Neratinib maleate

2025年4月15日，复宏汉霖隆重举办了2025年“聚·创”全球研发日（R&D Day）活动。复宏汉霖管理层与来自业界的顶级专家学者、创新研发负责人共聚一堂，聚焦创新研发领域的最新进展、未来战略规划以及前沿技术、疗法布局展开深度交流，现场吸引了来自学术界、产业界及投资界的数百名嘉宾共襄盛举。复宏汉霖执行董事、首席执行官朱俊博士表示：“复宏汉霖始终践行‘以患者为中心’的核心理念，以创新研发持续强化差异化竞争优势。公司持续推进H药 汉斯状®、抗HER2单抗HLX22、PD-L1 ADC HLX43等核心创新产品的开发进程，有望革新肺癌和消化道肿瘤治疗格局。此外，公司持续探索靶向、免疫、糖编辑疗法等前沿技术，构建多元化研发平台。国际化布局方面，复宏汉霖聚焦美国、欧盟、日本等关键市场，通过全产业链资源整合与国际合作深化，实现从产品出海到全球价值链构建的战略跃升。面向未来，复宏汉霖将持续深耕抗体药物研发，加速靶向治疗、免疫治疗等前沿领域创新突破持续推动中国创新药走向世界，以可负担的高品质生物药惠及全球患者，并着力锻造可持续发展的全球化价值内核。”复宏汉霖首席科学官袁纪军博士发言介绍了复宏汉霖差异化的创新研发策略，“复宏汉霖的研发实力，体现在我们的创新研发管线，更体现在平台优势的持续拓展。我们聚焦肿瘤、自免疾病等重点适应症，进一步拓展创新触角，形成蛋白药物及小分子、抗体偶联药物等多类新分子类型、推动管线产品间的协同增效。三特异性T细胞衔接器平台Hinova TCE、自主开发的ADC 平台HanjugatorTM 、AI驱动的人工智能新药开发平台HAI Club 已成为复宏汉霖最具代表性三大核心技术平台，形成协同研发矩阵。基于此，我们以平台为抓手、以AI为驱动，加速推动用于实体瘤治疗的T细胞衔接器等差异化创新分子的开发，加速打造更多潜在爆款。”在复宏汉霖的创新管线布局中，HLX22、HLX43等产品已进入临床后期阶段，其突破性优势展现出复宏汉霖驱动未来增长的新引擎。复宏汉霖战略产品副总经理冯立新博士带来HLX43的最新研究分享，“HLX43是一款精准设计的、靶向泛肿瘤靶点PD-L1的ADC产品，‘核心骨架’采用公司自主研发的创新抗PD-L1单抗，并引进宜联具备双重释放机制（胞内和胞外）的创新连接子-毒素，为全球第二、也是国内首款进入临床开发阶段的PD-L1 ADC。目前，HLX43已初步展现出一个创新PIP（pipeline in a pill）的潜质。在早期临床前验证中，HLX43展现了良好的成药性和安全性，肿瘤杀伤作用显著。同时，HLX43单药及联合H药 汉斯状®在多项实体瘤中的临床研究正在加速推进，有望为实体瘤患者带更加优异的治疗方案。”活动现场，HLX22国际多中心III期临床牵头主要研究者沈琳教授表示：“HLX22为一款极具潜力的HER2靶向治疗药物，无论在作用机制还是临床表现上，都展现了其独到之处。HLX22差异化的分子设计使得药物能够和曲妥珠单抗同时结合到HER2上，协同阻滞所有HER2二聚体的形成，阻断HER2调控的信号通路。此外，HLX22在临床设计上也极具前瞻性与突破性，选择了临床需求迫切但异质性高、挑战大的胃肠癌切入，并展现出优异的抗肿瘤疗效，有望革新HER2阳性胃癌的一线治疗方案。此外，HLX22还展现出适用于所有HER2阳性癌症的泛肿瘤治疗药物的临床开发潜力，期待HLX22能够造福更多患者。” 复宏汉霖在当前生物医药领域的重要创新方向紧密跟随，用AI技术赋能，为前沿创新磨砺利刃。现场，复宏汉霖首席技术官、高级副总裁许圣昌博士介绍了复宏汉霖在AI辅助药物开发领域的突破性进展，重点聚焦新一代透明质酸酶产品Henozye™。该产品通过AI建模技术设计，较传统方法大幅缩短开发周期，且酶活性和稳定性佳。Henozye™在多种缓冲体系和共制剂中表现优异，为皮下给药技术提供了关键支持，可突破注射液体积限制，助力高剂量药物开发。许圣昌强调，透明质酸酶技术平台将撬动皮下给药市场，并通过与合作伙伴的协同开发，加速创新药与生物类似药的皮下剂型落地，持续延长产品生命周期。复宏汉霖在深耕欧美市场、拓展东南亚新兴市场的同时，将国际化2.0战略突破口聚焦于日本市场。基于地理邻近性与人种相似性带来的临床开发优势，叠加老龄化社会与高福利医疗体系支撑的全球第三大医药市场地位，日本成为公司创新生物药全球布局的战略要塞。复宏汉霖药政事务部副总裁李锦表示，复宏汉霖正以日本市场为核心推进国际化2.0战略，基于胃癌、肺癌领域核心管线HLX22和斯鲁利单抗（HLX10）的差异化优势加速布局。目前公司已在日本启动临床试验，为适应症开发建立基础支撑。日本作为全球核心医药市场，其独特的患者年龄结构与创新药政策环境等形成重要战略机遇。复宏汉霖计划逐步推进本地化运营体系建设，并通过创新生物药强化市场地位。依托整合全球临床资源与本地化战略，公司将持续完善从临床开发到商业落地的全价值链体系，以中国药企的创新实践打开全球市场新格局。在加速驱动创新引擎的同时，复宏汉霖致力于在全球范围内构建创新网络，形成国际合作生态，打造从产品开发到市场准入以及本地化运营的合作范本。在“全球协作，创新共赢”——构建生物制药的国际合作生态的圆桌论坛环节，复宏汉霖首席商务发展官、高级副总裁曹平女士作为主持人，与2022诺贝尔化学奖得主、Palleon联合创始人Carolyn Bertozzi教授，Palleon联合创始人兼首席执行官James Broderick先生、宜联生物首席医学官秦续科先生、KGbio首席执行官Sie Djohan先生、Sermonix创始人兼首席执行官David Portman先生针对“全球协作，创新共赢”这一话题展开了热烈讨论。Carolyn Bertozzi教授首先介绍了唾液酸聚糖在疾病治疗中的关键作用，特别是其在肿瘤免疫逃逸和自身免疫疾病中的机制，以及作为全球前沿技术在新药开发中的巨大潜力。Palleon积极推进其自主开发的酶-抗体聚糖配体编辑（EAGLE）平台，并与复宏汉霖就基于EAGLE平台设计的双功能抗体-唾液酸酶融合蛋白和人唾液酸酶融合蛋白HLX79（E-602）分别围绕癌症及自身免疫疾病领域展开合作。之后的讨论中，各位嘉宾围绕与复宏汉霖的合作，对复宏汉霖在前沿创新、临床开发、生产制造方面的实力，以及团队的高效协作、迅敏反馈表示认可。合作伙伴指出，与复宏汉霖的合作源自对公司的信心，复宏汉霖已建成高效一体化覆盖研产销全链条的生物制药平台，在抗体研发领域深耕多年，且公司临床策略进展迅速且可靠，基于国际标准的生产质量体系为全球商业化运营奠定扎实基础。曹平表示，公司秉持“信任为基石、效率为驱动、创新为纽带”的合作理念，构建全球化合作生态。未来，复宏汉霖将持续深化技术互补性合作，加速前沿领域探索，同时依托强大的合作伙伴网络，加速推动创新疗法的全球可及性，让优质治疗方案惠及全球更多患者。在生物医药的研发中，从临床前研究到临床应用的转化鸿沟始终是行业难以回避的痛点，也是复宏汉霖以患者为中心，真正为患者带来临床获益的突破点。会议最后，袁纪军博士作为主持人，与赛诺菲转化医学及中国研发负责人唐蕾、Palleon首席科学官 Li Peng、英矽智能联席首席执行官、首席科学官任峰及丹望医疗创始人兼董事长华国强共同围绕“从研发到交付”一以患者为中心的创新实践这一主题展开圆桌讨论，与会嘉宾分别从跨国制药企业、前沿biotech、AI驱动的生物医药公司、领先的技术平台型公司等多维度视角分享了各自的思考和洞见，覆盖提升临床设计精度的工具创新，利用前沿AI技术数据加速创新研发的路径和现存的挑战，进而归结于行业协作、打破壁垒的生态构建，才能最终实现从“from discovery to delivery”的有效衔接。