Core Insights - The company Fuhong Hanlin has announced the completion of the first patient dosing in the Phase II clinical trial of its innovative anti-HER2 monoclonal antibody HLX22, in combination with Trastuzumab, for the treatment of HER2 low-expressing HR-positive locally advanced or metastatic breast cancer [1] Group 1 - The Phase II clinical study (HLX22-BC201) has been completed for the first patient in China [1] - The treatment area for HLX22 has expanded to include breast cancer, following its application in HER2-positive gastric cancer [1]

Core Insights - The article highlights the growth and global ambitions of Fuhong Hanlin, showcasing its achievements in providing affordable biopharmaceuticals to 750,000 patients globally and generating over 20 billion yuan in sales over the past four years [2] - Fuhong Hanlin is transitioning from a "follower" to a "definer" in the biopharmaceutical industry, with a focus on innovative drugs and breaking the monopoly of multinational pharmaceutical companies [4][5] - The company is leveraging strategic partnerships and advanced technology platforms to enhance its research and development capabilities, aiming to create a comprehensive "R&D-production-commercialization" loop [3][9] Company Growth and Market Strategy - Fuhong Hanlin has successfully launched six drugs, with four approved overseas, and is expanding its market presence in over 50 countries [2] - The company’s revenue from overseas markets is on the rise, supported by its "wall-breaking strategy" in regions like the EU and Japan [2][3] - The PD-1 monoclonal antibody, Hanshuang, has become the first approved treatment for extensive-stage small cell lung cancer globally, showcasing the company's innovative capabilities [4][5] Product Development and Innovation - The company has developed a diverse pipeline of approximately 50 molecules, including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs) [9] - Fuhong Hanlin's HLX22, targeting HER2-positive gastric cancer, demonstrates promising results in clinical trials, indicating its potential as a new first-line treatment option [12] - The company is also advancing its next-generation product, HLX43, a PD-L1 ADC drug, which shows significant efficacy in early trials for pancreatic and colorectal cancers [6] Technological Advancements - Fuhong Hanlin has established three major technology platforms to enhance its drug development process, including the Hinova TCE platform for T cell activation and the Hanjugator™ ADC platform to overcome traditional drug resistance [9][10] - The integration of AI in the drug development process has significantly reduced the research cycle for hyaluronidase from 18 months to 5 months, showcasing the company's commitment to innovation [12] Globalization and Strategic Partnerships - The company is strategically targeting six major global markets, with a focus on the U.S., EU, and Japan, while also establishing local partnerships in Southeast Asia, the Middle East, and Latin America [13][14] - Fuhong Hanlin has formed collaborations with notable entities, including Nobel laureate Carolyn Bertozzi, to develop dual-function antibodies and enhance its ADC product pipeline [14]

Core Insights - Fuhong Hanlin is focusing on innovative R&D to strengthen its competitive advantage, with a commitment to patient-centered principles [1] - The company is advancing key innovative products such as HLX22 and HLX43, which are expected to revolutionize treatment for lung cancer and gastrointestinal tumors [1][2] - Fuhong Hanlin is expanding its international strategy, particularly targeting the Japanese market for its core pipelines [3] Group 1: R&D and Product Development - The company is developing several core innovative products, including HLX22, HLX43, and the PD-L1 ADC product, which is designed for targeted cancer therapy [1][2] - Fuhong Hanlin has established three core technology platforms: HinovaTCE, HanjugatorTM, and HAI Club, which enhance its R&D capabilities [2] - The company’s products cover various therapeutic areas, including oncology and autoimmune diseases, with several already approved in multiple regions [2] Group 2: International Expansion Strategy - Fuhong Hanlin is implementing an internationalization strategy with a focus on the Japanese market, leveraging its differentiated advantages in gastric and lung cancer treatments [3] - The company has initiated clinical trials in Japan to support its product development for specific indications [3] - The expansion strategy also includes deepening its presence in the European and Southeast Asian markets [3]

