Recently, CMAB Biopharma (Suzhou) Inc’s (“CMAB”) partner QureBio Ltd (“QureBio”) has announced its innovative drug Q-1802 received United States Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND) application. This application is the first clinical research in the U.S. by QureBio.
Q-1802 is the lead candidate in QureBio’s pipeline and is the first bispecific antibody against PD-L1 and Claudin18.2 to be studied in a U.S. clinical trial. As part of the collaboration, CMAB provided integrated CDMO services for the Q-1802 program, utilizing its antibody production platform. Services included CMC development activities and successful production of drug substance and drug product batches in only 9 months.
“We are very glad to collaborate with CMAB. During the Q-1802 program, the two groups worked together and completed the CMC development and production of clinical samples efficiently and rapidly.” said Dr. Xiangdong Qu, Founder and CEO of QureBio. “The first-class technology and GMP level, as well as thoughtful services of CMAB team impressed us a lot during our collaboration. We are looking forward to continuing work with CMAB, and we are also striving to bring better innovative dual anti-drugs to patients as soon as possible.”
Dr. Yongzhong Wang, CEO of CMAB said, “We appreciate the trust of Dr.Qu and QureBio, and congratulation them on having Q-1802 become the world’s first bispecific antibody against PD-L1 and Claudin18.2 approved for a clinical trial in the US. There are unique development challenges when dealing with a bispecific antibody and we are very proud of our team who utilized our antibody platform in order to achieve, industry-leading speed to get a US IND approved successfully. It is also a testament to the excellent cooperation between CMAB and QureBio. CMAB will continue to accelerate the process of Q-1802 from QureBio, and look forward to reaching the next milestone early.”
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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About CMAB Biopharma (Suzhou), Inc.
CMAB is a flexible full-service CDMO dedicated to providing bespoke development manufacturing services of antibodies and biologics for clients in China and across the globe. CMAB complies with global quality standards, we get European commission EudraLex (EMA) Vol 4. GMP guidelines which is a successful external QP Audit by Parexel.
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CMAB Biopharma (Suzhou) Inc
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