HANSOH PHARMA(03692)
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翰森制药(03692):甲磺酸达麦利替尼片上市许可申请获国家药品监督管理局受理
智通财经网· 2026-02-27 12:33
智通财经APP讯,翰森制药(03692)发布公告,于2026年2月27日,集团创新药甲磺酸达麦利替尼片联合 甲磺酸阿美替尼片(阿美乐®)上市许可申请(NDA)获中国国家药品监督管理局(NMPA)受理,用于治疗表 皮生长因子受体(EGFR)基因突变阳性经EGFR 酪氨酸激酶抑制剂(TKI)治疗失败的伴间质-上皮转化因子 (MET)扩增的局部晚期或转移性非小细胞肺癌(NSCLC)患者。甲磺酸达麦利替尼片(HS-10241) 为一款集 团自主研发的口服高选择性c-MET TKI。 ...
翰森制药:甲磺酸达麦利替尼片上市许可申请获国家药品监督管理局受理
Zhi Tong Cai Jing· 2026-02-27 12:33
翰森制药(03692)发布公告,于2026年2月27日,集团创新药甲磺酸达麦利替尼片联合甲磺酸阿美替尼片 (阿美乐)上市许可申请(NDA)获中国国家药品监督管理局(NMPA)受理,用于治疗表皮生长因子受体 (EGFR)基因突变阳性经EGFR酪氨酸激酶抑制剂(TKI)治疗失败的伴间质-上皮转化因子(MET)扩增的局 部晚期或转移性非小细胞肺癌(NSCLC)患者。甲磺酸达麦利替尼片(HS-10241)为一款集团自主研发的口 服高选择性c-MET TKI。 ...
翰森制药(03692) - 自愿公告 - 甲磺酸达麦利替尼片上市许可申请获国家药品监督管理局受理
2026-02-27 12:09
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。 Hansoh Pharmaceutical Group Company Limited 翰森製藥集團有限公司 (於開曼群島註冊成立的有限公司) (股份代號:3692) 甲磺酸達麥利替尼片上市許可申請 獲國家藥品監督管理局受理 翰森製藥集團有限公司(「本公司」,連同其附屬公司統稱「本集團」)董事會(「董 事會」)欣然宣佈,於二零二六年二月二十七日,本集團創新藥甲磺酸達麥利替尼 片聯合甲磺酸阿美替尼片(阿美樂®)上市許可申請(NDA)獲中國國家藥品監督管 理局(NMPA)受理,用於治療表皮生長因子受體(「EGFR」)基因突變陽性經EGFR 酪氨酸激酶抑制劑(「TKI」)治療失敗的伴間質-上皮轉化因子(「MET」)擴增的 局部晚期或轉移性非小細胞肺癌(NSCLC)患者。甲磺酸達麥利替尼片(HS-10241) 為一款本集團自主研發的口服高選擇性c-MET TKI。 承董事會命 翰森製藥集團有限公司 主席 鍾慧娟 ...
港股收盘(02.24) | 恒指收跌1.82% AI模型“双雄”逆市上涨 存储概念、油气股走强
智通财经网· 2026-02-24 08:43
Market Overview - On the first trading day after the resumption of Northbound trading, Hong Kong's three major indices collectively declined, with the Hang Seng Index falling below the 27,000 mark, closing down 1.82% or 491.59 points at 26,590.32 points, with a total turnover of HKD 250.99 billion [1] - The Hang Seng China Enterprises Index dropped 2.06% to 9,007.86 points, while the Hang Seng Tech Index fell 2.13% to 5,270.70 points [1] Sector Performance - The technology sector remains a long-term investment focus, with valuation pressure easing after recent pullbacks, and potential for rebound driven by accelerated AI model updates and applications [1] - The energy and precious metals sectors are expected to rise amid heightened geopolitical risks in the Middle East and adjustments in U.S. tariff policies [1] - The consumer sector, currently undervalued, is anticipated to have upward potential as consumption policies are strengthened [1] Blue-Chip Stocks - WH Group (00288) led blue-chip gains, rising 4.42% to HKD 10.39, contributing 5.87 points to the Hang Seng Index [2] - Other notable blue-chip performers included Henderson Land (00012) up 2.08% and China Resources Beer (00291) up 2.02% [2] - China Biologic Products (01177) fell 6.58%, negatively impacting the index by 7.48 points [2] Hot Sectors - Major tech stocks faced pressure, with Tencent down over 3% and Alibaba down over 2% [3] - Storage concepts saw significant gains, with Zhaoyi Innovation (03986) up 11.91% and Longsys Technology (06809) up 4.92% [3] - Oil and gas stocks rose amid concerns over escalating tensions in Iran, with Shandong Molong (00568) up 11.41% [4] AI and Technology - The AI sector continues to show promise, with significant growth in token usage, particularly in Chinese models, which account for 61% of the total token volume [5] - The market anticipates ongoing rapid growth in AI applications and commercial viability [5] Film Sector - The film sector faced challenges, with the 2026 Spring Festival box office down approximately 40% year-on-year, indicating a need for improved content quality [6] - Major film stocks like Maoyan Entertainment (01896) and Huayi Brothers (01003) saw declines of 8.18% and 5.26%, respectively [6] Notable Stock Movements - Kwan Hung Holdings (01888) surged 12.37% following a profit forecast indicating a 165% increase in net profit for the fiscal year ending December 2025 [7] - Weichai Power (02338) rose 7.29% after a report highlighted its emergency generator's use in a major data center [8] - China Shipbuilding Defense (00317) reached a new high, up 5.37%, following a significant shipbuilding contract announcement [9] - Standard Chartered (02888) saw a 3.07% increase after reporting a 6% rise in operating income for the fiscal year 2025 [10] - China Duty Free Group (01880) faced a 10.51% drop due to losing some operating rights at major airports [11]
