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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 252 drug applications between 20 October 2022 and 26 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 48 drug names.

2022/10/20 – 2022/10/26

Period
2022/10/20 to 2022/10/26, 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
252
Drugs with new generic filings (by drug name, de-duplicated)
48
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

252filings, 58 of them generic

By application type

Application typeFilings
Supplement125
Generic58
New drug48
Import10
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug188
Therapeutic biologic37
TCM21
Biologic4
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

48 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Solution For Inhalation334
2Olaparib Tablets210
3Amisulpride Injection211
4Urapidil Hydrochloride Injection216
5盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
6Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules212
7盐酸西替利嗪滴剂 · No verified English name218
8Minoxidil Topical Solution210
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

158 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized12110
2Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized610
3Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized550
4Merck Sharp & Dohme LLC540
5HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.520
6Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized520
7Novo Nordisk A/S510
8Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized424
9AstraZeneca UK Limited410
10Novartis Pharma Schweiz AG330

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

83 this week

AcceptedDrugApplicants
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
2022/10/25New drug · Class 2.2 奥曲肽长效注射液 · No verified English nameCXHL2200831 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2022/10/25New drug · Class 1 谷美替尼片 · No verified English nameCXHL2200830 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized
2022/10/25New drug · Class 1 AK0706片 · No verified English nameCXHL2200829 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2022/10/25New drug · Class 1 AK0706片 · No verified English nameCXHL2200828 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2022/10/24Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHS2201811 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2022/10/24Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHS2201810 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2022/10/24New drug · Class 3.3 利妥昔单抗注射液 · No verified English nameCXSS2200086 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2022/10/22Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHS2200097 AbbVie Deutschland GmbH & Co.KG; AbbVie Ireland NL B.V.
2022/10/22Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHS2200095 AbbVie Deutschland GmbH & Co.KG; AbbVie Ireland NL B.V.
2022/10/22Import · Class 2.4 BMS-986165片 · No verified English nameJXHL2200310 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/10/22Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201805 Jian Min Pharma Group Co., Ltd. romanized
2022/10/22New drug · Class 1 注射用Q-1801 · No verified English nameCXSL2200541 Qi Yu Bio Technology (Shanghai) Co., Ltd. romanized
2022/10/22New drug · Class 1 TST003注射液 · No verified English nameCXSL2200540 Suzhou Chuang Sheng Pharmaceuticals Group Co., Ltd. romanized

53 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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