adverse events (TRAEs) were manageable and of grade 1-2, with minimal grade ≥3 hematological toxicity, and no TRAEs leading to treatment discontinuation or death [2]. Group 3: Future Development and Pipeline - Besides the approved second-line indication, a first-line application for HR+/HER2- breast cancer has been submitted to NMPA, with expectations for approval by July 2025 [3]. - The company has completed patient enrollment for the Phase III clinical trial for the adjuvant treatment indication, aiming for gradual approvals in the next two years [3]. - The company is focused on the breast cancer field, developing a pipeline that covers all molecular subtypes, including HR-positive, HER2-positive, low HER2 expression, and triple-negative breast cancer, with a comprehensive treatment strategy from new adjuvant to later lines [3].

该适应症的获批主要基于CULMINATE-1研究，显示库莫西利联合氟维司群较氟维司群取得了显著的中 位无进展生存期(PFS)改善，大幅降低了HR+/HER2-晚期乳腺癌疾病进展或死亡风险。 乳腺癌已成为全球及中国女性群体中的"第一大癌种"，HR+/HER2-乳腺癌是最主要的亚型。对于晚期 HR+乳腺癌，国内外指南目前均推荐CDK4/6抑制剂作为治疗选择，但CDK4/6抑制剂本身的耐药问题、 骨髓抑制问题也亟待解决。 作为新一代CDK2/4/6抑制剂，库莫西利独特分子结构设计：既能精准靶向抑制CDK4，又能显著增强对 CDK2的结合能力，同时对CDK6的抑制作用较弱，能有效降低骨髓抑制的用药风险。临床前数据显 示，库莫西利对CDK2、CDK4的抑制活性显著优于传统CDK4/6抑制剂。 库莫西利此次获批主要基于CULMINATE-1研究，该研究充分验证了产品的疗效与安全性。安全性方 面，库莫西利联合氟维司群组治疗相关不良事件(TRAEs)多为1-2级，较传统CDK4/6抑制剂具有更低的 骨髓抑制风险，为长期治疗的依从性提供了有效保障。 有券商在近期报告中将库莫西利列为潜在的"重磅炸弹"药物，仅在中国的峰值销售额便 ...

Core Insights - China Biologic Products (01177) announced the mid-analysis results of the Phase III clinical trial (CULMINATE-2) for its innovative drug, Kumosili capsules (CDK2/4/6 inhibitor), for first-line treatment of HR+/HER2- advanced breast cancer at the 2025 European Society for Medical Oncology (ESMO) [1] - CULMINATE-2 is the first global Phase III trial demonstrating positive results for an oral CDK2/4/6 inhibitor combined with endocrine therapy in HR+/HER2- advanced breast cancer [1] - Kumosili shows selective inhibition of CDK4 kinase, which may help delay clinical resistance and reduce bone marrow suppression, potentially positioning it as a Best-in-Class therapy [1] Regulatory Developments - The Center for Drug Evaluation (CDE) of the National Medical Products Administration has accepted the marketing application for Kumosili combined with Fulvestrant for previously treated HR+/HER2- locally advanced or metastatic breast cancer, expected to be reviewed by July 2024 [2] - A second indication for initial endocrine treatment in HR+/HER2- locally advanced or metastatic breast cancer is also under review, with an expected decision by July 2025 [2] - The company is advancing a Phase III clinical trial for Kumosili in adjuvant therapy, with all participants enrolled and a marketing application anticipated within the next two years [2] Market Potential - Kumosili is expected to comprehensively cover the treatment cycle for HR+/HER2- breast cancer, including first-line, subsequent lines, and adjuvant therapy, providing innovative treatment options for more patients [2]

