注射用HLX43

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十月开门红可期,黄金板块还有戏
Yang Zi Wan Bao Wang· 2025-10-08 23:17
Market Overview - The stock market experienced significant activity on the first trading day of October, with notable performances from various companies, including 蓝丰生化 (Bluefeng Biochemical) achieving a seven-day consecutive rise [1] - The total trading volume in the Shanghai and Shenzhen markets reached 2.18 trillion yuan, an increase of 20 billion yuan compared to the previous trading day [1] - Key sectors showing strong performance included non-ferrous metals and storage chips, while sectors such as liquor and large financials faced declines [1] Company Announcements - 复星医药 (Fosun Pharma) announced that its subsidiary received approval for clinical trials of a new drug for treating advanced solid tumors, with a total R&D investment of approximately 150,000 yuan expected by August 2025 [2] - 恒瑞医药 (Hengrui Medicine) received approval for clinical trials of its innovative anti-tumor drug HRS-2329, with a cumulative R&D investment of about 6.015 million yuan [2] External Market Influences - The US stock market saw the Nasdaq and S&P 500 indices reach new closing highs, with AMD shares rising over 11%, marking a 43% increase over three days, the best performance in nine years [3] - The Federal Reserve's probability of a 25 basis point rate cut in October is at 94.6%, indicating a strong expectation for a reduction in interest rates [4]
上海复星医药(集团)股份有限公司关于非执行董事、高级管理人员辞任的公告
Shang Hai Zheng Quan Bao· 2025-10-08 19:47
证券代码:600196 股票简称:复星医药 编号:临2025-155 上海复星医药(集团)股份有限公司 关于非执行董事、高级管理人员 辞任的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性承担法律责任。 2025年9月30日,上海复星医药(集团)股份有限公司(以下简称"本公司")董事会分别收到吴以芳先 生、周旭东先生的书面辞职函,具体如下: 一、因个人工作变动,吴以芳先生向董事会申请辞去非执行董事职务。根据《上海复星医药(集团)股 份有限公司章程》(以下简称"《公司章程》")规定,吴以芳先生的辞任于送达董事会时生效。吴以芳 先生已确认,其于任期内与董事会之间概无分歧。 吴以芳先生的辞任不会导致本公司董事会成员人数低于《中华人民共和国公司法》规定的法定最低人 数,不会对董事会的正常运作产生影响。本公司将依据《公司章程》的规定,尽快就补选董事事宜履行 相应程序。 董事会对吴以芳先生于本公司任职董事期间的工作表示感谢。 二、因个人发展原因,周旭东先生向董事会申请辞去高级副总裁职务。周旭东先生自2025年9月30日起 不再担任本公司高级副总裁职 ...
晚间公告丨9月30日这些公告有看头
Di Yi Cai Jing· 2025-09-30 11:44
Group 1 - Cambrian's private placement price is set at 1195.02 yuan per share, with a total fundraising amount of 3.985 billion yuan [2] - Bee Assistant plans to raise up to 984 million yuan for projects including cloud terminal computing power center and IoT terminal upgrades [3] - Kexing Pharmaceutical is planning to issue H-shares and list on the Hong Kong Stock Exchange [4] Group 2 - Three squirrels received approval from the China Securities Regulatory Commission for H-share issuance, planning to issue up to 81.5483 million shares [5] - Ruiming Technology has submitted an application for H-share issuance to the Hong Kong Stock Exchange [6] - Binhua Co. plans to invest 1.421 billion yuan in an integrated project for wind and solar energy [7] Group 3 - Sainz's subsidiary plans to invest up to 300 million yuan in the expansion of selection and extraction agents [8] - Hunan YN reported no significant changes in its internal and external operating environment [9] - Electric Power Investment plans to restructure assets and has received a notice from the Shenzhen Stock Exchange to suspend review [10] Group 4 - Guanzhong Ecology is in the planning stage to acquire 51% of Hangzhou Actuary [11] - Aima Technology announced the transfer and suspension of production capacity at its subsidiary in Guangdong [12] - Fosun Pharma's subsidiary received approval for clinical trials of a new drug [13] Group 5 - EVE Battery Investment received