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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 218 drug applications between 21 October 2022 and 27 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 43 drug names.

2022/10/21 – 2022/10/27

Period
2022/10/21 to 2022/10/27, 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
218
Drugs with new generic filings (by drug name, de-duplicated)
43
Accepted this week, now under review
2

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

218filings, 53 of them generic

By application type

Application typeFilings
Supplement111
Generic53
New drug26
Unspecified11
Import10
Import re-registration7

By drug type

Drug typeFilings
Chemical drug170
Therapeutic biologic22
TCM15
Biologic9
Prophylactic biologic2

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

43 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Solution For Inhalation334
2Metaraminol Tartrate Injection222
3Olaparib Tablets210
4Flumazenil Injection212
5Urapidil Hydrochloride Injection216
6盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
7Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules212
8盐酸西替利嗪滴剂 · No verified English name218
9Esomeprazole Magnesium Enteric-Coated Capsules214
10Acetylcysteine Injection1153

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

147 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized12110
2HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.520
3AstraZeneca UK Limited410
4Merck Sharp & Dohme LLC330
5Beijing SL Pharmaceutical Co., Ltd.331
6Shanxi Yi Qing Ke Pharma Co., Ltd. romanized330
7CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD320
8AbbVie Deutschland GmbH & Co.KG310
9B.Braun Melsungen AG310
10Patheon Italia S.P.A.310

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

62 this week

AcceptedDrugApplicants
2022/10/27Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSL2200187 sanofi-aventis groupe; Sanofi(China) Investment Co. LTD
2022/10/27Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2200312 AbbVie Inc.
2022/10/27Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2200311 AbbVie Inc.
2022/10/27Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2201838 Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/10/27Generic · Class 3 Flumazenil InjectionCYHS2201837 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2022/10/27Generic · Class 3 Flumazenil InjectionCYHS2201836 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2022/10/27Generic · Class 3 Nimodipine Oral SolutionCYHS2201834 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/10/27Generic · Class 3 Metaraminol Tartrate InjectionCYHS2201833 Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2022/10/27New drug · Class 2.2 重组人乳头瘤病毒6/11/16/18型四价疫苗(汉逊酵母) · No verified English nameCXSL2200545 Jiangsu Rui Ke Bio Technology Co., Ltd. romanized
2022/10/27New drug · Class 1 KYS202002A 注射液 · No verified English nameCXSL2200544 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/10/27New drug · Class 1 HSK16149胶囊 · No verified English nameCXHS2200058 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2022/10/27New drug · Class 1 TQB3616胶囊 · No verified English nameCXHL2200836 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/10/27New drug · Class 1 TQB3616胶囊 · No verified English nameCXHL2200835 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/10/26Import · Class 1 注射用AT-1501 · No verified English nameJXSL2200186 Eledon Pharmaceuticals Inc.; George (Beijing) Clinical Research Co. Ltd.
2022/10/26Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2201832 Hunan Jiudian Pharmaceutical Co., Ltd
2022/10/26Generic · Class 3 Eptifibatide InjectionCYHS2201831 Beijing SL Pharmaceutical Co., Ltd.
2022/10/26Generic · Class 3 Emtricitabine CapsulesCYHS2201829 Zhejiang Pu Li Pharma Co., Ltd. romanized
2022/10/26Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂 · No verified English nameCYHS2201828 Chongqing De Run Sheng Pharmaceuticals Co., Ltd. romanized; Di Sha Pharma Group Co., Ltd. romanized
2022/10/26Generic · Class 3 Metaraminol Tartrate InjectionCYHS2201827 Hainan Brilliant Pharmaceutical Co., Ltd.
2022/10/26Generic · Class 3 Diprophylline InjectionCYHS2201826 Sichuan Miao Ji Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2022/10/26Generic · Class 3 Pimavanserin Tartrate CapsulesCYHL2200097 Tianjin Tian Shi Li Sheng Te Pharmaceutical Co., Ltd. romanized
2022/10/26New drug · Class 1 注射用SKB264 · No verified English nameCXSL2200543 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2022/10/26New drug · Class 1 KC1036片 · No verified English nameCXHL2200834 Beijing Kang Chen Pharma Co., Ltd. romanized
2022/10/26New drug · Class 1 KC1036片 · No verified English nameCXHL2200833 Beijing Kang Chen Pharma Co., Ltd. romanized
2022/10/25Generic · Class 3 Desonide CreamCYHS2201820 Fu Yuan Pharma Co., Ltd. romanized
2022/10/25Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2201817 Tong He Biopharmaceuticals (Shandong) Co., Ltd. romanized; Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2022/10/25Generic · Class 3 Acetylcysteine InjectionCYHS2201814 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2022/10/25New drug · Class 3.2 阿基仑赛注射液 · No verified English nameCXSS2200087 Fu Xing Kai Te Bio Technology Co., Ltd. romanized
2022/10/25New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2200542 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2022/10/25New drug · Class 2.2 奥曲肽长效注射液 · No verified English nameCXHL2200832 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized

32 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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