New Zealand approved YishengBio COVID-19 vaccine trials

10 August 2021 | Tuesday | News

YishengBio Co., Ltd ("YishengBio") today 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).
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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 KingdomSouth AfricaBrazil 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 ChinaSoutheast Asia, the Middle Eastthe 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."

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