Represent subsidiary Tanvex BioPharma USA,Inc.
to announce the result of FDA inspection for
TX05(Herceptin Biosimilar)
Date of events
2022/07/30
To which item it meets
paragraph 51
Statement
1.Date of occurrence of the event:2022/07/30
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:Tanvex received a complete response letter (CRL) from
United States Food and Drug Administration (FDA) in response to the Biologics
License Application (BLA) for TX05, a proposed biosimilar to Herceptin.
6.Countermeasures:N/A
7.Any other matters that need to be specified:
(1)Name of the product：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)FDA review comments: Some biosimilarity issues between TX05 and reference
product should be further clarified. Tanvex didn't received significant
deficiency in clinical study and factory inspection from FDA.
(4)The next step in development:N/A
(5)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 TX05 or
confidentiality, in order to protect the rights and interests
of the company and investors, it will not be disclosed.
(6)The next step in development:
A.Estimated timeline: Based on the CRL, Tanvex will continue to update
FDA with supplemental information.
B.Estimated obligations: N/A
(7)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,
Perjeta and Keytruda.
(8)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 01 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 31 July 2022 22:33:01 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. 
