YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 308 drug applications between 14 November 2024 and 20 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 70 drug names.

2024/11/14 – 2024/11/20

Period
2024/11/14 to 2024/11/20, 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
308
Drugs with new generic filings (by drug name, de-duplicated)
70
Accepted this week, now under review
4

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

308filings, 95 of them generic

By application type

Application typeFilings
Supplement133
Generic95
New drug54
Import11
Unspecified9
Import re-registration5
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug227
TCM44
Therapeutic biologic28
Prophylactic biologic6
Biologic3

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

70 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Ambroxol Hydrochloride Oral Solution3246
3Brexpiprazole Tablets3131
4Pregabalin Oral Solution315
5Tobramycin Eye Drops222
6Glucosamine Sulfate Capsules2251
7Sodium Bicarbonate Injection2210
8西甲硅油乳剂 · No verified English name223
9Acetylcysteine Granules214
10Piperacillin Sodium for Injection2116

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

208 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Celgene Corporation610
2Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized610
3Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized540
4Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized440
5Chengdu Brilliant Pharmaceutical Co., Ltd.431
6Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized424
7Bristol-Myers Squibb Australia Pty Ltd410
8Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized333
9Qiong Lai Tian Yin Pharmaceutical Co., Ltd. romanized330
10Annora Pharma Private Limited320

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

101 this week

AcceptedDrugApplicants
2024/11/20Import · Class 1 VGX-3100 · No verified English nameJXSL2400224 Inovio Pharmaceuticals Inc.; Beijing Apollo Saturn Biological Technology Limited
2024/11/20Generic · Class 3 无水乙醇注射液 · No verified English nameCYHS2403977 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/11/20Generic · Class 3 Metformin Hydrochloride Oral SolutionCYHS2403972 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2024/11/20Generic · Class 3 Metformin Hydrochloride Oral SolutionCYHS2403971 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2024/11/20Generic · Class 3 Nitroglycerin InjectionCYHS2403970 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/11/20Generic · Class 3 Nitroglycerin InjectionCYHS2403969 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/11/20New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2400789 Ai Mei Rong Yu (Ningbo) Biopharmaceutical Co., Ltd. romanized
2024/11/20New drug · Class 1 AA001单抗 · No verified English nameCXSL2400788 Beijing Zhi Yuan Hong Cheng Biopharmaceuticals Co., Ltd. romanized
2024/11/20New drug · Class 2.2 水合氯醛口服溶液 · No verified English nameCXHS2400115 Hainan Kang Cheng Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
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

71 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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