Core Insights - The event "聚.创" Global R&D Day held by Fuhong Hanlin showcased the company's strategic vision and technological breakthroughs in innovative drug development, attracting significant industry attention [1] - Fuhong Hanlin emphasizes a patient-centered approach, having provided treatment solutions to at least 750,000 patients, resulting in cumulative sales exceeding 20 billion [2] - The company has six products on the market, with five developed entirely in-house, and reported a revenue of 5.72 billion last year, investing one-third in R&D while achieving profitability for two consecutive years [2] Internationalization Strategy - Fuhong Hanlin focuses on key markets such as the US, EU, and Japan, aiming to enhance its global value chain through resource integration and international collaboration [3] - The company plans to accelerate the development of core innovative products like H药汉斯状, anti-HER2 monoclonal antibody HLX22, and PD-L1 ADC HLX43, promoting affordable high-quality biopharmaceuticals globally [3] R&D Innovations - The company has established three core technology platforms: Hinova TCE, HanjugatorTM, and HAI Club, which facilitate collaborative R&D and enhance the development of differentiated innovative molecules [3] - HLX43, a PD-L1 ADC product, is in late clinical stages and shows promising potential for treating solid tumors, with ongoing clinical studies [4] AI-Driven Development - Fuhong Hanlin has made significant advancements in AI-assisted drug development, reducing the molecular design cycle from 18 months to 5 months, thus enhancing efficiency [5] - The company aims to leverage its AI platform to support the development of innovative drugs and biosimilars, particularly in the subcutaneous administration market [5] Global Collaboration - Fuhong Hanlin is building an international cooperation ecosystem to enhance its product development and market access, emphasizing trust, efficiency, and innovation in partnerships [6][7] - The company has established a comprehensive biopharmaceutical platform covering the entire value chain, which has garnered confidence from its partners [7] Overcoming Development Challenges - The company addresses the translational gap in biopharmaceutical R&D, focusing on patient-centered innovations to ensure clinical benefits [8] - Discussions at the event highlighted the importance of collaboration and breaking down barriers in the industry to achieve effective transitions from discovery to delivery [8] Future Outlook - Fuhong Hanlin aims to continue driving innovation and globalization, contributing to the global biopharmaceutical landscape and enhancing human health with Chinese wisdom [9]

Core Viewpoint - The financial data and commercialization results of biotech companies have become key indicators for secondary investors following rapid expansion and the bursting of the innovation drug market bubble in the biopharmaceutical sector [1] Group 1: Company Performance - Companies such as BeiGene and Kelun-Biotech have seen their market values double due to strong pipeline progress [1] - The company Fuhong Hanlin has experienced a stock price increase of over 90% since February, with a trading volume exceeding 2.4 billion HKD and a turnover rate of 52% [1] - In 2024, Fuhong Hanlin achieved a revenue of 5.724 billion CNY, a year-on-year increase of 6.1%, and a net profit of 820.5 million CNY, up 50.3% [7] - The cumulative sales of Fuhong Hanlin have surpassed 20 billion CNY [3] Group 2: Research and Development - Fuhong Hanlin's R&D expenditure reached 1.8405 billion CNY in 2024, a year-on-year increase of 28.4%, serving as a driving force for innovation growth [3] - The company has made significant progress in its pipeline, with multiple products receiving regulatory approvals, including HLX11 and HLX22 [3][4] - The company has committed one-third of its revenue to R&D, resulting in six marketed products and substantial benefits for 750,000 patients [5] Group 3: International Expansion - Fuhong Hanlin has accelerated its internationalization process, achieving a closed-loop in its global strategy with products launched in various countries [8] - The company has established a partnership network with over 100 global markets, enhancing its treatment offerings in breast cancer and other areas [9] - The company has built a commercial production capacity of 48,000 liters, ensuring stable supply across multiple regions [9] Group 4: Market Outlook - Analysts from Tianfeng and CMB Securities have given Fuhong Hanlin a "buy" rating, citing its continuous investment in biopharmaceutical innovation and global expansion as key growth drivers [9] - The company is expected to maintain steady growth as core products continue to gain market traction and new products are launched [9]

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 䎃䏞㜡デ 可負擔的創新 值得信賴的品質 使命 持續創新，卓越運營；以優質生物藥，造福全球病患。 願景 專注提供質高價優的生物藥， 成為全球最受信賴的創新生物製藥公司。 目錄 | 公司資料 | 2 | | --- | --- | | 主席致辭 | 4 | | 首席執行官回顧 | 5 | | 運營摘要 | 7 | | 管理層討論與分析 | 16 | | 董事會報告 | 43 | | 監事會報告 | 60 | | 企業管治報告 | 61 | | 董事、監事及高級管理層履歷詳情 | 75 | | 獨立核數師報告 | 85 | | 綜合損益表 | 90 | | 綜合全面收益表 | 91 | | 綜合財務狀況表 | 92 | | 綜合權益變動表 | 93 | | 綜合現金流量表 | 94 | | 財務報表附註 | 96 | | 釋義 | 173 | 1 上海復宏漢霖生物技術股份有限公司 公司資料 董事 主席及非執行董事 Wenjie Zhang1 執行董事 朱 ...

