Drug Registration and Acceptance

Drug Name

Exact

Active Ingredient

Acceptance No.

Manufacturers

Acceptance Date

Status Date

Classification

Review Status

Drug Type

Submission

Evaluation Conclusion

ATC Category

Special Approval Varieties

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Major Special Varieties

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Stock Code

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
CSL20020055	注射用重组人组织型纤溶酶原激活剂TNK突变体(rhTNK-tPA)	Recombinant Human TNK Tissue-type Plasminogen Activator	Lyophilized	Biological Products(2)	New Drug Application	2002-07-30	广州铭康生物工程有限公司	Guangzhou Recomgen Biotech Co Ltd	Certificate Issued	2003-03-25	view
CXSB1700010	注射用重组人TNK组织型纤溶酶原激活剂	Recombinant Human TNK Tissue-type Plasminogen Activator	Lyophilized	Biological Products	Supplementary Application	2017-12-08	广州铭康生物工程有限公司	Guangzhou Recomgen Biotech Co Ltd	Certificate Issued	2018-07-27	view
CXSB2101003	注射用重组人TNK组织型纤溶酶原激活剂	Recombinant Human TNK Tissue-type Plasminogen Activator	Lyophilized	Biological Products	Supplementary Application	2021-03-27		Guangzhou Recomgen Biotech Co Ltd			view
CXSL1700001	注射用重组人TNK组织型纤溶酶原激活剂	Recombinant Human TNK Tissue-type Plasminogen Activator	Lyophilized	Biological Products(7)	New Drug Application	2017-02-20	广州铭康生物工程有限公司	Guangzhou Recomgen Biotech Co Ltd	Certificate Issued	2017-05-26	view
CXSS0900027	注射用重组人组织型纤溶酶原激活剂TNK突变体(rhTNK-tPA)	Recombinant Human TNK Tissue-type Plasminogen Activator	Lyophilized	Biological Products(7)	New Drug Application	2009-09-09	广州铭康生物工程有限公司	Guangzhou Recomgen Biotech Co Ltd	Certificate Issued	2015-01-26	view
CXSS2200090	注射用重组人TNK组织型纤溶酶原激活剂	Recombinant Human TNK Tissue-type Plasminogen Activator	Lyophilized	Biological Products(2.2)	New Drug Application	2022-11-15		Guangzhou Recomgen Biotech Co Ltd			view
CYSB2000108	注射用重组人TNK组织型纤溶酶原激活剂	Recombinant Human TNK Tissue-type Plasminogen Activator	Lyophilized	Biological Products	Supplementary Application	2020-05-28	广州铭康生物工程有限公司	Guangzhou Recomgen Biotech Co Ltd	Certificate Issued	2021-01-15	view
CYSB2101302	注射用重组人TNK组织型纤溶酶原激活剂	Recombinant Human TNK Tissue-type Plasminogen Activator	Lyophilized	Biological Products	Supplementary Application	2021-12-28		Guangzhou Recomgen Biotech Co Ltd			view
CYSB2300158	注射用重组人TNK组织型纤溶酶原激活剂	Recombinant Human TNK Tissue-type Plasminogen Activator	Lyophilized	Biological Products(1)	Supplementary Application	2023-09-01		Guangzhou Recomgen Biotech Co Ltd			view