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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 324 drug applications between 18 March 2023 and 24 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 56 drug names.

2023/03/18 – 2023/03/24

Period
2023/03/18 to 2023/03/24, 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
324
Drugs with new generic filings (by drug name, de-duplicated)
56
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

324filings, 75 of them generic

By application type

Application typeFilings
Supplement145
Generic75
New drug32
Import re-registration30
Import22
Unspecified20

By drug type

Drug typeFilings
Chemical drug249
TCM36
Therapeutic biologic32
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

56 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cefalexin Granules for Oral Suspension310
2Ampicillin Sodium and Sulbactam Sodium for Injection3113
3Pamidronate Disodium Injection222
4Norepinephrine Bitartrate Injection229
5Sodium Valproate Concentrated Solution for Injection210
6Tacrolimus Ointment216
7Lansoprazole Enteric Capsules213
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

190 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
4Eli Lilly and Company610
5Shijiazhuang No.4 Pharmaceutical Co., Ltd.521
6Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized440
7CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD430
8Janssen Research & Development LLC420
9He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized420
10Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized333

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
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
2023/03/24New drug · Class 1.1 天癸苁盈颗粒 · No verified English nameCXZL2300022 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2023/03/24New drug · Class 3.2 注射用A型肉毒毒素(148 kDa,不含复合蛋白) · No verified English nameCXSL2300214 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized
2023/03/24New drug · Class 1 新邦干细胞注射液 · No verified English nameCXSL2300213 Shandong Xing Rui Bio Technology Co., Ltd. romanized
2023/03/24New drug · Class 1 重组抗EpCAM-CD3抗体注射液 · No verified English nameCXSL2300212 Tian Mai Yuan He Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2023/03/24New drug · Class 1 ABO2011注射液 · No verified English nameCXSL2300211 Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized; Suzhou Ai Bo Bio Technology Co., Ltd. romanized
2023/03/24New drug · Class 1 人源TH-SC01细胞注射液 · No verified English nameCXSL2300210 Jiangsu Tuo Hong Kang Heng Pharmaceuticals Co., Ltd. romanized
2023/03/24New drug · Class 1 TQC2731注射液 · No verified English nameCXSL2300209 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/03/24New 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 nameCXSL2300208 Shanghai Fu Xing Pharmaceuticals Industry Development 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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