CDE drug review weekly report (April 4, 2016 to April 10, 2016)

Guide: this week, two imported drugs applied for clinical application in China for the first time Watson bio has another class 1 PD-1 monoclonal antibody in the review process The review of Kaine technology NS5A inhibitor kw-136 capsule and Shanghai Pharmaceutical sph3127 tablet has been completed This week: 1 Novartis applied for the clinical application of qaw039, an anti asthma drug, for the first time; 2 Ansteel applied for the clinical application of asp8273, a permanent EGFR inhibitor; 3 Jiahe biology, a subsidiary of Watson biology, entered the review process for the second class 1 therapeutic biological product, PD-1 monoclonal antibody and jienuobin injection this year; 4 99 drugs entered the review stage this week, without new class 1.1 chemicals; 5 Kaine technology class 1.1 NS5A inhibitor kw-136 capsule has been reviewed, and is in the approval stage; 6 Shanghai Pharmaceutical class 1.1 new drug sph3127 has been reviewed; 7 Boston biotechnology company cancer cell stem inhibitor bbi-608 has been reviewed; 8 Pembrolizumab, the first FDA approved PD-1 inhibitor, has been reviewed for clinical application in China Bbi-608, a key drug, is developed by Boston biomedical company It is a gene expression inhibitor of STAT3 related cancer stem cells It can work on very malignant cancer stem cells and other heterogeneous cancer cells At present, three phases of clinical treatment in the United States are mainly for gastric cancer, gastric junction cancer and colorectal cancer, and other cancer trials are still in the early stage, hoping that this cancer liver cell therapy can bring new treatment methods This week, the clinical application of this product in China is in the review stage Qaw039: developed by Novartis, this product is a prostaglandin D2 receptor (DP2 / CRTH2) inhibitor, which can promote the integrity of airway epithelium, and may reduce airway remodeling in asthmatic patients, mainly for the treatment of asthma At present, it is the first time to apply for clinical application in China when it is in phase 3 clinical stage in the United States It should be to carry out international multicenter trials in China Asp8273 capsule: This product is developed by Astaire It is the third generation of EGFR tyrosine kinase inhibitor, designed to permanently prevent mutation of EGFR Laboratory studies have shown that asp8273 can prevent the growth of EGFR mutant tumor cells and is effective after treatment with erlotinib or afatinib This week, the clinical application of this product in China is in the review stage If this permanent inhibitor is really on the market, it is still worth looking forward to Jienumab injection: This product is the second class 1 new drug of biological products for treatment (the first is jieruimab injection declared at the beginning of the year) applied by Jiahe biology, a subsidiary of Watson biology, for clinical research in China Genomab is an innovative anti-PD-1 monoclonal antibody with a new sequence Jiahe biology owns the core independent intellectual property rights PD-1 / PD-L1 is the hottest target of monoclonal antibody At present, the main indications of PD-1 / PD-L1 monoclonal antibody include melanoma, non-small cell lung cancer, renal cancer and other solid tumors and blood cancer This week, jienuumab injection has entered the review stage and is expected to be approved Kw-136 capsule: This product is declared by Kaine technology as an NS5A inhibitor for the treatment of hepatitis C Kaine technology has developed three drugs for the treatment of hepatitis C In addition to kw-136, there are also NS5B inhibitor kw-014 and NS3 / 4A inhibitor kw-016 It seems that efforts have been made to lay out anti hepatitis C drugs This week, the review of kw-136 was completed and it is in the approval stage Sph3127 tablets: This product is the first class 1.1 new drug that can be found in SHP at present, and belongs to major special varieties and special evaluation varieties The target and indications of this product can not be found at present Some known partners told me to edit it Pembrolizumab injection: developed by methadone, this product is the first anti-PD-1 monoclonal antibody approved by FDA At present, five imported clinical applications have been submitted in China, one of which has been reviewed this week.