相关临床试验
2
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2018
进行中(未招募)
1
50.0%
已完成
1
50.0%
暂无批准数据
- GC Biopharma has secured contract manufacturing rights for amezosvatein (CRV-101), a recombinant shingles vaccine designed to reduce injection-site pain and systemic reactions compared to current market leader Shingrix. - The vaccine demonstrated non-inferior immune activity to the leading competitor in early Phase 2 trials and is currently being tested in an expanded Phase 2 study of 640 adults aged 50 and older. - This partnership positions GC Biopharma to enter the rapidly growing global shingles vaccine market, which has expanded from KRW 1 trillion in 2017 to approximately KRW 6 trillion in 2024. - Curevo Vaccine aims to complete the Phase 2 trial by 2026 and proceed directly to Phase 3, potentially offering healthcare providers a differentiated alternative in a market dominated by GSK's Shingrix.
- Curevo Vaccine's amezosvatein demonstrated non-inferiority to Shingrix in a Phase 2 trial, meeting all primary endpoints for immunogenicity. - The trial, involving 876 participants, showed amezosvatein had a 100% vaccine response rate compared to Shingrix's 97.9%. - Amezosvatein exhibited lower rates of local and systemic adverse events, suggesting improved tolerability over the existing Shingrix vaccine. - Curevo plans to advance amezosvatein into global Phase 3 trials in 2024, targeting the $4 billion shingles vaccine market.