Last reviewed 2026-05-28 · How we verify

TX05 (trastuzumab)

Tanvex BioPharma USA, Inc. · Phase 3 active Biologic Under review Quality 0/100

TX05 (trastuzumab) is a HER2-targeted monoclonal antibody Biologic drug developed by Tanvex BioPharma USA, Inc.. It is currently in Phase 3 development for HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer (adjuvant/neoadjuvant), HER2-positive metastatic gastric cancer.

Trastuzumab is a monoclonal antibody that binds to HER2 receptors on cancer cells, blocking growth signals and triggering immune-mediated cell death.

TX05 (trastuzumab) is a biosimilar antibody that targets the Receptor tyrosine-protein kinase erbB-2, a receptor protein-tyrosine kinase inhibitor. It is being studied for the treatment of HER2-positive Breast Cancer, specifically in early breast cancer, in a randomized, double-blind, Phase III trial.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	TX05 (trastuzumab)
Sponsor	Tanvex BioPharma USA, Inc.
Drug class	HER2-targeted monoclonal antibody
Target	HER2 (human epidermal growth factor receptor 2)
Modality	Biologic
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Trastuzumab targets human epidermal growth factor receptor 2 (HER2), a protein overexpressed in certain cancers. By binding to HER2, it prevents ligand-induced signaling and recruits immune cells to destroy HER2-positive tumor cells through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).

Approved indications

HER2-positive metastatic breast cancer
HER2-positive early-stage breast cancer (adjuvant/neoadjuvant)
HER2-positive metastatic gastric cancer

Common side effects

Cardiotoxicity / left ventricular dysfunction
Infusion reactions
Nausea
Diarrhea
Fatigue
Headache
Fever

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

TX05 (trastuzumab) CI brief — competitive landscape report
TX05 (trastuzumab) updates RSS · CI watch RSS
Tanvex BioPharma USA, Inc. portfolio CI

Frequently asked questions about TX05 (trastuzumab)

What is TX05 (trastuzumab)?

TX05 (trastuzumab) is a HER2-targeted monoclonal antibody drug developed by Tanvex BioPharma USA, Inc., indicated for HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer (adjuvant/neoadjuvant), HER2-positive metastatic gastric cancer.

How does TX05 (trastuzumab) work?

Trastuzumab is a monoclonal antibody that binds to HER2 receptors on cancer cells, blocking growth signals and triggering immune-mediated cell death.

What is TX05 (trastuzumab) used for?

TX05 (trastuzumab) is indicated for HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer (adjuvant/neoadjuvant), HER2-positive metastatic gastric cancer.

Who makes TX05 (trastuzumab)?

TX05 (trastuzumab) is developed by Tanvex BioPharma USA, Inc. (see full Tanvex BioPharma USA, Inc. pipeline at /company/tanvex-biopharma-usa-inc).

What drug class is TX05 (trastuzumab) in?

TX05 (trastuzumab) belongs to the HER2-targeted monoclonal antibody class. See all HER2-targeted monoclonal antibody drugs at /class/her2-targeted-monoclonal-antibody.

What development phase is TX05 (trastuzumab) in?

TX05 (trastuzumab) is in Phase 3.

What are the side effects of TX05 (trastuzumab)?

Common side effects of TX05 (trastuzumab) include Cardiotoxicity / left ventricular dysfunction, Infusion reactions, Nausea, Diarrhea, Fatigue, Headache.

What does TX05 (trastuzumab) target?

TX05 (trastuzumab) targets HER2 (human epidermal growth factor receptor 2) and is a HER2-targeted monoclonal antibody.

Drug class: All HER2-targeted monoclonal antibody drugs
Target: All drugs targeting HER2 (human epidermal growth factor receptor 2)
Manufacturer: Tanvex BioPharma USA, Inc. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for HER2-positive metastatic breast cancer
Indication: Drugs for HER2-positive early-stage breast cancer (adjuvant/neoadjuvant)
Indication: Drugs for HER2-positive metastatic gastric cancer

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing