GC Biopharma (006280.KS), a South Korean biopharmaceutical company, announced that it has signed an agreement with Curevo Vaccine to secure contract manufacturing (CMO) rights for amezosvatein (development name: CRV-101), a recombinant shingles vaccine currently under clinical development.

Under the terms of the agreement, GC Biopharma will be responsible for producing a portion of the commercial supply of amezosvatein for global markets.

The global shingles vaccine market is currently dominated by GSK's Shingrix. Since its launch in 2018, the market has grown at an average annual rate of approximately 20%, expanding from KRW 1 trillion in 2017 to around KRW 6 trillion (USD ~4.4 billion) in 2024. Shingrix recorded over KRW 5 trillion (GBP 3.4 billion^[1]) in global sales last year, capturing more than 90% of the market.

Amezosvatein is an adjuvanted recombinant protein vaccine, similar in format to Shingrix, but uses a synthetic adjuvant designed to reduce local (injection-site pain) and systemic (influenza-like) reactions after vaccination to levels typical of conventional vaccines. The company believes this feature could position the product as a differentiated alternative with a superior tolerability profile.

In fact, amezosvatein demonstrated non- inferior immune system activity in early Phase 2 trials compared to the leading competitor and showed favorable tolerability results. Currently, Curevo Vaccine is conducting an expanded Phase 2 study in 640 adults aged 50 and older. The company aims to complete this trial by 2026 and move directly into Phase 3, paving the way for global commercialization.

The company expects that the addition of amezosvatein to the shingles vaccine landscape will offer patients and healthcare providers a valuable alternative, expanding choice in a market currently dominated by a single product.

"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."

^[1] Source: GSK Q4 2024 Earnings Announcement