Drug Registration and Acceptance

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Status Date

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Evaluation Conclusion

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Special Approval Varieties

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Visualized Analysis Export Evaluation Conclusion Evaluation Progress

Acceptance No.	Drug Name	Active Ingredient	Dosage Form	Classification	Submission	Acceptance Date	Manufacturers	Manufacturers	Review Status	Status Date	View
CXSL1700077	重组全人源抗细胞毒T淋巴细胞相关抗原4（CTLA-4）单克隆抗体注射液		Injection	Biological Products(2)	New Drug Application	2017-08-16	苏州信达生物科技有限公司	Suzhou Xinda Biotechnology Co Ltd	Certificate Issued	2018-03-06	view
CXSL1700211	重组全人源抗RANKL单克隆抗体注射液	denosumab	Injection	Biological Products(2)	New Drug Application	2018-01-31	苏州信达生物科技有限公司	Suzhou Xinda Biotechnology Co Ltd	Certificate Issued	2018-07-06	view
JTS2000062	伊匹木单抗注射液	ipilimumab	Injection	Biological Products	Disposable Import Drug Application	2021-01-01	苏州信达生物科技有限公司	Suzhou Xinda Biotechnology Co Ltd	Pending Approval	2021-06-22	view