Represent subsidiary Tanvex BioPharma USA,Inc. to
announce BLA resubmission for TX01(Neupogen Biosimilar)
Date of events
2022/08/15
To which item it meets
paragraph 51
Statement
1.Date of occurrence of the event:2022/08/15
2.Company name:Tanvex BioPharma USA, Inc.
3.Relationship to the Company (please enter "head office" or
"subsidiaries"):Subsidiary
4.Reciprocal shareholding ratios:Wholly owned subsidiary of
Tanvex BioPharma, Inc.
5.Cause of occurrence:Tanvex resubmit Biologics License Applications (BLA)
for TX01(Neupogen Biosimilar)
6.Countermeasures:
(1)Name of the product：Filgrastim biosimilar candidate TX01
(Neupogen Biosimilar).
(2)Indication：Same indications as Neupogen, Neutropenia.
(3)The next step in development:N/A
(4)Current stage of the Research and Development：
A.Submit application／Approved／Not approved：
Biologics License Application(BLA) in the U.S.A.
B.Risks faced by the company, if it failed to receive the approval
from Governmental Authority：N/A
C.Future direction if it receives the approval from Governmental
Authority ：N/A
D.Cumulative research and development expenses：Due to the
possibility of future international collaboration of TX01 or
confidentiality, in order to protect the rights and interests
of the company and investors, it will not be disclosed.
(5)The next step in development:
A.Estimated timeline: The review process usually takes 6-12 months,
but it depends on FDA
B.Estimated obligations: N/A
(6)Market:According to KBV Research data, worldwide sales of filgrastim
products will be approximately US$649 million in 2022. The sales will grow
to approximately US$953 in 2027.CAGR is 8%.
7.Any other matters that need to be specified:
Tanvex is a BioTech company that aims to develop biosimilar and new drug
products. Due to the lengthy R&D process, extensive spending, failure to
obtain the regulatory approval of government authorities which may result
in non-productive R&D activities, investors should assess carefully the
risks of investment.
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Tanvex Biopharma Inc. published this content on 15 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 August 2022 08:12:05 UTC.
Tanvex BioPharma, Inc. is a Cayman Islands-based biopharmaceutical company focused on the biosimilar market. The company has expertise in areas, including strain and cell-line development in both microbial and mammalian systems, cell culture, protein purification, process scale-up, drug substance and product manufacturing, and others. The Companyâs product pipeline includes Neupogen (TX-01), Herceptin (TX-05), Neulasta (TX-04), Avastin (TX-16), Perjeta (TX-52), and others. The Company offers a vertically integrated manufacturing platform for biopharmaceuticals. The Company is developing and delivering biologic and biosimilar drugs to people.
TANVEX BIOPHARMA, INC. 