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复宏汉霖(02696) - 自愿公告 - 重组抗VEGF人源化单克隆抗体注射液HLX04-O的上市註...
2025-08-13 09:00
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) 自願公告 重組抗VEGF人源化單克隆抗體注射液HLX04-O 的上市註冊申請(NDA)獲國家藥品監督管理局(NMPA)受理 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。 茲提述本公司於2020年10月15日及2023年2月22日刊發的公告,內容有關本 公司將HLX04-O(本公司自主研發的重組抗VEGF人源化單克隆抗體眼用注射 液,原項目代碼:HLX04)(「HLX04-O」)於全球範圍眼科治療用途和╱或療 法的獨家權利許可給Essex Bio-Investment Limited及珠海億勝生物製藥有限 公司(合稱「Essex」),並約定與Essex共同開發相關產 ...
国内第2款!复宏汉霖和亿胜生物“贝伐珠单抗”眼科制剂申报上市
Core Viewpoint - The joint application for the market approval of HLX04-O, a recombinant anti-VEGF monoclonal antibody injection for treating wet age-related macular degeneration (wAMD), has been submitted by Fuhong Hanlin and Edding Bio, marking the second such application for a bevacizumab ophthalmic formulation in China [2][4]. Group 1: Product Development - HLX04-O is developed using genetic engineering technology and specifically binds to VEGF, blocking its interaction with receptors on endothelial cells, thereby inhibiting endothelial cell proliferation and reducing neovascularization [2]. - The drug has successfully met the primary endpoint in a Phase III clinical trial (NCT05003245) comparing its efficacy and safety against ranibizumab in wAMD patients, showing non-inferiority in terms of best-corrected visual acuity improvement [3]. - An international multi-center Phase III clinical study (NCT04740671) is also being conducted for HLX04-O, with participants recruited from China, Australia, the EU, and the US [3]. Group 2: Market Context - Currently, there are no approved bevacizumab formulations for treating ophthalmic diseases in China, making HLX04-O a significant addition to the market [4]. - The only other application for a bevacizumab ophthalmic formulation, TAB014, was submitted by Zhaoke Ophthalmology and Dongyao Pharmaceutical in June 2023 for the treatment of wAMD [4].
国内第2款!复宏汉霖和亿胜生物"贝伐珠单抗"眼科制剂申报上市
Core Viewpoint - The joint application for the market approval of HLX04-O, a recombinant anti-VEGF monoclonal antibody injection for the treatment of wet age-related macular degeneration (wAMD), has been submitted by Fuhong Hanlin and Edding Bio, marking the second such application for a bevacizumab ophthalmic formulation in China [1][2][3] Group 1: Product Development - HLX04-O is developed using genetic engineering technology and specifically binds to VEGF, inhibiting its interaction with receptors on endothelial cells, thereby reducing neovascularization associated with wAMD [1] - The drug has successfully met the primary endpoint in a Phase III clinical trial (NCT05003245) comparing its efficacy and safety against Ranibizumab in wAMD patients, showing non-inferiority in terms of best-corrected visual acuity improvement [2] - An international multi-center Phase III clinical study (NCT04740671) is also being conducted for HLX04-O, with participants recruited from China, Australia, the EU, and the US [2] Group 2: Market Context - Currently, there are no approved bevacizumab formulations for ophthalmic diseases in China, making HLX04-O the second reported application for such a drug after TAB014 [3]
复宏汉霖(02696) - 将於2025年8月29日举行的2025年第三次临时股东大会(或其任何续会...
2025-08-12 11:06
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) 將於2025年8月29日舉行的2025年第三次臨時股東大會 (或其任何續會)適用的代表委任表格 | 本代表委任表格所代 | 非上市股份 | | --- | --- | | (附註1) 表的股份數目 | H股 | 本人╱吾等 (附註 2 ) | 地址為 | | | --- | --- | | 為上海復宏漢霖生物技術股份有限公司(「本公司」)股本中每股面值人民幣1.00元非上市股份╱H股股份 | 股 | | (附註3) 之股東 ,茲委任大會主席或 | (附註4) | | 地址為 | | | 為本人╱吾等的代表,代表本人╱吾等出席本公司謹訂於2025年8月29日(星期五)下午4時正假座中國上海市徐匯區宜州路188號B8幢10樓會議室舉 | | | 行的2025年第三次臨時股東大會(「臨時股東大會」)(及其任何續會),並按以下指示就日期為2025年8月29日的臨時股東大會通告所載決議案投票, | | | 及如無作出指示,則受委代表可自行酌情投票。除另有界定 ...
