LAVAL, QC and BEIJING, China, March 30, 2021 /PRNewswire/ - Nexelis and JOINN Laboratories announced today that the two companies have signed a Letter of Intent ("LOI") to partner on supporting sponsors conducting bioanalytical studies in China.
Nexelis, a portfolio company of Ampersand Capital Partners, is a leading provider of advanced assay development and laboratory testing services in the infectious diseases, metabolic diseases and oncology fields working with leading pharmaceutical companies, innovative biotechnology companies, and prestigious governmental and non-governmental institutions who seek to include China in their international clinical programs.
JOINN Laboratories, publicly dual listed on the Shanghai (603127.SH) and Hong Kong (06127.HK) stock exchange markets, is one of the most experienced integrated CROs (non-clinical, clinical and testing lab services) and the largest non-clinical CRO in China with professional teams of more than 1,500 employees. JOINN Laboratories established high standard quality system and has been qualified by US FDA and other major regulatory agencies worldwide. The data and study reports generated by JOINN Laboratories have been supporting global filing of new drugs for the clients.
Nexelis conducted an exhaustive study of the bioanalytical market in China during the last year and concluded that JOINN Laboratories is the best qualified company in terms of capacity and quality of services to support international clinical trials led by Nexelis.
Both companies agreed upon the terms of a partnership ensuring international sponsors that their timelines and quality expectations will be met or exceeded in China. Due diligence, QA work, and training have been initiated with the aim to have several clinical grade fully validated assays by September 1st, 2021 followed by commencement of bioanalytical clinical testing.
Activities initially targeted include ELISA, neutralization, and qPCR testing on vaccine programs pre-ordered to Nexelis after a technology transfer from Nexelis sites, led on fully bridged platforms by dedicated Chinese scientists and analysts following the same training and SOPs as their North American and European colleagues.
Benoit Bouche, CEO of Nexelis, commented on the news: "We are currently receiving requests to support international programs in China almost every week and we are extremely happy to have reached this milestone in the development of a strategic relationship with a company having such an outstanding reputation for scientific expertise and quality work in numerous areas that will enable us to further develop our global footprint".
Conglin Zuo, Vice-Chairman of JOINN Laboratories Board added: "Nexelis' global leadership and expertise in the vaccine clinical field is impressive and we are proud to soon be in a situation to serve the clinical stage needs of international clients working on life-threatening illnesses including COVID-19. This partnership will also contribute to the ongoing transformation of our company from a leading nonclinical CRO into one with comprehensive capabilities from discovery through late clinical stages and post marketing service activities".
With unrivaled expertise in immunology, 5 operating sites in North America and Europe, and a translational offer of services covering the needs of the pharmaceutical industry from the lead selection to the late clinical stage, Nexelis is a leading provider of assay development and advanced laboratory testing services in the infectious, metabolic and oncologic fields. Our versatile team of scientists, working with state of the art technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines and biologics, anti-viral drugs, immunotherapy, gene and cell therapy products. Additional information about Nexelis is available at www.nexelis.com
JOINN was established in 1995 as the first privately owned Chinese nonclinical CRO. Headquartered in Beijing BDA with a "Heptagon" facility in Suzhou Taicang Biomedical Industrial Park. JOINN went public on August 25, 2017 on the Shanghai Stock Exchange (603127) and became dual listed on the Hong Kong Stock Exchange (6127) on February 26, 2021. Both facilities have been honored with numerous qualifications and certificates for their core businesses under GLP by CFDA and many major international regulatory bodies including USFDA, OECD and AAALAC. JOINN's clinical teams focus on early stage clinical research (generic BE, phase I, and PK research), with quality management system in line with international standards, and provides one-stop service to encompass clinical CRO / Phase I center management and clinical sample analysis. JOINN has completed the seamless connection between GLP and GCP and provides its international clients timely and quality products aimed at becoming the standard in the industry. Additional information about JOINN is available at www.joinnlabs.com