从生物类似药到全球首创疗法，从主流市场深耕到多极市场开拓，复宏汉霖以创新、全球化等多维引擎持续突破行业天花板。2025年，复宏汉霖将继续以“聚·创”为核心，进一步驱动创新引擎，实现从技术积淀到临床价值的高效转化，推动创新技术与国际合作生态的双重变革，持续书写中国生物医药的全球篇章，为人类健康事业贡献中国智慧。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。Henlius 2025 Global R&D Day:Harnessing the Power of Innovation toPropel Global Strategy to New HeightsShanghai, April 15, 2025 — Henlius (2696.HK) held its 2025 Global R&D Day under the theme of “Collaborate to Create”. Senior executives from Henlius gathered with leading experts, scholars, and heads of innovation from across the industry to engage in in-depth discussions on the latest advances in R&D, future strategic planning, and the deployment of cutting-edge technologies and therapies. The event drew hundreds of guests from academia, industry, and the investment community, making it a grand gathering of shared insight and collaboration.Jason Zhu, Executive Director and CEO of Henlius, stated: "At Henlius, we remain steadfast in our patient-centric philosophy and continue to strengthen our differentiated competitive edge through innovation-driven R&D. We are advancing the development of several key innovative assets, including  HANSIZHUANG (serplulimab, anti-PD-1 mAb), HLX22 (anti-HER2 mAb), and HLX43 (PD-L1 ADC), with the potential to reshape the treatment landscape for lung and gastrointestinal cancers. Beyond that, we are actively exploring frontier technologies such as targeted therapies, immunotherapies, and glyco-editing, as we build a diversified innovation platform. In terms of global expansion, Henlius is strategically focused on major markets such as the U.S., EU, and Japan. Through full value chain integration and deepening international partnerships, we are making a strategic leap from exporting products to building a global value chain. Looking ahead, Henlius will continue to focus on antibody drug innovation, accelerate breakthroughs in targeted and immune therapies, and drive the global advancement of China's innovative biologics. Our goal is to deliver high-quality, affordable biologics to patients around the world while forging a sustainable, globally integrated value core."Jijun Yuan, CSO of Henlius, elaborated on the company's differentiated innovation strategy: "Henlius' R&D strength is reflected not only in our innovative pipeline but also in the continuous expansion of our platform capabilities. We focus on key therapeutic areas such as oncology and autoimmune diseases, extending our innovation reach to diverse modalities—including protein-based therapies, small molecules, and ADCs—to maximize synergistic potential across pipeline assets. Our three flagship technology platforms—the Hinova TCE (tri-specific T-cell engager) platform, the independently developed ADC platform Hanjugator™, and the AI-driven drug discovery platform HAI Club—have formed a collaborative R&D matrix. Leveraging these platforms and AI-driven approaches, we are accelerating the development of differentiated molecules, such