未知机构:国泰海通医药创新药推荐观点更新进一步推荐具备价值重估空间的pharma以-20260224
未知机构· 2026-02-24 03:00
Summary of Key Points from the Conference Call Industry Overview - The focus is on the **Pharmaceutical (Pharma)** and **Biopharmaceutical/Biotech** sectors, highlighting companies with potential for value re-evaluation and those entering a performance ramp-up phase [1][2]. Core Insights and Arguments 1. **Value Re-evaluation of Pharma Companies**: - There is a recommendation to further support Pharma companies that have the potential for value re-evaluation, particularly emphasizing key marginal changes. The BD (Business Development) revenue for Pharma is expected to normalize, which will drive an upward shift in the valuation framework [1][2]. 2. **Performance Ramp-up in Biopharma/Biotech**: - Continuous recommendation for Biopharma/Biotech companies that are entering a performance ramp-up phase and have pipelines that are consistently delivering results. The expectation is that by 2026, leading Biopharma/Biotech companies will enter a period of accelerated performance [2]. 3. **Key Marginal Changes**: - The core marginal change driving the value re-evaluation logic for Pharma companies is the normalization of BD revenue. This is supported by two main factors: - Leading Pharma companies have a more comprehensive technology platform and pipeline layout, enhancing their ability to continuously produce BD assets [2]. - External transactions are evolving from sporadic single-asset licensing to a more platform-based and series-based licensing model, making upfront payments, milestones, and revenue sharing more replicable and predictable. Recent collaborations, such as the partnership between **Shiyao** and **AstraZeneca** for a long-acting weight loss drug (total package of $18.5 billion) and **Innovent** with **Eli Lilly** in oncology and immunology (total package of $8.9 billion), exemplify this trend [2]. Recommendations - Specific companies recommended for investment include: - **Hengrui Medicine** - **Hansoh Pharmaceutical** - **Shiyao Group** (new addition in February) - **China National Pharmaceutical Group** - **Sinopharm** (new addition in February) - **Haisco** [2]. Additional Important Insights - The oncology, metabolism, and autoimmune sectors are expected to see a concentration of critical data releases. The integration of new technology platforms such as small nucleic acids, bispecific/trispecific antibodies, next-generation ADCs, and PROTAC/molecular glue is anticipated to provide significant valuation elasticity for leading companies at key data points, potentially opening up overseas BD opportunities [3].
医药周报:春节期间医药行业重点事件梳理
Guolian Minsheng Securities· 2026-02-23 07:45
Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical industry [5] Core Insights - The underlying logic of the current pharmaceutical industry era is innovation and international expansion, with a focus on innovative drugs and technology-driven sectors [2][3] - The report highlights the strong performance of the CRO market and suggests a dual investment strategy focusing on both "0 to 1" technology innovation and low-position stocks [2][3] - The report emphasizes the ongoing trend of BD (Business Development) transactions in innovative drugs, with significant growth expected in 2026 [4][15] Summary by Sections 1. Key Events in the Pharmaceutical Industry During the Spring Festival - Innovative drug BD transactions have seen a strong start, with significant overseas development and registration progress for key products [13][14] - The total amount of BD transactions for innovative drugs in China for 2026 has already surpassed one-third of the total for 2025 [15] - The revision of the National Essential Medicines List Management Measures may signal changes in the essential medicines directory [28] 2. Pharmaceutical Market Review