Looking for collaboration: 6vGBS vaccine

International Partnering Opportunity

Suzhou Juwei Biotech Co., Ltd., China

The Opportunity

Suzhou Juwei Biotech Co., Ltd. is seeking international development and commercialization partners for its Hexavalent Group B Streptococcus (6vGBS) polysaccharide–protein conjugate vaccine, covering serotypes Ia, Ib, II, III, IV and V. The primary safety assessment in Phase I has been completed, with long-term follow-up ongoing. Given the current feasibility of maternal Immunization studies in China, the next stages of clinical development are planned to be conducted outside China.

Disease Background & Development Rationale

• Group B Streptococcus is a major cause of neonatal sepsis and meningitis. Maternal colorization is common, and serotypes I–V account for the majority of invasive isolates.

• Intrapartum antibiotic prophylaxis (IAP) can reduce early-onset disease but does not prevent late-onset disease and may be difficult to implement consistently in settings without established screening infrastructure.

• Maternal immunization is being investigated as a potential strategy to reduce neonatal and infant GBS disease. WHO has identified GBS as a priority pathogen for vaccine development and is advancing work on serological approaches to support vaccine development and regulatory pathways.

• Global access initiatives, including Gavi's investment strategy, indicate potential future relevance of maternal GBS vaccination in lower-income and high-burden settings.

Product Profile

Development Status

Preclinical: Three independent lots each of the monovalent conjugates and the 6-valent formulation were manufactured.

Immunogenicity and protection were reproduced across lots, with serotype-specific IgG and functional opsonophagocytic activity demonstrated for all six serotypes.

Phase I: Randomised, blinded, placebo-controlled study in 80 healthy adults aged 18–49, with two age cohorts and 3:1 vaccine-to-placebo randomisation. A sentinel cohort with DSMB review preceded expansion. Single-dose and two-dose regimens one month apart were evaluated. Through Day 30, no statistically significant difference in adverse reaction rates was observed between vaccine and placebo arms in the evaluated groups; reactions were predominantly Grade 1–2. Serotype-specific IgG responses were observed against all six serotypes after a single dose. Six-month sampling and long-term safety follow-up to 12 months are ongoing.

Analytical methods: Luminex multiplex assay for serotype-specific antibody and opsonophagocytic killing assays (OPA) have been established for all six serotypes.

Manufacturing & Platform

Juwei's headquarters site comprises 16 buildings and approximately 130,000 m² of floor area, with designed capacity of approximately 45 million doses per year. Building and equipment qualification and validation are complete; technology transfer and process performance qualification (PPQ) are in progress.

A production workshop of approximately 900 m² has been established with one fermentation train, one purification train and two conjugation lines. At commercial scale, polysaccharide output is projected at approximately 60 g per serotype per batch and finished product at approximately 120,000 doses per batch. Cost of goods will be assessed after the commercial process is locked.

Partnership Opportunities

• Co-development: shared development of ex-China clinical studies, registration and launch.

• Out-licensing: regional or global rights, with commercial terms to be negotiated.

• Technology transfer: modular transfer of manufacturing process, analytical methods and QC specifications, with technical support through validation.

• Contract manufacturing: supply of drug substance or finished product from qualified capacity.

Juwei is particularly interested in partners with capabilities in maternal vaccine clinical development, regulatory strategy, regional or global commercialisation, manufacturing and/or public-health access.

Next Step

Subject to interest, Juwei welcomes an introductory discussion to explore potential development, licensing, manufacturing or commercialisation collaboration.