China BiosimilarS Out of the Sea: Quto-Zhu single anti-biosimilar HLX02 received positive rating from CHMP
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Last Update: 2020-06-05
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Source: Internet
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Author: User
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Shanghai Fuhong Hanxuan and Accord Healthcare Co., Ltdjointly announced that the European Medicines Agency (EMA) Human Medicines Committee (CHMP) has a positive opinion on the quto-bead monobiosimilar HLX02HLX02 is used to treat HER2-positive early breast and stomach cancersAccording to THE EMA, the HLX02 is highly similar to the reference product Herceptin ®.SThe data show that the HLX02 has the same quality, safety and efficacy as Herceptin ®HLX02 is a biosimilar monoclonal antibody (mAb) developed and produced by Fuhong Hanjun in accordance with biosimilar guidelines and will be sold by Accord in EuropeCHMP's comments will be reviewed by the European Commission (EC) and regulatory decisions are expected within the next 2-3 months"We are pleased to receive chlacion's positive review of HLX02 from CHMP," said DrScott Liu, co-founder and CEO of Fuhong HanjunFuhong Hanxuan has been recognized by international drug regulatory bodies for the development and production of biological agentsWe look forward to the launch of HLX02 to provide high-quality and affordable treatment options for HER2-positive breast and stomach cancer patients, and we will continue to work with Accord to advance HLX02's accessibility in Europe and beyond and to the benefit of patients around the world."
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