and Hotspot Tracking - The pharmaceutical sector's performance was relatively weak, with a weekly decline of 0.81%, ranking 20th among all industries [34][38] - The total trading volume for pharmaceuticals was 401.12 billion yuan, accounting for 3.83% of the total market, below the historical average of 7.09% [55] - The report notes a rising valuation level for the pharmaceutical industry, with a PE ratio of 29.25, which is below the historical average [52] 3. Stock Performance Review - The report lists the top-performing stocks, including Dongyangguang and Zhendemedical, while highlighting the underperformers like Huayuan Biology and *ST Sailong [58][59]
协合新能源年度盈利同比降约8成 汇聚科技配股融资逾16亿港元
Xin Lang Cai Jing· 2026-02-20 12:32
Company News - Xiehe New Energy (00182.HK) expects a net profit decline of over 80% in 2025, compared to approximately 800 million yuan in the previous year, primarily due to a decrease in revenue and gross margin from power generation business and asset impairment [2] - Dingdang Health (09886.HK) anticipates a significant narrowing of net loss by over 80% for the fiscal year 2025, mainly due to a reduction in goodwill impairment; adjusted net profit is expected to be no less than approximately 5 million yuan, turning profitable year-on-year [2] - Honghui Group (00183.HK) issued a profit warning, expecting a substantial decrease in interim loss attributable to shareholders by 30% to 40% [2] - Huiju Technology (01729.HK) completed the placement of 108 million shares, raising approximately 1.635 billion HKD, with about 50% allocated for strategic investments and acquisitions, and 30% for global business development and overseas expansion [2] - Hansoh Pharmaceutical (03692.HK) received approval for the marketing of Amivantamab in the European Union for monotherapy [2] - Inspur Intelligent (03696.HK) has been included in the Hang Seng Composite Index constituent stocks [2] Buyback Activities - Xiaomi Group-W (01810.HK) repurchased 4.2824 million shares for 152 million HKD, with buyback prices ranging from 35.32 to 35.74 HKD [2] - Geely Automobile (00175.HK) repurchased 1.631 million shares for 27.5125 million HKD, with buyback prices between 16.69 and 16.99 HKD [2] - Kingsoft (03888.HK) repurchased 732,200 shares for 19.9956 million HKD, with buyback prices from 27.02 to 27.5 HKD [3] - NetEase Cloud Music (09899.HK) repurchased approximately 96,000 shares for 14.9974 million HKD, with buyback prices between 153.8 and 158.2 HKD [3] - Meitu Inc. (01357.HK) repurchased 2.057 million shares for 12.5085 million HKD, with buyback prices ranging from 6.04 to 6.1 HKD [3]
港股公告掘金 | 英矽智能、图达通及长风药业获纳入恒生综合指数成份股
Zhi Tong Cai Jing· 2026-02-20 01:28
英矽智能(03696)获纳入恒生综合指数成份股 图达通(02665)获纳入恒生综合指数成份股 长风药业(02652)获纳入恒生综合指数成份股 翰森制药(03692):甲磺酸阿美替尼片单药治疗于欧盟获批上市 【重大事项】 拨康视云-B(02592):CBT-199新药临床试验申请已生效,临床试验被认定为可安全推进 石药集团(01093):GLP -1/GIP受体双偏向性激动多肽长效注射液在美国获临床试验批准 石药集团(01093):罗哌卡因长效注射液(SYH9089注射液)在中国获临床试验批准 复宏汉霖(02696):HLX15-SC (重组抗CD38全人单克隆抗体注射液-皮下注射)用于多发性骨髓瘤治疗的1 期临床试验申请获美国FDA批准 【财报数据】 首钢资源(00639)发盈警 预计2025年度公司拥有人应占综合溢利约6亿港元至7亿港元 石四药集团(02005)发盈警,预期年度股权持有人应占溢利同比下降约45%至60% 好孩子国际(01086)发盈警 预期2025年纯利同比下降约35%至 45% 速腾聚创(02498)2025财年激光雷达产品销售持续增长 Q4首次单季实现盈利 ...
翰森制药(03692):甲磺酸阿美替尼片单药治疗于欧盟获批上市
智通财经网· 2026-02-19 23:05
智通财经APP讯,翰森制药(03692)公布,于2026年2月12日,集团创新药甲磺酸阿美替尼片(中国商品 名:阿美乐®,海外商品名:Aumseqa®)单药治疗已于欧盟获批上市,用于:(i)具有表皮生长因子受体 (EGFR)外显子19缺失或外显子21(L858R) 置换突变的晚期非小细胞肺癌(NSCLC)成人患者的一线治疗, 以及(ii)晚期 EGFR T790M突变阳性NSCLC成人患者的治疗。此次批准由欧盟委员会(EC)基于欧洲药品 管理局(EMA)人用药品委员会(CHMP)的积极意见作出。 ...
翰森制药(03692) - 自愿公告 - 甲磺酸阿美替尼片单药治疗於欧盟获批上市
2026-02-19 23:00
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。 Hansoh Pharmaceutical Group Company Limited 翰森製藥集團有限公司 甲磺酸阿美替尼片 單藥治療於歐盟獲批上市 翰森製藥集團有限公司(「本公司」,連同其附屬公司統稱「本集團」)董事會(「董 事會」)欣然宣佈,於二零二六年二月十二日,本集團創新藥甲磺酸阿美替尼片 (中國商品名:阿美樂®,海外商品名:Aumseqa®)單藥治療已於歐盟獲批上市, 用於:(i)具有表皮生長因子受體(「EGFR」)外顯子19缺失或外顯子21(L858R) 置換突變的晚期非小細胞肺癌(「NSCLC」)成人患者的一線治療,以及(ii)晚期 EGFR T790M突變陽性NSCLC成人患者的治療。此次批准由歐盟委員會(EC)基於 歐洲藥品管理局(EMA)人用藥品委員會(CHMP)的積極意見作出。 關於甲磺酸阿美替尼片 甲磺酸阿美替尼片是中國首個原研三代EGFR-TKI創新藥,此前已獲國家藥 品監督 ...