Last reviewed 2026-05-23 · How we verify

Subcutaneous single and mutiple dose

Shanghai Minwei Biotechnology Co., Ltd · Phase 1 active Small molecule ✓ Verified May 2026

Subcutaneous single and mutiple dose is a Small molecule drug developed by Shanghai Minwei Biotechnology Co., Ltd. It is currently in Phase 1 development.

Here's a 2-sentence factual summary of Subcutaneous single and multiple dose of ASC22: ASC22 is a subcutaneously injected PD-L1 antibody being studied in Phase II clinical trials for chronic hepatitis B and overweight or obese conditions. The trials involve evaluating the safety, tolerability, and pharmacokinetics of single and multiple doses of ASC22, as well as a placebo and sodium chloride, in patients with chronic hepatitis B.

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	Subcutaneous single and mutiple dose
Sponsor	Shanghai Minwei Biotechnology Co., Ltd
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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:

Subcutaneous single and mutiple dose CI brief — competitive landscape report
Subcutaneous single and mutiple dose updates RSS · CI watch RSS
Shanghai Minwei Biotechnology Co., Ltd portfolio CI

Frequently asked questions about Subcutaneous single and mutiple dose

What is Subcutaneous single and mutiple dose?

Subcutaneous single and mutiple dose is a Small molecule drug developed by Shanghai Minwei Biotechnology Co., Ltd.

Who makes Subcutaneous single and mutiple dose?

Subcutaneous single and mutiple dose is developed by Shanghai Minwei Biotechnology Co., Ltd (see full Shanghai Minwei Biotechnology Co., Ltd pipeline at /company/shanghai-minwei-biotechnology-co-ltd).

What development phase is Subcutaneous single and mutiple dose in?

Subcutaneous single and mutiple dose is in Phase 1.

Manufacturer: Shanghai Minwei Biotechnology Co., Ltd — full pipeline

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