Drug Registration and Acceptance

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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
CYSB2000181	聚乙二醇化重组人粒细胞刺激因子注射液	PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor	Injection	Biological Products	Supplementary Application	2020-07-04	石药集团百克（山东）生物制药股份有限公司	CSPC Baike(shandong)Bio-Pharmaceutical Co Ltd	Certificate Issued	2020-08-12	view
CYSB2000119	聚乙二醇化重组人粒细胞刺激因子注射液	PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor	Injection	Biological Products	Supplementary Application	2020-05-28	石药集团百克（山东）生物制药股份有限公司	CSPC Baike(shandong)Bio-Pharmaceutical Co Ltd	In Review	2020-05-27	view
CXSL2000091	注射用重组抗IgE单克隆抗体	omalizumab	Lyophilized	Biological Products(2)	New Drug Application	2020-05-06	石药集团百克（山东）生物制药股份有限公司	CSPC Baike(shandong)Bio-Pharmaceutical Co Ltd	In Review	2020-05-01	view
CXSL2000271	注射用重组抗IgE单克隆抗体	omalizumab	Lyophilized	Biological Products(3.3)	New Drug Application	2020-09-22	石药集团百克（山东）生物制药股份有限公司	CSPC Baike(shandong)Bio-Pharmaceutical Co Ltd	In Review	2020-09-21	view