中国，上海——近日，由维亚生物创新中心投资孵化，专注于创新大分子生物药研发的公司——启愈生物技术（上海）有限公司宣布，其自主研发的注射用重组抗Claudin18.2和PD-L1人源化双特异性抗体（代号：Q-1802）IND申请获FDA批准。
SHANGHAI, March 1, 2021 -- Feb 27th, 2021, the U.S. Food and Drug Administration granted IND approval for Q-1802 from QureBio.Ltd. Q-1802 is a bispecific antibody which can target PD-L1 and Claudin18.2 simultaneously. This is the first FDA-approved bispecific antibody against PD-L1 and Claudin18.2. Q-1802 is designed to use multiple immune mechanisms to kill tumor cells which open a new therapy strategy for advanced solid tumors with high claudin18.2 expression.
About QureBio Ltd.
QureBio Ltd. was established in July 2017. It is a company incubated by Viva Biotech that focuses on the research and development of innovative macromolecular biopharmaceuticals. The company is registered in the Shanghai Pilot Free Trade Zone. QureBio aims to develop novel therapeutic drugs for the treatment of tumors, autoimmune diseases and metabolic diseases in China and the world to benefit patients. The company has multiple technology platforms for antibody drug development including phage display, hybridoma as well as protein and antibody engineering. In addition, the company's goal is to make effective and robust manufacturing process for biologics.
QureBio recently received tens of millions of A + rounds of financing, and the investor is the Shenzhen Capital Group Company, Ltd. ("SCGC"). This round of financing will mainly be used to advance the pre-clinical development of Q-1802 and Q-1801 projects. Q-1802 is a bispecific antibody immunotherapy for solid tumors such as gastric cancer. It has completed three batches of pilot production and is expected to complete the dual IND filings in both China and the United States this year. The Q-1801 project is a bispecific antibody drug targeting the tumor microenvironment signaling pathway. It is expected to complete the clinical declaration in 2021.
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