NMPA accepts new drug listing application for rituximab
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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recently, Cinda Bio
Pharmaceutical(http://and Lilly Pharmaceuticals announced that the NationalDrug(http://Regulatory Authority (NMPA) has accepted a joint development of theDrug(http://rituxiximab, the product name: Mera/Rituxan injection biosimilar drugs (IBI301http://
)theis the fourth new drug to be approved by NMPA after the listing application and inclusion in the priority review following the submission and priority review of the Daboshu ® (Sindili mono-injection), Adamu mono-injection biosimilars (IBI303) and Bevala mono-injectable biosimilars (IBI305)about IBI301
IBI301 is a recombinant human-rat cherome anti-cell alto protein (CD20) monoclonal antibody injection developed by Sinda Biopharmaceuticals and Lilly Pharmaceuticals in accordance with the original research drug Rituximab (rituximab, meryl/Rituxan) for the treatment of non-Hodgkin's lymphoma (NHL) and other diseasesCinda Biopharmaceuticals and Lilly Pharmaceuticals conducted a clinical lylerating clinical study of IBI301 in patients with CD20-positive B-cell lymphoma treated with complete remission of CD20 positive B-cell lymphoma, pharmacokinetics (PK) comparison study and clinical effectiveness ratio in CD20-positive large B-cell lymphoma (DLBCL) patients clinical trial (http:// results show that both major pairs reached the main end of the study
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