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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 303 drug applications between 19 March 2023 and 25 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 51 drug names.

2023/03/19 – 2023/03/25

Period
2023/03/19 to 2023/03/25, 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
303
Drugs with new generic filings (by drug name, de-duplicated)
51
Accepted this week, now under review
1

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

303filings, 70 of them generic

By application type

Application typeFilings
Supplement130
Generic70
New drug30
Import re-registration30
Import25
Unspecified18

By drug type

Drug typeFilings
Chemical drug232
Therapeutic biologic34
TCM30
Biologic5
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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Polyvinyl Alcohol Eye Drops4324
2Cefalexin Granules for Oral Suspension310
3Ampicillin Sodium and Sulbactam Sodium for Injection3113
4Pamidronate Disodium Injection222
5Norepinephrine Bitartrate Injection229
6Tacrolimus Ointment216
7Oxcarbazepine Oral Suspension212
8Acetaminophen Injection211
9Levocarnitine Injection214
10Torasemide Tablets210

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

175 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bracco Imaging Italia S.r.L.2410
2Shanghai Qing Ping Pharma Co., Ltd. romanized1190
3Zhu Zhou Qian Jin Pharma Co., Ltd. romanized650
4Shijiazhuang No.4 Pharmaceutical Co., Ltd.632
5Eli Lilly and Company610
6Janssen Research & Development LLC420
7Novartis Europharm Limited420
8He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized420
9Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized333
10Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized330

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

81 this week

AcceptedDrugApplicants
2023/03/25Import · Class 2.2 贝利尤单抗注射液(皮下注射) · No verified English nameJXSL2300061 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Company Limited
2023/03/25Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300901 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/03/25Generic · Class 3 Polyvinyl Alcohol Eye DropsCYHS2300898 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/03/25Generic · Class 3 Polyvinyl Alcohol Eye DropsCYHS2300897 Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/03/25New drug · Class 1 赛立奇单抗注射液 · No verified English nameCXSS2300015 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2023/03/25New drug · Class 1 SHR-3167注射液 · No verified English nameCXSL2300216 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/03/25New drug · Class 1 HJ178胶囊 · No verified English nameCXHL2300330 Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized
2023/03/25New drug · Class 1 HJ178胶囊 · No verified English nameCXHL2300329 Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized
2023/03/24Import · Class 1 注射用SAR443579 · No verified English nameJXSL2300060 Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD
2023/03/24Import · Class 3.1 Bimekizumab注射液 · No verified English nameJXSL2300059 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2023/03/24Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2300058 Sanofi-Aventis Recherche & Développement; Sanofi(China) Investment Co. LTD
2023/03/24Import · Class 1 Zibotentan胶囊 · No verified English nameJXHL2300060 Astrazeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/03/24Import · Class 1 Zibotentan胶囊 · No verified English nameJXHL2300059 Astrazeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/03/24Import · Class 1 Zibotentan胶囊 · No verified English nameJXHL2300058 Astrazeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/03/24Import · Class 2.3 注射用氨曲南阿维巴坦 · No verified English nameJXHL2300057 Pfizer Inc.; Pfizer Investment CO. Ltd.
2023/03/24Generic · Class 3 Levofolinate Calcium for InjectionCYHS2300895 Sichuan Bai Li Pharma Co., Ltd. romanized
2023/03/24Generic · Class 3 Pamidronate Disodium InjectionCYHS2300894 Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/03/24Generic · Class 3 Pamidronate Disodium InjectionCYHS2300892 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/03/24Generic · Class 3 Metaraminol Tartrate InjectionCYHS2300889 Henan Lan Tu Pharmaceutical Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized
2023/03/24Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2300888 Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized
2023/03/24Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2300887 Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized
2023/03/24Generic · Class 3 Polyvinyl Alcohol Eye DropsCYHS2300885 Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized; Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized
2023/03/24Generic · Class 3 Polyvinyl Alcohol Eye DropsCYHS2300884 Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized; Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized
2023/03/24Generic · Class 3 Cimetidine InjectionCYHS2300880 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2023/03/24Generic · Class 3 水溶性黄体酮注射液 · No verified English nameCYHS2300879 Changchun Jin Sai Pharma Co., Ltd. romanized; Jilin Sheng Jin Pai Ge Pharma Co., Ltd. romanized
2023/03/24Generic · Class 3 Calcium Gluconate InjectionCYHS2300877 Jinan Chen Xin Pharmaceuticals Technology Co., Ltd. romanized; CISEN PHARMACEUTICAL CO., LTD.
2023/03/24Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2300876 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; Guangdong An Nuo Pharma Co., Ltd. romanized
2023/03/24Generic · Class 3 Loxoprofen sodium hydrate gelCYHL2300041 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2023/03/24Generic · Class 3 Cabozantinib TabletsCYHL2300039 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/03/24Generic · Class 3 Cabozantinib TabletsCYHL2300038 Qilu Pharmaceutical (Hainan) Co., Ltd

51 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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