YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 236 drug applications between 28 December 2021 and 3 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 41 drug names.

2021/12/28 – 2022/01/03

Period
2021/12/28 to 2022/01/03, 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
236
Drugs with new generic filings (by drug name, de-duplicated)
41
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

236filings, 60 of them generic

By application type

Application typeFilings
Supplement92
Generic60
New drug60
Import11
Import re-registration8
Unspecified4
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug181
Therapeutic biologic38
TCM16
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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Venlafaxine Hydrochloride Sustained-Release Capsules320
2Sildenafil Citrate Tablets3112
3Losartan Potassium and Hydrochlorothiazide Tablets311
4阿普米司特片 · No verified English name313
5Glucosamine Sulfate Capsules2251
6Olanzapine Orally Disintegrating Tablets210
7Ticagrelor Tablets2110
8Tranexamic Acid Injection2111
9Sacubitril Valsartan Sodium Tablets2170
10注射用盐酸头孢吡肟/氯化钠注射液 · No verified English name210

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

137 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Run Shuang He Pharma Co., Ltd. romanized753
2Yang Zi Jiang Pharma Group Jiangsu Pharmaceutical Co., Ltd. romanized660
3Zhejiang Nord Pharmaceutical Co., Ltd636
4Shandong Run Ze Pharmaceutical Co., Ltd. romanized610
5Guangdong Ke Lun Pharma Co., Ltd. romanized510
6Guangzhou Run Er Yan Ke Bio Technology Co., Ltd. romanized510
7Yi Chang Ren Fu Pharma Co., Ltd. romanized443
8AstraZeneca AB420
9Beijing Rui Ye Pharmaceutical Co., Ltd. romanized422
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

84 this week

AcceptedDrugApplicants
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
2021/12/31New drug · Class 2.2 孟鲁司特钠凝胶 · No verified English nameCXHL2101853 Jiang Yin Bei Rui Sen Pharmaceutical Co., Ltd. romanized
2021/12/31New drug · Class 1 KL130008胶囊 · No verified English nameCXHL2101852 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/12/31New drug · Class 1 KL130008胶囊 · No verified English nameCXHL2101851 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/12/31New drug · Class 1 KL130008胶囊 · No verified English nameCXHL2101850 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/12/31New drug · Class 2.2 BCM235缓释干混悬剂 · No verified English nameCXHL2101825 Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized
2021/12/30Import · Class 3.1 注射用维博妥珠单抗 · No verified English nameJXSS2101037 Roche Pharma (Schweiz)AG; F. Hoffmann-La Roche AG
2021/12/30Import · Class 3.1 注射用维博妥珠单抗 · No verified English nameJXSS2101036 Roche Pharma (Schweiz)AG; BSP Pharmaceuticals S.p.A.
2021/12/30Import · Class 1 Sepantronium Bromide注射液 · No verified English nameJXHL2101289 Cothera Bioscience Inc.; Beijing Percans Oncology Co. Ltd.
2021/12/30Generic · Class 3 Thioctic Acid TabletsCYHS2102326 Ya Bao Pharma Group Co., Ltd. romanized
2021/12/30Generic · Class 3 Thioctic Acid TabletsCYHS2102325 Ya Bao Pharma Group Co., Ltd. romanized
2021/12/30Generic · Class 3 Ornidazole InjectionCYHS2102322 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2021/12/30Generic · Class 3 注射用盐酸头孢吡肟/氯化钠注射液 · No verified English nameCYHS2102321 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2021/12/30Generic · Class 3 注射用盐酸头孢吡肟/氯化钠注射液 · No verified English nameCYHS2102318 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2021/12/30Generic · Class 3 Tranexamic Acid InjectionCYHS2102317 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2021/12/30Generic · Class 3 Tranexamic Acid InjectionCYHS2102316 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2021/12/30New drug · Class 1.1 秦苓颗粒 · No verified English nameCXZL2101043 Beijing Niu Wei Po Ao Pharmaceuticals Technology Co., Ltd. romanized
2021/12/30New drug · Class 1.1 驹藿片 · No verified English nameCXZL2101042 Beijing Niu Wei Po Ao Pharmaceuticals Technology Co., Ltd. romanized
2021/12/30New drug · Class 1.1 牛贝消核颗粒 · No verified English nameCXZL2101041 Guangdong Qi Fang Pharma Co., Ltd. romanized

54 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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