YS Biopharma Co., Ltd. (NASDAQ: YS), a China-based global biopharmaceutical company, announced on Tuesday that it has enrolled its first subject in its Phase three clinical trial of the Company's PIKA Rabies Vaccine.

The trial is intended to evaluate the safety, immunogenicity, and lot-to-lot consistency of the PIKA Rabies Vaccine. It is expected to enrol around 4,500 subjects in total.

The PIKA Rabies Vaccine, which utilizes YS Biopharma's proprietary PIKA adjuvant technology, is designed to produce a more robust immune response in an accelerated timespan compared to existing rabies vaccines. Previous Phase 1 and Phase 2 clinical trials of the PIKA Rabies Vaccine have demonstrated its safety and strong immunogenicity, with the PIKA Rabies Vaccine eliciting a detectable immune response in as quick as seven days. Given these results, the PIKA Rabies Vaccine has the potential to achieve best-in-class accelerated protection and meet the WHO's goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens.

The Phase three trial, a randomised, comparator-controlled, double-blind, multi-country and multi-centre study, is to be conducted in Pakistan and the Philippines. Its primary goal is to assess the lot-to-lot consistency, immunogenicity, and safety of the PIKA Rabies Vaccine, while also seeking to demonstrate the immunologic non-inferiority and superiority of the PIKA Rabies Vaccine compared to a control vaccine. During the Trial, the PIKA Rabies Vaccine will be administered to healthy adults using a post-exposure prophylaxis schedule.