Infectious Disease

COVID-19 Vaccine

PIKA Recombinant COVID-19 Vaccine

PIKA recombinant COVID-19 vaccine is an innovative prophylactic and therapeutics vaccine candidate against multiple SARS-CoV-2 variants. PIKA recombinant COVID-19 vaccine is composed of YS Group’s proprietary PIKA adjuvant and recombinant trimeric SARS-CoV-2 spike (S) protein subunit antigen (CHO cells). Results from YS Biopharma’s preclinical studies have demonstrated that PIKA recombinant COVID-19 vaccine achieved rapid, long-lasting and broad immune response against SARS-CoV-2. YS Biopharma completed Phase I trial of PIKA recombinant COVID-19 vaccine in the UAE in the first half of 2022, and the preliminary results showed that as basic immunization and sequential booster immunization, PIKA recombinant COVID-19 vaccines can induce the production of high-level neutralizing antibodies, which are effective for a variety of mutant strains, including Delta, Omicron sublineages BA.1, BA.2, BA.3, BA.4/5 and BA 2.12.1.

PIKA Rabies Vaccine

PIKA rabies vaccine is a lyophilized human-use rabies vaccine composed of cell culture-derived rabies antigen mixed with PIKA adjuvant which acts as a TLR3 agonist. This vaccine candidate is based upon our deep foundation in YSJATM rabies vaccine, with enhancement from our proprietary PIKA adjuvant and advanced manufacturing techniques. PIKA rabies vaccine is designed to induce accelerated and strong cellular immunity and stimulate the body to rapidly produce higher humoral immune response.

The clinical studies to date have shown that PIKA rabies vaccine can achieve protective level of neutralizing antibodies as early as seven days post vaccination and elicit more robust immunogenic response compared to that of the control arm vaccine, which is a widely used commercially available vaccine. Its accelerated onset of immune response allows a three-visit one-week regimen superior to the currently available vaccine with a five-visit one-month or three-visit three-week regimen, which shortens the treatment period by two to three weeks.

PIKA rabies vaccine was designated by a WHO expert committee background paper publication as an innovative rabies vaccine in 2017. PIKA rabies vaccine has received the ODD from the U.S. FDA for the prevention of rabies infection.

YS-HBV-001

Preventive Hepatitis B Vaccine with a Short Duration Regimen

PIKA YS-HBV-001 is a hepatitis B vaccine composed of genetically engineered recombinant hepatitis B surface antigen protein (HBsAg) and PIKA adjuvant, with the potential to become a hepatitis B vaccine with accelerated regimen. We have completed the Phase I clinical trial of PIKA YS-HBV-001 in Singapore, which has demonstrated good reactogenicity and tolerability and immunogenicity under accelerated regimen.

YS-HBV-002

Biotherapeutic for Chronic Hepatitis B

PIKA YS-HBV-002 is being developed as an immuno-therapeutic vaccine to treat chronic HBV infection, a significant unmet medical need worldwide. PIKA YS-HBV-002 contains PIKA adjuvant and multiple HBV antigens, whose primary indication is the treatment of patients with chronic hepatitis B. Leveraging our proprietary PIKA immunomodulating technology in developing PIKA YS-HBV-001, PIKA YS-HBV-002 seeks to control and eliminate HBV from infected patients, which cannot be achieved through currently available anti-viral drugs.