Recently, Shanghai Henlius Biotech, Inc. (2696.HK) announced that its wholly owned Japanese subsidiary, Fosun Henlius Pharmaceutical K.K., has obtained a Type I Marketing Authorization Holder (MAH) License for Pharmaceuticals from Tokyo Metropolitan Government. The license grants Henlius the legal status required to commercialize prescription medicines in Japan. This milestone marks an important step in Henlius’ development in the Japanese market and lays a solid foundation for further expansion into major Asian and global pharmaceutical markets.
Ms. Jin Li, Head of Japan Market & VP of Regulatory Affairsat Henlius, said:"Japan, the world’s fourth-largest pharmaceutical market1, offers significant strategic value with its rigorous and mature regulatory environment. Obtaining the MAH license marks a substantive step forward in our presence in this key market. We will continue to advance the clinical development and commercialization of our innovative pipeline and bring more high-quality innovative biologics to patients in Japan and worldwide."
Japan’s MAH system is known for its stringent requirements. To meet the lifecycle quality management standards required under the MAH framework, Henlius’ Japanese subsidiary established a professional governance structure, appointing qualified and experienced personnel to serve as General Marketing Supervisor, Quality Management Supervisor, and Safety Management Supervisor. Based on this structure, the company further strengthened its Good Quality Practice (GQP) and Good Vigilance Practice (GVP) systems and successfully passed rigorous document reviews and on-site inspections conducted by Japanese regulatory authorities.
Obtaining the MAH license demonstrates that Henlius’ quality management system, pharmacovigilance capabilities, and risk management standards meet the stringent requirements of Japan, one of the world’s major regulatory markets. Supported by a global quality management system aligned with the highest international standards, Henlius has established a large-scale commercial manufacturing platform in Shanghai, China, with a total capacity of 84,000 liters. The facility has received GMP certifications from China, the European Union (EU), the United States, Southeast Asia, and Latin America, enabling the company to provide long-term, stable, and high-quality biologics supply to global markets, including Japan.
Henlius’ Japanese subsidiary is actively building core capabilities in regulatory affairs and supply chain management to support future product launches in Japan. Previously, Henlius and Eisai Co., Ltd. concluded an exclusive commercialization and co-exclusive development and manufacturing license agreement for the anti-PD-1 antibody serplulimab (generic name, marketed as HANSIZHUANG in China and Hetronifly® in the EU) in Japan. In Japan, Henlius is currently conducting a Phase II bridging clinical trial for extensive-stage small cell lung cancer, and plans to submit an application for fiscal year 2026 based on the results of this trial as well as the Phase III clinical trial data that supported approvals for this indication in China and Europe. Furthermore, a Phase III multi-national clinical trial for microsatellite stability (MSS) metastatic colorectal cancer and a clinical trial for perioperative gastric cancer are also underway in Japan
Looking ahead, Henlius will continue accelerating the global advancement of its innovative pipeline across more countries and regions, committed to bringing high-quality innovative biologics to patients worldwide.
References
1.Data Source: IQVIA MIDAS, MAT December 2024.