TRACON Pharmaceuticals Announces Acceptance of the Envafolimab (KN035) NDA by the NMPA in China for Priority Review

SAN DIEGO, Jan. 19, 2021 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., today announced its corporate partners, Alphamab Oncology and 3D Medicines, received notification that the New Drug Application (NDA) for envafolimab was granted priority review by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) in the indication of MSI-H/dMMR cancer.
a??We congratulate our partners on the acceptance of the initial regulatory submission for envafolimab in China for priority review, which marks another important milestone in the development and potential commercialization of this promising program,a?? said Charles Theuer, M.D., Ph.D., TRACON Chief Executive Officer. a??In addition to the registration trial in MSI-H/dMMR advanced solid tumors in China, envafolimab is being studied in two other registration trials, a randomized Phase 3 trial in biliary tract cancer in China being conducted by Alphamab and 3D Medicines, and our ENVASARC trial in sarcoma in the U.S., which has now dosed multiple patients.a??About Priority Review by the NMPAPriority review is a procedure established to encourage the research and development of new drugs and accelerate the review and approval of new drugs with obvious clinical value and urgent clinical needs. According to the new "Drug Registration Rules" (SAMR Order No.27) and Working Procedures for Priority Review and Approval of Drug Marketing Authorization (Interim) (No. 82 of 2020) implemented on July 1, and July 7, 2020, respectively, once granted Priority Review, the NMPA will prioritize the review process and resources for applications with expected shorter review timelines.About Envafolimab (KN035)
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