a cash dividend of 375 million HKD from its indirect associate, Simoer International [14] - Shanmei International announced a change in its board leadership due to personnel changes [15] - Weiye Co. announced the resignation of its chairman for personal reasons [16] Group 6 - Jiaoda Sinuo's chairman is under detention, and the company has appointed a new acting chairman [17] - Duorui Pharmaceutical is planning a change in control, leading to a stock suspension [18] - ST Zhengping's stock price has seen an abnormal increase, leading to a suspension for investigation [19] Group 7 - Daqian Ecology's shareholder plans to reduce its stake by up to 3% [20] - Rundat Medical's shareholders plan to collectively reduce their stake by up to 2.99% [21] - Seli Medical's shareholder plans to reduce its stake by up to 2% [22] Group 8 - Tianyong Intelligent has been awarded a contract worth 58.8 million yuan for an engine assembly line project [23] - Zhongwu Drone signed a significant contract worth 615 million yuan for drone systems [24]
复星医药(02196.HK)控股子公司药品获临床试验批准
Ge Long Hui· 2025-09-30 10:33
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the National Medical Products Administration to conduct clinical trials for HLX43 and HLX07 in treating advanced/metastatic solid tumors [1] Group 1: Clinical Trial Approval - The company has been granted permission to initiate clinical trials for the combination treatment of HLX43 and HLX07 [1] - The clinical trials will be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan [1] Group 2: Drug Details - HLX43 is a targeted PD-L1 antibody-drug conjugate developed by linking a novel DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody [1] - HLX07 is an innovative biological drug developed by the company targeting the EGFR pathway, intended for the treatment of advanced solid tumors [1]
复宏汉霖(02696.HK)注射用HLX43联合HLX07用于晚期/转移性实体瘤治疗的1b/2期临床试验申请获国家药监局批准
Ge Long Hui· 2025-09-30 09:40
Core Viewpoint - The company announced the approval of a clinical trial application for HLX43 in combination with HLX07 for the treatment of advanced/metastatic solid tumors by the National Medical Products Administration (NMPA) [1] Group 1: Product Development - HLX43 is a targeted PD-L1 antibody-drug conjugate (ADC) developed by the company, utilizing a novel DNA topoisomerase I inhibitor small molecule toxin linked to a self-developed PD-L1 targeting antibody [1] - HLX07 is an innovative biological drug developed by the company targeting the EGFR pathway, intended for the treatment of advanced solid tumors [1] Group 2: Clinical Trials - The 1b/2 phase clinical trial results for HLX07 in combination with chemotherapy for advanced solid tumors showed good safety and tolerability [1] - Multiple phase 2 clinical studies for HLX07 are currently underway in China, including studies for HLX07 as a monotherapy for advanced cutaneous squamous cell carcinoma (CSCC) and in combination with Hanshu® for advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) [1]
复宏汉霖:注射用HLX43联合HLX07用于晚期/转移性实体瘤治疗的1b/2期临床试验申请获国家药监局批准
Zhi Tong Cai Jing· 2025-09-30 09:40
HLX07为公司自主研发的针对EGFR靶点的创新型生物药,计划用于晚期实体瘤治疗。2023年2月, HLX07联合化疗用于晚期实体瘤治疗的1b/2期临床研究结果显示其安全性及耐受性良好。目前,多项关 于HLX07的2期临床研究正于中国境内开展,主要包括HLX07单药用于治疗晚期皮肤鳞状细胞癌(CSCC) 等实体瘤的2期临床试验及汉斯状联合HLX07用于治疗晚期或转移性鳞状非小细胞肺癌(sqNSCLC)等实 体瘤的2期临床试验。 复宏汉霖(02696)发布公告,近日,注射用HLX43(靶向PD-L1抗体偶联药物)(HLX43)联合HLX07(重组抗 EGFR人源化单克隆抗体注射液)(HLX07)用于晚期/转移性实体瘤治疗的1b/2期临床试验申请获国家药品 监督管理局(NMPA)批准。 HLX43是由公司利用许可引进的新型DNA拓扑异构酶I抑制剂小分子毒素-肽链连接子与公司自主研发的 靶向PD-L1的抗体进行偶联开发的靶向PD-L1的抗体偶联药物(ADC),拟用于晚期/转移性实体瘤的治 疗。 ...
