South Korean biopharmaceutical company GC Biopharma has entered into a strategic manufacturing agreement with Curevo Vaccine to produce amezosvatein (CRV-101), a next-generation recombinant shingles vaccine designed to address tolerability concerns associated with current treatments. Under the contract manufacturing organization (CMO) agreement announced October 13, 2025, GC Biopharma will handle a portion of the global commercial supply for the investigational vaccine.
Market Opportunity in Rapidly Growing Sector
The global shingles vaccine market represents a significant commercial opportunity, having experienced explosive growth since GSK's Shingrix launch in 2018. The market has expanded at an average annual rate of approximately 20%, growing from KRW 1 trillion in 2017 to around KRW 6 trillion (USD ~4.4 billion) in 2024. Shingrix currently dominates the landscape with over KRW 5 trillion (GBP 3.4 billion) in global sales last year, capturing more than 90% of the market share.
Differentiated Vaccine Design Targets Tolerability
Amezosvatein represents an adjuvanted recombinant protein vaccine similar in format to Shingrix but incorporates a synthetic adjuvant specifically engineered to reduce both local injection-site pain and systemic influenza-like reactions. The company believes this enhanced tolerability profile could position amezosvatein as a differentiated alternative to the current standard of care.
Early clinical data supports this positioning, with amezosvatein demonstrating non-inferior immune system activity compared to the leading competitor in Phase 2 trials while showing favorable tolerability results. These findings suggest the vaccine could maintain efficacy while offering improved patient experience.
Clinical Development Progress
Curevo Vaccine is currently conducting an expanded Phase 2 study evaluating amezosvatein in 640 adults aged 50 and older. The company has outlined an aggressive development timeline, aiming to complete this pivotal trial by 2026 and proceed directly into Phase 3 studies, positioning the vaccine for potential global commercialization.
The clinical strategy reflects confidence in the vaccine's profile and addresses the significant unmet need for better-tolerated shingles prevention options in an aging global population.
Strategic Partnership Benefits
For GC Biopharma, the manufacturing agreement represents a strategic entry point into the lucrative shingles vaccine market. "This agreement marks a critical milestone in securing long-term growth drivers for GC Biopharma," said Huh Eun-Chul, CEO of GC Biopharma. "We will continue to expand our global vaccine business through strategic collaborations and differentiated technologies."
The partnership leverages GC Biopharma's extensive manufacturing experience, built over more than half a century of developing and producing plasma derivatives and vaccines. The company recently expanded its global presence with the successful US market entry of Alyglo (intravenous immunoglobulin G) in 2024.
Market Impact Potential
The addition of amezosvatein to the shingles vaccine landscape could significantly impact treatment options for patients and healthcare providers. Currently, the market lacks meaningful alternatives to Shingrix, creating an opportunity for a differentiated product with superior tolerability to capture market share.
The company expects that amezosvatein's improved side effect profile could expand patient acceptance and healthcare provider adoption, particularly among populations who may have avoided vaccination due to tolerability concerns with existing options.
