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复宏汉霖(02696):注射用HLX43(靶向PD-L1抗体偶联药物)获FDA批准开展用于治疗胸腺癌的1期临床试验
智通财经网· 2025-08-07 10:04
智通财经APP讯,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) 获美国食品药品管理局(FDA)批准开展用于治疗胸腺癌(TC)的1期临床试验,可继续推进后续临床相关 工作。公司拟于条件具备后于澳大利亚、日本、美国等国家开展胸腺癌(TC)适应症相关临床试验。 ...
复宏汉霖(02696) - 自愿公告 - 注射用HLX43(靶向PD-L1抗体偶联药物)获美国食品药...
2025-08-07 10:00
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) 本公司董事會(「董事會」)欣然宣佈,近日,注射用HLX43(靶向PD-L1抗體 偶聯藥物)(「HLX43」)獲美國食品藥品管理局(FDA)批准開展用於治療胸腺 癌(TC)的1期臨床試驗,可繼續推進後續臨床相關工作。本公司擬於條件具 備後於澳大利亞、日本、美國等國家開展胸腺癌(TC)適應症相關臨床試驗。 B. 關於HLX43 HLX43是由本公司利用許可引進的新型DNA拓撲異構酶I抑制劑小分子毒 素-肽鏈連接符與本公司自主研發的靶向PD-L1的抗體進行偶聯開發的靶向 PD-L1的抗體偶聯藥物(ADC),擬用於晚期/轉移性實體瘤的治療。截至本公 告日,HLX43及相關聯合療法的最新進展情況如下: | 產品/聯合療法 | 適應症 | 最新進展 | | ...
港股公告掘金|国泰航空上半年股东应占溢利36.51亿港元 百济神州上半年业绩扭亏为盈至9559万美元
Jin Rong Jie· 2025-08-06 16:52
中国生物制药(01177) 自主研发的罗伐昔替尼片"TQ05105 (JAK/ROCK抑制剂)"被纳入突破性治疗药物程 序 复宏汉霖(02696):HLX79注射液联合汉利康® 治疗活动期肾小球肾炎的2期临床研究于中国境内完成首 例患者给药 瑛泰医疗(01501)拟出资不超过1.1亿元参设怀格广泰基金 晋景新能(01783)建议股份拆细 【财报数据】 国泰航空(00293)发布中期业绩 股东应占溢利36.51亿港元 同比增长1.1% 中期息每股20港仙 【重大事项】 国泰航空(00293)购买十四架波音777-9型飞机 恒瑞医药(01276):注射用瑞康曲妥珠单抗联合阿得贝利单抗注射液和化疗用于胃癌或胃食管结合部腺 癌适应症获得美国 FDA孤儿药资格认定 百济神州(06160)发布第二季度业绩 净利润9432万美元 同比扭亏为盈 新鸿基公司(00086)发盈喜 预计中期股东应占溢利同比增加至不低于8亿港元 维信金科(02003)发盈喜,预期中期综合净利润不少于2亿元 同比大幅增长 赤子城科技(09911)发盈喜 预计中期股东应占利润同比增长约108.9%至126.7% 华显光电(00334)发盈喜 预期上半年 ...
