On March 2, 2021 CMAB Biopharma (Suzhou) Inc’s ("CMAB") partner QureBio Ltd ("QureBio") reported its innovative drug Q-1802 received United States Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND) application (Press release, CMAB Biopharma, MAR 2, 2021, View Source [SID1234575875]). This application is the first clinical research in the U.S. by QureBio.
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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."