The NMPA is also sprinting as the year is coming to an end. In the past November, 4 Class 1 new drugs, 4 blockbuster first generics, 2 Class 3 generic drugs have been approved for marketing (or will soon be approved for marketing), and 2 Class 1 new drugs have been approved new indications.
The marketing application status of 4 Class 1 new drugs changed in November; wherein, Hansoh's flumatinib and Green Valle's GV-971 were approved for marketing, and BeiGene's anti-PD-1 monoclonal antibody tislelizumab and AstraZeneca's anti-PD-L1 monoclonal antibody durvalumab will be approved for marketing soon.
Acceptance No. | Drug name | Developed by | Target | Indication | Status | Status start date |
CXHS1800037, 38 | Sodium Oligomannurarate Capsules | Green Valley | APP | Alzheimer's disease | Approved | Nov. 2, 2019 |
CXHS1800016, 17 | Flumatinib Mesylate Tablets | Hansoh | Bcr-Abl | Chronic myelogenous leukemia | Approved | Nov. 26, 2019 |
JXSS1800040, JXSS1800041 | Durvalumab | AstraZeneca | PD-L1 | Stage III non-small cell lung cancer | Under approval | Nov. 22, 2019 |
CXSS1800019 | Tislelizumab Injection | BeiGene | PD-1 | Hodgkin lymphoma | Under approval | Nov. 29, 2019 |
(Source: CDE, official websites of the companies)
Shanghai Green Valley's Sodium Oligomannurarate Capsules (i.e., GV-971) was approved by the NMPA for marketing on Nov. 2, which is used to treat moderate to mild Alzheimer's disease (AD) and has become the world's first multi-targeting carbohydrate-based innovative drug against AD. Unlike traditional targeted antibody drugs, GV-971 is a marine oligosaccharide molecule extracted from algae and can capture beta amyloid (Aβ) in multiple points, segments and states, inhibit the formation of Aβ fibrils and depolymerize the formed fibrils into nontoxic monomers. See the article "Breaking News! Shanghai Green Valley's Class 1 New Drug for Alzheimer's Disease Conditionally Approved for Marketing and Already Having the Registration Approval!" for the details.
Flumatinib, a Class 1 new drug independently developed by and the 2nd Class 1 new drug approved for marketing of Hansoh, was approved for marketing on Nov. 26. As a second-generation Bcr-Abl tyrosine-kinase inhibitor (TKI), the drug is used to treat chronic myelogenous leukemia and can improve the clinical treatment effects of some imatinib-resistant patients, with good safety and tolerance. See the article "Breaking News! Hansoh's Class 1 New Drug Flumatinib to be Approved for Marketing Soon" for the details.
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