港股公告掘金 国泰航空上半年股东应占溢利36.51亿港元 百济神州上半年业绩扭亏为盈至9559万美元
Jin Rong Jie· 2025-08-06 16:03
Major Events - Cathay Pacific (00293) has purchased fourteen Boeing 777-9 aircraft [1] - Hengrui Medicine (01276) received FDA orphan drug designation for the combination of injection Rituximab and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma [1] - China National Pharmaceutical Group (01177) has its self-developed drug TQ05105 (JAK/ROCK inhibitor) included in the breakthrough therapy designation program [1] - Junshi Biosciences (02696) completed the first patient dosing in a Phase II clinical study of HLX79 injection combined with Hanli Kang® for active glomerulonephritis in China [1] - YingTai Medical (01501) plans to invest no more than 110 million yuan to establish the Huai Ge Guang Tai Fund [1] - JinJing New Energy (01783) proposed a stock split [1] Financial Data - Cathay Pacific (00293) reported a mid-term profit attributable to shareholders of 3.651 billion HKD, a year-on-year increase of 1.1%, with an interim dividend of 0.2 HKD per share [1] - Uni-President Enterprises China (00220) reported a mid-term profit attributable to shareholders of 1.287 billion CNY, a year-on-year increase of 33.24% [1] - BeiGene (06160) reported a net profit of 94.32 million USD in the second quarter, returning to profitability year-on-year [1] - New World Development Company (00086) issued a profit warning, expecting mid-term profit attributable to shareholders to increase to no less than 800 million HKD year-on-year [1] - Weixin Jinkao (02003) issued a profit warning, expecting mid-term comprehensive net profit to be no less than 200 million CNY, a significant year-on-year increase [1] - ZhiZi Cheng Technology (09911) issued a profit warning, expecting mid-term profit attributable to shareholders to increase by approximately 108.9% to 126.7% year-on-year [1] - Huaxian Optoelectronics (00334) issued a profit warning, expecting a year-on-year increase of no less than 600% in profit attributable to the parent company [1] - Xinli International (00732) reported a total operating revenue of approximately 1.468 billion HKD in July, a year-on-year decrease of about 3.3% [1]
港股公告精选|百济神州上半年营收同比增超4成 中国海外发展前7月销售额超1300亿元
Xin Lang Cai Jing· 2025-08-06 12:09
1)业绩速递 百济神州(06160.HK):上半年营收175.18亿元,同比上升46%;产品收入为173.6亿元,同比上升45.8%;净利润4.5亿元,同比扭亏为盈。 统一企业中国(00220.HK):上半年收入约为170.87亿元,同比上升10.6%;净利润约12.87亿元,同比上升33.2%。 赤子城科技(09911.HK):发布盈喜,预计中期收入约31.35亿-32.15亿元,同比增约38.0%-41.5%;净利润约为4.7亿-5.1亿元。同比增长约108.9%-126.7%。 智通财经8月6日讯(编辑 冯轶 汤赞淇)智通财经为您带来今日港股重要公告 维信金科(02003.HK):发布盈喜,预计中期净利润超2亿元,同比大幅增长。 翼辰实业(01596.HK):发布盈喜,预计中期净利润约4870万元,同比扭亏为盈。 华显光电(00334.HK):发布盈喜,预计中期净利润超4880万元,同比增超600%。 迈富时(02556.HK):发布盈喜,预计中期净利润约3180万-4100万元,同比扭亏为盈。 心玮医疗-B(06609.HK):发布盈喜,预计中期净利润超4000万元,同比扭亏为盈。 中国核能科技(00 ...
复宏汉霖(02696) - 截至2025年7月31日止月份之股份发行人的证券变动月报表
2025-08-06 11:03
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年7月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 上海復宏漢霖生物技術股份有限公司 呈交日期: 2025年8月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02696 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 163,428,541 | RMB | | 1 RMB | | 163,428,541 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 163,428,541 | RMB | | 1 RMB | | 163,428,541 | | 2. 股份分類 | 普通股 | 股份類別 | 其他類別 (請 ...
复宏汉霖(02696):HLX79注射液联合汉利康® 治疗活动期肾小球肾炎的2期临床研究于中国境内完成首例患者给药
Zhi Tong Cai Jing· 2025-08-06 09:37
Core Viewpoint - The company has initiated the first patient dosing in a Phase II clinical study of HLX79 injection combined with Hanlikang for the treatment of active glomerulonephritis in mainland China [1][2]. Group 1: Clinical Study Overview - The study is a double-blind, randomized, controlled, multi-center Phase II trial aimed at evaluating the efficacy, safety, and tolerability of HLX79 combined with Hanlikang compared to a placebo in patients with active glomerulonephritis, including lupus nephritis (LN) and membranous nephropathy (MN) [2]. - The study consists of two phases: the first phase is a dose-escalation period where eligible participants will receive HLX79 (10 mg/kg, 20 mg/kg, or 30 mg/kg) combined with either Hanlikang or a Hanlikang placebo (375 mg/m²) weekly [2]. - The second phase is a preliminary efficacy exploration period, where eligible participants will receive HLX79 (high dose/low dose) combined with Hanlikang (375 mg/m²), HLX79 placebo combined with Hanlikang, or HLX79 placebo combined with Hanlikang placebo weekly, with the primary objective of evaluating clinical efficacy [2]. Group 2: Market Context - As of the date of the announcement, there are no similar combination therapies approved for marketing globally [3].
