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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 373 drug applications between 12 November 2024 and 18 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 114, covering 79 drug names.

2024/11/12 – 2024/11/18

Period
2024/11/12 to 2024/11/18, 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
373
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
8

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

373filings, 114 of them generic

By application type

Application typeFilings
Supplement169
Generic114
New drug60
Import13
Unspecified9
Import re-registration7
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug271
TCM59
Therapeutic biologic29
Prophylactic biologic9
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

79 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Fluoxetine Hydrochloride Oral Solution410
2Glucosamine Sulfate Capsules3351
3Multiple Electrolyte Additive For Injection332
4Ambroxol Hydrochloride Oral Solution3246
5Brexpiprazole Tablets3131
6Pregabalin Oral Solution315
7Tobramycin Eye Drops222
8Bisoprolol Fumarate and Amlodipine Besylate Tablets229
9Isavuconazonium Sulfate for Injection2215
10Sodium Bicarbonate Injection2210

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

244 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
2Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized640
3Celgene Corporation610
4Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized550
5Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized550
6Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized540
7Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized424
8Bristol-Myers Squibb Australia Pty Ltd410
9Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized414
10Chengdu Di Kang Pharma 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

117 this week

AcceptedDrugApplicants
2024/11/18Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2403955 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Si Wei Pharmaceuticals Technology Co., Ltd. romanized
2024/11/18Generic · Class 3 Sodium Bicarbonate InjectionCYHS2403952 Hubei Duo Rui Pharma Co., Ltd. romanized
2024/11/18Generic · Class 3 Epalrestat TabletsCYHS2403950 Guangdong Jiu Ming Pharmaceutical Co., Ltd. romanized
2024/11/18Generic · Class 3 硝苯地平缓释片(Ⅱ) · No verified English nameCYHS2403949 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized
2024/11/18New drug · Class 2.2 恩朗苏拜单抗注射液 · No verified English nameCXSL2400782 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/11/18New drug · Class 2.4 注射用KJ101 · No verified English nameCXSL2400781 Shanghai Bao Ji Pharma Co., Ltd. romanized
2024/11/16Import · Class 1 JNJ-77242113-AAC片 · No verified English nameJXHL2400267 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/11/16Generic · Class 3 右美沙芬安非他酮缓释片 · No verified English nameCYHL2400228 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/11/16New drug · Class 1 注射用SKB445 · No verified English nameCXSL2400780 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2024/11/16New drug · Class 1 自体天然肿瘤浸润淋巴细胞注射液 · No verified English nameCXSL2400779 Shanghai Jun Sai Bio Technology Co., Ltd. romanized
2024/11/16New drug · Class 1 力胜克拉片 · No verified English nameCXHS2400114 Suzhou Ya Sheng Pharma Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2024/11/16New drug · Class 1 力胜克拉片 · No verified English nameCXHS2400113 Suzhou Ya Sheng Pharma Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2024/11/16New drug · Class 1 力胜克拉片 · No verified English nameCXHS2400112 Suzhou Ya Sheng Pharma Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2024/11/16New drug · Class 1 BL0175注射液 · No verified English nameCXHL2401248 Shanghai Bi Ling Bio Technology Co., Ltd. romanized
2024/11/16New drug · Class 2.2; 2.4 KEM2111凝胶贴膏 · No verified English nameCXHL2401247 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2024/11/16New drug · Class 2.2; 2.4 KEM2111凝胶贴膏 · No verified English nameCXHL2401246 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2024/11/16New drug · Class 2.2; 2.4 KEM2111凝胶贴膏 · No verified English nameCXHL2401245 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
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

87 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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