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，概不就因本公告全部或任何部分內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 替恩戈替尼聯合氟維司群治療經治失敗的HR陽性╱HER2陰性 或低表達的復發或轉移性乳腺癌II期 臨床試驗獲批開展 本公告由藥捷安康（南京）科技股份有限公司（「本公司」，連同其附屬公司統稱「本 集團」）自願刊發，以向本公司股東及潛在投資者提供有關本集團的最新業務。 本公司董事會（「董事會」）欣然宣佈，公司核心產品替恩戈替尼(Tinengotinib, TT-00420)聯合氟維司群治療經治失敗的激素受體陽性(HR+)且人表皮生長因子受 體2陰性或低表達(HER2-)的復發或轉移性乳腺癌II期臨床試驗，已於2025年9月 10日獲得了中國國家藥品監督管理局的臨床默示許可。 本試驗為在中國開展的一項評價替恩戈替尼片聯合氟維司群注射液用於經治失敗 的HR+/HER2-的復發或轉移性乳腺癌患者的安全性、療效及藥代動力學的開放標 籤、多中心、II期臨床研究。 替恩戈替尼早期臨床研究結果表明，替恩戈替尼單藥在經歷過多 ...

Market Overview - The US non-farm employment data has been significantly revised downwards, leading to sustained expectations for interest rate cuts. The Hong Kong stock market has risen again, with the Hang Seng Index breaking the 26,000 mark, reaching a nearly four-year high. The index closed up 1.01% or 262.13 points at 26,200.26, with a total turnover of HKD 288.21 billion [1] Blue Chip Performance - Lenovo Group (00992) led the blue-chip stocks, rising 4.63% to HKD 11.31, contributing 5.88 points to the Hang Seng Index. Huatai Securities expects Lenovo to benefit from strong demand for AI products in the second half of the year, maintaining a buy rating with a target price of HKD 16 [2] - Other notable blue-chip performances include JD Logistics (02618) up 4.45%, Sun Hung Kai Properties (00016) up 4.28%, while Xinyi Solar (00968) and Xiaomi Group-W (01810) saw declines of 2.77% and 2.22%, respectively [2] Sector Highlights - Large technology stocks performed well, with Bilibili rising over 7% and JD up over 3%. Cloud computing stocks also saw gains, with Kingsoft Cloud rising nearly 9% [3] - Oracle's cloud business showed strong performance, with cloud revenue growing 28% year-on-year and cloud infrastructure revenue increasing 55%. The company expects cloud infrastructure revenue to reach USD 18 billion in FY2026, a 77% increase from FY2025 [4] Real Estate Sector - Hong Kong real estate stocks generally rose, with Sun Hung Kai Properties up 4.28% and Hang Lung Properties (00101) up 2.79% [4] - The Hong Kong government is set to release its 2025 policy address, with expectations of further reductions in property stamp duties and measures to attract more mainland visitors [5] Lithium Sector - Lithium stocks faced significant declines, with Ganfeng Lithium (01772) down 7.02% and Tianqi Lithium (09696) down 7.97%. The price of lithium carbonate is expected to fall below RMB 70,000 per ton due to a resurgence of supply surplus [6][5] Popular Stocks - Yunfeng Financial (00376) surged 27.83% after receiving approval to upgrade its securities license to offer virtual asset trading services [7] - Yaojie Ankang-B (02617) reached a new high, rising 27.57% after being included in the Hong Kong Stock Connect list [8] - Longfor Group (03380) rose 9.47% after reaching a revised agreement with creditors regarding offshore debt restructuring [9] - Shandong Molong (00568) increased by 7.92% amid rising oil prices due to geopolitical tensions in the Middle East [10]

Summary of Key Points Group 1: Stock Performance - As of September 10, a total of 131 stocks reached their 52-week highs, with notable performers including China Property Investment (00736) at a high rate of 57.14%, Yunfeng Financial (00376) at 32.81%, and Yaojie Ankang-B (02617) at 31.81% [1] - The closing prices and highest prices for the top three stocks are as follows: China Property Investment closed at 0.760 with a peak of 0.880, Yunfeng Financial closed at 5.420 with a peak of 5.950, and Yaojie Ankang-B closed at 90.000 with a peak of 104.000 [1] Group 2: Additional High Performers - Other notable stocks that reached their 52-week highs include: - Jiali International (01050) with a high rate of 26.67% - Charoen Pokphand International (03839) at 21.23% - Zhong An Smart Life (02271) at 19.58% [1] - The list continues with stocks like Feiyu Technology (01022) and KFM Jinde (03816) showing increases of 11.59% and 10.13% respectively [1] Group 3: 52-Week Lows - The report also highlights stocks that reached their 52-week lows, with New Century Medical (01518) showing a significant decline of 34.38% [4] - Other stocks with notable declines include Global Friendly Drink Smart (08496) at -28.81% and Wanma Holdings (02935) at -16.67% [4] - The lowest prices recorded for these stocks were 0.420 for New Century Medical and 0.042 for Global Friendly Drink Smart [4]

