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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 308 drug applications between 22 February 2025 and 28 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 64 drug names.

2025/02/22 – 2025/02/28

Period
2025/02/22 to 2025/02/28, 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)
64
Accepted this week, now under review
6

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, 79 of them generic

By application type

Application typeFilings
Supplement162
Generic79
New drug40
Import15
Unspecified6
Import re-registration6

By drug type

Drug typeFilings
Chemical drug202
TCM64
Therapeutic biologic32
Prophylactic biologic6
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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapagliflozin Tablets4284
2Oxaliplatin Injection314
3Bromhexine Hydrochloride Injection228
4Lactulose Oral Solution2134
5Procaterol Hydrochloride Solution for Inhalation212
6多种油脂肪乳注射液(C?~??) · No verified English nameThe source text contains a character that cannot be displayed.210
7Cefuroxime Sodium for Injection218
8Nafamostat Mesilate for Injection2138
9Lysine Acetylsalicylate For Injection218
10环硅酸锆钠散 · No verified English name2112

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

183 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized1690
2Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized15130
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized1230
4Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized660
5Shanghai Bei Jie Group Guan Dong Pharma Co., Ltd. romanized550
6Guizhou San Ren Tang Pharma Co., Ltd. romanized550
7Boehringer Ingelheim International GmbH540
8Heilongjiang Han Hong Pharma Co., Ltd. romanized440
9Baxter Holding B.V.330
10ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.333

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

88 this week

AcceptedDrugApplicants
2025/02/28Generic · Class 3 Ferrous Succinate TabletsCYHS2500883 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized
2025/02/28Generic · Class 3 Bifonazole SolutionCYHS2500881 Tang Shan Hong Xing Pharma Co., Ltd. romanized
2025/02/28Generic · Class 3 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2500880 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/02/28Generic · Class 3 Oxaliplatin InjectionCYHS2500879 Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized
2025/02/28Generic · Class 3 Oxaliplatin InjectionCYHS2500878 Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized
2025/02/28Generic · Class 3 Oxaliplatin InjectionCYHS2500877 Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized
2025/02/28Generic · Class 3 Brivaracetam Oral SolutionCYHS2500876 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/02/28Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2500872 Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized
2025/02/28Generic · Class 3 Metronidazole Vaginal GelCYHL2500053 Hua Kong Innovation (Beijing) Drug Research Institute Co., Ltd. romanized
2025/02/28New drug · Class 3.1 半夏泻心汤颗粒 · No verified English nameCXZS2500010 Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized
2025/02/28New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500187 Beijing Tuo Hua Wei Ye Bio Technology Co., Ltd. romanized
2025/02/28New drug · Class 1 注射用QLS4131 · No verified English nameCXSL2500186 Qilu Pharmaceutical Co., Ltd.
2025/02/28New drug · Class 1 注射用BG-C9074 · No verified English nameCXSL2500185 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/02/28New drug · Class 1 TQC2731注射液 · No verified English nameCXSL2500184 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/02/28New drug · Class 1.4 24价肺炎球菌结合疫苗 · No verified English nameCXSL2500183 Suzhou Ju Wei Bio Technology Co., Ltd. romanized
2025/02/28New drug · Class 1 BGB-16673片 · No verified English nameCXHL2500230 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/02/28New drug · Class 1 BGB-16673片 · No verified English nameCXHL2500229 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/02/28New drug · Class 1 BGB-16673片 · No verified English nameCXHL2500228 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/02/28New drug · Class 1 BGB-16673片 · No verified English nameCXHL2500227 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/02/28New drug · Class 1 TCC1727片 · No verified English nameCXHL2500226 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2025/02/28New drug · Class 1 TCC1727片 · No verified English nameCXHL2500225 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2025/02/28New drug · Class 1 KH607片 · No verified English nameCXHL2500224 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2025/02/28New drug · Class 1 KH607片 · No verified English nameCXHL2500223 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2025/02/27Import · Class 1 注射用MK-2400 · No verified English nameJXSL2500028 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/02/27Import · Class 1 瑞米布替尼片 · No verified English nameJXHS2500034 Novartis Pharma Schweiz AG; Novartis Pharmaceutical Manufacturing LLC; Beijing Novartis Pharma Co. Ltd.
2025/02/27Generic · Class 3 Calcium Acetate Oral SolutionCYHS2500871 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2025/02/27Generic · Class 3 Mannitol-S InjectionCYHS2500870 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2025/02/27Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2500869 Hainan Mei Kang Da Pharma Co., Ltd. romanized; Li Sheng Pharmaceuticals (Suzhou) Co., Ltd. romanized
2025/02/27Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2500868 Hainan Mei Kang Da Pharma Co., Ltd. romanized; Li Sheng Pharmaceuticals (Suzhou) Co., Ltd. romanized
2025/02/27Generic · Class 3 Lysine Acetylsalicylate For InjectionCYHS2500867 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized

58 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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