Core Viewpoint - The company, Jiangsu Hengrui Medicine Co., Ltd., has received clinical approval for its core product, Tinengotinib (TT-00420), in combination with Fulvestrant for the treatment of HR+/HER2- recurrent or metastatic breast cancer that has failed previous treatments [1] Group 1: Clinical Trial Details - The clinical trial is a Phase II, open-label, multi-center study evaluating the safety, efficacy, and pharmacokinetics of Tinengotinib combined with Fulvestrant in patients with HR+/HER2- recurrent or metastatic breast cancer [1] - The trial has received clinical implicit approval from the National Medical Products Administration of China as of September 10, 2025 [1] Group 2: Early Research Results - Early clinical research results indicate that Tinengotinib as a monotherapy shows promising clinical effects in HR+/HER2- breast cancer patients who have undergone multiple treatments, including endocrine therapy, CDK4/6 inhibitors, and chemotherapy [1] - Preclinical studies suggest that the combination of Tinengotinib and Fulvestrant exhibits pharmacological synergy against endocrine-resistant breast cancer cells [1] Group 3: Potential Impact - The clinical treatment strategy involving Tinengotinib in combination with Fulvestrant may provide a new breakthrough in the treatment of breast cancer patients who have developed resistance to endocrine therapy [1]

Core Viewpoint - The company has received clinical approval for its core product, Tinengotinib, in combination with Fulvestrant, for the treatment of HR+/HER2- recurrent or metastatic breast cancer that has failed previous treatments [1] Group 1: Clinical Trial Details - The clinical trial is a Phase II, open-label, multi-center study conducted in China, evaluating the safety, efficacy, and pharmacokinetics of Tinengotinib combined with Fulvestrant in patients with HR+/HER2- breast cancer [1] - The trial received clinical implicit approval from the National Medical Products Administration of China on September 10, 2025 [1] Group 2: Early Research Findings - Early clinical research results indicate that Tinengotinib as a monotherapy shows promising clinical effects in HR+/HER2- breast cancer patients who have undergone multiple treatments, including endocrine therapy, CDK4/6 inhibitors, and chemotherapy [1] - Preclinical studies suggest that the combination of Tinengotinib and Fulvestrant exhibits pharmacological synergy against endocrine-resistant breast cancer cells [1] Group 3: Potential Impact - The clinical treatment strategy involving Tinengotinib and Fulvestrant may provide a new breakthrough in the treatment of breast cancer patients who have developed resistance to endocrine therapy [1]

智通财经APP讯，药捷安康-B(02617)公布，公司核心产品替恩戈替尼(Tinengotinib, TT-00420)联合氟维 司群治疗经治失败的激素受体阳性(HR+)且人表皮生长因子受体2阴性或低表达(HER2-)的复发或转移性 乳腺癌II期临床试验，已于2025年9月 10日获得了中国国家药品监督管理局的临床默示许可。 本试验为在中国开展的一项评价替恩戈替尼片联合氟维司群注射液用于经治失败的HR+/HER2-的复发 或转移性乳腺癌患者的安全性、疗效及药代动力学的开放标签、多中心、II期临床研究。 替恩戈替尼早期临床研究结果表明，替恩戈替尼单药在经歷过多种治疗(例如内分泌治疗、CDK4/6抑制 剂治疗和化疗)的HR+╱HER2-乳腺癌患者中，有令人鼓舞的临床效果。临床前实验结果表明，替恩戈 替尼与氟维司群的联合用药针对内分泌治疗耐药的乳腺癌细胞具有药理学协同作用。因此替恩戈替尼联 合氟维司群的临床治疗策略将可能为此类乳腺癌患者的治疗带来新的突破。 ...

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。 ...