Statement
|
1.Date of occurrence of the event:2022/05/10
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:FDA has approved the name for biosimilar candidate TX05
6.Countermeasures:N/A
7.Any other matters that need to be specified:
(1)Name of the product:Trastuzumab biosimilar candidate TX05
(Herceptin Biosimilar).
(2)Indication:Same indications as HerceptinR, currently including the
treatment of Human Epidermal growth factor Receptor
2-positive (HER2+) breast cancer and HER2+ gastric cancer.
(3)The next step in development:Prepare commercialization in the US.
(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 :Prepare commercialization in the US.
D.Cumulative research and development expenses:Due to the
possibility of future international collaboration of TX05 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 10-12 months,
but it depends on FDA
B.Estimated obligations: N/A
(6)Market:According to 2020 IQVIA marketing data, US sales of HerceptinR
were approximately US$2.3 billion . There are various ways
to treat breast cancer, there are several biologics in market
including Herceptin, Avastin, Perjeta and Keytruda.
(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.
|