Last reviewed 2026-05-19 · How we verify

anti PD-1 with nab-paclitaxel

Fudan University · Phase 1 active Small molecule ✓ Verified May 2026 Quality 15/100

anti PD-1 with nab-paclitaxel is a Small molecule drug developed by Fudan University. It is currently in Phase 1 development. Also known as: SHR1210.

Nab-paclitaxel is a small molecule used in combination with anti-PD-1 therapies to treat various types of cancer, including Head and Neck Squamous Cell Carcinoma, Squamous Non Small Cell Lung Cancer, Anatomic Stage III and IV Breast Cancer, and Locally Advanced Triple-Negative Breast Carcinoma. The exact combination of nab-paclitaxel with anti-PD-1 therapies is not specified, but it has been studied in clinical trials with other interventions such as Avelumab, Bevacizumab, and Capecitabine.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	anti PD-1 with nab-paclitaxel
Also known as	SHR1210
Sponsor	Fudan University
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Anaemia
Neutrophil count decreased
White blood cell count decreased
Alopecia
Platelet count decreased
Alanine aminotransferase increased
Aspartate aminotransferase increased
Decreased appetite
Constipation
Nausea
Rash
Leukopenia

Competitive intelligence

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

anti PD-1 with nab-paclitaxel CI brief — competitive landscape report
anti PD-1 with nab-paclitaxel updates RSS · CI watch RSS
Fudan University portfolio CI

Frequently asked questions about anti PD-1 with nab-paclitaxel

What is anti PD-1 with nab-paclitaxel?

anti PD-1 with nab-paclitaxel is a Small molecule drug developed by Fudan University.

Who makes anti PD-1 with nab-paclitaxel?

anti PD-1 with nab-paclitaxel is developed by Fudan University (see full Fudan University pipeline at /company/fudan-university).

Is anti PD-1 with nab-paclitaxel also known as anything else?

anti PD-1 with nab-paclitaxel is also known as SHR1210.

What development phase is anti PD-1 with nab-paclitaxel in?

anti PD-1 with nab-paclitaxel is in Phase 1.

What are the side effects of anti PD-1 with nab-paclitaxel?

Common side effects of anti PD-1 with nab-paclitaxel include Anaemia, Neutrophil count decreased, White blood cell count decreased, Alopecia, Platelet count decreased, Alanine aminotransferase increased.

Manufacturer: Fudan University — full pipeline
Also known as: SHR1210

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