Core Insights - Shanghai Junshi Biosciences Co., Ltd. (referred to as "Junshi") and Eisai Co., Ltd. (referred to as "Eisai") have announced an exclusive commercialization and co-development agreement for the anti-PD-1 monoclonal antibody Hansizhuang (sulunlimab) in Japan [1] - Under the agreement, Eisai will pay Junshi an upfront payment of $75 million, with potential regulatory milestone payments up to $80.1 million and sales milestone payments up to $233.3 million, in addition to a double-digit percentage royalty on product sales [1] - Hansizhuang has already been approved in China for multiple indications, including squamous non-small cell lung cancer (sqNSCLC), extensive small cell lung cancer (ES-SCLC), non-squamous non-small cell lung cancer (nsqNSCLC), and esophageal squamous cell carcinoma (ESCC) [1] Group 1 - The agreement allows Hansizhuang to enter the Japanese market [1] - In Japan, Hansizhuang will be used for the treatment of extensive small cell lung cancer and non-microsatellite instability-high metastatic colorectal cancer, with plans for clinical research in perioperative treatment of gastric cancer [1] - Junshi will also assume the marketing authorization holder (MAH) responsibilities for the product in Japan [1] Group 2 - Junshi is currently conducting a Phase II bridging clinical trial for extensive small cell lung cancer in Japan, with plans to submit a marketing application during Eisai's fiscal year 2026 based on the trial results [2] - Additionally, Junshi is advancing an international multicenter Phase III clinical trial for Hansizhuang targeting non-microsatellite instability-high metastatic colorectal cancer, with further new indications in planning [2]
复宏汉霖：抗PD-1单抗汉斯状“出海”日本