Henlius

#HenliusInFocus We're excited to exhibit at #CPHI2025 in Frankfurt (Oct 28–30)! Visit us at Booth 3.1A92 to： 🔹Discover Henozye® – our next-generation recombinant human hyaluronidase with independent IP, a powerful innovation designed to redefine subcutaneous biologic delivery with enhanced stability, versatility, and co-formulation potential. 🔹Explore our expanding global portfolio of 9 approved biologics and cutting-edge R&D platforms, including innovative assets like HLX43 (PD-L1 ADC), HLX22 (novel epitope anti-HER2 mAb), and HLX07 (anti-EGFR mAb). Let's collaborate to drive global access to quality, affordable biologics and unlock new possibilities in global healthcare. See you in #CPHI! 👋

#HenliusMedicalHub We’re proud to announce that the ASTRUM-006 Phase 3 trial of serplulimab has met its primary endpoint of event-free survival (EFS). This is the world’s first perioperative gastric cancer regimen replacing adjuvant chemotherapy with PD-1 monotherapy — marking a major step forward in immunotherapy. Early regulatory submission is supported with the advantages below. 🔹 Serplulimab + chemotherapy significantly improved EFS vs. placebo + chemotherapy 🔹 Pathologic complete response (pCR) rate was over 3× higher than control 🔹 Strong safety profile With this achievement, Henlius continues to advance the treatment paradigm of GI cancers, alongside its differentiated HER2 antibody HLX22 and PD-L1 ADC HLX43, expanding the frontier of “high-efficacy, low-toxicity” precision oncology. Read More: https://lnkd.in/g8icj9Jt #GastricCancer #Immunotherapy #Oncology

#HenliuMedicalHub We are pleased to share that the U.S. FDA has cleared Henlius to initiate clinical trials of HLX13, our proposed biosimilar to ipilimumab (CTLA-4 mAb).   Ipilimumab is a foundational therapy in immuno-oncology. With commercialization rights granted to Sandoz, Henlius is advancing HLX13 through clinical development with the aim of broadening patient access to high-quality, cost-effective immunotherapies.   This FDA clearance underscores our commitment to meeting global regulatory standards and delivering affordable innovation with reliable quality to patients worldwide.   Read more: https://lnkd.in/dxCqtKNg #HenliusInFocus #Biosimilars #FDA

#HenliuInFocus In an exclusive Bloomberg Television, our CEO Jason Zhu MD PhD Pharmaceutical shared Henlius' latest progress and vision.   🔑 Key insights: → Our biosimilar business lays the foundation—cash flow, GMP/GCP capabilities, and global partnerships—that fuels our innovative drug pipeline. → The evolving regulatory landscape in the U.S. and EU: streamlined biosimilar requirements give Henlius greater confidence to accelerate development and expand access, thanks to our in-house U.S. clinical teams. → HLX43 (PD-L1 ADC) could be a potential pipeline-in-a-pill (PiP) asset, demonstrating strong potential across multiple cancer indications.   Proud to shape the future of #Oncology with science, strategy, and patient-centric innovation.   👉Watch the full interview here: https://lnkd.in/d2ArDJjR

#HenliusInFocus We recently gathered world-renowned experts in Shanghai for our Scientific Advisory Board meeting, diving deep into the next-generation biotherapeutics. Key takeaways: ✔️ Explored breakthrough strategies in ADC technology & novel antibody design ✔️Strengthened our "affordable innovation" vision with global clinical insights ✔️Aligned R&D roadmap to deliver Best-in-Class & First-in-Class candidates Grateful for the collaborative spirit driving our mission to turn cutting-edge science into patient-ready solutions. 🌍💊

#HenliusMedicalHub We're proud to announce that new data from multiple studies of our self-developed innovative anti-PD-1 mAb, serplulimab, have been accepted at 2025 #ESMO Congress！ Key highlights:  ✅Final analysis of serplulimab + chemo in nsqNSCLC (LBA)  ✅Oral on neoadjuvant use in stage lIB-IIIC NSCLC  ✅Poster presentations in gastric, rectal & pancreatic cancers From lung to Gl oncology, serplulimab continues to demonstrate its versatile clinical value —bringing hope to more patients worldwide.

🌎 Henlius Expands Global Clinical Footprint to Latin America Our novel epitope HER2-targeting monoclonal antibody, HLX22, has achieved first patient dosing in Argentina for its head-to-head Ph3 trial in HER2+ advanced gastric cancer. 👉 This marks our first clinical milestone in Latin America, highlighting our commitment to differentiated innovation and global reach. 👉 Learn more: https://lnkd.in/giHGHZ_k #HenliusInFocus #GastricCancer

#HenliusInFocus We were proud to have our Chief Business Development Officer & SVP, Ping Cao, represent the company at the FDA biosimilars industry meeting alongside regulators, experts, and leading global players including Sandoz, Samsung Bioepis, and Teva. During the discussion, Henlius provided an overview of the company and highlighted its achievements in the biosimilar field and engaged in in-depth exchanges with the FDA. By continuing to actively participate in international policy dialogues that shape the future of biosimilar development, regulation, and access, we are committed to bringing quality, affordable biologics to patients worldwide, while strengthening collaboration with global partners and regulators. #Biosimilars #RegulatoryAffairs #AffordableCare #GlobalHealth

We're pleased to announce that the European Commission has approved two of our #biosimilars, in collaboration with Organon, for all approved indications of the reference products, including #osteoporosis and certain cancer-related bone disease. Coming shortly after recent U.S. approvals, these EC decisions provide the opportunity to further enhance patient access to potentially more affordable treatments across the EU. Through our commitment to scientific excellence and product quality, we continue working to help expand the reach of accessible therapies worldwide. Learn More: https://lnkd.in/dPTbp8xH

#HenliusInFocus At a medical media panel during #WCLC25, leading oncologists, including Ely Benaim, Henlius' U.S. CMO, shared insights on the future of lung cancer treatment. One of the key highlights was HLX43, Henlius' novel PD-L1 ADC, showing promising potential for patients with resistant NSCLC and squamous tumors. Panelists also referenced serplulimab in discussions around FDA’s evolving regulatory framework, indicating a new way of regulatory compliance which brings innovative drugs to U.S. patients faster than they would have. With global collaborations and a patient-centered mission, Henlius is committed to advancing innovative and affordable medicines worldwide. 🎬 Click to watch the full panel: https://lnkd.in/dEhFZnXc