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复宏汉霖:汉斯状 (斯鲁利单抗注射液)联合化疗用于胃癌新辅助/辅助治疗的3期临床研究达到主要研究终点
Zhi Tong Cai Jing· 2025-10-09 08:42
Core Viewpoint - The company, Fuhong Hanlin (02696), has announced that its self-developed drug, Hanshu (Sru Li Antibody Injection), has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for the treatment of early gastric cancer, supporting an early application for market approval [1] Group 1: Clinical Trial Details - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hanshu combined with chemotherapy against a placebo combined with chemotherapy for early gastric cancer patients [1] - The independent data monitoring committee (IDMC) conducted a pre-specified interim analysis, which showed significant improvement in EFS for the Hanshu combination therapy compared to the placebo group [1] Group 2: Efficacy and Safety Results - The pathological complete response (pCR) rate for the Hanshu group was more than three times that of the control group, indicating a substantial efficacy advantage [1] - The risk of recurrence for patients receiving Hanshu was significantly reduced, and no new safety signals were identified, demonstrating good safety [1]
复宏汉霖(02696.HK):汉斯状®(斯鲁利单抗注射液)联合化疗用于胃癌新辅助/辅助治疗的3期临床研究达到主要研究终点
Ge Long Hui· 2025-10-09 08:39
格隆汇10月9日丨复宏汉霖(02696.HK)宣布,近日,一项比较公司自主开发的汉斯状®(斯鲁利单抗注射 液)("汉斯状®")或安慰剂联合化疗(奥沙利铂+替吉奥)新辅助/辅助治疗胃癌的3期临床研究在计划的期中 分析中,经独立数据监查委员会(Independent Data Monitoring Committee,"IDMC")评估达到了无事件生 存期(EFS)的主要研究终点,可支持提前申报上市。 汉斯状®为公司自主开发的创新型抗PD-1单抗,其于中国境内(不包括中国港澳台地区,下同)已获批上 市的适应症包括联合化疗一线治疗鳞状非小细胞肺癌(sq-NSCLC),广泛期小细胞肺癌(ES-SCLC)、食管 鳞状细胞癌(ESCC)及非鳞状非小细胞肺癌(nsq-NSCLC)。同时,汉斯状®亦已分别于欧盟、英国、印度 尼西亚、柬埔寨、泰国、马来西亚、新加坡、及印度等国家/地区获批上市,并分别获美国、欧盟、瑞 士及韩国等国家/地区的药品监督管理部门授予孤儿药资格认定(Orphan-drug Designation)。 此外,公司正有序推进汉斯状®及相关联合疗法在全球开展的多项临床试验,广泛覆盖肺癌、食管癌、 头颈鳞癌、结 ...
生物股份(600201.SH):累计回购1.4134%公司股份
Ge Long Hui A P P· 2025-10-09 08:34
Core Viewpoint - The company, BioShares (600201.SH), has announced a share buyback program, indicating a commitment to returning value to shareholders and potentially signaling confidence in its future performance [1] Summary by Categories Share Buyback Details - As of September 30, 2025, the company has repurchased a total of 15.7133 million shares, which represents 1.4134% of its total share capital [1] - The highest transaction price during the buyback was 8.97 yuan per share, while the lowest was 6.37 yuan per share [1] - The total amount spent on the buyback was 108.4854 million yuan, excluding transaction fees such as commissions and transfer fees [1]
复宏汉霖(02696) - 自愿公告 - 汉斯状(斯鲁利单抗注射液)联合化疗用於胃癌新辅助/辅助治疗...
2025-10-09 08:30
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倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 (於中華人民共和國註冊成立的股份有限公司) C. 關於漢斯狀® 漢斯狀®為本公司自主開發的創新型抗PD-1單抗,其於中國境內(不包括中國 港澳台地區,下同)已獲批上市的適應症包括聯合化療一線治療鱗狀非小細 胞肺癌(sq-NSCLC),廣泛期小細胞肺癌(ES-SCLC)、食管鱗狀細胞癌(ESCC) 及非鱗狀非小細胞肺癌(nsq-NSCLC)。同時,漢斯狀®亦已分別於歐盟、英 國、印度尼西亞、柬埔寨、泰國、馬來西亞、新加坡、及印度等國家/地區獲 批上市,並分別獲美國、歐盟、瑞士及韓國等國家/地區的藥品監督管理部門 授予孤兒藥資格認定(Orphan-drug Designation)。 (股份代號:2696) 自願公告 漢斯狀® (斯魯利單抗注射液)聯合化療用於 胃癌新輔助/輔助治療的3期臨床研究達到主要研究終點 A ...
生物股份:累计回购1571.33万股
Mei Ri Jing Ji Xin Wen· 2025-10-09 08:21
截至发稿,生物股份市值为108亿元。 每经头条(nbdtoutiao)——与美元脱钩后,暴涨102倍,揭秘黄金疯涨背后神秘的"无形之手"!专家: 推动金价上涨的逻辑没有变 (记者 曾健辉) 每经AI快讯,生物股份(SH 600201,收盘价:9.73元)10月9日晚间发布公告称,截至2025年9月30 日,公司通过上海证券交易所交易系统以集中竞价交易方式累计回购公司股份1571.33万股,占公司总 股本的比例为1.4134%,成交最高价为8.97元/股,成交最低价为6.37元/股,支付的资金总额约为1.08亿 元。 2024年1至12月份,生物股份的营业收入构成为:生物制药占比94.42%,其他行业占比3.18%,其他业 务占比2.4%。 ...
