Canada Accepts Tanvex NDS submission for TX01

Canada Accepts Tanvex NDS submission for TX01 March 11, 2019 Tanvex BioPharma, Inc. (TWSE: 6541) submitted its New Drug Submission (NDS) to the Health Canada for TX-01. Today, we are pleased to announce that the submission has been accepted for review by Health Canada. US Food and Drug Administration (FDA) had accepted the Biologics License Application (BLA) submission in November 2018 for TX-01, a proposed biosimilar to the reference product Neupogen® (filgrastim) which is indicated for chemotherapy induced neutropenia. According to data from IMS, filgrastim product sales (including Neupogen® and Grastofil®) were over $100 million (USD) in the Canada for the 12 months ended November 30, 2018. About Tanvex Tanvex BioPharma, Inc. (TWSE: 6541) is a biopharmaceutical company focused on the biosimilar market. The Company is vertically integrated with end-to-end in-house development, manufacturing and commercialization capabilities. Tanvex BioPharma, Inc. is registered in Cayman Islands and has operations and facilities in Irvine, CA, San Diego, CA, and Taipei, Taiwan. Tanvex is publicly traded on the Taiwan Stock Exchange.

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