YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 261 drug applications between 26 May 2023 and 1 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 55 drug names.

2023/05/26 – 2023/06/01

Period
2023/05/26 to 2023/06/01, 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
261
Drugs with new generic filings (by drug name, de-duplicated)
55
Accepted this week, now under review
4

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

261filings, 80 of them generic

By application type

Application typeFilings
Supplement123
Generic80
New drug28
Import19
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug188
TCM45
Therapeutic biologic26
Prophylactic biologic2

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

55 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oxacillin Sodium for Injection7313
2Lactulose Oral Solution3334
3Urapidil Hydrochloride Injection326
4Selexipag Tablets3124
5Tranexamic Acid Injection3111
6Desvenlafaxine Extended-release Tablets310
7阿普米司特片 · No verified English name313
8Famotidine Injection228
9Dopamine Hydrochloride Injection223
10Doxofylline Injection215

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

176 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized660
2Eli Lilly and Company610
3Changsha Ai Bei Gao Pharma Co., Ltd. romanized550
4Chongqing Sai Wei Pharma Co., Ltd. romanized510
5Ping Guang Pharmaceutical Co., Ltd. romanized440
6AbbVie Inc.420
7Yi Chang Ren Fu Pharma Co., Ltd. romanized423
8Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized320
9HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.320
10Anhui Lei Yun Shang Pharma Co., Ltd. romanized320

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

83 this week

AcceptedDrugApplicants
2023/06/01Import · Class 2.2 格菲妥单抗注射液 · No verified English nameJXSL2300101 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/06/01Import · Class 1 Epcoritamab注射液 · No verified English nameJXSL2300100 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2023/06/01Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2300134 AbbVie Inc.
2023/06/01Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2301499 Jiangsu Zhong Bang Pharmaceutical Co., Ltd. romanized
2023/06/01Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2301498 Jiangsu Zhong Bang Pharmaceutical Co., Ltd. romanized
2023/06/01Generic · Class 3 Ebastine Oral SolutionCYHS2301495 Hunan Jin Pu Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/06/01Generic · Class 3 Milrinone InjectionCYHS2301494 Zhejiang Ya Se Pharmaceuticals Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized
2023/06/01Generic · Class 3 Milrinone InjectionCYHS2301493 Zhejiang Ya Se Pharmaceuticals Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized
2023/06/01Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301488 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2023/06/01Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301487 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2023/06/01Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301485 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2023/06/01Generic · Class 3 Brivaracetam Solution for InjectionCYHL2300072 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2023/06/01New drug · Class 1 注射用SG1827 · No verified English nameCXSL2300387 Hangzhou Shang Jian Bio Technology Co., Ltd. romanized
2023/06/01New drug · Class 1 盐酸希美替尼片 · No verified English nameCXHL2300588 Zhongguo Ke College Shanghai Drug Research Institute romanized; Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2023/06/01New drug · Class 1 HSK34890片 · No verified English nameCXHL2300587 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/06/01New drug · Class 1 HSK34890片 · No verified English nameCXHL2300586 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/06/01New drug · Class 1 TQ-B3234胶囊 · No verified English nameCXHL2300585 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Shou Yao Holding (Beijing) Co., Ltd. romanized
2023/06/01New drug · Class 1 TQ-B3234胶囊 · No verified English nameCXHL2300584 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Shou Yao Holding (Beijing) Co., Ltd. romanized
2023/06/01New drug · Class 1 TQ-B3234胶囊 · No verified English nameCXHL2300583 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Shou Yao Holding (Beijing) Co., Ltd. romanized
2023/05/31Import · Class 1 PF-06823859注射液 · No verified English nameJXSL2300099 Pfizer Inc.; Pfizer Investment Co. Ltd.
2023/05/31Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2301483 Nanjing Kang Chuan Ji Pharmaceuticals Technology Co., Ltd. romanized; Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized
2023/05/31Generic · Class 3 Diprophylline InjectionCYHS2301480 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2023/05/31Generic · Class 3 Desvenlafaxine Extended-release TabletsCYHS2301475 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/05/31Generic · Class 3 Desvenlafaxine Extended-release TabletsCYHS2301474 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/05/31Generic · Class 3 Desvenlafaxine Extended-release TabletsCYHS2301473 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/05/31Generic · Class 3 Peramivir InjectionCYHS2301470 Anhui Chang Jiang Pharma Co., Ltd. romanized
2023/05/31Generic · Class 3 Salbutamol Sulfate injectionCYHS2301469 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2023/05/31Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301467 Name not romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized
2023/05/31Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301466 Name not romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized
2023/05/31Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301465 Name not romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized

53 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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