Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
CXSL1800084 | 重组抗PD-1全人源单克隆抗体注射液 | Recombinant anti-PD-1 humanized monoclonal antibody | Injection | Biological Products(1) | New Drug Application | 2018-08-01 | 杭州尚健生物技术有限公司 | Hangzhou Shangjian Biotechnology Co Ltd | Certificate Issued | 2018-10-15 | view |
CXSL2000213 | 重组抗CD38人源化单克隆抗体注射液 | Recombinant Anti-CD38 Humanized Monoclonal Antibody | Injection | Biological Products(1) | New Drug Application | 2020-07-24 | 杭州尚健生物技术有限公司 | Hangzhou Shangjian Biotechnology Co Ltd | In Review | 2020-07-23 | view |