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基石药业-B:CS2009(PD-1/VEGF/CTLA-4三特异性抗体)II期临床试验申请获美国FDA批准
Zhi Tong Cai Jing· 2026-02-16 00:10
CS2009用于晚期实体瘤的II期IND申请获FDA批准,标志着这一创新免疫疗法的全球开发取得重要进 展。该II期全球多中心临床试验正在澳大利亚和中国积极入组,共包含15个单药/联合用药伫列及9个实 体瘤适应症,包括但不限于:非小细胞肺癌(NSCLC)、结直肠癌(CRC)、三阴性乳腺癌(TNBC)、广泛期 小细胞肺癌(ES-SCLC)和铂类耐药卵巢癌(PROC)。CS2009的I期临床研究初步数据已在2025年欧洲肿瘤 内科学会(ESMO)年会上公布,安全性与耐受性良好,抗肿瘤活性数据积极。更多I期和II期临床研究数 据预计将在今年召开的美国临床肿瘤学会(ASCO)和ESMO会议上公布。 基石药业首席执行官、研发总裁及执行董事杨建新博士表示:"非常高兴能够看到CS2009的全球多中心 II期临床试验高效推进并获FDA批准开展。此次IND获批,是基于基石药业与美国FDA进行的积极会议 沟通,以及FDA对CS2009在I期临床试验中表现出的良好安全性、抗肿瘤活性等剂量递增和剂量扩展阶 段关键结果的充分肯定。在该会议中,双方进一步确认了II期临床的研究方案,包括剂量优化策略、剂 量拓展设计以及其他核心要素。目前,我 ...
中国白银集团拟折让约17.74%发行合共9.1亿股认购股份 净筹约4.63亿港元
Zhi Tong Cai Jing· 2026-02-16 00:03
中国白银集团(00815)发布公告,于2026年2月13日,本公司分别与六名认购人订立六份认购协议,据 此,认购人有条件同意认购,而本公司有条件同意按认购价每股认购股份0.51港元配发及发行合共9.1亿 股认购股份。 认购价较股份于2026年2月13日(即认购协议日期)在联交所所报收市价每股0.62港元折让约17.74%。 于本公告日期,本公司有30.36亿股已发行股份。假设于本公告日期至完成日期的间本公司已发行股本 概无变动,则认购股份相当于本公司于本公告日期现有已发行股本的约29.97%,并相当于本公司经配 发及发行认购股份扩大后(须待认购事项完成后方可作实)的已发行股本的约23.06%。 认购事项募集的所得款项总额将约为4.64亿港元,经扣除所有相关开支后,所得款项净额将约为4.63亿 港元。所得款项净额的约40%将用作本公司按其于日喀则矿的20%股权的预期资本开支出资,用于在日 喀则矿进行普查及其他勘探作业、所得款项净额的约40%将预留作向西藏日喀则(即日喀则矿的项目公 司)提供进一步融资的用,所得款项净额的约20%将分配用作本集团的一般营运资金。 ...
智通港股早知道 | 恒生指数成份股增加至90只 注意行业政策引导性
Zhi Tong Cai Jing· 2026-02-16 00:00
Group 1: Market Updates - The Hang Seng Index will increase its constituent stocks from 88 to 90, adding CATL, Luoyang Molybdenum, and Laopu Gold [1] - The Dow Jones Industrial Average rose by 48.95 points to 49,500.93, a gain of 0.1%, while the S&P 500 increased by 3.41 points to 6,836.17, a rise of 0.05%. The Nasdaq Composite fell by 50.48 points to 22,546.67, a decline of 0.22% [2] - Gold and silver futures both rose over 2%, with gold prices surpassing $5,000, closing at $5,063.80 per ounce, and silver at $77.27 per ounce [3] Group 2: Regulatory Developments - The State Administration for Market Regulation issued the "Antitrust Compliance Guidelines for Internet Platforms," aimed at clarifying the boundaries of competitive behavior for platform operators [4] - The Financial Regulatory Bureau, in conjunction with the Market Regulation Bureau and the People's Bank of China, held discussions with six travel platform companies regarding compliance in lending practices [5] - The People's Bank of China and the Financial Regulatory Bureau released a list of 21 systemically important banks, categorized into five groups based on their importance scores [6] Group 3: Industry Performance - In January, the national port equipment operating rate was 33.85%, an increase of 2.97 percentage points year-on-year, indicating strong demand in foreign trade [7] - SF Holding reported a total revenue of 26.86 billion yuan in January, a year-on-year increase of 2.22%, driven by growth in supply chain and international logistics [9] - Sands China Limited reported a net profit of $896 million for 2025, a decrease of 14.3%, while total revenue increased by 5.1% to $7.44 billion [10] Group 4: Technological Advancements - MIKRON Heart Technology announced that its new generation implantable cardioverter-defibrillator (ICD) is entering the special review process for innovative medical devices, potentially becoming the first domestically approved MRI-safe ICD [8] - The release of the national certification standard for automotive steering systems is seen as a significant step towards the mass production of steer-by-wire technology, which offers advantages such as improved cabin space and enhanced driving comfort [11]
知乎-W2月13日斥资11.66万美元回购9.9万股
Zhi Tong Cai Jing· 2026-02-15 23:51
Group 1 - The company Zhihu-W (02390) announced a share buyback plan on February 13, 2026, with an investment of $116,600 to repurchase 99,000 shares [1]
SHANGHAI GROWTH1月末每股资产净值为0.04美元
Zhi Tong Cai Jing· 2026-02-15 23:22
SHANGHAI GROWTH(00770)发布公告,于2026年1月31日,公司未经审核的每股资产净值为0.04美 元。 ...
