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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 193 drug applications between 29 December 2021 and 4 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 52, covering 33 drug names.

2021/12/29 – 2022/01/04

Period
2021/12/29 to 2022/01/04, 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
193
Drugs with new generic filings (by drug name, de-duplicated)
33
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

193filings, 52 of them generic

By application type

Application typeFilings
Supplement77
Generic52
New drug48
Import8
Import re-registration5
Unspecified2
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug153
Therapeutic biologic26
TCM13
Drug-device combination1

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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Gabapentin Capsules310
2Enarodustat Tablets310
3Sildenafil Citrate Tablets3112
4Losartan Potassium and Hydrochlorothiazide Tablets311
5Nicorandil for Injection311
6阿普米司特片 · No verified English name313
7Ticagrelor Tablets2110
8Tranexamic Acid Injection2111
9注射用盐酸头孢吡肟/氯化钠注射液 · No verified English name210
10Dobutamine Hydrochloride Injection213

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

102 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Run Shuang He Pharma Co., Ltd. romanized753
2Zhejiang Nord Pharmaceutical Co., Ltd636
3Shandong Run Ze Pharmaceutical Co., Ltd. romanized610
4Guangdong Ke Lun Pharma Co., Ltd. romanized510
5Guangzhou Run Er Yan Ke Bio Technology Co., Ltd. romanized510
6AstraZeneca AB420
7Ren He Yi Kang Group Co., Ltd. romanized424
8Beijing Rui Ye Pharmaceutical Co., Ltd. romanized422
9Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized420
10Shandong Luo Xin Pharma Group Co., Ltd. romanized420

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

71 this week

AcceptedDrugApplicants
2022/01/04Generic · Class 3 Enarodustat TabletsCYHS2102356 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/01/04Generic · Class 3 Enarodustat TabletsCYHS2102355 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/01/04Generic · Class 3 Enarodustat TabletsCYHS2102354 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/01/04Generic · Class 3 Nicorandil for InjectionCYHS2102350 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2022/01/04Generic · Class 3 Nicorandil for InjectionCYHS2102349 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2022/01/04Generic · Class 3 Nicorandil for InjectionCYHS2102348 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2022/01/04New drug · Class 1 KL-A167注射液 · No verified English nameCXSL2101533 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2022/01/04New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2101869 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2022/01/04New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2101868 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2022/01/04New drug · Class 2.2 SHR8028滴眼液 · No verified English nameCXHL2101867 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/01/04New drug · Class 1 HY1839颗粒 · No verified English nameCXHL2101866 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2022/01/04New drug · Class 1 HY1839颗粒 · No verified English nameCXHL2101865 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2022/01/04New drug · Class 1 ET0111胶囊 · No verified English nameCXHL2101864 Shanghai Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized
2022/01/04New drug · Class 1 ET0111胶囊 · No verified English nameCXHL2101863 Shanghai Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized
2022/01/04New drug · Class 1 HTMC0435片 · No verified English nameCXHL2101859 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2022/01/04New drug · Class 1 HTMC0435片 · No verified English nameCXHL2101858 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2022/01/04New drug · Class 1 HTMC0435片 · No verified English nameCXHL2101857 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2022/01/04New drug · Class 1 LL-10 · No verified English nameCXHL2101818 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2021/12/31Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2102338 Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
2021/12/31Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2102337 Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
2021/12/31Generic · Class 3 Digoxin InjectionCYHS2102336 Zhong Run Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/12/31Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2102335 Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized
2021/12/31Generic · Class 3 Flurbiprofen Axetil InjectionCYHL2101059 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/12/31New drug · Class 2.4 注射用重组A型肉毒毒素 · No verified English nameCXSL2101534 Chongqing Yu Yan Pharmaceutical Co., Ltd. romanized
2021/12/31New drug · Class 1 GC304腺相关病毒注射液 · No verified English nameCXSL2101532 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2021/12/31New drug · Class 1 靶向HLA-A*02:01/NY-ESO-1的TCR-T细胞注射液 · No verified English nameCXSL2101531 Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized
2021/12/31New drug · Class 1 靶向Survivin DC细胞注射液 · No verified English nameCXSL2101530 Qi Chen Sheng Bio Technology (Zhuhai) Co., Ltd. romanized
2021/12/31New drug · Class 1 JMKX000623片 · No verified English nameCXHL2101856 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2021/12/31New drug · Class 1 JMKX000623片 · No verified English nameCXHL2101855 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2021/12/31New drug · Class 2.2; 2.4 孟鲁司特钠凝胶 · No verified English nameCXHL2101854 Jiang Yin Bei Rui Sen Pharmaceutical Co., Ltd. romanized

41 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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