截至2025年9月10日午间收盘，恒生医疗保健指数下跌0.72%。成分股方面涨跌互现，健康之路领涨3.97%，药明合联上涨1.94%，佰泽医疗上涨1.73%；方舟 健客领跌3.96%，医脉通下跌3.12%，微创脑科学下跌1.73%。恒生医疗ETF(513060)下跌0.40%，最新报价0.75元。拉长时间看，截至2025年9月9日，恒生医 疗ETF近1周累计上涨2.59%。 流动性方面，港股创新药精选ETF盘中换手25%，成交9419.79万元，市场交投活跃。拉长时间看，截至9月9日，港股创新药精选ETF近1周日均成交1.84亿 元。 【事件/资讯】 1）恒瑞医药与IDEAYA联合开发的DLL3 ADC药物SHR4849（IDE849）在治疗小细胞肺癌（SCLC）的I/II期临床中展现出同类最优（BIC）潜力。在＞ 2.4mg/kg剂量组中，二线及以上患者ORR达73%、DCR达93%、中位PFS为6.7个月，疗效数据显著优于其他机制药物，同时安全性良好，血液学毒性可控， 因不良反应导致的停药率仅2%。 2）摩根士丹利预测，凭借显著的研发效率与成本优势，中国创新药全球影响力将持续提升。预计到2040年，中国原 ...

9月10日早盘，港股通创新药板块震荡走低，创新药纯度100%的港股通创新药ETF（520880）盘中翻绿 跌逾1%，新进成份股药捷安康-B却逆市走强，一度狂飙超47%再创历史新高！ 消息面上，9月8日，药捷安康-B同时被纳入港股通标的，及港股通创新药ETF（520880）标的指数成份 股。 此外，该公司核心产品替恩戈替尼近期迎来首例患者给药等多重利好。国元国际指出，替恩戈替尼是全 球首个且唯一进入注册临床阶段用于治疗复发或难治性胆管癌患者的FGFR抑制剂。 值得关注的是，除药捷安康-B之外，早盘多只逆市上扬的创新药股均为港股通创新药ETF（520880）新 进成份股，映恩生物-B大涨超7%，MIRXES-B涨超3%，巨头恒瑞医药也飘红。 数据来源于恒生指数公司，统计区间： 2021 ． 12.31-2025.9.5 资金积极响应，用脚投票！行情数据显示，港股通创新药ETF（520880）早盘下跌区间，场内持续宽幅 溢价，溢价率一度飙升至0．6%，显示买盘资金尤为旺盛。而此前6日，520880已连续吸金合计1．8亿 元。 | 序号 | 代码 | 名称 | 现价 | 涨跌幅 ▼ | 总市值 | 成交额 | | - ...

消息面上，上交所、深交所发布公告，药捷安康被调入港股通标的名单，自9月8日起生效。国元国际表 示，公司在细分行业研发领先，替恩戈替尼是全球首个且唯一进入注册临床阶段用于治疗复发或难治性 胆管癌患者的FGFR抑制剂。它也是全球首个可能同时抑制FGFR/JAK通路并针对转移性去势抵抗性前 列腺癌具有临床疗效证据的研究药物。 此外，药捷安康核心产品替恩戈替尼近期迎多重利好。公司近日宣布，替恩戈替尼分别联用康方生物的 开坦尼/依达方的治疗晚期肝细胞癌(HCC)的开放性、多中心II期临床研究，于近日完成首例患者给药。 此前，替恩戈替尼获得美国食品药物管理局(FDA)授予治疗转移性去势抵抗性前列腺癌的快速通道认 证。 药捷安康-B(02617)早盘飙升近40%，高见98.45港元，再创上市新高。截至发稿，涨29.48%，报91.8港 元，成交额1.27亿港元。 ...