as TCEs for solid tumors, to rapidly deliver more potential blockbuster therapies."In Henlius' innovative pipeline, late-stage clinical assets such as HLX22 and HLX43 have emerged as breakthrough candidates, underscoring the company's potential to drive future growth. Lixin Feng, Strategic Products Deputy GM of Henlius, shared that, "HLX43 is a precisely designed ADC targeting the pan-tumor antigen PD-L1. Its core framework incorporates the company's proprietary novel anti-PD-L1 mAb, combined with MediLink Therapeutics' innovative linker-toxin payload featuring a dual-release mechanism (intracellular and extracellular). As the world's second and China's first PD-L1 ADC to enter clinical development, HLX43 has demonstrated early potential as an innovative PIP (pipeline in a pill).Preclinical studies have shown favorable druggability and safety profiles with significant tumor-killing activity. Meanwhile, clinical studies of HLX43 as both monotherapy and in combination with HANSIZHUANG are accelerating across multiple solid tumors, with the potential to deliver superior treatment options for patients." At the event, Professor Lin Shen, the leading principal investigator of the MRCT Phase 3 trial for HLX22, remarked: "Henlius' HLX22 is a highly promising HER2-targeted therapy distinguished by both its mechanism of action and clinical performance. Its differentiated molecular design enables simultaneous binding to HER2 alongside trastuzumab, synergistically blocking all HER2 dimer formation and disrupting HER2-mediated signaling pathways. Moreover, HLX22's clinical development strategy is both pioneering and ambitious—it targets gastrointestinal cancers, a field with urgent unmet needs and high heterogeneity, where the drug has demonstrated exceptional antitumor efficacy. This positions HLX22 to potentially redefine first-line treatment for HER2-positive gastric cancer. HLX22 has demonstrated clinical development potential as a pan-tumor therapeutic for all HER2-positive cancers. We look forward to HLX22 benefiting more patients worldwide."Henlius is strategically advancing key innovations in biopharma by harnessing AI to sharpen its cutting-edge capabilities. Simon Hsu, CTO and SVP of Henlius, highlighted breakthroughs in AI-driven drug development, with a focus on next-generation hyaluronidase Henozye™, "Utilizing AI modeling, Henozye™ achieved significantly faster development cycles versus conventional methods while demonstrating superior enzyme activity and stability. Its exceptional performance across buffer systems and co-formulations provides critical support for subcutaneous delivery—overcoming injection volume limits to enable high-dose drug development," He emphasized that this hyaluronidase platform will transform the subcutaneous delivery market. "Through collaborative partnerships, we're accelerating subcutaneous formulations for both novel drugs and biosimilars, extending product lifecycles sustainably."While deepening its presence in Europe and the U.S. and expanding into emerging markets in Southeast Asia, Henlius is advancing its Globalization 