Core Viewpoint - The stock of Hong Kong innovative pharmaceutical company, Yaojie Ankang, experienced significant volatility, soaring over 50% before plummeting to a closing price of 192 HKD after a series of announcements regarding its clinical trials and product developments [1][5]. Group 1: Stock Performance - Since September, Yaojie Ankang's stock price surged from around 60 HKD to over 600 HKD, drawing considerable market attention [2]. - The stock saw a notable increase following a September 4 announcement regarding the initiation of a clinical trial for its core product, Tinengotinib, which is aimed at treating advanced liver cancer [2]. - Following the announcement, the stock price rose by 5.43% on September 5, reaching 63.1 HKD, and continued to climb, hitting 90 HKD with a 27.57% increase on September 10 [2][3]. Group 2: Clinical Developments - Yaojie Ankang's core product, Tinengotinib, is a unique MTK inhibitor currently in the registration clinical stage, targeting several difficult-to-treat solid tumors [2]. - On September 10, the company announced the approval of a Phase II clinical trial for Tinengotinib in combination with Fulvestrant for treating HR+/HER2- breast cancer, which is expected to provide new treatment options for patients [3]. Group 3: Financial Performance - Despite the stock price surge, Yaojie Ankang reported zero revenue, with significant operating losses of 343 million RMB and 275 million RMB expected for 2023 and 2024, respectively, due to high R&D and management costs [4]. - As of mid-2023, the company had not generated any revenue, with a loss of 123 million RMB reported for the first half of the year [4].

Market Overview - A-shares experienced a rebound in the afternoon, with the Sci-Tech 50 index showing strong performance, rising over 2% during the session [1] - The Shanghai Composite Index closed slightly up by 0.04% at 3861.87 points, while the Shenzhen Component rose by 0.45% to 13063.97 points, and the ChiNext Index increased by 0.68% to 3087.04 points [1] - The total trading volume in the Shanghai and Shenzhen markets reached 23.673 billion yuan, an increase of 639 million yuan compared to the previous day [1] Sector Performance - The logistics sector saw significant gains, with companies like New Ning Logistics, Jushen Co., and Yiatong hitting the daily limit [1] - The automotive supply chain stocks were active, with Hengshuai Co. and Junsheng Electronics also reaching the daily limit [1] - The robotics concept stocks surged, with Anpeilong and Hanwei Technology hitting the daily limit and achieving new highs [1][3] Robotics Sector Developments - The robotics concept saw renewed activity, with several companies including Hengshuai Co., Anpeilong, Hongchang Technology, and Hanwei Technology all hitting the 20% limit up [3] - Yushu Technology announced the open-source UnifoLM-WMA-0 architecture, aimed at advancing the global embodied intelligence industry [4] - Elon Musk mentioned the progress of Tesla's Optimus Gen3 at the All-In Summit, highlighting its human-like dexterity and plans for mass production [5] Company-Specific News - The stock of Yaojie Ankang experienced a dramatic drop, closing down 53.7% after previously surging over 60% during the day [6][7] - Yaojie Ankang's board confirmed that they were unaware of the reasons behind the stock price fluctuations, stating that the company's operations and financial status remain stable [9] - The company recently received clinical approval for its core product, Tinengotinib, for treating specific types of breast cancer [9]

Core Viewpoint - The stock price of药捷安康-B (02617.HK) experienced significant volatility, dropping 45% after previously surging 63% to a peak of 679.5 HKD per share [1][3]. Company Overview -药捷安康 is a clinical-stage biopharmaceutical company focused on developing innovative small molecule therapies for oncology, inflammation, and cardiovascular metabolic diseases [3]. - The company has no commercialized products and reported zero revenue with a loss of 123 million HKD in the first half of the year [3]. Stock Performance - The stock price increased dramatically, with a cumulative rise of over 30 times since its IPO price of 13.15 HKD, reaching a market capitalization exceeding 120 billion HKD [3]. - The stock was recently included in the Hong Kong Stock Connect program, allowing southbound funds to invest in it [3]. Clinical Developments - On September 10, the company announced that its core product, Tinengotinib (TT-00420), received clinical approval from the National Medical Products Administration of China for a Phase II trial in treating HR+/HER2- metastatic breast cancer [3][4]. - Early clinical results indicated promising effects of Tinengotinib as a monotherapy in patients with HR+/HER2- breast cancer who have undergone multiple treatments [4]. Competitive Landscape - There are currently no other products in development with the same mechanism as Tinengotinib, although there are various competitors in related cancer treatment areas [7]. - The market for small molecule drugs is competitive, with larger biologics generally having greater potential [7]. Shareholding Structure - The founder, Wu Yongqian, holds a 32.98% stake in the company, contributing to a limited market float with only 15.281 million shares available for trading out of a total of 397 million shares [7]. - The stock exhibited a trading volatility of 131.09% with a low turnover rate of 4.74% as of September 12 [7]. Company History -药捷安康 has faced challenges in its journey to listing, having attempted to go public on three occasions in 2021, 2022, and 2024 [8]. - The company has a pipeline of six clinical-stage candidates and one preclinical candidate [8].