Group 1 - The core viewpoint of the article highlights that Fuhong Hanlin (02696) has successfully had 10 lung cancer research abstracts selected for the 2025 World Lung Cancer Conference (WCLC), including 4 oral presentations and 2 poster discussions, covering key clinical scenarios in non-squamous/squamous non-small cell lung cancer (nsNSCLC/sqNSCLC) and extensive small cell lung cancer (ES-SCLC) first-line treatments [1] - The selected studies focus on the company's three core products: PD-L1 ADC HLX43, PD-1 monoclonal antibody Surulitinib (Hanshu), and anti-EGFR monoclonal antibody HLX07 [1] - HLX43 is noted as the world's first PD-L1 ADC to enter Phase II trials, demonstrating excellent efficacy in NSCLC patients with negative driver gene mutations; Surulitinib is the first PD-1 monoclonal antibody approved for first-line treatment of SCLC, currently approved in nearly 40 countries and regions globally; HLX07 combined with immunotherapy achieved a 100% disease control rate (DCR) and a progression-free survival (PFS) of 17.4 months in EGFR high-expressing lung squamous carcinoma, showcasing strong survival benefits [1] Group 2 - The market has responded positively to the company's global expansion and innovation capabilities, with Fuhong Hanlin's stock price reaching approximately 79 HKD during trading [1] - Citigroup's latest report indicates that data updates for HLX43 at WCLC are expected to further validate its potential in NSCLC treatment, raising the company's target price from 35 HKD to 95 HKD while maintaining a "Buy/High Risk" rating, suggesting that the progress of the company's innovative pipeline will continue to drive valuation reassessment [1]

Core Insights - The World Conference on Lung Cancer (WCLC) 2025 has selected 10 research abstracts from the company, indicating its growing influence in the lung cancer field [1] - The selected studies focus on three core innovative drugs: anti-PD-1 monoclonal antibody Hansizhuang® (Sruvilizumab), anti-EGFR monoclonal antibody HLX07, and the world's first PD-L1 ADC HLX43 entering Phase II clinical trials [1] Group 1: Research Highlights - HLX07 combined with Sruvilizumab and chemotherapy demonstrated a 100% disease control rate and a median progression-free survival (PFS) of 17.4 months in patients with EGFR high-expressing squamous non-small cell lung cancer (NSCLC) [1] - HLX43 showed superior efficacy in specific subgroups, such as EGFR wild-type non-squamous NSCLC, with an overall response rate (ORR) of 47.4%, highlighting both efficacy and safety [1] Group 2: Market Performance - The company has established a differentiated product portfolio in the lung cancer sector, with multiple products approved in nearly 40 countries globally, strengthening its fundamentals [1] - The stock price of the company rose by 2.88% to HKD 76.9, with a total market capitalization of HKD 41.8 billion, reflecting a cumulative increase of nearly 350% since January 23 this year [1]

Core Viewpoint - The announcement highlights a collaboration between the company and Shanghai Junshi Biosciences Co., Ltd. to jointly develop a biological drug for the treatment of wet age-related macular degeneration (wet AMD) [1] Group 1: Licensing Agreement - The company has entered into a joint development licensing agreement with Shanghai Junshi Biosciences, granting exclusive rights to the licensed product [1] - The licensed product is a recombinant anti-VEGF humanized monoclonal antibody intended for use as a raw material drug [1] Group 2: Product Development - The anti-VEGF eye injection biological drug (HLX04-O) has recently been accepted for review by the National Medical Products Administration (NMPA) in China [1] - HLX04-O is developed based on Junshi's independently developed Hanbeitai (Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [1] Group 3: Clinical Trials - A Phase III clinical trial (AURA-1) for HLX04-O in Chinese patients with wet AMD is set to reach its primary endpoint by April 2025 [2] - An international multicenter Phase III clinical trial (AURA-2) is ongoing in multiple European countries, Australia, the United States, and China, with the last patient visit scheduled for January 2025 [2]

Core Viewpoint - The announcement indicates that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for HLX04-O, a treatment for wet age-related macular degeneration (wAMD) [1] Group 1: Clinical Study Results - The NDA submission is primarily based on a multicenter, randomized, double-blind, positive-controlled Phase III study comparing intravitreal injection (IVT) of HLX04-O with ranibizumab for treating wAMD [1] - The study results show that the average change in best-corrected visual acuity (BCVA) from baseline at week 48 in the HLX04-O group was non-inferior to that of the ranibizumab group, achieving the primary endpoint of the study [1] - HLX04-O demonstrated good safety, with no new safety signals observed [1]

Core Viewpoint - The National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for HLX04-O, a treatment for wet age-related macular degeneration (wAMD) by the company [1] Company Summary - HLX04-O's NDA is based on a multicenter, randomized, double-blind, positive-controlled Phase III study comparing intravitreal injection of HLX04-O with ranibizumab for treating wAMD [1] - The study results indicate that the average change in best-corrected visual acuity (BCVA) at week 48 for the HLX04-O group was non-inferior to that of the ranibizumab group, achieving the primary endpoint [1] - HLX04-O demonstrated good safety, with no new safety signals observed [1] Industry Summary - As of the announcement date, there are no approved products for wAMD in China that are based on bevacizumab [1] - According to the latest data from IQVIA CHPA, the sales revenue for drugs targeting wAMD in China is projected to be approximately RMB 4.9 billion in 2024 [1]

Core Viewpoint - The company, Fuhong Hanlin (02696), has received acceptance for its New Drug Application (NDA) for HLX04-O, a treatment for wet age-related macular degeneration (wAMD), from the National Medical Products Administration (NMPA) [1] Group 1 - The NDA for HLX04-O is based on a multicenter, randomized, double-blind, positive-controlled Phase III study comparing intravitreal injection (IVT) of HLX04-O with Ranibizumab for treating wAMD [1] - The study results indicate that the average change in Best Corrected Visual Acuity (BCVA) at week 48 for the HLX04-O group was non-inferior to that of the Ranibizumab group, achieving the primary endpoint of the study [1] - The safety profile of HLX04-O is favorable, with no new safety signals observed [1]

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 ...

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].

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]

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 ...