Boan Biotech (6955.HK) announced today that the first patient in Phase III clinical trial of its Nivolumab Injection (BA1104) in China has been enrolled. BA1104 is the first biosimilar to Opdivo® to undergo a Phase III study in China.Nivolumab is a monoclonal antibody that can enhance the immune response of T cells against tumors by preventing the programmed cell death 1 (PD-1) receptor from binding to its ligands PD-L1 and PD-L2.

Boan Biotech（6955.HK）今天宣布，其在中国的Nivolumab注射液（BA1104）III期临床试验的第一名患者已经入组。BA1104是Opdivo®在中国进行III期研究的第一个生物仿制药.Nivolumab是一种单克隆抗体，可通过阻止程序性细胞死亡1（PD-1）受体结合来增强T细胞对肿瘤的免疫应答。其配体PD-L1和PD-L2。

As a broad-spectrum anticancer medication, Nivolumab has been approved for multiple indications both in China and abroad. These include its use as a neoadjuvant, an adjuvant, or a first-line or later-line therapy for advanced cancers. It can be used as a standalone treatment, in combination with chemotherapy, or alongside novel immune checkpoint inhibitors.

作为一种广谱抗癌药物，Nivolumab已被批准用于国内外的多种适应症。这些包括将其用作晚期癌症的新辅助剂，佐剂或一线或更晚线疗法。它可以作为独立治疗，联合化疗或与新型免疫检查点抑制剂一起使用。

Nivolumab has become a product of basic therapy for a variety of solid tumors.The development of BA1104 follows the relevant guidelines for biosimilars. Pre-clinical studies show that BA1104 is highly similar to Opdivo® in pharmaceutical and non-clinical activities. The results of the completed Phase I clinical trial support a demonstration of biosimilarity to Opdivo® in terms of pharmacokinetics(PK), safety, and immunogenicity, and all study endpoints were met.

Nivolumab已成为各种实体瘤基础治疗的产品。BA1104的开发遵循生物仿制药的相关指南。临床前研究表明，BA1104在药物和非临床活动方面与Opdivo®高度相似。完成的I期临床试验的结果支持在药代动力学（PK），安全性和免疫原性方面证明与Opdivo®的生物相似性，并且满足了所有研究终点。

The Phase III clinical trial is a randomized, double-blind, multicenter study designed to compare the efficacy, safety, and immunogenicity of BA1104 and Opdivo® combined respectively with chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma. According to the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars issued by the Center for Drug Evaluation of the National Medical Products Administration, after the completion of the Phase III clinical trial, BA1104 can apply and.

III期临床试验是一项随机，双盲，多中心研究，旨在比较BA1104和Opdivo®联合化疗对晚期或转移性食管鳞状细胞癌患者的疗效，安全性和免疫原性。根据国家医药产品监督管理局药品评价中心发布的生物仿制药相似性评价和指示外推指南，在完成III期临床试验后，BA1104可以申请和。