复宏汉霖(02696) - 自愿公告 - 注射用HLX43(靶向PD-L1抗体偶联药物)联合HLX0...
2025-09-30 09:30
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) (股份代號:2696) 自願公告 注射用HLX43(靶向PD-L1抗體偶聯藥物) 聯合HLX07(重組抗EGFR人源化單克隆抗體注射液) 用於晚期/轉移性實體瘤治療的1b/2期臨床試驗申請 獲國家藥品監督管理局批准 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司(「本公司」)自願作出,以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會(「董事會」)欣然宣布,近日,注射用HLX43(靶向PD-L1抗體 偶聯藥物)(「HLX43」)聯合HLX07(重組抗EGFR人源化單克隆抗體注射液) (「HLX07」)用於晚期/轉移性實體瘤治療的1b/2期臨床試驗申請獲國家藥品 監督管理局(「NMPA」)批准。 1 B. 關於HLX43及HLX07 HLX43是由本 ...
复星医药:HLX43联合HLX07治疗晚期/转移性实体瘤开展临床试验获得批准
Zhi Tong Cai Jing· 2025-09-30 09:22
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of HLX43 in combination with HLX07 for the treatment of advanced/metastatic solid tumors [1] Group 1 - The approved treatment plan involves HLX43, a targeted PD-L1 antibody-drug conjugate developed by linking a novel DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody [1] - HLX07 is an innovative biological drug independently developed by the company, targeting EGFR for the treatment of advanced solid tumors [1] - The clinical trials for this treatment plan will be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan [1]
复星医药:控股子公司拟用于治疗晚期实体瘤等的创新药获临床试验批准 全球范围内尚无同类联合用药治疗方案获批上市
Mei Ri Jing Ji Xin Wen· 2025-09-30 09:16
每经AI快讯,9月30日,复星医药(600196)(600196.SH)公告称,公司控股子公司复宏汉霖收到国家药 品监督管理局关于同意注射用HLX43联合HLX07治疗晚期/转移性实体瘤开展临床试验的批准。复宏汉 霖拟于条件具备后于中国境内开展该治疗方案的Ib/II期临床试验。HLX43为复宏汉霖利用许可引进的新 型DNA拓扑异构酶I抑制剂小分子毒素-肽链连接子与其自主研发的靶向PD-L1的抗体进行偶联开发的靶 向PD-L1的抗体偶联药物(ADC),拟用于治疗晚期/转移性实体瘤;HLX07为复宏汉霖自主研发的针对 EGFR靶点的创新型生物药,拟用于治疗晚期实体瘤。截至2025年8月,本集团现阶段针对本次治疗方 案的累计研发投入约为人民币15万元。根据中国相关法规要求,本次治疗方案及所涉在研药品均尚处于 临床试验阶段,且尚需在中国境内开展一系列临床研究并经国家药品审评部门审批通过后,方可上市。 截至本公告日期,于全球范围内尚无同类联合用药治疗方案获批上市。 ...
复星医药(600196.SH):控股子公司药品获临床试验批准
Ge Long Hui· 2025-09-30 09:01
格隆汇9月30日丨复星医药(600196.SH)公布,公司控股子公司上海复宏汉霖生物技术股份有限公司及其控股子公司(以下合称"复宏汉霖")收到国家药品监督管理局关于同意注射用HLX43( 本次治疗方案中所涉HLX43为复宏汉霖利用许可引进的新型DNA拓扑异构酶I抑制剂小分子毒素-肽链连接子与其自主研发的靶向PD-L1的抗体进行偶联开发的靶向PD-L1的抗体偶联药物(ADC) ...