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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 280 drug applications between 1 March 2023 and 7 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 48 drug names.

2023/03/01 – 2023/03/07

Period
2023/03/01 to 2023/03/07, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
280
Drugs with new generic filings (by drug name, de-duplicated)
48
Accepted this week, now under review
0

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

280filings, 70 of them generic

By application type

Application typeFilings
Supplement139
Generic70
New drug37
Unspecified15
Import10
Import re-registration9

By drug type

Drug typeFilings
Chemical drug196
TCM51
Therapeutic biologic25
Prophylactic biologic5
Biologic3

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

48 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution4234
2Minoxidil Topical Solution420
3Dapagliflozin Tablets4284
4Phenylephrine Hydrochloride Injection325
5Palbociclib Capsules310
6Lidocaine and Prilocaine Cream2224
7Carbazochrome Sodium Sulfonate Injection211
8Torsemide Injection211
9Aminophylline Injection213
10Dexrazoxane for Injection211

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

188 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1NAPP PHARMACEUTICALS LIMITED910
2Eurofins Analytical Science Laboratories Inc.550
3Guangdong Dong Yang Guang Pharma Co., Ltd. romanized520
4Shi Qi Pharmaceutical (Guangdong) Co., Ltd. romanized440
5Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized440
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.431
7N.V. Organon420
8Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized420
9Suzhou Erye Pharmaceutical Co., Ltd420
10Nei Menggu Yi Li Pharmaceutical Co., Ltd. romanized330

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

80 this week

AcceptedDrugApplicants
2023/03/07Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2300021 Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2023/03/07Generic · Class 3 Cetirizine Hydrochloride InjectionCYHS2300724 Shandong Ke Xin Hui Yi Pharma Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/03/07Generic · Class 3 Sodium Bicarbonate InjectionCYHS2300723 Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Kang Yuan Pharmaceutical Co., Ltd. romanized
2023/03/07Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂(II) · No verified English nameCYHS2300722 Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized
2023/03/07Generic · Class 3 Lidocaine CataplasmsCYHS2300719 Hunan Jiudian Pharmaceutical Co., Ltd
2023/03/07Generic · Class 3 Famotidine InjectionCYHS2300718 Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
2023/03/07Generic · Class 3 Minoxidil Topical SolutionCYHS2300716 Hubei Shu Bang Pharma Co., Ltd. romanized
2023/03/07Generic · Class 3 Minoxidil Topical SolutionCYHS2300715 Hubei Shu Bang Pharma Co., Ltd. romanized
2023/03/07Generic · Class 3 Peramivir InjectionCYHS2300714 Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized
2023/03/07Generic · Class 3 Dexrazoxane for InjectionCYHS2300709 CSPC OUYI PHARMACEUTICAL CO., LTD.
2023/03/07Generic · Class 3 Dexrazoxane for InjectionCYHS2300708 CSPC OUYI PHARMACEUTICAL CO., LTD.
2023/03/07Generic · Class 3 Aceclofenac TabletsCYHS2300707 Jiangsu Ji Bei Er Pharma Co., Ltd. romanized
2023/03/07Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2300705 Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/03/07Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2300704 Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/03/07New drug · Class 1 CBG002 CAR-T细胞注射液 · No verified English nameCXSL2300174 Zhejiang Kang Bai Yu Bio Technology Co., Ltd. romanized
2023/03/07New drug · Class 1 B901注射液 · No verified English nameCXSL2300173 Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized
2023/03/07New drug · Class 1 重组人 PD-L1/CD3 双抗 II 型单纯疱疹病毒注射液(Vero 细胞) · No verified English nameCXSL2300172 Wuhan Bin Hui Bio Technology Co., Ltd. romanized
2023/03/07New drug · Class 1 注射用BL0006 · No verified English nameCXHL2300280 Shanghai Bi Ling Bio Technology Co., Ltd. romanized
2023/03/07New drug · Class 1 TY-2699a胶囊 · No verified English nameCXHL2300279 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2023/03/07New drug · Class 1 TY-2699a胶囊 · No verified English nameCXHL2300278 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2023/03/07New drug · Class 1 HDM1002片 · No verified English nameCXHL2300277 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2023/03/07New drug · Class 1 HDM1002片 · No verified English nameCXHL2300276 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2023/03/07New drug · Class 1 HDM1002片 · No verified English nameCXHL2300275 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2023/03/07New drug · Class 1 HY-078020片 · No verified English nameCXHL2300274 Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized; Hefei En Rui Te Pharma Co., Ltd. romanized
2023/03/07New drug · Class 1 HY-078020片 · No verified English nameCXHL2300273 Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized; Hefei En Rui Te Pharma Co., Ltd. romanized
2023/03/07New drug · Class 1 APG-2575片 · No verified English nameCXHL2300272 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2023/03/07New drug · Class 1 APG-2575片 · No verified English nameCXHL2300271 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2023/03/07New drug · Class 2.4 林普利塞片 · No verified English nameCXHL2300270 Shanghai Ying Li Pharma Co., Ltd. romanized
2023/03/06New drug · Class 2.2; 2.4 注射用辅酶I · No verified English nameCXHL2300269 Hefei Kang Nuo Biopharmaceutical Co., Ltd. romanized
2023/03/04Import · Class 2.2 Upadacitinib口服溶液 · No verified English nameJXHL2300042 AbbVie Inc.

50 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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