Trastuzumab biosimilar(Shanghai Henlius Biotech, Inc.)

SHANGHAI, April 16, 2025 /PRNewswire/ -- 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 Henlius Henlius (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. 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SHANGHAI, April 16, 2025 /PRNewswire/ -- On April 15, 2025, Henlius (2696.HK) released the "2024 Environmental, Social, and Governance (ESG) Report" (hereinafter referred to as the "ESG Report" or "Report"). This marks the sixth consecutive year that the company has submitted an ESG-related report to global stakeholders, comprehensively showcasing Henlius' remarkable achievements and steadfast commitment across 5 key ESG pillars: Product, Talent, Environment, Society, and Corporate Governance. Together for Health Guided by patient needs, Henlius has consistently strengthened its R&D innovation. In 2024, R&D investment reached RMB1.8405 billion. To date, the company has successfully launched 6 products across about 50 countries and regions, benefiting over 750,000 patients. Henlius continues to focus on therapeutic areas such as oncology and autoimmune diseases, rapidly advancing about 50 pipeline molecules. The company has achieved broad coverage in high-incidence cancers such as lung cancer, colorectal cancer, gastric cancer, and esophageal squamous cell carcinoma. Additionally, it is actively developing 5 orphan drugs and rare disease treatments across multiple therapeutic areas, including oncology, chronic inflammatory, and neurological diseases. In terms of accessible healthcare, 5 of Henlius' products have been included in China's National Reimbursement Drug List (NRDL). Its trastuzumab biosimilar HANQUYOU has been covered by public health insurance in countries including China, the UK, France, and Germany. The PD-1 inhibitor HANSIZHUANG has been included in 118 provincial or municipal-level government-backed supplemental insurance programs (Huiminbao), making high-quality biologics more accessible. Furthermore, through collaborations with international partners such as Abbott and SVAX, Henlius is expanding into emerging markets like Latin America and the Middle East, bringing Chinese innovation to the world and improving global health. Together for Talent Growth Upholding a people-centric talent philosophy, Henlius is dedicated to building a diverse talent ecosystem. In 2024, women made up 53% of the workforce. The company released Diversity Policy and launched an internal platform called "H-Voice" to promote open, transparent communication and feedback channels. Henlius emphasized employee growth and development, supporting 144 employees in obtaining professional certifications. Through the online learning platform "Henlius Academy" and customized training programs, the company continues to build its talent pipeline and empower future development. In 2024, it reached an average training time of 70.37 hours per employee. In 2024, Henlius was recognized as one of HR Asia's Best Companies to Work for in Asia for the third consecutive year and was also awarded one of Universum's Most Attractive Employers for Chinese Students for the first time. Together for a Green Future Henlius understands the importance of green development and embeds environmental protection in its core values and practices. In 2024, the company invested RMB7.8445 million in environmental protection, up 26% year-over-year, underscoring its strong environmental commitment. Throughout the year, Henlius completed 230 lean improvement projects, achieving a 2.87% year-over-year reduction in comprehensive energy consumption, a 5.47% decrease in greenhouse gas emissions, and a 5.93% reduction in water consumption—contributing to cleaner air and water. The Songjiang Facility successfully passed ISO 14001:2015 environmental management system certification, a testament to its environmental standards in line with international best practices. Henlius also promoted green supply chain initiatives, with 80% of direct procurement suppliers signing on to green supply chain agreements, jointly advancing low-carbon transformation across the industry chain. Together for a Thriving Community Driven by its "patient-centric" public welfare philosophy, Henlius carried out numerous social care initiatives in 2024, with total charity donations reaching RMB134.84 million. The company continued its Breast Cancer Rural Healthcare Outreach Program, and hosted public awareness activities for breast cancer and International Lung Cancer Awareness Month, including a charity cycling event to promote healthy lifestyles and holistic patient care. In supply chain management, Henlius adopted BI systems to enhance transparency. 80% of its local suppliers are now introduced into its GMP system, resulting in approximately RMB55.65 million in procurement savings. This continuous effort drives cost reduction, efficiency improvement, and enhances the stability of the supply chain. Together for Stronger Governance Henlius builds its ESG strategy on a foundation of compliance and governance, supported by a four-tier ESG governance structure. In 2024, the company held 2 dedicated ESG meetings and hosted its first company-wide ESG Culture Month, further embedding ESG practices into its operations. Henlius remains committed to responsible operations, conducting 99 compliance training sessions with a total of 4,569 attendants, with 100% of employees signing the Compliance Commitment Letter. The commercial team received targeted responsible marketing training through 39 sessions with a total of 4,867 attendants. In 2024, Henlius filed 22 patent applications and got 10 invention or utility model patents granted. The company also passed the ISO 27001:2022 information security management system recertification. Driven by innovation, with accessibility as the goal, sustainability as the foundation, social responsibility as the driving force, and governance as the guarantee, Henlius continuously creates value for patients, employees, society, and the industry. Looking ahead, Henlius will stay true to its patient-centered mission, integrating ESG into its business development, and contributing more "Chinese strength" to global health to co-create a brighter future for human well-being. About Henlius Henlius (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. SOURCE Henlius WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED