CDE of NMPA Approves to Initiate Ph 3 Trial of 9MW2821 for Urothelial Carcinoma in Combination with PD-1 Inhibitor
“Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for “a randomized, controlled, open-label, multicenter Phase III clinical study of 9MW2821 in combination with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer” has been approved. The corresponding Phase III clinical study has been initiated and is currently in the enrollment stage. As of the announcement, 9MW2821 has been approved for three pivotal clinical trials.”
Share:
More News
“Cancer, a leading cause of death worldwide, exacts an immense toll on individuals, families, and communities. No person, family, scientist, clinician, hospital, policy maker, company or country can or should face this devastating disease alone. We all must work together to win, which is why we are committed to playing
“Our encouraging Phase 2 data for GRANITE in MSS-CRC continue to mature and demonstrate durable benefit over time. With two additional months of follow-up, relative progression-free survival has further improved in the analysis of all patients treated with GRANITE, and most notably, in those with a lower tumor burden at
“Patients in the EU with ROS1 -positive non-small cell lung cancer and NTRK -positive solid tumors face a great unmet need for new therapies that may improve their outcomes and address or delay the difficult issue of treatment resistance,” said Joseph Fiore, vice president, global program lead, repotrectinib, Bristol Myers
“The acquisition of Biotheus builds on our successful ongoing collaboration on BNT327/PM8002 and other investigational bispecific antibodies,” said Prof. Ugur Sahin, M.D., Ph.D., CEO and co-founder of BioNTech. “We believe that BNT327/PM8002 has the potential to set a new standard of care in multiple oncology indications, surpassing traditional checkpoint inhibitors.
