CSPC PHARMA (01093.HK) starts Phase I trial of SYS6077 injection, an off-the-shelf mRNA cancer vaccine

NewTimeSpace News: On 28 October, CSPC Pharmaceutical Group Limited (CSPC PHARMA, 01093.HK) announced that the Phase I clinical trial (SYS6077-001) of SYS6077 injection for the treatment of advanced malignant tumours has been officially launched at the first study site in China. Registered as a Class 1 therapeutic biologic, the product is a universal off-the-shelf therapeutic messenger RNA (mRNA) cancer vaccine developed on a nano-delivery technology platform; it encodes multiple tumour neoantigens to activate antigen-specific T-cell immune responses and strengthen the body's ability to recognise and attack tumour cells.

Preclinical studies showed that the product induces specific T-cell immune responses against multiple tumour antigens and demonstrated anti-tumour activity in multiple animal tumour models; compared with other mRNA anti-tumour vaccines, it offers broader population coverage, a lower risk of immune escape and a shorter manufacturing cycle. The group received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration in September 2026 and launched the SYS6077-001 trial after approval.

The approved trial is a multicentre Phase I study designed to evaluate the safety, tolerability, immunogenicity, pharmacokinetic profile and preliminary anti-tumour activity of different doses of the product in patients with malignant tumours. Participant recruitment and screening are currently progressing.