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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 396 drug applications between 9 November 2024 and 15 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 130, covering 88 drug names.

2024/11/09 – 2024/11/15

Period
2024/11/09 to 2024/11/15, 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
396
Drugs with new generic filings (by drug name, de-duplicated)
88
Accepted this week, now under review
7

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

396filings, 130 of them generic

By application type

Application typeFilings
Supplement173
Generic130
New drug65
Import13
Unspecified9
Import re-registration5
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug289
TCM55
Therapeutic biologic35
Prophylactic biologic12
Biologic4
In vitro diagnostic reagent1

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

88 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Propranolol Hydrochloride Injection424
2Fluoxetine Hydrochloride Oral Solution410
3Glucosamine Sulfate Capsules3351
4Multiple Electrolyte Additive For Injection332
5Nicergoline Tablets321
6Brexpiprazole Tablets3131
7Pregabalin Oral Solution315
8Sodium sulfate, magnesium sulfate, and potassium chloride Tablets222
9Tobramycin Eye Drops222
10Bisoprolol Fumarate and Amlodipine Besylate Tablets229

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

258 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized12110
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
3Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized640
4Celgene Corporation610
5Chengdu Di Kang Pharma Co., Ltd. romanized550
6Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized540
7Chengdu Brilliant Pharmaceutical Co., Ltd.431
8Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized424
9Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized424
10Bristol-Myers Squibb Australia Pty Ltd410

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

131 this week

AcceptedDrugApplicants
2024/11/15Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2403938 Name not romanized; Hefei Hua Wei Pharma Co., Ltd. romanized
2024/11/15Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2403936 Chongqing Tian Zhi Pharma Co., Ltd. romanized; Henan Tian Zhi Pharma Co., Ltd. romanized
2024/11/15Generic · Class 3 Piperacillin Sodium for InjectionCYHS2403935 Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2024/11/15Generic · Class 3 Piperacillin Sodium for InjectionCYHS2403934 Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2024/11/15Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2403928 Jiangsu Qian Ren Bio Technology Co., Ltd. romanized
2024/11/15Generic · Class 3 Ferrous Succinate TabletsCYHS2403926 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2024/11/15Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2403923 Hai Xi Xin Yao Chuang Zhi (Fuzhou) Co., Ltd. romanized; Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2024/11/15Generic · Class 3 Pregabalin Oral SolutionCYHS2403917 Gai Tian Li Pharmaceuticals Holding Group Pharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2024/11/15Generic · Class 3 Pregabalin Oral SolutionCYHS2403916 Gai Tian Li Pharmaceuticals Holding Group Pharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2024/11/15Generic · Class 3 Pregabalin Oral SolutionCYHS2403915 Gai Tian Li Pharmaceuticals Holding Group Pharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2024/11/15Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2400227 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2024/11/15New drug · Class 3.3 13价肺炎球菌多糖结合疫苗 · No verified English nameCXSS2400123 Ai Mei Jian Chi Biopharmaceutical Co., Ltd. romanized
2024/11/15New drug · Class 1.2 SYS6017(带状疱疹mRNA疫苗) · No verified English nameCXSL2400778 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/11/15New drug · Class 1 重组抗CD19m-CD3抗体注射液 · No verified English nameCXSL2400777 Tian Mai Yuan He Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2024/11/15New drug · Class 1 HSK44459片 · No verified English nameCXHL2401244 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2024/11/15New drug · Class 1 HSK44459片 · No verified English nameCXHL2401243 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2024/11/15New drug · Class 1 NBB-002 · No verified English nameCXHL2401242 Zhong Peng (Xiamen) Biopharmaceuticals Co., Ltd. romanized
2024/11/15New drug · Class 1 HWH340片 · No verified English nameCXHL2401241 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2024/11/15New drug · Class 1 HWH340片 · No verified English nameCXHL2401240 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2024/11/15New drug · Class 1 ADC308片 · No verified English nameCXHL2401239 Jia Xing An Di Kang Bio Technology Co., Ltd. romanized
2024/11/15New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHL2401238 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
2024/11/15New drug · Class 2.2; 2.4 注射用紫杉醇聚合物胶束 · No verified English nameCXHL2401237 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized
2024/11/14Import · Class 1 注射用MK-2400 · No verified English nameJXSL2400222 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/11/14Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2400221 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2024/11/14Import · Class 1 Itepekimab注射液 · No verified English nameJXSL2400220 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/11/14Generic · Class 3 Latamoxef Sodium for InjectionCYHS2403909 Hainan Brilliant Pharmaceutical Co., Ltd.
2024/11/14Generic · Class 3 Latamoxef Sodium for InjectionCYHS2403908 Hainan Brilliant Pharmaceutical Co., Ltd.
2024/11/14Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2403905 Kang Pu Pharma Co., Ltd. romanized
2024/11/14Generic · Class 3 Cefmetazole Sodium for InjectionCYHS2403901 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Shenyang San Jiu Pharma Co., Ltd. romanized
2024/11/14Generic · Class 3 Cefmetazole Sodium for InjectionCYHS2403900 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Shenyang San Jiu Pharma Co., Ltd. romanized

101 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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