March 22, 2020 — A recombinant novel coronavirus vaccine candidate (Ad5-nCoV), developed by CanSino Biologics Inc. and China’s Academy of Military Medical Sciences, received Chinese regulatory approval to start human trials against COVID-19 on March 22, 2020.
Results from preclinical animal studies of Ad5-nCoV show that the vaccine candidate induces strong immune responses in animal models. Preclinical animal safety studies demonstrate a good safety profile supporting clinical development. Multiple vaccines for the novel coronavirus (COVID-19) are expected to complete preclinical research in April and enter clinical trials in China, NMPA officials declared at a press conference on March 17, 2020.
In response to the outbreak of coronavirus (COVID-19), JOINN assembled a team of internal experts to develop study designs tailored to evaluate different types of novel therapies against COVID-19. We have established clinical sample analysis centers in Wuhan to support clinical trials. JOINN participated in the safety assessment of most anti-SARS-CoV-2 drugs in China, including DNA vaccines, mRNA vaccines, recombinant protein-based vaccines, peptide vaccines, inactivated virus vaccines and other drugs such as antibodies, stem-cell therapy drugs, etc. Most drugs are still in the pre-clinical stage, some have already been submitted to the regulatory department of the NMPA (National Medical Products Administration) of China.
Founded in 1995, JOINN Laboratories (JOINN, SH603127) is China’s first private nonclinical CRO. JOINN subsidiaries are located in Beijing, Suzhou, Chongqing, and Wuzhou (GuangXi Province) in China, and Richmond (CA) and Worcester (MA) in the United States. JOINN is CNAS/ILAC-MRA accredited (China National Accreditation Service for Conformity Assessment/International Laboratory Accreditation Cooperation-Mutual Recognition Arrangement), AAALAC accredited (Association for Assessment & Accreditation of Lab Animal Care International) and OLAW accredited, and is NMPA (CFDA), US FDA, OECD and Ko-rean MFDS GLP certified/inspected/compliant. JOINN employs 1500+ pharmaceutical professionals and provides services from early-stage R&D to clinical trials and to post-approval pharmacovigilance, tailored to the sponsor’s needs.
JOINN has extensive experience on anti-virus drug safety assessment. We have participated in the drug R & D and safety assessment of SARS, H5N1, H1N1, H7N9 and Ebola virus. In response to the outbreak of coronavirus (COVID-19), JOINN developed a green channel for rapid response to antivirus non-clinical and clinical requests. We can help sponsors to communicate with local regulatory authorities, accelerating antivirus therapy development.
For the full report with language translation, see here.