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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 247 drug applications between 2 December 2021 and 8 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 47 drug names.

2021/12/02 – 2021/12/08

Period
2021/12/02 to 2021/12/08, 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
247
Drugs with new generic filings (by drug name, de-duplicated)
47
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

247filings, 58 of them generic

By application type

Application typeFilings
Supplement114
Generic58
New drug42
Unspecified12
Import re-registration11
Import10

By drug type

Drug typeFilings
Chemical drug171
TCM42
Therapeutic biologic31
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

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Rabeprazole Sodium Enteric-coated Tablets320
2Lactulose Oral Solution3134
3Candesartan Cilexetil and Hydrochlorothiazide Tablets210
4Rifampin For Injection212
5Cefminox Sodium for Injection210
6Palonosetron Hydrochloride Injection211
7Guanfacine Hydrochloride Extended Release Tablets214
8Sitagliptin Phosphate Tablets212
9Valsartan Film-Coated Tablets210
10Acetylcysteine Effervescent Tablets113

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

154 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Run Shuang He Pharma Co., Ltd. romanized1070
2Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized990
3Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized990
4Shenzhen Xin Li Tai Pharma Co., Ltd. romanized610
5Shaanxi Chang Ming Pharmaceutical Co., Ltd. romanized550
6Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized530
7Wuhan Ai Min Pharmaceutical Co., Ltd. romanized440
8Qi Yuan Bio (Hangzhou) Co., Ltd. romanized410
9Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized330
10Shandong Xin Shi Dai Pharma Co., Ltd. romanized332

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

66 this week

AcceptedDrugApplicants
2021/12/08Generic · Class 3 Pregabalin Oral SolutionCYHS2102160 Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized; Bao Ding Ai Hui Pharma Co., Ltd. romanized
2021/12/08Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2102158 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2021/12/08Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2102157 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2021/12/08Generic · Class 3 Nicorandil for InjectionCYHS2102156 Chengdu Easton Biopharmaceuticals Co.,Ltd.; Shanxi Pu De Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 HB0028注射液 · No verified English nameCXSL2101471 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 KN060注射液 · No verified English nameCXSL2101468 Suzhou Kang Ning Jie Rui Bio Technology Co., Ltd. romanized
2021/12/08New drug · Class 1 LNF1904 · No verified English nameCXSL2101466 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 QY201片 · No verified English nameCXHL2101729 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2021/12/08New drug · Class 1 QY201片 · No verified English nameCXHL2101728 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2021/12/08New drug · Class 1 盐酸BGB-23339薄膜包衣片 · No verified English nameCXHL2101727 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/12/08New drug · Class 1 盐酸BGB-23339薄膜包衣片 · No verified English nameCXHL2101726 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/12/08New drug · Class 1 PRJ1-3024胶囊 · No verified English nameCXHL2101725 Zhuhai Yu Fan Bio Technology Co., Ltd. romanized
2021/12/08New drug · Class 1 SAL0114片 · No verified English nameCXHL2101724 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 SAL0114片 · No verified English nameCXHL2101723 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 SAL0114片 · No verified English nameCXHL2101722 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 SAL0114片 · No verified English nameCXHL2101721 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 SAL0114片 · No verified English nameCXHL2101720 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 SAL0114片 · No verified English nameCXHL2101719 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 QY201片 · No verified English nameCXHL2101718 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2021/12/08New drug · Class 1 QY201片 · No verified English nameCXHL2101717 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2021/12/08New drug · Class 2.2 氨酚羟考酮缓释片 · No verified English nameCXHL2101702 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/12/08New drug · Class 2.2 氨酚羟考酮缓释片 · No verified English nameCXHL2101701 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/12/07Generic · Class 3 Amisulpride Oral SolutionCYHS2102152 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2021/12/07New drug · Class 1 SK10散 · No verified English nameCXSL2101470 Guangzhou Zhi Yi Bio Technology Co., Ltd. romanized
2021/12/07New drug · Class 1 LBL-007注射液 · No verified English nameCXSL2101469 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2021/12/07New drug · Class 1 注射用QLS31906 · No verified English nameCXSL2101467 Qilu Pharmaceutical Co., Ltd.
2021/12/07New drug · Class 1 YH002注射液 · No verified English nameCXSL2101465 Name not romanized
2021/12/07New drug · Class 1 YH001注射液 · No verified English nameCXSL2101464 Name not romanized
2021/12/07New drug · Class 1 LF0376片 · No verified English nameCXHL2101714 Shenzhen Shi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/07New drug · Class 1 LF0376片 · No verified English nameCXHL2101713 Shenzhen Shi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized

36 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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