Core Viewpoint - The article highlights the significant collaboration between Innovent Biologics and Takeda Pharmaceutical, marking a historic milestone in China's innovative drug development, particularly focusing on the promising drug IBI363 [3][11]. Summary by Sections Collaboration Details - Innovent Biologics has entered into a licensing agreement with Takeda Pharmaceutical, potentially worth up to $11.4 billion, which includes an upfront payment of $1.2 billion and milestone payments that could reach $10.2 billion [4][5]. - The collaboration involves three drug candidates: IBI363, IBI343, and IBI3001, with IBI363 being a dual-action PD-1/IL-2α-bias fusion protein [6][10]. Focus on IBI363 - IBI363 is noted for its unique molecular design, capable of blocking the PD-1/PD-L1 pathway while activating the IL-2 pathway, targeting a wide range of indications with positive clinical data across multiple tumors [7][10]. - The drug has received FDA approval for its first global Phase III clinical trial for treating immune-resistant squamous non-small cell lung cancer (NSCLC) [8]. Clinical Trials and Efficacy - Currently, a head-to-head study of IBI363 against pembrolizumab (Keytruda) for melanoma is ongoing in China, alongside global Phase III trials for NSCLC and colorectal cancer [9]. - In a study involving 68 patients with advanced or metastatic colorectal cancer who failed standard treatments, IBI363 showed an overall response rate (ORR) of 12.7%, with an ORR of 30.8% in patients with PD-L1 CPS ≥ 1 [9]. Industry Implications - This collaboration is seen as a representation of the shift in China's innovative drug industry from a "follower" to a "leader" in the global market [11].
信达生物刷新历史：114亿美元重新定价中国创新药