智通财经APP获悉，复宏汉霖(02696)涨超4%，截至发稿，涨4.45%，报31.7港元，成交额2551.34万港 元。 据介绍，H药汉斯状是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国、欧洲和东南亚等30 多个国家和地区获批上市。截至目前，H药已获批用于治疗鳞状非小细胞肺癌(sqNSCLC)、广泛期小细 胞肺癌(ES-SCLC)、食管鳞状细胞癌(ESCC)和非鳞状非小细胞肺癌(nsNSCLC)。聚焦肺癌和消化道肿瘤 等全球高发癌种，复宏汉霖在全球同步开展10余项以H药为核心的免疫联合疗法临床研究，于中国、美 国、日本、土耳其、波兰、格鲁吉亚等国家和地区累计入组逾4900人。 消息面上，据市场消息报道，由国际胃癌协会(International Gastric Cancer Association,IGCA)主办的第16 届国际胃癌大会(International Gastric Cancer Congress, IGCC 2025)将于2025年5月7日-10日在荷兰阿姆斯 特丹召开。此届大会上，复宏汉霖自主研发的创新型单抗H药汉斯状(斯鲁利单抗，欧洲商品名： Hetronifly)两项胃癌领 ...

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-新型DNA拓扑异构 酶I抑制剂偶联药物)(HLX43)联合汉斯状®(斯鲁利单抗注射液)(汉斯状)治疗晚期/转移性实体瘤患者的 1b/2期临床研究于中国境内(不包括港澳台地区，下同)完成首例患者给药。 本研究为一项旨在评估HLX43联合汉斯状治疗晚期/转移性实体瘤患者的安全性、耐受性和有效性的 1b/2期临床研究。研究分为1b期剂量递增和2期剂量拓展两个阶段。第一阶段为开放标签研究，合格的 受试者将接受不同剂量的 HLX43联合固定剂量的汉斯状静脉输注给药，每3周一次(Q3W)。第二阶段为 多中心、随机、开放标签的对照研究，在第一阶段数据的基础上，评估3个不同剂量的HLX43联合固定 剂量汉斯状在晚期非小细胞肺癌(NSCLC)患者中的安全性和有效性。第一阶段的主要终点为剂量限制性 毒性(DLT)观察期内每个剂量组发生DLT事件的受试者比例和HLX43联合汉斯状用药的最大耐受剂量 (MTD)。第二阶段的主要终点为独立影像评估委员会(IRRC)根据实体瘤疗效评价标准(RECIST)v1.1评估 的客观缓解率(ORR)。 H ...

智通财经APP讯，复宏汉霖(02696)发布公告，近日，重组抗VEGF人源化单克隆抗体注射液HLX04- O(HLX04-O)在一项于湿性年龄相关性黄斑变性(wet age-related macular degeneration, wAMD)中国患者中 开展的3期临床研究达到主要研究终点。 本研究为一项多中心、随机、双盲、阳性对照的非劣效3期临床研究，旨在比较HLX04-O与雷珠单抗玻 璃体内注射(IVT)在湿性年龄相关性黄斑变性(wAMD)患者中的有效性和安全性。入组的患者按照1:1的 比例随机接受 HLX04-O(1.25 mg)IVT或雷珠单抗(0.5 mg)IVT给药，每四周一次，在患者未发生死亡、 撤回知情同意、失访或申办方终止研究的情况下，持续治疗一年。本次研究的主要研究终点为第48周最 佳矫正视力(BCVA)较基线改善的平均字母数变化，次要研究终点为其他有效性、安全性、耐受性及药 代动力学指标。研究结果显示，HLX04-O组第48周BCVA较基线改善的平均字母数变化结果非劣于雷珠 单抗组，达到主要研究终点。此外，HLX04-O和雷珠单抗对湿性年龄相关性黄斑变性(wAMD)患者人群 整体、眼部、 ...

复宏汉霖(02696)：HLX22联合XELOX对比XELOX 联合或不联合帕博利珠单抗一线治疗HER2阳性局 部晚期或转移性胃食管交界部和胃癌的国际多中心3 期临床研究完成日本首例患者给药 本次研究是一项双盲、国际多中心随机对照3期研究，旨在比较HLX22联合曲妥珠单抗和化疗对比曲妥 珠单抗和化疗联合或不联合帕博利珠单抗，一线治疗HER2阳性局部晚期或转移性胃癌/胃食管交界部癌 患者的疗效和安全性。符合条件的受试者将以1:1的比例随机分配至试验组(接受HLX22(15 mg/kg)联合 曲妥珠单抗和化疗)或对照组(接受安慰剂联合曲妥珠单抗和化疗，联合或不联合帕博利珠单抗)。该研究 的主要终点为独立影像评估委员会 (IRRC)基于RECIST v1.1评估的无进展生存期(PFS)和总生存期(OS); 次要终点包括研究者评估的无进展生存期(PFS)、独立影像评估委员会(IRRC)或研究者评估的客观缓解 率(ORR)、下一线治疗的无进展生存期(PFS2)、缓解持续时间(DOR)、生活质量、安全性、免疫原性和 药代动力学特征。 智通财经APP讯，复宏汉霖(02696)发布公告，近日，一项HLX22(重组人源化抗 H ...