YishengBio Announces PIKA recombinant COVID-19 vaccine received Phase I clinical trial IND clearance from New Zealand

YishengBio Co., Ltd announced that it received IND clearance for PIKA recombinant COVID-19 vaccine (CHO cell, S Protein) to conduct Phase I clinical trial from New Zealand Medicines and Medical Devices Safety Authority ("MEDSAFE"), which was following a similar IND approval by the United Arab Emirates Ministry of Health & Prevention. PIKA recombinant COVID-19 vaccine is a PIKA adjuvanted recombinant trimeric SARS-Cov-2 spike (S) protein subunit vaccine (CHO cells).  YishengBio is a biopharmaceutical company focusing on discovery, development, manufacturing and commercialization of new generations of vaccines and therapeutic biologics in the field of infectious diseases and cancer. Once completing necessary clinical studies, YishengBio is to seek emergency use authorization ("EUA") and approval to market PIKA recombinant COVID-19 vaccine in multiple countries.

PIKA recombinant COVID-19 vaccine represents a new generation of COVID-19 vaccine based on recombinant protein and novel adjuvant technologies. Preclinical studies have demonstrated that it has the potential to become a universal prophylactic and therapeutic vaccine against existing and emerging variants, including the alpha, beta, gamma and delta variants from the United Kingdom, South Africa, Brazil and India. It is capable of inducing rapid and efficient production of neutralizing antibody and cellular immunity and has achieved effective long-term protection broadly against those prevalent variants even at day 406 post vaccination based on animal serum studies. In addition, PIKA recombinant COVID-19 vaccine exhibits promising therapeutic benefit in non-human primates challenge study.

Dr Chris Wynne, Medical Director & Chief Operations Officer of New Zealand Clinical Research (NZCR), commented, "We are very delighted to lead the clinical study of PIKA recombinant COVID-19 vaccine in New Zealand.  PIKA recombinant COVID-19 vaccine has showed high and durable neutralization capability against multiple prevalent COVID-19 variants in preclinical studies. We are looking forward to the desired clinical benefits and advantages to be demonstrated in human subjects and supporting its global clinical development efforts." 

Mr. Yi Zhang, YishengBio's chairman and the project leader, expressed his enthusiasm saying "Today's approval by the MEDSAFE of New Zealand along with the recent approval from the United Arab Emirates Ministry of Health & Prevention to our PIKA recombinant COVID-19 vaccine echoed the global urgency and our joint commitment to rapidly developing a new generation of COVID-19 vaccines against the emerging and prevalent virus variants.  We appreciate the unified and swift steps taken by various healthcare authorities and collaborators in moving this program into clinical stage. As part of our commercialization strategy, we are about to finish the construction of a state-of-art manufacturing facility with annual production capacity of up to one billion doses to meet the future need of mass immunization."

Dr. Zhongkai Shi, chief medical officer of YishengBio shared his view saying "considering emergence of prevalent variants of concerns around the globe，we would like to accelerate the clinical development plan of PIKA recombinant COVID-19 vaccine by conducting a series of clinical trials in China, Southeast Asia, the Middle East, the United States and Europe. We look forward to the next clinical milestone of PIKA recombinant COVID-19 vaccine in the global fight against the COVID-19 pandemic."

About New Zealand Clinical Research (NZCR)

New Zealand Clinical Research (NZCR) was formed in 2020 by the amalgamation of Auckland Clinical Studies (ACS) and Christchurch Clinical Studies Trust (CCST). The merger of these highly respected, world-renowned early phase clinical research units will ensure New Zealand is a stronger player in the global clinical research industry. NZCR investigates potential new medicines for the global pharmaceutical and biotechnology industry and other research organizations. NZCR has a combined research experience of over 35 years with ACS and CCST having conducted over 500 research studies involving more than 15,000 New Zealanders.

About YishengBio

YishengBio is a fully integrated biopharmaceutical company with a global footprint that is discovering, developing and commercializing innovative biotherapeutics for infectious disease and cancer. The PIKA immunomodulating technology platform is developed in-house through which it empowered and nurtured a diverse pipeline of vaccines and therapeutic biologics with better efficacy and safety potential to address the unmet medical needs in infectious disease and cancer fields. In addition, YishengBio has a revenue generating marketed product, YSJA™ (依生君安™) rabies vaccine, which is the first aluminum-free lyophilized rabies vaccine launched in China. YishengBio's other product candidates also include PIKA rabies vaccine, PIKA recombinant COVID-19 vaccine, PIKA YS-ON-001, and PIKA YS-HBV-001, PIKA YS-HBV-002, PIKA YS-ON-002 and PIKA influenza vaccine. YishengBio is headquartered in Beijing with more than 600 employees in China, U.S., Singapore.

About PIKA recombinant COVID-19 vaccine

PIKA recombinant COVID-19 vaccine is an innovative prophylactic and therapeutic vaccine candidate against multiple SARS-COV-2 variants. It is a PIKA adjuvanted recombinant trimeric SARS-Cov-2 spike (S) protein subunit vaccine (CHO cells). Preclinical studies have demonstrated that PIKA recombinant COVID-19 vaccine is capable of inducing rapid and efficient production of neutralizing antibody and cellular immunity against the currently prevalent virus variants of SARS-CoV-2, including the alpha, beta, gamma and delta variants from the United Kingdom, South Africa, Brazil and India. The PIKA recombinant COVID-19 vaccine has achieved effective long-term protection broadly against those prevalent variants even at day 406 post vaccination based on animal serum studies, indicating good durability of the immune response. In addition, PIKA recombinant COVID-19 vaccine exhibits promising therapeutic benefit in non-human primates challenge study.