复宏汉霖(02696.HK):HLX79联合汉利康®治疗活动期肾小球肾炎的2期临床研究于中国境内完成首例患者给药
Ge Long Hui· 2025-08-06 09:30
格隆汇8月6日丨复宏汉霖(02696.HK)发布公告,近日,一项HLX79注射液(人唾液酸酶融合蛋白) ("HLX79")联合汉利康®(利妥昔单抗注射液)("汉利康®")治疗活动期肾小球肾炎的2期临床研究于中国境 内(不包括中国港澳台地区)完成首例患者给药。 ...
复宏汉霖:HLX79注射液联合汉利康 治疗活动期肾小球肾炎的2期临床研究于中国境内完成首例患者给药
Zhi Tong Cai Jing· 2025-08-06 09:29
Core Viewpoint - The company Fuhong Hanlin (02696) has announced the completion of the first patient dosing in a Phase II clinical trial for HLX79 injection combined with Hanlikang (Rituximab injection) for the treatment of active glomerulonephritis in China, excluding Hong Kong, Macau, and Taiwan [1] Group 1 - The study is a double-blind, randomized, controlled, multi-center Phase II clinical trial aimed at evaluating the efficacy, safety, and tolerability of HLX79 combined with Hanlikang compared to placebo in patients with active glomerulonephritis, specifically lupus nephritis (LN) and membranous nephropathy (MN) [2] - The trial consists of two phases: the first phase is a dose-escalation period where eligible participants will receive weekly doses of HLX79 (10 mg/kg, 20 mg/kg, or 30 mg/kg) combined with Hanlikang or Hanlikang placebo (375 mg/m²) [2] - The primary objective of the first phase is to assess the safety and tolerability of HLX79 combined with Hanlikang compared to placebo combined with Hanlikang in treating active glomerulonephritis [2] Group 2 - The second phase is an exploratory efficacy phase where eligible participants will receive weekly doses of HLX79 (high dose/low dose) combined with Hanlikang (375 mg/m²), HLX79 placebo combined with Hanlikang, or HLX79 placebo combined with Hanlikang placebo in a 2:2:1:1 ratio [2] - The primary objective of the second phase is to evaluate the clinical efficacy of HLX79 combined with Hanlikang, placebo combined with Hanlikang, and placebo treatment for active glomerulonephritis on top of standard treatment [2] - Secondary objectives include assessing other clinical efficacy, safety, tolerability, pharmacokinetic characteristics, and immunogenicity, while exploratory objectives aim to evaluate the dynamic changes of potential biomarkers [2] - As of the date of the announcement, there are no similar combination therapies approved for marketing globally [2]
复宏汉霖(02696) - 自愿公告 - HLX79注射液(人唾液酸酶融合蛋白)联合汉利康(利妥昔单...
2025-08-06 09:15
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 HLX79注射液(人唾液酸酶融合蛋白) 聯合漢利康® (利妥昔單抗注射液) 治療活動期腎小球腎炎的 2期臨床研究於中國境內完成首例患者給藥 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,一項HLX79注射液(人唾液酸酶 融合蛋白)(「HLX79」)聯合漢利康® (利妥昔單抗注射液)(「漢利康®」)治療活 動期腎小球腎炎的2期臨床研究於中國境內(不包括中國港澳台地區,下同) 完成首例患者給藥。 B. 臨床試驗設計及目的 本研究為一項雙盲、隨機對照、多中心的2期臨床試驗,旨在評估HLX79 聯合漢利康®對比安慰劑在活 ...