Recently, during the 63rd Annual Meeting of the Japan Society of Clinical Oncology (JSCO), Henlius successfully hosted the “Bridging Horizons · Henlius Japan Reception 2025” expert exchange symposium in Yokohama, Japan. The event brought together leading clinical researchers and partners from both China and Japan in the fields of lung cancer and gastrointestinal tumors, including Prof. Liu Junling from the Sun Yat-sen University Cancer Center, Dr. Yusuke Suwa from the Yokohama City University Medical Center, and Dr. Hidekazu Hirano from the National Cancer Center Hospital (Tokyo). The participants held in-depth discussions around Henlius’ vision of “benefiting patients worldwide,” focusing on its self-developed innovative biologics pipeline, including the PD-1 inhibitor HANSIZHUANG (serplulimab, Europe trade name: Hetronifly^®), the potential best-in-class PD-L1 ADC HLX43, and the novel epitope anti-HER2 monoclonal antibody HLX22.

Strengthening Presence in Core Global Markets

Henlius is a global biopharmaceutical company committed to delivering high-quality, innovative biologics to patients around the world. With fully integrated capabilities spanning from R&D to commercial operations, the Company has launched 9 products worldwide, reaching approximately 60 countries and regions across Asia, Europe, Latin America, North America, and Oceania.

Following its expansion into the U.S. and Europe, Henlius is now accelerating its strategic deployment in Japan — one of the world’s most mature healthcare markets — injecting new momentum into the global rollout of its innovative therapies.

Ms. Jin Li, Head of Japan Market & Vice President of Regulatory Affairs at Henlius remarked, “We chose Japan not only for its strategic position as the world’s fourth-largest pharmaceutical market with well-established regulatory systems, but also because of its shared disease profiles with China — a unique advantage for clinical data utilization and product development. We have already established core teams in clinical operations, quality, and regulatory affairs in Japan and are actively pursuing Marketing Authorization Holder (MAH). Henlius will spare no effort to advance regulatory filings and clinical development in Japan, striving to bring our innovative therapies to local patients as early as possible.”

Mr. Jing Li, Vice President of Global Product Development at Henlius added, “Our strategy is to proactively target differentiated indications that can fundamentally reshape treatment paradigms. For example, HLX22 is designed to precisely address HER2-positive gastric cancer; our potential best-in-class PD-L1 ADC HLX43 shows broad anti-tumor potential with high efficacy, low toxicity, and inherent I/O functionality, and may unlock further benefits in combination regimens across various solid tumors. Meanwhile, serplulimab has already set multiple global clinical milestones in small cell lung cancer and perioperative gastric cancer. By deeply transforming the current treatment landscape, we want to enable more patients to achieve long-term survival.”

Serplulimab Gains Strong Expert Backing

During the event, Chinese and Japanese clinical experts shared their perspectives on Henlius’ progress in lung cancer, colorectal cancer, gastric cancer and other high-incidence cancers in Asia. Serplulimab has achieved several global breakthroughs: it is the world’s first anti-PD-1 monoclonal antibody approved as first-line therapy for extensive-stage small cell lung cancer, and the only anti-PD-1 monoclonal antibody to succeed in a phase 3 perioperative gastric cancer trial. Its recent achievement of the primary endpoint in the perioperative gastric cancer phase 3 study has drawn widespread attention. Serplulimab's robust clinical performance and unique positioning in these indications have earned high recognition from attending experts. 

Prof. Liu Junling remarked, “In the phase 3 ASTRUM-005 study of serplulimab plus chemotherapy as first-line treatment for ES-SCLC, the 4-year overall survival (OS) rate reached 21.9%, and 22.4% in Asian patients, demonstrating durable survival benefits. Moreover, ASTRUM-005R — the largest real-world study in China for ES-SCLC to date — showed a median real-world PFS of 8.2 months and median OS of 17.2 months among 635 patients, once again validating its strong clinical efficacy. We look forward to seeing this outstanding Chinese innovation benefit more patients globally.”

Dr. Yusuke Suwa commented, “There is currently no available PD-1 antibody for pMMR/MSS-type mCRC, leaving a significant unmet need in this population. We see serplulimab as a promising candidate to bridge this gap. So far, the enrolled patients have shown encouraging prognosis with manageable toxicities.”

Dr. Hidekazu Hirano added, “Serplulimab’s exploration in perioperative gastric cancer is pioneering in its attempt to replace traditional postoperative chemotherapy with immunotherapy monotherapy. It has the potential to deliver both superior efficacy and better tolerability. This is nothing short of a paradigm shift, and we are eager to see how the data evolves.”

The success of the event reflects not only Henlius’ robust innovation pipeline in cutting-edge therapeutic areas but also its global vision and commitment as a leading Chinese biopharmaceutical company. Moving forward, Henlius will continue to deepen international collaboration, bringing scientific innovations from China to the world, and steadfastly advancing its mission to “benefit patients worldwide.”