复宏汉霖(02696) - 临时股东大会通告
2025-08-12 11:01
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通告的內容概不負責,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通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) 臨時股東大會通告 主席 茲通告上海復宏漢霖生物技術股份有限公司(「本公司」)謹訂於2025年8月29日 (星期五)下午4時正假座中國上海市徐匯區宜州路188號B8幢10樓會議室舉行臨時股東 大會(「臨時股東大會」),以考慮及酌情通過下列決議案。除非另有界定,否則本通告 所用詞彙與本公司日期為2025年8月12日之通函所定義者具相同涵義: 普通決議案 – 1 – 1. 考慮及批准有關重新委任及委任第四屆董事會董事之決議案: 1.1 重新委任現屆執行董事朱俊博士為第四屆董事會執行董事; 1.2 重新委任現屆非執行董事Wenjie Zhang先生為第四屆董事會非執行董 事; 1.3 重新委任現屆非執行董事陳啟宇先生為第四屆董事會非執行董事; 1.4 ...
复宏汉霖(02696) - (1)建议委任第四届董事会董事、(2)建议委任第四届监事会股东代表监事、...
2025-08-12 10:56
此乃要件 請即處理 閣下如對本通函任何方面或應採取之行動有任何疑問,應諮詢股票經紀或其他註冊證券商、銀行經理、律師、專業會 計師或其他專業顧問。 閣下如已出售或轉讓名下所有上海復宏漢霖生物技術股份有限公司之股份,應立即將本通函連同隨附之代表委任表格 送交買主或承讓人,或經手買賣或轉讓之銀行、股票經紀或其他代理商,以便轉交買主或承讓人。 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通函之內容概不負責,對其準確性或完整性亦不發表任何 聲明,並表明概不就因本通函全部或任何部分內容而產生或因倚賴該等內容而引致之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) (1)建議委任第四屆董事會董事 (2)建議委任第四屆監事會股東代表監事 (3)建議修訂公司章程 (4)建議修訂《股東大會議事規則》 (5)建議修訂《董事會議事規則》 (6)建議修訂《監事會議事規則》 (7)建議修訂《防止控股股東及其關聯方╱關連人士佔用公司資金制度》 (8)建議修訂《利潤分配管理制度》 及 臨時股東大會 ...
复宏汉霖(02696)CEO朱俊连任执行董事,年内股价涨超200%
智通财经网· 2025-08-08 10:24
Group 1 - The company Huahong Hanhlin (02696) announced the appointment of its fourth board of directors, with Dr. Zhu Jun continuing as an executive director and three non-executive directors joining, including prominent figures from Fosun Pharma and former GE Healthcare executives, which will enhance the company's global strategy and innovation pipeline [1] - Huahong Hanhlin has shown strong growth, with six products approved in China and four launched overseas, benefiting over 800,000 patients across more than 50 countries [1] - The company's stock price has increased by over 200% since 2025 and was included in the MSCI Global Small Cap Index in May, indicating rising market recognition [1] Group 2 - The company has made significant progress in its core product pipeline, with the PD-L1 ADC HLX43 for advanced NSCLC receiving approval for international multi-center Phase II clinical trials in multiple countries, and initial dosing completed [2] - The I phase clinical data for HLX43 was presented at the 2025 ASCO annual meeting, showing promising efficacy and safety, with a competitive edge in development [2] - The innovative dual-pathway anti-HER2 monoclonal antibody HLX22 is advancing in international Phase III studies for HER2-positive advanced gastric cancer, and a Phase II trial for HER2 low-expressing HR-positive breast cancer has also commenced [2]
复宏汉霖建议委任第四届董事会董事及监事会股东代表监事
Zhi Tong Cai Jing· 2025-08-08 09:17
Group 1 - The company proposed the reappointment of current executive director Dr. Zhu Jun for the fourth board of directors [1] - The company suggested the reappointment of current non-executive directors Mr. Wenjie Zhang, Mr. Chen Qiyu, Ms. Guan Xiaohui, and Dr. Xingli Wang for the fourth board of directors [1] - The company recommended the reappointment of current independent non-executive directors Mr. Su Deyang, Dr. Chen Liyuan, and Dr. Song Ruilin for the fourth board of directors [1] Group 2 - The supervisory board proposed the reappointment of current shareholder representative supervisors Ms. Feng Rongli and Mr. Kong Deli for the fourth supervisory board [1] - Ms. Feng Rongli and Mr. Kong Deli will continue to perform their supervisory duties until the temporary shareholders' meeting elects the members of the fourth supervisory board [1] - The current employee representative supervisor Mr. Liu Zhiyong was reappointed for the fourth supervisory board at the employee representative meeting scheduled for August 8, 2025 [1]
复宏汉霖(02696) - 建议委任第四届董事会董事建议委任第四届监事会股东代表监事及委任职工代表监...
