Last reviewed 2026-05-26 · How we verify

STSP-0601 for Injection

Staidson (Beijing) Biopharmaceuticals Co., Ltd · Phase 3 active Small molecule Under review

STSP-0601 for Injection is a Interferon alpha fusion protein Small molecule drug developed by Staidson (Beijing) Biopharmaceuticals Co., Ltd. It is currently in Phase 3 development for Chronic hepatitis B, Chronic hepatitis C.

STSP-0601 is a recombinant human serum albumin-interferon alpha fusion protein that enhances antiviral and immunomodulatory responses.

STSP-0601 for Injection is being studied in a Phase 2 trial for its safety and efficacy in treating adult patients with hemophilia A or B without inhibitor. The exact mechanism of STSP-0601 is currently unknown.

Likelihood of approval

59.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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	STSP-0601 for Injection
Sponsor	Staidson (Beijing) Biopharmaceuticals Co., Ltd
Drug class	Interferon alpha fusion protein
Target	Interferon alpha receptor (IFNAR)
Modality	Small molecule
Therapeutic area	Virology/Immunology
Phase	Phase 3

Mechanism of action

STSP-0601 combines human serum albumin with interferon alpha to improve the pharmacokinetic properties and biological activity of interferon. The albumin fusion extends the half-life and reduces immunogenicity while maintaining the interferon alpha-mediated antiviral and immune-stimulating effects through JAK-STAT pathway activation.

Approved indications

Chronic hepatitis B
Chronic hepatitis C

Common side effects

Flu-like symptoms
Fatigue
Fever
Headache
Myalgia

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:

STSP-0601 for Injection CI brief — competitive landscape report
STSP-0601 for Injection updates RSS · CI watch RSS
Staidson (Beijing) Biopharmaceuticals Co., Ltd portfolio CI

Frequently asked questions about STSP-0601 for Injection

What is STSP-0601 for Injection?

STSP-0601 for Injection is a Interferon alpha fusion protein drug developed by Staidson (Beijing) Biopharmaceuticals Co., Ltd, indicated for Chronic hepatitis B, Chronic hepatitis C.

How does STSP-0601 for Injection work?

STSP-0601 is a recombinant human serum albumin-interferon alpha fusion protein that enhances antiviral and immunomodulatory responses.

What is STSP-0601 for Injection used for?

STSP-0601 for Injection is indicated for Chronic hepatitis B, Chronic hepatitis C.

Who makes STSP-0601 for Injection?

STSP-0601 for Injection is developed by Staidson (Beijing) Biopharmaceuticals Co., Ltd (see full Staidson (Beijing) Biopharmaceuticals Co., Ltd pipeline at /company/staidson-beijing-biopharmaceuticals-co-ltd).

What drug class is STSP-0601 for Injection in?

STSP-0601 for Injection belongs to the Interferon alpha fusion protein class. See all Interferon alpha fusion protein drugs at /class/interferon-alpha-fusion-protein.

What development phase is STSP-0601 for Injection in?

STSP-0601 for Injection is in Phase 3.

What are the side effects of STSP-0601 for Injection?

Common side effects of STSP-0601 for Injection include Flu-like symptoms, Fatigue, Fever, Headache, Myalgia.

What does STSP-0601 for Injection target?

STSP-0601 for Injection targets Interferon alpha receptor (IFNAR) and is a Interferon alpha fusion protein.

Drug class: All Interferon alpha fusion protein drugs
Target: All drugs targeting Interferon alpha receptor (IFNAR)
Manufacturer: Staidson (Beijing) Biopharmaceuticals Co., Ltd — full pipeline
Therapeutic area: All drugs in Virology/Immunology
Indication: Drugs for Chronic hepatitis B
Indication: Drugs for Chronic hepatitis C

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