Last reviewed 2026-05-29 · How we verify

ABP-745 Dose A

Atom Therapeutics Co., Ltd · Phase 2 active Small molecule Under review

ABP-745 Dose A is a Bispecific antibody Small molecule drug developed by Atom Therapeutics Co., Ltd. It is currently in Phase 2 development for Non-small cell lung cancer, metastatic or locally advanced, PD-L1 positive, Head and neck squamous cell carcinoma, metastatic.

ABP-745 is a bispecific antibody that targets and blocks PD-1 and CTLA-4 receptors.

ABP-745 Dose A is being studied in a Phase II clinical trial for its efficacy and safety in treating conditions such as atherosclerosis, cardiovascular disease, and acute gouty arthritis. The study is comparing ABP-745 Dose A to a placebo and ABP-745 Dose B in patients with atherosclerosis.

Likelihood of approval

13.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 2 attrition -2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	ABP-745 Dose A
Sponsor	Atom Therapeutics Co., Ltd
Drug class	Bispecific antibody
Target	PD-1 and CTLA-4
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

By binding to both PD-1 and CTLA-4, ABP-745 enhances T-cell activation and proliferation, leading to an anti-tumor immune response. This mechanism is thought to be beneficial in treating various types of cancer.

Approved indications

Non-small cell lung cancer, metastatic or locally advanced, PD-L1 positive
Head and neck squamous cell carcinoma, metastatic

Common side effects

Fatigue
Diarrhea
Nausea
Rash
Pruritus

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:

ABP-745 Dose A CI brief — competitive landscape report
ABP-745 Dose A updates RSS · CI watch RSS
Atom Therapeutics Co., Ltd portfolio CI

Frequently asked questions about ABP-745 Dose A

What is ABP-745 Dose A?

ABP-745 Dose A is a Bispecific antibody drug developed by Atom Therapeutics Co., Ltd, indicated for Non-small cell lung cancer, metastatic or locally advanced, PD-L1 positive, Head and neck squamous cell carcinoma, metastatic.

How does ABP-745 Dose A work?

ABP-745 is a bispecific antibody that targets and blocks PD-1 and CTLA-4 receptors.

What is ABP-745 Dose A used for?

ABP-745 Dose A is indicated for Non-small cell lung cancer, metastatic or locally advanced, PD-L1 positive, Head and neck squamous cell carcinoma, metastatic.

Who makes ABP-745 Dose A?

ABP-745 Dose A is developed by Atom Therapeutics Co., Ltd (see full Atom Therapeutics Co., Ltd pipeline at /company/atom-therapeutics-co-ltd).

What drug class is ABP-745 Dose A in?

ABP-745 Dose A belongs to the Bispecific antibody class. See all Bispecific antibody drugs at /class/bispecific-antibody.

What development phase is ABP-745 Dose A in?

ABP-745 Dose A is in Phase 2.

What are the side effects of ABP-745 Dose A?

Common side effects of ABP-745 Dose A include Fatigue, Diarrhea, Nausea, Rash, Pruritus.

What does ABP-745 Dose A target?

ABP-745 Dose A targets PD-1 and CTLA-4 and is a Bispecific antibody.

Drug class: All Bispecific antibody drugs
Target: All drugs targeting PD-1 and CTLA-4
Manufacturer: Atom Therapeutics Co., Ltd — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-small cell lung cancer, metastatic or locally advanced, PD-L1 positive
Indication: Drugs for Head and neck squamous cell carcinoma, metastatic

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