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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 272 drug applications between 21 February 2025 and 27 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 57 drug names.

2025/02/21 – 2025/02/27

Period
2025/02/21 to 2025/02/27, 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
272
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
5

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

272filings, 70 of them generic

By application type

Application typeFilings
Supplement141
Generic70
New drug31
Import19
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug188
TCM41
Therapeutic biologic33
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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapagliflozin Tablets4284
2Bromhexine Hydrochloride Injection228
3Procaterol Hydrochloride Solution for Inhalation212
4多种油脂肪乳注射液(C?~??) · No verified English nameThe source text contains a character that cannot be displayed.210
5Cefuroxime Sodium for Injection218
6Nafamostat Mesilate for Injection2138
7Lysine Acetylsalicylate For Injection218
8环硅酸锆钠散 · No verified English name2112
9盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
10Isoprenaline Hydrochloride Injection217

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

171 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized1690
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized820
3Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized660
4Shanghai Bei Jie Group Guan Dong Pharma Co., Ltd. romanized550
5Boehringer Ingelheim International GmbH540
6AstraZeneca AB420
7AstraZeneca UK Limited410
8Baxter Holding B.V.330
9TIANJIN LISHENG PHARMACEUTICAL CO., LTD331
10Sanofi B.V.320

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

78 this week

AcceptedDrugApplicants
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
2025/02/27Generic · Class 3 Lysine Acetylsalicylate For InjectionCYHS2500866 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2025/02/27Generic · Class 3 比拉斯汀口崩片 · No verified English nameCYHS2500863 Jiangsu He Chen Pharma Co., Ltd. romanized
2025/02/27Generic · Class 3 Sodium Bicarbonate InjectionCYHS2500860 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2025/02/27Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2500854 Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Xian Yuan Da De Tian Pharma Co., Ltd. romanized
2025/02/27Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2500052 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2025/02/27New drug · Class 1 注射用YL217 · No verified English nameCXSL2500182 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2025/02/27New drug · Class 1.2 呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2500181 Ai Mei Innovation Zhe Biopharmaceuticals Research (Shanghai) Co., Ltd. romanized; Ai Mei Tan Suo Zhe Sheng Ming Ke Xue Research and Development Co., Ltd. romanized; Ai Mei Yi Miao Co., Ltd. romanized
2025/02/27New drug · Class 1.4 冻干二价重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2500180 Guangzhou Sui He Bio Technology Co., Ltd. romanized
2025/02/27New drug · Class 1 SH009注射液 · No verified English nameCXSL2500179 Nanjing Sheng He Pharma Co., Ltd. romanized
2025/02/26Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2500852 Anhui Pioneer Pharmaceutical Co., Ltd
2025/02/26Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2500847 YaoPharma Co., Ltd.
2025/02/26Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2500846 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2025/02/26Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2500845 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2025/02/26New drug · Class 1 FG-B901注射液 · No verified English nameCXSL2500178 Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized
2025/02/26New drug · Class 1 FG-M108注射液 · No verified English nameCXSL2500177 Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized
2025/02/26New drug · Class 1.2 冻干鼻喷流感减毒活疫苗 · No verified English nameCXSL2500176 Di Fu Run Si (Hefei) Bio Technology Co., Ltd. romanized; Zhejiang Di Fu Run Si Bio Technology Co., Ltd. romanized
2025/02/26New drug · Class 1 注射用HDM2005 · No verified English nameCXSL2500175 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/02/26New drug · Class 1 CPD704吸入混悬液 · No verified English nameCXHL2500222 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2025/02/26New drug · Class 2.2 BCM995 · No verified English nameCXHL2500221 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2025/02/26New drug · Class 2.2 HKGM-333 · No verified English nameCXHL2500220 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized
2025/02/26New drug · Class 1 BGB-45035片 · No verified English nameCXHL2500219 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/02/26New drug · Class 1 BGB-45035片 · No verified English nameCXHL2500218 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/02/25Import · Class 2.2 特泽利尤单抗注射液 · No verified English nameJXSS2500020 AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd.

48 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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