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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 304 drug applications between 30 May 2023 and 5 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 59 drug names.

2023/05/30 – 2023/06/05

Period
2023/05/30 to 2023/06/05, 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
304
Drugs with new generic filings (by drug name, de-duplicated)
59
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

304filings, 93 of them generic

By application type

Application typeFilings
Supplement144
Generic93
New drug40
Import16
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug237
Therapeutic biologic35
TCM32

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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oxacillin Sodium for Injection7313
2Lactulose Oral Solution4434
3Glucosamine Sulfate Capsules3351
4Doxofylline Injection325
5Urapidil Hydrochloride Injection326
6Selexipag Tablets3124
7Desvenlafaxine Extended-release Tablets310
8阿普米司特片 · No verified English name313
9预充式甲氨蝶呤注射液 · No verified English name310
10Peramivir Injection227

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

180 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ping Guang Pharmaceutical Co., Ltd. romanized10100
2AbbVie Inc.940
3Changsha Ai Bei Gao Pharma Co., Ltd. romanized550
4Novo Nordisk A/S510
5Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized510
6Chongqing Sai Wei Pharma Co., Ltd. romanized510
7Yi Chang Ren Fu Pharma Co., Ltd. romanized423
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized420
9Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized410
10Xiu Zheng Pharma Group Tian Han Pharma 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

88 this week

AcceptedDrugApplicants
2023/06/05Generic · Class 3 Cimetidine InjectionCYHS2301528 Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/06/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2300045 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/06/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2300044 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/06/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2300043 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/06/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2300042 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/06/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2300041 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/06/03New drug · Class 1 HW060015胶囊 · No verified English nameCXHL2300604 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized
2023/06/03New drug · Class 1 HW060015胶囊 · No verified English nameCXHL2300603 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized
2023/06/03New drug · Class 1 HW060015胶囊 · No verified English nameCXHL2300602 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized
2023/06/03New drug · Class 1 TLL-018缓释片 · No verified English nameCXHL2300601 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2023/06/03New drug · Class 1 TLL-018缓释片 · No verified English nameCXHL2300600 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2023/06/03New drug · Class 1 TLL-018缓释片 · No verified English nameCXHL2300599 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2023/06/03New drug · Class 1 TLL-018缓释片 · No verified English nameCXHL2300598 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2023/06/03New drug · Class 1 TLL-018缓释片 · No verified English nameCXHL2300597 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2023/06/02Import · Class 2.4 BMS-986165片 · No verified English nameJXHL2300136 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/06/02Import · Class 2.4 BMS-986165片 · No verified English nameJXHL2300135 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/06/02Generic · Class 3 Potassium Citrate Extendedrelease TabletsCYHS2301506 Chengdu Shuo De Pharma Co., Ltd. romanized
2023/06/02Generic · Class 3 Potassium Citrate Extendedrelease TabletsCYHS2301505 Chengdu Shuo De Pharma Co., Ltd. romanized
2023/06/02Generic · Class 3 Peramivir InjectionCYHS2301504 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized
2023/06/02Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2301503 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized
2023/06/02Generic · Class 3 Cetirizine Hydrochloride InjectionCYHL2300074 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/06/02New drug · Class 1 伊努西单抗注射液 · No verified English nameCXSS2300043 Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized
2023/06/02New drug · Class 1 伊努西单抗注射液 · No verified English nameCXSS2300042 Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized
2023/06/02New drug · Class 1 伊努西单抗注射液 · No verified English nameCXSS2300041 Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized
2023/06/02New drug · Class 1 伊努西单抗注射液 · No verified English nameCXSS2300040 Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized
2023/06/02New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2300389 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/06/02New drug · Class 1 BGB-A445注射液 · No verified English nameCXSL2300388 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2023/06/02New drug · Class 1 HRS-6209片 · No verified English nameCXHL2300596 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/06/02New drug · Class 1 HRS-6209片 · No verified English nameCXHL2300595 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/06/02New drug · Class 1 BGB-15025片 · No verified English nameCXHL2300594 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized

58 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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