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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 386 drug applications between 27 November 2024 and 3 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 107, covering 86 drug names.

2024/11/27 – 2024/12/03

Period
2024/11/27 to 2024/12/03, 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
386
Drugs with new generic filings (by drug name, de-duplicated)
86
Accepted this week, now under review
11

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

386filings, 107 of them generic

By application type

Application typeFilings
Supplement194
Generic107
New drug52
Import15
Import re-registration10
Unspecified8

By drug type

Drug typeFilings
Chemical drug260
TCM77
Therapeutic biologic43
Biologic5
Prophylactic biologic1

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

86 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets5360
2Sacubitril Valsartan Sodium Tablets3170
3氧 · No verified English name2215
4Isavuconazonium Sulfate for Injection2215
5Clopidogrel Hydrogen Sulphate Tablets226
6Glucosamine Sulfate Capsules2251
7Quetiapine Fumarate Extended-release Tablets210
8Brexpiprazole Tablets2131
9Sildenafil Citrate Tablets2112
10Lysine Acetylsalicylate For Injection218

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

240 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized1440
2Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized990
3The Wellcome Foundation Limited720
4Fresenius Kabi Deutschland GmbH610
5Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized555
6Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized550
7Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized530
8Hua Zhong Pharma Co., Ltd. romanized523
9Novo Nordisk A/S510
10Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized510

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

100 this week

AcceptedDrugApplicants
2024/12/03Import · Class 1 PIT565 · No verified English nameJXSL2400232 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/12/03Generic · Class 3 Cetylpyridinium Chloride Buccal TabletsCYHS2404168 Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized
2024/12/03Generic · Class 3 Phloroglucinol Orally Disintegrating TabletsCYHS2404166 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/12/03Generic · Class 3 Olmesartan Medoxomil Orally Disintegrating TabletsCYHS2404165 Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized
2024/12/03Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2404164 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/12/03Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2404163 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/12/03Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHS2404162 Rui Yang Pharmaceutical Co., Ltd. romanized
2024/12/03Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2404161 Shanxi Jiu Kang Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/12/03Generic · Class 3 Epalrestat TabletsCYHS2404160 Hainan Sai Li Ke Pharma Co., Ltd. romanized
2024/12/03Generic · Class 3 Lysine Acetylsalicylate For InjectionCYHS2404158 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2024/12/03Generic · Class 3 Lysine Acetylsalicylate For InjectionCYHS2404156 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2024/12/03Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2404145 Shandong Xu Lie Bio Technology Co., Ltd. romanized; Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2024/12/03Generic · Class 3 Famotidine InjectionCYHS2404140 Guangdong Jun Kang Pharma Co., Ltd. romanized; Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized
2024/12/03Generic · Class 3 Aripiprazole Oral SolutionCYHS2404139 Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2024/12/03Generic · Class 3 雷芬那辛吸入溶液 · No verified English nameCYHL2400239 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2024/12/03New drug · Class 1.1 小儿热平颗粒 · No verified English nameCXZL2400083 Jiu Hua Hua Yuan Pharma Co., Ltd. romanized
2024/12/03New drug · Class 1.1 小儿热平颗粒 · No verified English nameCXZL2400082 Jiu Hua Hua Yuan Pharma Co., Ltd. romanized
2024/12/03New drug · Class 1.1 补髓益智颗粒 · No verified English nameCXZL2400081 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2024/12/03New drug · Class 3.2 皮下注射人免疫球蛋白 · No verified English nameCXSS2400133 Chengdu Rong Sheng Pharma Co., Ltd. romanized
2024/12/03New drug · Class 3.3 利拉鲁肽注射液 · No verified English nameCXSS2400132 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized
2024/12/03New drug · Class 1 注射用重组病毒巨噬细胞炎性蛋白 · No verified English nameCXSL2400814 Guangzhou Hong Run Bio Technology Co., Ltd. romanized
2024/12/03New drug · Class 1 IBI3017 · No verified English nameCXSL2400813 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/12/03New drug · Class 1 DC50292A片 · No verified English nameCXHL2401311 Beijing Shuang He Run Chuang Technology Co., Ltd. romanized
2024/12/03New drug · Class 1 DC50292A片 · No verified English nameCXHL2401310 Beijing Shuang He Run Chuang Technology Co., Ltd. romanized
2024/12/03New drug · Class 1 AL2846胶囊 · No verified English nameCXHL2401309 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/12/03New drug · Class 1 QB0208-1胶囊 · No verified English nameCXHL2401308 Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized
2024/12/03New drug · Class 1 QB0208-1胶囊 · No verified English nameCXHL2401307 Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized
2024/12/03New drug · Class 1 LT-002-158片 · No verified English nameCXHL2401306 Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized
2024/12/03New drug · Class 1 LT-002-158片 · No verified English nameCXHL2401305 Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized
2024/12/02Generic · Class 3 Bumetanide InjectionCYHS2404137 Shijiazhuang No.4 Pharmaceutical Co., Ltd.

70 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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