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Akeso's Penpulimab Monoclonal Antibody Submitted BLA in the United States


Akeso s Penpulimab Monoclonal Antibody Submitted BLA in the United States
First Chinese PD-1 drug being BLA reviewed by the FDA under RTOR
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HONG KONG, May 24, 2021 /PRNewswire/ On May 24, 2021, Akeso, Inc. (HKEx: 9926.HK) announced that Penpulimab (research and development code: AK105), an PD-1 monoclonal antibody drug co-developed by the Company with Sino Biopharmaceutical Limited (HKEx: 1177.HK), has submitted a Biologics License Application ( BLA ) to the Food and Drug Administration of the United States ( FDA ) for third-line treatment of metastatic nasopharyngeal carcinoma.
The FDA will review the BLA under the new policy of Real-Time Oncology Review ( RTOR ), which aims to accelerate the process of drug approval. This is the first Chinese PD-1 drug being BLA reviewed by the FDA under RTOR. ....

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PAVmed Subsidiary Lucid Diagnostics Announces Upcoming Presentation at Digestive Disease Week 2021

Dr. David Poppers to present on his initial experience with Lucid’s EsoCheck and EsoGuard NEW YORK, May 13, 2021 (GLOBE NEWSWIRE) PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (“PAVmed” or the “Company”), a highly differentiated, multi-product, commercial-stage medical technology company, and its major subsidiary Lucid Diagnostics Inc. (“Lucid”), announced today that David Poppers, M.D. Ph.D. will be presenting data on his team’s initial experience using Lucid’s EsoCheck® Esophageal Cell Collection Device and EsoGuard® Esophageal DNA Test at the upcoming Digestive Disease Week 2021 medical conference, which will be held virtually May 21-23, 2021. Dr. Poppers is Clinical Professor, Division of Gastroenterology and Hepatology at NYU Langone Medical Center in New York City, and an expert in advanced endoscopy and esophageal disease. His presentation, entitled EsoCheck/EsoGuard: a Novel, Simple, Outpatient Technology for the Ea ....

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