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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 332 drug applications between 13 November 2024 and 19 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 73 drug names.

2024/11/13 – 2024/11/19

Period
2024/11/13 to 2024/11/19, 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
332
Drugs with new generic filings (by drug name, de-duplicated)
73
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

332filings, 103 of them generic

By application type

Application typeFilings
Supplement147
Generic103
New drug56
Import14
Unspecified7
Import re-registration4
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug238
TCM52
Therapeutic biologic29
Prophylactic biologic9
Biologic3
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

73 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Fluoxetine Hydrochloride Oral Solution410
2Glucosamine Sulfate Capsules3351
3Ambroxol Hydrochloride Oral Solution3246
4Brexpiprazole Tablets3131
5Pregabalin Oral Solution315
6Tobramycin Eye Drops222
7Bisoprolol Fumarate and Amlodipine Besylate Tablets229
8Isavuconazonium Sulfate for Injection2215
9Sodium Bicarbonate Injection2210
10西格列汀二甲双胍片(Ⅰ) · No verified English name221

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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized640
2Celgene Corporation610
3Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized610
4Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized540
5Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized440
6Novartis Pharma Schweiz AG430
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

104 this week

AcceptedDrugApplicants
2024/11/19Import · Class 1 VAY736注射液 · No verified English nameJXSL2400223 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/11/19Import · Class 1 INCB057643片 · No verified English nameJXHL2400269 Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd.
2024/11/19Import · Class 1 INCB057643片 · No verified English nameJXHL2400268 Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd.
2024/11/19Generic · Class 3 Doxofylline GranulesCYHS2403960 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/11/19Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2403958 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/11/19Generic · Class 3 Mannitol-S InjectionCYHL2400229 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized
2024/11/19New drug · Class 1 重组抗IL-17A人源化单克隆抗体注射液 · No verified English nameCXSS2400124 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2024/11/19New drug · Class 1 JSKN033注射液 · No verified English nameCXSL2400787 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2024/11/19New drug · Class 2.2 A140注射液 · No verified English nameCXSL2400786 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2024/11/19New drug · Class 1 注射用BGB-A3055 · No verified English nameCXSL2400785 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2024/11/19New drug · Class 1 GLS-W1100胶囊 · No verified English nameCXSL2400784 Hangzhou Yuan Da Biopharmaceutical Co., Ltd. romanized
2024/11/19New drug · Class 1 HX044注射液 · No verified English nameCXSL2400783 Han Si Ai Tai Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2024/11/19New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2401257 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/11/19New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2401256 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/11/19New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2401255 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/11/19New drug · Class 2.4 格索雷塞片 · No verified English nameCXHL2401254 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/11/19New drug · Class 2.4 注射用西罗莫司(白蛋白结合型) · No verified English nameCXHL2401253 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2024/11/19New drug · Class 1 注射用ZHB601 · No verified English nameCXHL2401252 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2024/11/19New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2401251 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/11/19New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2401250 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/11/19New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2401249 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
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

74 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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