Last reviewed 2026-05-28 · How we verify

Minhai-HIB

Beijing Minhai Biotechnology Co., Ltd · Phase 3 active Biologic ✓ Verified May 2026

Minhai-HIB is a Conjugate vaccine Biologic drug developed by Beijing Minhai Biotechnology Co., Ltd. It is currently in Phase 3 development for Prevention of invasive Haemophilus influenzae type b disease in infants and children.

Minhai-HIB is a Haemophilus influenzae type b (Hib) conjugate vaccine that stimulates immune responses against the polysaccharide capsule of H. influenzae type b bacteria.

Minhai-HIB is a Haemophilus Influenzae Type b conjugate vaccine that has been studied in a Phase III clinical trial. The vaccine was tested for safety and immunogenicity in a double-blind, parallel-controlled, randomized study.

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	Minhai-HIB
Sponsor	Beijing Minhai Biotechnology Co., Ltd
Drug class	Conjugate vaccine
Target	Haemophilus influenzae type b polysaccharide capsule
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

The vaccine consists of the Hib polysaccharide conjugated to a protein carrier, which enhances immunogenicity and promotes T-cell dependent B-cell responses. This generates both antibody and cellular immunity against H. influenzae type b, preventing invasive bacterial infections including meningitis, bacteremia, and epiglottitis.

Approved indications

Prevention of invasive Haemophilus influenzae type b disease in infants and children

Common side effects

Injection site reactions (erythema, swelling, pain)
Fever
Irritability
Drowsiness

Key clinical trials

Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine，Freeze-dried (PHASE3)

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:

Minhai-HIB CI brief — competitive landscape report
Minhai-HIB updates RSS · CI watch RSS
Beijing Minhai Biotechnology Co., Ltd portfolio CI

Frequently asked questions about Minhai-HIB

What is Minhai-HIB?

Minhai-HIB is a Conjugate vaccine drug developed by Beijing Minhai Biotechnology Co., Ltd, indicated for Prevention of invasive Haemophilus influenzae type b disease in infants and children.

How does Minhai-HIB work?

Minhai-HIB is a Haemophilus influenzae type b (Hib) conjugate vaccine that stimulates immune responses against the polysaccharide capsule of H. influenzae type b bacteria.

What is Minhai-HIB used for?

Minhai-HIB is indicated for Prevention of invasive Haemophilus influenzae type b disease in infants and children.

Who makes Minhai-HIB?

Minhai-HIB is developed by Beijing Minhai Biotechnology Co., Ltd (see full Beijing Minhai Biotechnology Co., Ltd pipeline at /company/beijing-minhai-biotechnology-co-ltd).

What drug class is Minhai-HIB in?

Minhai-HIB belongs to the Conjugate vaccine class. See all Conjugate vaccine drugs at /class/conjugate-vaccine.

What development phase is Minhai-HIB in?

Minhai-HIB is in Phase 3.

What are the side effects of Minhai-HIB?

Common side effects of Minhai-HIB include Injection site reactions (erythema, swelling, pain), Fever, Irritability, Drowsiness.

What does Minhai-HIB target?

Minhai-HIB targets Haemophilus influenzae type b polysaccharide capsule and is a Conjugate vaccine.

Drug class: All Conjugate vaccine drugs
Target: All drugs targeting Haemophilus influenzae type b polysaccharide capsule
Manufacturer: Beijing Minhai Biotechnology Co., Ltd — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease
Indication: Drugs for Prevention of invasive Haemophilus influenzae type b disease in infants and children

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