YishengBio announces that PIKA’s recombinant COVID-19 vaccine has received IND clearance from New Zealand’s Phase I clinical trial
BEIJING, August 9, 2021 / PRNewswire / – YishengBio Co., Ltd (“YishengBio”) announced today that it has IND-approved PIKA (CHO cell, S protein) recombinant COVID-19 vaccine for Phase I clinical trials – Study received from New Zealand Medicines and Medical Devices Safety Authority (“MEDSAFE”), which followed a similar IND approval by the United Arab Emirates’ Department of Health and Prevention. PIKA’s 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 focused on the discovery, development, manufacture and commercialization of new generations of vaccines and therapeutic biologics in the infectious diseases and cancer fields. Upon completion of the necessary clinical studies, YishengBio will apply for Emergency Authorization (“EUA”) and marketing authorization for the recombinant COVID-19 vaccine PIKA in multiple countries.
PIKA’s recombinant COVID-19 vaccine represents a new generation of COVID-19 vaccines based on recombinant protein and novel adjuvant technologies. Preclinical studies have shown 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 of the United Kingdom, South Africa, Brazil and India. It is able to induce rapid and efficient production of neutralizing antibodies and cellular immunity, and based on animal serum studies, has achieved effective long-term protection against these predominant variants even on day 406 after vaccination. In addition, PIKA’s recombinant COVID-19 vaccine shows promising therapeutic benefit in a challenge study with non-human primates.
DR Chris Wynne, Medical Director & Chief Operations Officer of New Zealand Clinical Research (NZCR), commented, “We are delighted to lead the clinical trial of PIKA’s recombinant COVID-19 vaccine in New Zealand. The COVID-19 recombinant vaccine from PIKA has proven to be high and durable. ” Ability to neutralize several widespread COVID-19 variants in preclinical studies. We look forward to the desired clinical benefits and benefits demonstrated in humans to support global clinical development efforts. ”
Gentleman. Yi Zhang, Chairman and Project Leader of YishengBio, expressed his enthusiasm and said, “Today’s approval from MEDSAFE by New Zealand along with the recent approval of our recombinant COVID-19 vaccine PIKA by the United Arab Emirates’ Department of Health and Prevention, the global urgency and shared commitment quickly reflected a new generation of COVID-19 vaccines against the emerging and widely common virus variants to develop. We appreciate the consistent and rapid steps that various health authorities and employees have taken to bring this program to the clinical stage. As part of our commercialization strategy, we are nearing completion of the construction of a state-of-the-art manufacturing facility with an annual production capacity of up to one billion cans to meet future mass immunization needs. “
DR. Zhongkai Shi, YishengBio’s Chief Medical Officer, shared his view, “Given the emergence of widespread varieties of concerns around the world, we would like to accelerate the clinical development plan of the PIKA-COVID-19 recombinant vaccine by conducting a number of clinical trials in China, South East Asia, the middle East, The United States and Europe. We look forward to the next clinical milestone of PIKA’s 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 founded in 2020 through the merger of Auckland Clinical Studies (ACS) and Christchurch Clinical Studies Trust (CCST). The amalgamation of these highly regarded, world-renowned clinical research units in the early stages will ensure that New Zealand is a stronger player in the global clinical research industry. NZCR is investigating potential new drugs for the global pharmaceutical and biotechnology industries and other research organizations. NZCR has over 35 years of combined research experience, with ACS and CCST having conducted over 500 research studies with more than 15,000 New Zealanders.
YishengBio is a fully integrated biopharmaceutical company with a global presence that discovers, develops, and commercializes innovative biotherapeutics for infectious diseases and cancer. PIKA’s immunomodulatory technology platform is being developed in-house, promoting and promoting a diverse pipeline of vaccines and therapeutic biologics with better efficacy and safety potential to meet unmet medical needs in the infectious disease and cancer areas. In addition, YishengBio has a marketed revenue generating product, YSJA ™ (依 生 君安 ™) Rabies Vaccine, the first aluminum-free lyophilized rabies vaccine available in. was put on the market China. YishengBio’s other product candidates also include the PIKA rabies vaccine, the recombinant PIKA 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, US, Singapore.
About the recombinant COVID-19 vaccine PIKA
The recombinant COVID-19 vaccine PIKA is an innovative prophylactic and therapeutic vaccine candidate against several SARS-COV-2 variants. It is a PIKA-adjuvanted recombinant trimeric SARS-Cov-2-Spike (S) protein subunit vaccine (CHO cells). Preclinical studies have shown that the recombinant COVID-19 vaccine PIKA is able to induce rapid and efficient production of neutralizing antibodies and cellular immunity against the currently predominant virus variants of SARS-CoV-2, including the alpha, beta , Gamma and delta variants of the United Kingdom, South Africa, Brazil and India. Based on animal serum studies, the recombinant COVID-19 vaccine from PIKA achieved effective long-term protection against these widespread variants on day 406 after vaccination, which indicates a good resistance of the immune response. In addition, PIKA’s recombinant COVID-19 vaccine shows promising therapeutic benefit in a challenge study with non-human primates.
SOURCE YishengBio Co., Ltd