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AffaMed Ok'd to Begin Phase III Trial of Samsung Bioepis Biosimilar in China

publication date: Dec 19, 2019

AffaMed Therapeutics, a Shanghai startup formed by C-Bridge Capital, received approval of its Clinical Trial Application in China to conduct a Phase III trial of a Samsung Bioepis biosimilar to trastuzumab. Trastuzumab is a Roche drug known as Herceptin that is indicated for HER2 positive breast cancer. The biosimilar, SB3, has already been approved in the US and EU, where it is marketed as Ontruzant. AffaMed was established in February of this year to bring three Samsung Bioepis biosimilars to China. The other two are biosimilars to Lucentis and Eylea. More details....

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