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
JXSB2300033	达雷妥尤单抗注射液（皮下注射）	daratumumab	Injection	Biological Products(3.4)	Supplementary Application	2023-03-28		Cilag AG;Janssen Research & Development LLC			view
JXSL2200010	达雷妥尤单抗注射液（皮下注射）	daratumumab	Injection	Biological Products(3.4)	Import Drug Application	2022-01-19		Janssen Research & Development LLC;Johnson & Johnson (CHINA) Investment Ltd			view
JXSL2300040	达雷妥尤单抗注射液（皮下注射）	daratumumab	Injection	Biological Products(3.1)	Import Drug Application	2023-02-23		Janssen-Cilag International NV;Johnson & Johnson (CHINA) Investment Ltd			view
JXSS2000050	达雷妥尤单抗注射液（皮下注射）	daratumumab	Injection	Biological Products(2.2)	Import Drug Application	2020-11-06	西安杨森制药有限公司	Xian Janssen Pharmaceutical Ltd;Cilag AG;Janssen-Cilag International NV	Certificate Issued	2021-10-11	view
JXSS2200013	达雷妥尤单抗注射液（皮下注射）	daratumumab	Injection	Biological Products(3.1)	Import Drug Application	2022-04-15		Cilag AG;Xian Janssen Pharmaceutical Ltd;Janssen-Cilag International NV			view
JXSS2500061	达雷妥尤单抗注射液（皮下注射）	daratumumab	Injection	Biological Products(3.1)	Import Drug Application	2025-05-14		Johnson & Johnson;Cilag AG;Janssen-Cilag International NV			view
JYSB2200015	达雷妥尤单抗注射液（皮下注射）	daratumumab	Injection	Biological Products	Supplementary Application	2022-01-30		Cilag AG;Janssen-Cilag International NV			view
JYSB2200040	达雷妥尤单抗注射液（皮下注射）	daratumumab	Injection	Biological Products	Supplementary Application	2022-03-10		Cilag AG;Janssen-Cilag International NV			view
JYSB2300140	达雷妥尤单抗注射液（皮下注射）	daratumumab	Injection	Biological Products	Supplementary Application	2023-08-18		Cilag AG;Janssen-Cilag International NV			view
JYSB2300204	达雷妥尤单抗注射液（皮下注射）	daratumumab	Injection	Biological Products	Supplementary Application	2023-12-08		Cilag AG;Janssen-Cilag International NV			view
JYSB2500022	达雷妥尤单抗注射液（皮下注射）	daratumumab	Injection	Biological Products	Supplementary Application	2025-02-07		Cilag AG;Janssen-Cilag International NV			view
JYSB2500075	达雷妥尤单抗注射液（皮下注射）	daratumumab	Injection	Biological Products	Supplementary Application	2025-03-22		Cilag AG;Janssen-Cilag International NV			view