Represent subsidiary Tanvex BioPharma USA,Inc. to announce that TX01(Neupogen Biosimilar) got Drug Establishment Licence from Health Canada
· Issued by Tanvex BioPharma, Inc.
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Today's Information
Provided by: Tanvex BioPharma, Inc.
SEQ_NO
1
Date of announcement
2022/07/25
Time of announcement
11:28:10
Subject
Represent subsidiary Tanvex BioPharma USA,Inc.
to announce that TX01(Neupogen Biosimilar) got
Drug Establishment Licence from Health Canada
Date of events
2022/07/20
To which item it meets
paragraph 51
Statement
1.Date of occurrence of the event:2022/07/20
2.Company name:Tanvex BioPharma USA
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:TX01(Neupogen Biosimilar) got Drug Establishment
Licence from Health Canada on July 19, 2022(Canada time)
6.Countermeasures:N/A
7.Any other matters that need to be specified:
(1)Name of the product：TX01(Neupogen Biosimilar)
(2)Indication：Neutropenia, caused by chemotherapy for cancer
(3)The next step in development:N/A
(4)Current stage of the Research and Development：
A.Submit application／Approved／Not approved：
Got Drug Establishment Licence from Health Canada.
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: N/A
B.Estimated obligations: N/A
(6)Market:According to 2021 IQVIA marketing data, Canada sales of TX01
(reference Neupogen)(Filgrastim) were approximately CAD$100 million .
(7)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.