2.0 strategy with a focused breakthrough in the Japanese market. Leveraging the advantages of geographic proximity and ethnic similarity for clinical development, along with Japan's status as the world's third-largest pharmaceutical market—supported by an aging population and a robust universal healthcare system—Henlius positions Japan as a strategic stronghold for the global rollout of its innovative biologics. Jin Li, Vice President of Henlius Regulatory Affairs, stated that "We are advancing our Internationalization 2.0 Strategy with Japan as a key market, leveraging the differentiated advantages of our core pipeline assets HLX22 (anti-HER2 mAb) and serplulimab (HLX10, anti-PD-1 mAb) in gastric cancer and lung cancer. We have initiated clinical trials in Japan to establish foundational support for indication development. Japan represents a strategic priority as a global pharmaceutical hub, offering unique opportunities through its aging population dynamics and innovative drug policy environment. We are systematically building local operational capabilities while strengthening our market position through innovative biologics. By integrating global clinical resources with localized strategies, we are creating an end-to-end value chain from clinical development to commercialization. As a Chinese biopharma innovator, we are reshaping the landscape in global markets through this approach."Henlius is committed to building a global innovation network and fostering an international collaborative ecosystem, setting a benchmark for partnerships spanning product development, market access, and localized operations. During the panel discussion moderated by Henlius SVP and Chief Business Development Officer, Ping Cao, 2022 Nobel Laureate and Palleon Co-founder Professor Carolyn Bertozzi, Palleon CEO James Broderick, MediLink CMO Steve Chin, KGbio CEO Sie Djohan and Sermonix Founder and CEO David Portman joined the discussion under the theme "Partnering for Success - Building a Global Biopharma Ecosystem."Professor Carolyn Bertozzi highlighted the critical role of sialoglycans in disease treatment, particularly their mechanism in tumor immune evasion and autoimmune diseases, as well as their vast potential as a cutting-edge global technology for novel drug development. Palleon is actively advancing its proprietary Enzyme-Antibody Glycan Ligand Editing (EAGLE) platform and has entered into collaborations with Henlius to develop bifunctional antibody-sialidase fusion proteins and human sialidase fusion protein HLX79 (E-602)—leveraging the EAGLE platform to target cancer and autoimmune diseases, respectively. During the follow-up discussion, panelists unanimously recognized Henlius' comprehensive capabilities spanning cutting-edge innovation, clinical development, and manufacturing excellence, while particularly commending the team's efficient collaboration and responsive partnership approach. Industry partners emphasized that their decision to collaborate with Henlius was rooted in strong confidence in the company's fully integrated biopharmaceutical platform that