Japanese approval for Gilead’s remdesivir
Plus Plasma Alliance partners with NIAID; and three Chinese biotechs join to make antibody therapy
Less than a week after FDA granted Emergency Use Authorization to Gilead’s COVID-19 therapy remdesivir, Japan approved the antiviral as Veklury. Separately, a global plasma coalition sealed a deal with NIH, and three Chinese biotechs partnered to develop an antibody therapeutic.
The Japanese Ministry of Health, Labour and Welfare approved Veklury remdesivir to treat COVID-19 via an exceptional approval pathway due to the pandemic. The approval references the antiviral’s EUA, which FDA granted on May 1 in certain COVID-19 patients with severe disease.
Gilead Sciences Inc. (NASDAQ:GILD) is building consortium of chemical and pharmaceutical manufacturing companies to make remdesivir available in Europe, Asia and developing countries through at least 2022 (see “Gilead Building Coalition”).
Plasma Alliance expands
The CoVIg-19 Plasma Alliance, which is developing an unbranded hyperimmune globulin therapy to treat COVID-19, said it will work with NIH’s National Institute of Allergy and Infectious Diseases to test the treatment. A global study is slated to start this summer.
CSL Ltd. (ASX:CSL) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) are co-leading the alliance, which welcomed four new members Thursday: ADMA Biologics Inc. (NASDAQ:ADMA), BioPharma Plasma, GC Pharma and Sanquin. Existing members include Biotest AG (Xetra:BIO), Bio Products Laboratory Ltd., LFB S.A. and Octapharma AG (see “Alliance Advancing Unbranded Hyperimmune Globulin Product”).
Chinese trio join to develop antibody
Shanghai Henlius Biotech Inc. (HKEX:2696) partnered with Sanyou Biopharmaceuticals Co. Ltd. and Shanghai ZJ Bio-Tech Co. Ltd. to develop a COVID-19 antibody therapy.
Henlius, which will have an exclusive license to IP for the antibody program, will be responsible for the development of cell lines, preclinical testing and an IND application in China and potential other countries.
Sanyou is an antibody services CRO, and ZJ Bio-tech manufactures molecular diagnostic reagents.
The antibody therapy has completed a preliminary in vitro neutralization activity test.
Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.