成大生物:累计回购约38万股
Mei Ri Jing Ji Xin Wen· 2025-10-09 08:20
Group 1 - The company Chengda Bio announced a share buyback of approximately 380,000 shares, accounting for about 0.092% of its total share capital, with a total expenditure of approximately 10.79 million RMB [1] - The highest and lowest prices for the repurchased shares were 29.61 RMB and 27.2 RMB per share, respectively [1] - As of the report, Chengda Bio's market capitalization stands at 11.3 billion RMB [1] Group 2 - For the year 2024, the company's revenue composition is entirely from biopharmaceuticals, with a 100% share [1]
研报掘金丨天风证券:维持君实生物“买入”评级,PD-1/VEGF双抗进入II期临床
Ge Long Hui A P P· 2025-10-09 08:12
Core Viewpoint - Junshi Bioscience reported a significant revenue increase and reduced net loss in H1 2025, driven by the performance of its flagship drug, Toripalimab, which is gaining traction in the domestic market with new indications approved [1] Financial Performance - In H1 2025, Junshi Bioscience's revenue reached 1.168 billion yuan, marking a year-on-year growth of 48.64% [1] - The net loss for the same period was 413 million yuan, reflecting a year-on-year reduction in loss by 36.01% [1] Product Development and Approvals - Toripalimab's domestic sales revenue was approximately 954 million yuan in H1 2025, representing a year-on-year increase of about 42% [1] - The drug has received approval for a total of 12 indications in China, with two new indications added in 2025, including liver cancer and melanoma [1] - A supplemental new drug application (sNDA) for the combination treatment of HER2+ urothelial carcinoma has been accepted by NMPA [1] Clinical Trials and Research - The PD-1/VEGF dual antibody JS207 is currently in Phase II clinical trials, showing strong anti-tumor activity in preclinical studies [1] - The drug is being explored in combination therapies across various cancer types, including NSCLC, CRC, TNBC, and liver cancer [1] - The international clinical trial for BTLA in LS-SCLC has enrolled nearly 400 participants [1] International Expansion - Junshi Bioscience has established commercial partnerships in over 80 countries, including the EU and the UK, with approvals in 40 regions such as the US, EU, UK, and Australia [1] - The company achieved commercialization in the US and received approval for nasopharyngeal cancer treatment in Australia in January 2025 [1] Investment Rating - The company maintains a "Buy" rating based on its robust pipeline and market performance [1]
百克生物(688276.SH):吸附无细胞百白破b型流感嗜血杆菌联合疫苗临床试验申请获得批准
Ge Long Hui A P P· 2025-10-09 08:03
Core Viewpoint - The company, Baike Biotechnology (688276.SH), has received approval from the National Medical Products Administration for the clinical trial of its combined vaccine, which targets whooping cough, diphtheria, tetanus, and Haemophilus influenzae type b [1] Group 1 - The approved vaccine is referred to as the "acellular combined whooping cough-diphtheria-tetanus and Hib vaccine" [1] - This vaccine is designed for infants aged 2 months and older, aiming to stimulate immune responses to prevent invasive infections caused by the targeted diseases [1] - The vaccine provides simultaneous protection against whooping cough, diphtheria, tetanus, and invasive infections from Haemophilus influenzae type b [1]
鲁股观察 | 科兴制药赴港上市,创新药管线能否赢得市场青睐
Xin Lang Cai Jing· 2025-10-09 08:03
Core Viewpoint - The company, Kexing Pharmaceutical, announced plans to issue H-shares for a Hong Kong listing, joining a wave of A-share companies pursuing dual listings to enhance internationalization and diversify financing channels [1][5] Group 1: Company Developments - Kexing Pharmaceutical's revenue for the first half of 2025 was 700 million yuan, a year-on-year decrease of 7.82%, while net profit attributable to shareholders reached 80.34 million yuan, a significant increase of 576.45% [1] - The company reported a net cash flow from operating activities of 30 million yuan, a year-on-year increase of approximately 188%, attributed to increased sales collections and reduced operating expenses [2] - The company has made significant progress in innovative drug research, with its interferon α1b inhalation solution being included in the list of breakthrough therapies by the National Medical Products Administration [2][3] Group 2: Market Position and Strategy - Kexing Pharmaceutical's overseas commercialization platform has expanded to over 40 countries, covering emerging markets with populations over 100 million and GDP rankings within the top thirty [4] - The company aims to build a dual financing platform through the A+H listing, facilitating coordinated development in domestic and international markets and accelerating its internationalization process [5] - The company focuses on various therapeutic areas, including antiviral, oncology, and immunology, with a research and development investment of approximately 95.97 million yuan in the first half of 2025, representing 13.70% of its revenue [3]
正海生物:口腔可吸收生物膜完成首例受试者入组
Xin Lang Cai Jing· 2025-10-09 08:03
Core Viewpoint - The company Zhenghai Biological has announced that its research project "Oral Resorbable Biological Membrane" has officially entered clinical trials, aiming to evaluate its effectiveness and safety for guiding bone regeneration [1] Group 1: Clinical Trial Details - The clinical trial is a multi-center, randomized controlled, single-blind, non-inferiority trial [1] - The trial aims to assess the effectiveness and safety of the oral resorbable biological membrane in guiding bone regeneration [1] - The project has successfully completed the random enrollment of the first subject [1] Group 2: Product Characteristics - The oral resorbable biological membrane is made from decellularized dermal matrix material [1] - It provides a favorable scaffold for cell infiltration and migration, facilitating bone tissue growth and deposition [1] - The product aims to achieve regenerative repair in areas of bone defects [1]