YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 283 drug applications between 22 April 2022 and 28 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 45 drug names.

2022/04/22 – 2022/04/28

Period
2022/04/22 to 2022/04/28, 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
283
Drugs with new generic filings (by drug name, de-duplicated)
45
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

283filings, 64 of them generic

By application type

Application typeFilings
Supplement160
Generic64
New drug32
Import14
Unspecified10
Import re-registration3

By drug type

Drug typeFilings
Chemical drug221
Therapeutic biologic35
TCM16
Biologic6
Prophylactic biologic5

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

45 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cariprazine hydrochloride Capsules413
2Levofloxacin and Sodium Chloride Injection3214
3Cefminox Sodium for Injection310
4Ibuprofen Suspension2214
5Tandospirone Citrate Tablets222
6Sodium Valproate Concentrated Solution for Injection210
7Nintedanib Esilate Soft Capsules216
8Tacrolimus Ointment216
9Digoxin Injection213
10Ornidazole Injection210

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

169 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bristol-Myers Squibb Pharma EEIG820
2Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized721
3Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized710
4Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized660
5Pfizer Inc.530
6ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.524
7Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized510
8Wu Hu Dao Run Pharma Co., Ltd. romanized440
9Ji Chuan Pharma Group Co., Ltd. romanized431
10Hebei Tian Cheng Pharma Co., Ltd. romanized422

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

63 this week

AcceptedDrugApplicants
2022/04/28Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200687 Sichuan Zi Ren Pharmaceutical Co., Ltd. romanized
2022/04/28Generic · Class 3 Ozagrel Sodium InjectionCYHS2200686 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2022/04/28Generic · Class 3 布洛芬混悬滴剂 · No verified English nameCYHS2200685 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2022/04/28Generic · Class 3 Digoxin InjectionCYHS2200680 Chengdu Brilliant Pharmaceutical Co., Ltd.
2022/04/28Generic · Class 3 Digoxin InjectionCYHS2200679 Chengdu Brilliant Pharmaceutical Co., Ltd.
2022/04/28Generic · Class 3 Ornidazole InjectionCYHS2200678 Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized; Henan Run Hong Pharmaceutical Co., Ltd. romanized
2022/04/28Generic · Class 3 Ornidazole InjectionCYHS2200677 Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized; Henan Run Hong Pharmaceutical Co., Ltd. romanized
2022/04/28New drug · Class 3.3 阿柏西普眼内注射溶液 · No verified English nameCXSS2200044 Qilu Pharmaceutical Co., Ltd.
2022/04/28New drug · Class 1 人源多巴胺能前体细胞注射液 · No verified English nameCXSL2200194 Wuhan Rui Jian Pharmaceuticals Technology Co., Ltd. romanized
2022/04/28New drug · Class 1 注射用重组HER2人源化单克隆抗体单甲基奥瑞他汀F偶联剂 · No verified English nameCXSL2200189 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2022/04/28New drug · Class 2.2 510口服溶液 · No verified English nameCXHL2200263 Ao Xin Yang Guang (Beijing) Pharma Technology Co., Ltd. romanized
2022/04/27New drug · Class 1 QL1706注射液 · No verified English nameCXSL2200193 Qilu Pharmaceutical Co., Ltd.
2022/04/27New drug · Class 1 Hemay005片 · No verified English nameCXHL2200261 Gan Zhou He Mei Pharma Co., Ltd. romanized
2022/04/26Import · Class 2.2 那西妥单抗注射液 · No verified English nameJXSL2200047 Y-mAbs Therapeutics Inc.; SciClone Pharmaceuticals (China) Co. Ltd.
2022/04/26Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2200660 Shandong Tai Sheng Drug Research Co., Ltd. romanized; Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2022/04/26Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2200659 Shandong Tai Sheng Drug Research Co., Ltd. romanized; Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2022/04/26New drug · Class 1 HB0034注射液 · No verified English nameCXSL2200191 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/04/26New drug · Class 1 HLX53 · No verified English nameCXSL2200190 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/04/25Generic · Class 3 Citicoline InjectionCYHS2200652 Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/04/25Generic · Class 3 Tranexamic Acid InjectionCYHS2200651 Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/04/25Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200649 Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized
2022/04/25New drug · Class 2.2 尼妥珠单抗注射液 · No verified English nameCXSS2200041 Bai Tai Bio Pharma Co., Ltd. romanized
2022/04/25New drug · Class 3.4 治疗用卡介苗 · No verified English nameCXSL2200188 Chengdu Ke En Bio Technology Co., Ltd. romanized
2022/04/25New drug · Class 2.2 盐酸伊立替康脂质体注射液 · No verified English nameCXHS2200019 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/04/25New drug · Class 1 SC0062胶囊 · No verified English nameCXHL2200260 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2022/04/25New drug · Class 1 RJ4287片 · No verified English nameCXHL2200259 Nanjing Ao Li Mo Si Pharmaceuticals Technology Co., Ltd. romanized
2022/04/25New drug · Class 1 RJ4287片 · No verified English nameCXHL2200258 Nanjing Ao Li Mo Si Pharmaceuticals Technology Co., Ltd. romanized
2022/04/25New drug · Class 1 TSN333片 · No verified English nameCXHL2200257 Tai Li Bio Technology (Shanghai) Co., Ltd. romanized
2022/04/25New drug · Class 1 TSN333片 · No verified English nameCXHL2200256 Tai Li Bio Technology (Shanghai) Co., Ltd. romanized
2022/04/24Import · Class 2.2 Efgartigimod浓缩注射液 · No verified English nameJXSL2200050 argenx BV; Zai Lab (Shanghai) Co. Ltd.

33 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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