(Yicai Global) Dec. 7 -- Walvax Biotechnology Co. [SHE:300142], which is based in southwestern China’s Yunnan province, is about to conclude its clinical research into self-developed 13-valent pneumococcal conjugate vaccine, in the hope that it can grasp a share of the market mostly dominated by US-based Pfizer, Inc. [NYSE:PFE].
The firm has completed the initial data analysis in Phase III clinical trial in its reserach, and is engaging in the analysis of clinical trial data and the summary of clinical research, said the company in a statement issued yesterday.
After acquiring the summary report of the clinical research into vaccine, Walvax can file an application to China food and drug administration (CFDA) for drug production approval letter. Such a letter and GMP certification will allow the firm to start manufacturing and sell the product on the market with a batch release certificate, said the statement. The listed company is well-prepared for the preliminary work required for obtaining the production approval letter for the vaccine, it added.
The 13-valent pneumococcal conjugate vaccine, designed for preventing the invasive diseases caused by the infection of 13 kinds of serotype pneumococcus in vaccines, enjoys a better sales performance than any other variety of vaccines worldwide. At present, only Pfizer produces and sells 13-valent pneumococcal conjugate vaccine worldwide, whose global sales exceeded USD5.7 billion in 2016.Keywords: R&D, CFDA, Clinical Trial, Vaccine, Walvax Biotechnology