covers the entire value chain from research to commercialization. With established expertise in antibody development and a demonstrated ability to execute rapid yet reliable clinical strategies, Henlius has built a world-class manufacturing quality system meeting international standards, creating a robust foundation for global commercialization. Ping articulated the company's partnership philosophy: "We build on trust as our foundation, drive progress through efficiency, and connect through innovation." This guiding principle continues to shape Henlius' growing global collaborative ecosystem. Moving forward, the company remains committed to deepening complementary technology partnerships and accelerating exploration in frontier therapeutic areas. By leveraging its strong partner network, Henlius aims to enhance worldwide access to innovative therapies and deliver high-quality treatment solutions to patients across the globe.In biopharmaceutical R&D, the translational gap from preclinical research to clinical application remains a persistent challenge across the industry. For Henlius, this very gap represents a critical breakthrough point to truly deliver clinical benefit by staying centered on the patient. At the close of the event, Jijun Yuan moderated a panel discussion on the theme "From Discovery to Delivery: Patient-Centric Innovation in Practice." He was joined by Lei Tang, Head of Translational Medicine Unite China R&D at Sanofi; Li Peng, CSO of Palleon; Feng Ren, Co-CEO and CSO of Insilico; and Guoqiang Hua, Founder and Chairman of Dan1Med. Guests shared insights from the perspectives of multinational pharma, cutting-edge biotech, AI-driven biopharma company and technology platform company. Discussions spanned innovations in tools that enhance precision in clinical trial design, the acceleration of R&D through advanced AI-driven data strategies, and the current challenges faced. Ultimately, all perspectives converged on a shared vision: building a collaborative, barrier-free ecosystem is essential to truly achieving a seamless transition "from discovery to delivery."From biosimilars to first-in-class therapies, and from deepening presence in mainstream markets to expanding into multi-polar global markets, Henlius continues to push the boundaries of the industry with its multiple driving forces such as innovation and globalization. In 2025, Henlius will remain committed to its core theme of "Collaborate to Create", further powering its innovation engine to accelerate the transformation from technological strength to clinical value. The company aims to drive explosive growth across its innovative pipeline while advancing both technological breakthroughs and international collaboration. Looking ahead, Henlius will continue to write a new chapter for China's biopharmaceutical industry on the global stage—bringing Chinese innovation to contribute to the advancement of human health worldwide.About HenliusHenlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.联系方式媒体：PR@Henlius.com投资者：IR@Henlius.com喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看