宏业基二次递表港交所
Zhi Tong Cai Jing· 2026-02-15 23:21
Core Viewpoint - Shenzhen Hongye Jiyuan Geotechnical Technology Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange for the second time, with Guangyin International as its sole sponsor [1] Group 1: Company Overview - Hongye is the largest non-state-owned geotechnical engineering company in South China by revenue projected for 2024 [1] - The company ranks first among non-state-owned enterprises participating in large geotechnical engineering projects in South China, with a market share of 1.9% for 2024 [1] - Hongye is positioned as the second-largest non-state-owned enterprise in China's top 10 foundation construction companies for 2024 [1] Group 2: Service Offerings - The company has over 23 years of experience in geotechnical engineering since its establishment in 2002 [3] - Hongye primarily focuses on providing geotechnical engineering services, including: - Pile foundation engineering - Excavation engineering - Combined pile foundation and excavation support engineering [3]
中国生物制药:贝莫苏拜单抗注射液非小细胞肺癌放化疗后维持适应症获批上市
Zhi Tong Cai Jing· 2026-02-15 22:45
Core Viewpoint - China National Pharmaceutical Group's innovative drug Bemosituzumab (brand name: Andevate) has received approval from the National Medical Products Administration (NMPA) for a new indication in treating unresectable stage III non-small cell lung cancer (NSCLC) patients who have not progressed after platinum-based chemotherapy [1] Group 1 - The approval is based on positive results from the R-ALPS study, which was presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] - The study included patients with locally advanced or unresectable stage III NSCLC who had not progressed after synchronous/sequential chemoradiotherapy, comparing Bemosituzumab to a placebo [1] Group 2 - The median follow-up time was 19.4 months, with a median progression-free survival (PFS) of 9.69 months for the Bemosituzumab group compared to 4.17 months for the placebo group (HR=0.53, 95% CI 0.39-0.72, p<0.0001), indicating a 47% reduction in the risk of disease progression or death [2] - Subgroup analyses showed consistent benefit trends across various groups, demonstrating the broad applicability of this treatment [2] - Overall survival (OS) data is not yet mature, with median OS not reached, but a trend towards OS benefit was observed (HR=0.76, 95% CI 0.50-1.14) [2] Group 3 - The incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 29.4% in the Bemosituzumab group compared to 19.7% in the placebo group [2] - Bemosituzumab is the third PD-L1 inhibitor approved in China for consolidation therapy after radical chemoradiotherapy for locally advanced or unresectable NSCLC [2] - The company aims to continue focusing on innovation in lung cancer treatment, developing a pipeline that covers multiple molecular subtypes and treatment scenarios to enhance patient survival benefits [2]
北海康成-B拟折让约14.70%发行合共8403.36万股 净筹约1.99亿港元
Zhi Tong Cai Jing· 2026-02-15 22:32
Core Viewpoint - Beihai Kangcheng-B (01228) has announced a subscription agreement to issue a total of 84.0336 million subscription shares at a price of HKD 2.38 per share, representing a discount of approximately 14.70% compared to the closing price of HKD 2.79 on February 13, 2026 [1] Group 1: Subscription Details - The total amount raised from the subscription is expected to be approximately HKD 200 million, with a net amount of about HKD 199 million after deducting related expenses [1] - The net issue price per subscription share is estimated to be HKD 2.37 [1] Group 2: Use of Proceeds - The net proceeds from the subscription will be used for working capital for commercialized products and maintenance of registrations, research and development expenses for existing product lines, and settlement of trade payables of the group [1]
瑞尔集团委任国卫为新任核数师
Zhi Tong Cai Jing· 2026-02-15 12:06
根据本公司的章程细则,董事会可填补本公司核数师职位的任何临时空缺。继罗兵咸永道辞任后,董事 会经审核委员会建议,已决议委任国卫会计师事务所有限公司(国卫)为本公司新任核数师,以填补临时 空缺,自2026年2月14日起生效(该委任)。 瑞尔集团(06639)发布公告,罗兵咸永道会计师事务所(罗兵咸永道)已辞任本公司核数师,自2026年2月 13日起生效。 ...
德兰明海递表港交所
Zhi Tong Cai Jing· 2026-02-15 11:47
据港交所2月15日披露,深圳市德兰明海新能源股份有限公司(简称:德兰明海)向港交所主板递交上市 申请书,清科资本为其独家保荐人。该公司以BLUETTI品牌经营,为领先的便携储能产品供应商和创 新者。根据弗若斯特沙利文的资料,该公司以收入占比(6.6%)及出货量占比(7.5%)计算在全球位居第 四,彰显在快速增长产业中的领导地位。 据招股书,自2020年推出BLUETTI品牌以来,该公司凭借快速产品迭代(由内部研发团队支持)及全通路 品牌建设实现迅速扩张,已建立显著的全球品牌影响力,产品销往超过120个国家与地区。截至2025年 12月31日,该公司在全球累计出货超过350万台储能产品。 ...