Multinational biotherapeutics major, HiFiBiO Therapeutics, has reportedly entered into a collaborative agreement with Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry RAS and Pharmsynthez PJSC, a Russian pharmaceutical company. The agreement will further the clinical development of a COVID-19 neutralizing antibody, called HFB30132A, followed by its commercial sale in Russia.

As per sources, the candidate awaits the approval of the Ministry of Health, Russia, an IND regarding which has already been submitted to the Ministry. The terms of the transaction state that Pharmsynthez will buy HFB30132A for clinical trials in Russia, continuing with its commercialization after obtaining regulatory approval.

With regards to the agreement, Kirill Mayorov, the President of Pharmsynthez, has expressed that the company believes that HFB30132A will be capable of furnishing a reliable level of protection for people infected with coronavirus. Mayorov has also stated that this antibody possesses the capacity of helping the prevention of a cascade of serious global complications by combating active infections. Pharmsynthez will do its best for the integration of HFB30132A into the array of Russian medicine once the company secures regulatory approval, added Mayorov.

Over a period of less than six months, HiFiBiO has edged its expertise in the areas of single cell science and immune modulation for the rapid discovery, engineering, and development of HFB30132A. The company is presently dosing the second unit of healthy volunteers in a Phase I mounting dose study that is being conducted for assessing the pharmacokinetics, safety, and tolerability of HFB30132A. Following the completion of this study, HiFiBiO will commence the global phase II/III clinical trials in high-risk adults having mild or asymptomatic to moderate COVID-19.

For the uninitiated, Pharmsynthez is Russia’s first publicly listed biopharmaceutical major specialized in the manufacturing, development, and distribution of vaccines and biologicals. The company is known for providing numerous proprietary prescription medicines, comprising Fenazid, Neovir, and Segidrin, for deployment in gynecology, oncology, and infection diseases.

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https://www.businesswire.com/news/home/20201123005643/en/HiFiBiO-Therapeutics-Inks-Partnership-with-Pharmsynthez-and-IBCh-for-the-Clinical-Development-and-Commercialization-of-its-SARS-CoV-2-Neutralizing-Antibody-in-Russia