此外，药捷安康核心产品替恩戈替尼近期迎多重利好。公司近日宣布，替恩戈替尼分别联用康方生物的 开坦尼/依达方的治疗晚期肝细胞癌(HCC)的开放性、多中心II期临床研究，于近日完成首例患者给药。 此前，替恩戈替尼获得美国食品药物管理局(FDA)授予治疗转移性去势抵抗性前列腺癌的快速通道认 证。 消息面上，上交所、深交所发布公告，药捷安康被调入港股通标的名单，自9月8日起生效。国元国际表 示，公司在细分行业研发领先，替恩戈替尼是全球首个且唯一进入注册临床阶段用于治疗复发或难治性 胆管癌患者的FGFR抑制剂。它也是全球首个可能同时抑制FGFR/JAK通路并针对转移性去势抵抗性前 列腺癌具有临床疗效证据的研究药物。 智通财经APP获悉，药捷安康-B(02617)早盘飙升近40%，高见98.45港元，再创上市新高。截至发稿， 涨29.48%，报91.8港元，成交额1.27亿港元。 ...

继上日强势大涨后，今日（9月8日），创新药迎来整理行情。 A股创新药涨跌不一，复星医药大涨6.26%，三生国健跌6%，药ETF（562050）重仓创新药，午后翻红 后顽强收涨，续创收盘新高！ 事件方面，重点关注港股通创新药ETF（520880）标的指数"提纯"修订生效。 根据恒生指数公司此前公告，港股通创新药ETF（520880）跟踪的恒生港股通创新药精选指数"提纯"修 订9月8日正式生效。本次指数修订重点有三大变化：明确剔除CXO；选样范围放宽至全部港股通公 司；采用流动性折让系数来赋权。 这意味着，当前，恒生港股通创新药精选指数已成为一只不含CXO、纯度100%的创新药指数。自本次 起，小市值的潜力股有机会更早纳入指数，流动性优秀的成份股将被赋予更高权重。 根据港股通创新药ETF（520880）9月8日申赎清单，其标的指数成份股14进6出，成份股总数增至37 只。剔除成份股包括药明系、晶泰控股等4家主营业务在CXO的公司，以及金斯瑞生物科技、锦欣生殖 两家医疗服务公司。 新进成份股全部为创新药研发型企业，既包括年内BD交易总金额已突破150亿美元的巨头恒瑞医药，以 及荣昌生物、君实生物等国产创新药龙头企业 ...

资金面上，此前4个交易日，港股通创新药ETF（520880）连续获资金净申购，金额合计9630万元，彰 显资金后市信心。方正证券认为，创新药强主线属性不变，9月份有可能是创新药新一波行情的起点。 周一（9月8日）午后，AH创新药概念震荡回暖。重仓A股创新药的药ETF（562050）成功翻红。全仓 港股创新药的港股通创新药ETF（520880）早盘冲高回落，午后V字回升，场内维持宽幅溢价，显示买 盘尤为强劲，成交近7亿元。 港股创新药个股表现上，港股通创新药ETF（520880）成份股走势分化，药捷安康-B飙涨17%，映恩生 物-B涨超10%；康方生物跌近7%居前，乐普生物-B跌逾4%。 值得关注的是，领涨的药捷安康-B、映恩生物-B均为港股通创新药ETF（520880）标的指数新进成份 股。根据恒生指数公司此前公告，港股通创新药ETF（520880）跟踪的恒生港股通创新药精选指数"提 纯"今日正式生效，这意味着，当前该指数已成为一只不含CXO、纯度100%的创新药指数。 根据港股通创新药ETF（520880）9月8日申赎清单，其标的指数成份股14进6出，成份股总数增至37 只。剔除成份股包括药明系、晶泰控股等 ...

Core Viewpoint - The stock of药捷安康-B (02617) surged over 10% in early trading, reaching a new high of 78 HKD, driven by its inclusion in the Hong Kong Stock Connect program and the progress of its clinical trials for its core product, Tinengotinib [1] Group 1 - The stock price of药捷安康-B increased by 10.54%, trading at 69.75 HKD with a transaction volume of 54.34 million HKD [1] - The company has been added to the Hong Kong Stock Connect eligible list, effective from September 8 [1] - The company announced the completion of the first patient dosing in a Phase II clinical study for its core product Tinengotinib in combination with other therapies for advanced hepatocellular carcinoma [1]