Recently, Henlius (2696.HK) successfully convened its 2025 Scientific Advisory Board (SAB) Meeting in Shanghai. The event brought together world-renowned scholars and clinical experts from leading institutions, including Professor K. Christopher Garcia, a Professor of Molecular and Cellular Physiology, and of Structural Biology at the Stanford University School of Medicine. members of the US National Academy of Science and the National Academy of Medicine; Professor Kun-Liang Guan, a Chair Professor at Westlake University College of Life Sciences; Professor Yang-Xin Fu, an Endowed Professor at Tsinghua University; Professor Alberto Mantovani, Emeritus Professor of Pathology at the Humanitas University in Milan; Professor Jun Wang, an Assistant Professor of Pathology at NYU Grossman School of Medicine New York University; The meeting facilitated in-depth discussions on frontier areas such as cancer immunotherapy, autoimmune diseases, and innovative drug development, providing strategic guidance for the company’s global innovation initiatives.

During the meeting, Henlius scientific advisors and clinical experts shared breakthroughs in biopharmaceutical research, covering novel strategies in immuno-oncology, next-generation cytokine therapies, antibody-mimetic technologies, emerging targets in inflammation and oncology, and innovative approaches for autoimmune diseases. These advancements are expected to help Henlius address indeed unmet clinical needs and accelerate the development of differentiated innovative therapies with global competitiveness, reinforcing its commitment to "affordable innovation."

In brainstorming sessions moderated by Dr Jijun Yuan, Chief Scientific Officer of Henlius, participants engaged in a high-level international dialogue on critical topics such as the design and optimization of novel antibodies, breakthroughs in ADC technology, and strategies to advance translational medicine research. Under Dr Yuan’s guidance, the exchange sparked forward-looking scientific concepts and provided actionable insights for Henlius’ R&D pipeline optimization.

Over the past year, Henlius has deepened its innovation-driven strategy focused on oncology and autoimmune diseases, accelerating the expansion of its antibody-based pipeline while achieving significant milestones for the core innovative products.

• Serplulimab，the world’s first anti-PD-1 mAb approved for first-line treatment of small cell lung cancer (SCLC), has demonstrated differentiated potential as neoadjuvant/adjuvant therapy for gastric cancer (GC), as well as first-line treatment of metastatic colorectal cancer (mCRC) . Patient enrollment has been completed in pivotal clinical trials targeting limited-stage SCLC, colorectal cancer, and neoadjuvant gastric cancer. Additionally, a Biologics License Application (BLA) is planned for submission to the U.S. FDA in 2026 for extensive-stage SCLC.

• The novel epitope anti-HER2 mAb HLX22 has advanced into pivotal global Phase 3 clinical studies. It has been granted Orphan Drug Designation (ODD) by both the U.S. FDA and the European Commission (EC), demonstrating significant potential to redefine first-line standard therapy for HER2-positive gastric cancer‌.

• HLX43, a potential best-in-class anti-PD-L1 ADC, demonstrates promising broad-spectrum antitumor activity with a favorable safety profile. It mediates a dual mechanism of action integrating immune checkpoint inhibition with targeted cytotoxic payload delivery, and exhibits efficacy independent of PD-L1 expression status. Phase I clinical data have shown that, HLX43 has superior efficacy in the EGFR wild-type NSCLC subgroup and breakthrough potential in later-line treatment of thymic carcinoma (TC), positioned to address the critical gap as ADC therapies for this rare, highly aggressive malignancy. To date, HLX43 has progressed into muti-regional phase 2 clinical trials.

  
  

By leveraging these high-potential molecules, clinical experts and scientific advisors joined forces with Henlius’s R&D team to enhance the clinical development strategy, maximizing their therapeutic and commercial impact.

Beyond the core product portfolio, Henlius has made continuous progress in expanding target coverage and molecular diversity. For the cutting-edge preclinical molecules, the scientific advisors conducted a thorough analysis of their pioneering science and development strategy. Their resounding endorsement of its scientific merit was coupled with key insights for navigating the transition from discovery to clinical proof-of-concept. While driving independent innovation, the company has also forged strategic partnerships with leading global biopharmaceuticals to access next-generation molecules and platforms, further pushing the boundaries of innovation.

Dr Jason Zhu, Executive Director & CEO of Henlius stated‌: "Driven by unmet medical needs, Henlius has established global competitiveness through differentiated R&D. Our pipeline now balances risk diversification—excelling in validated targets to deliver ‘Best-in-Class’ (BIC) candidates while strategically advancing into ‘First-in-Class’ innovation. We look forward to deeper collaboration with our Scientific Advisory Board to refine decision-making and accelerate the global development of novel therapeutics."

Mr Qiyu Chen, Co-CEO of Fosun International, addressed the meeting: "Henlius’ nearly 16-year journey—from biosimilars to differentiated innovative products like anti-PD-1 mAb, serplulimab and PD-L1 ADC HLX43, exemplifies its R&D philosophy integrating unmet clinical needs, scientific rigor, and international standards. Moving forward, we expect Helius to further strengthen internal R&D capabilities, continuously enhance its globally competitive pipeline, and progress steadily towards a world-class biopharmaceutical company."

Moving forward, Henlius remains committed to addressing unmet medical needs through globalized R&D strategy. By leveraging close collaborations with Scientific Advisory Board (SAB) and world-renowned experts, the company will accelerate the development of groundbreaking therapies with clear clinical value, ensuring broader and faster access to high-quality therapeutics for patients worldwide.