Yisheng re­ceives ap­proval for ra­bies vac­cine clin­i­cal study

BioSpectrum (Asia) - - REGULATORY NEWS -

Yisheng Bio­pharma Co., Ltd., a bio­phar­ma­ceu­ti­cal com­pany fo­cus­ing on re­search, de­vel­op­ment, man­u­fac­tur­ing, sales and mar­ket­ing of im­mune mod­u­la­tor bio­ther­a­peu­tics and vac­cines, has an­nounced that the China Food and Drug Ad­min­is­tra­tion (CFDA) has pro­vided clear­ance to pro­ceed with a clin­i­cal trial of its PIKA ra­bies vac­cine. The PIKA ra­bies vac­cine has the po­ten­tial to be­come a “best-in-class” ra­bies vac­cine and was in­de­pen­dently de­vel­oped by Yisheng Bio­pharma using pro­pri­etary toll-like re­cep­tor-3 (TLR-3) im­munomod­u­lat­ing tech­nol­ogy. This prod­uct can­di­date was granted or­phan drug des­ig­na­tion by the U.S. FDA in 2016 and has been funded as a “Na­tional Key Medicine In­no­va­tion” by the gov­ern­ment of China. This pro­gramme was also cited by the Strate­gic Ad­vi­sory Group of Ex­perts (SAGE) Work­ing Group on ra­bies vac­cines and im­munoglob­u­lins, af­fil­i­ated with the World Health Or­ga­ni­za­tion (WHO), in 2017. The PIKA ra­bies vac­cine has com­pleted Phase I and Phase II clin­i­cal stud­ies in Sin­ga­pore and the Com­pany is pre­par­ing for a Phase III piv­otal trial at sites in South­east Asia coun­tries.

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