Tanvex BioPharma, Inc. Announces Initiation of Pivotal Trial of TX01 (a Proposed Biosimilar of Neupogen®)

FOR IMMEDIATE RELEASE Tanvex BioPharma, Inc. Announces Initiation of Pivotal Trial of TX01 (a Proposed Biosimilar of Neupogen®) Irvine, CA, October 3, 2016 Tanvex BioPharma, Inc. (Tanvex) (TPEx: 6541), a biopharmaceutical company focused on biosimilar products, announced, pursuant to feedback from the U.S. Food and Drug Administration (FDA), the company has initiated pivotal clinical studies for TX01, a proposed biosimilar of filgrastim (Neupogen®). “The initiation of these pivotal clinical studies is a major milestone for our company and a key step towards achieving our goal of developing a robust portfolio of biosimilar products. We are one step closer to expanding access to affordable, high quality products to patients with serious illness,” said Allen Chao, PhD, CEO of Tanvex. About TX01 TX01 is a proposed biosimilar of filgrastim (Neupogen®). Filgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF) analog. About Tanvex BioPharma, Inc. Tanvex BioPharma, Inc. is engaged in the development, production/manufacturing, and marketing of biosimilar products. An international company registered in Cayman Islands with operations and facilities in Irvine, CA, San Diego, CA, and Taipei, Taiwan, Tanvex has end-to- end in-house development and manufacturing capabilities. Our goal is to deliver value to patients by providing safe, effective and affordable biological products. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding Tanvex, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the ability of Tanvex to obtain regulatory approval of pivotal clinical studies from the FDA for TX01, its ability to submit a 351(k) (biosimilar) license application for TX01 on its desired timeline and the potential benefits of TX01. Such forward-looking statements involve substantial risks and uncertainties that relate to future events and the actual results could differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the biosimilar development process, including the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality or supply for TX01 and Neupogen® and patient safety. Tanvex undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see the company's current and future reports filed with the Taipei Stock Exchange. ###

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