Tanvex Biopharma Inc.

05/10/2022 | Press release | Distributed by Public on 05/10/2022 03:38

Represent subsidiary Tanvex BioPharma USA,Inc. to announce that the name of TX05 (Herceptin Biosimilar) is Valheric

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Provided by: Tanvex BioPharma, Inc.
SEQ_NO 1 Date of announcement 2022/05/10 Time of announcement 17:29:21
Subject
 Represent subsidiary Tanvex BioPharma USA,Inc.
to announce that the name of TX05
(Herceptin Biosimilar) is Valheric
Date of events 2022/05/10 To which item it meets paragraph 51
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.