2025-08-08 09:05
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) 建議委任第四屆董事會董事 建議委任第四屆監事會股東代表監事 及 委任職工代表監事 建議重新委任及委任第四屆董事會董事 第三屆董事會的任期於近期屆滿,各董事將繼續履行彼等的董事職責,直至選 舉產生第四屆董事會成員之臨時股東大會結束。 董事會現時由十一名董事組成,包括一名執行董事、六名非執行董事及四名獨立 非執行董事。第三屆董事會的任期於近期屆滿,各董事將繼續履行彼等作為董事 的職責,直至選舉產生第四屆董事會成員之臨時股東大會結束。 董事會建議第四屆董事會由十一名董事組成,其中包括一名執行董事、六名非 執行董事及四名獨立非執行董事。董事會已審議及批准重新委任及委任以下第 四屆董事會董事候選人: 董事會建議(i)重新委任現屆執行董事朱俊博士為第四屆董 ...
港股公告掘金|中国移动上半年股东应占利润同比增加5.03%至842.35亿元 中芯国际二季度股东应占溢利同比减少19.5%
Jin Rong Jie· 2025-08-07 17:39
Major Events - Silver诺医药-B (02591) is set to conduct an IPO from August 7 to August 12, with an expected listing date of August 15 [1] - Boan Biotech (06955) plans to place 48 million shares at a discount of approximately 8.78%, aiming to raise about HKD 780 million [1] - Derin Holdings (01709) intends to raise HKD 653.3 million, focusing on the development of blockchain, RWA, and virtual asset businesses [1] - Fuhong Hanlin (02696) received FDA approval to initiate a Phase 1 clinical trial for HLX43, a PD-L1 targeted antibody-drug conjugate for thymic cancer treatment [1] - China Biopharmaceutical (01177) obtained NMPA approval for the Phase II clinical trial application of LM-24C5, a dual antibody targeting CEACAM5/4-1BB [1] Financial Reports - China Mobile (00941) reported a shareholder profit of HKD 84.235 billion, a year-on-year increase of 5.03% [1] - Manulife Financial-S (00945) announced a core profit of CAD 1.7 billion for the second quarter [1] - Swire Properties (01972) reported a basic profit attributable to shareholders of HKD 4.42 billion, a year-on-year growth of 15% [1] - Hutchison Whampoa (00013) posted a net profit of USD 455 million, a significant year-on-year increase of 1663.32% [1] - MGM China (02282) disclosed a net profit of HKD 2.383 billion, a year-on-year decrease of 11.25% [1] - SMIC (00981) reported a shareholder profit of USD 132 million for the second quarter, with a revenue guidance for the third quarter indicating a sequential growth of 5% to 7% [1] - Zai Lab (09688) achieved a total revenue of approximately USD 216 million for the first half of the year, reflecting a year-on-year growth of 15.35% [1] - Innovent Biologics (01801) reported total product revenue exceeding RMB 5.2 billion for the first half of the year, maintaining a strong growth rate of over 35% [1] - Pacific Basin Shipping (02343) announced a profit attributable to shareholders of USD 25.6 million, a year-on-year decrease of 56% [1] - Lee & Man Paper Manufacturing (02314) reported a net profit of HKD 811 million, a year-on-year increase of 0.7%, with an interim dividend of HKD 0.066 per share [1] - Swire Group reported a profit attributable to shareholders of HKD 815 million for the first half of the year, a year-on-year decrease of 79% [1] - Lee & Man Chemical Company (00746) reported a profit increase of 36.0% to HKD 327 million, with an interim dividend of HKD 0.195 per share [1] - Hua Hong Semiconductor (01347) reported a profit attributable to parent company owners of USD 7.952 million for the second quarter, a year-on-year increase of 19.2% [1] - Wharf Real Estate Investment (01997) reported a loss attributable to shareholders of HKD 2.406 billion, a year-on-year increase of 128.71%, with the first interim dividend of HKD 0.066 per share [1] - Dekang Agriculture (02419) issued a profit warning, expecting a year-on-year increase in fair value adjustments of biological assets to approximately RMB 1.1 billion to 1.4 billion [1] - Mongol Mining (00975) issued a profit warning, anticipating a net loss of approximately USD 15 million to 25 million for the first half of the year, marking a shift from profit to loss [1] - Dongfeng Motor Group (00489) issued a profit warning, expecting a decline in net profit attributable to the parent company of 90% to 95% for the first half of the year [1]