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

Task Type

Major Special Varieties

Sequence No.

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
CXHL2100071	IBI362注射液	mazdutide	Injection	Chemical Drugs(1)	New Drug Application	2021-01-29	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	In Review	2021-01-28	view
CXHL2100072	IBI362注射液	mazdutide	Injection	Chemical Drugs(1)	New Drug Application	2021-01-29	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	In Review	2021-01-28	view
CXHL2100073	IBI362注射液	mazdutide	Injection	Chemical Drugs(1)	New Drug Application	2021-01-29	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	In Review	2021-01-28	view
CXSB1700005	重组人抗肿瘤坏死因子-α单克隆抗体注射液	adalimumab	Injection	Biological Products	Supplementary Application	2017-08-18	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2018-01-17	view
CXSB1900010	信迪利单抗注射液	sintilimab	Injection	Biological Products	Supplementary Application	2019-05-16	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2019-06-05	view
CXSB2000004	信迪利单抗注射液	sintilimab	Injection	Biological Products	Supplementary Application	2020-02-14	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2020-09-29	view
CXSB2100002	信迪利单抗注射液	sintilimab	Injection	Biological Products(原1)	Supplementary Application	2021-01-06	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2021-09-02	view
CXSL1200088	重组人-鼠嵌合抗CD20单克隆抗体注射液		Injection	Biological Products(2)	New Drug Application	2013-02-04	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2014-09-24	view
CXSL1400002	重组人抗肿瘤坏死因子-α单克隆抗体注射液	adalimumab	Injection	Biological Products(2)	New Drug Application	2014-02-17	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2016-01-13	view
CXSL1400005	重组人抗肿瘤坏死因子-α单克隆抗体注射液	adalimumab	Injection	Biological Products(2)	New Drug Application	2014-02-19	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2016-01-13	view
CXSL1500008	重组人血管内皮生长因子受体-抗体-人补体受体1融合蛋白注射液		Injection	Biological Products(1)	New Drug Application	2015-04-21	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2016-12-22	view
CXSL1500009	重组人血管内皮生长因子受体-抗体-人补体受体1融合蛋白注射液		Injection	Biological Products(1)	New Drug Application	2015-04-21	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2016-12-22	view
CXSL1500010	重组抗VEGF人源化单克隆抗体注射液		Injection	Biological Products(2)	New Drug Application	2015-04-21	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2016-05-19	view
CXSL1500044	重组抗VEGF人源化单克隆抗体注射液		Injection	Biological Products(2)	New Drug Application	2015-05-25	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2016-05-19	view
CXSL1500136	IBI308	sintilimab	Injection	Biological Products(1)	New Drug Application	2016-01-25	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2016-09-04	view
CXSL1600128	重组全人源抗前蛋白转化酶枯草溶菌素9（PCSK-9）单克隆抗体注射液		Injection	Biological Products(1)	New Drug Application	2017-02-13	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2017-09-27	view
CXSL1800012	注射用重组全人源抗肿瘤坏死因子受体超家族成员4（OX40）单克隆抗体		Lyophilized	Biological Products(1)	New Drug Application	2018-02-09	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2018-07-06	view
CXSL1800074	IBI188	letaplimab	Injection	Biological Products(1)	New Drug Application	2018-07-04	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2018-09-03	view
CXSL1800081	重组抗VEGF人源化单克隆抗体注射液		Injection	Biological Products(2)	New Drug Application	2018-07-30	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2018-10-08	view
CXSL1800082	信迪利单抗注射液	sintilimab	Injection	Biological Products(1)	New Drug Application	2018-07-30	信达生物制药（苏州）有限公司	Innovent Biologics (Suzhou) Co Ltd	Certificate Issued	2018-10-08	view