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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 283 drug applications between 20 February 2025 and 26 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 50 drug names.

2025/02/20 – 2025/02/26

Period
2025/02/20 to 2025/02/26, 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
283
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
9

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

283filings, 61 of them generic

By application type

Application typeFilings
Supplement150
Generic61
New drug37
Import21
Unspecified8
Import re-registration6

By drug type

Drug typeFilings
Chemical drug191
TCM48
Therapeutic biologic37
Biologic3
Prophylactic 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

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapagliflozin Tablets4284
2Bromhexine Hydrochloride Injection228
3多种油脂肪乳注射液(C?~??) · No verified English nameThe source text contains a character that cannot be displayed.210
4氯雷他定口服溶液 · No verified English name213
5Nafamostat Mesilate for Injection2138
6环硅酸锆钠散 · No verified English name2112
7盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
8Isoprenaline Hydrochloride Injection217
9草酸艾司西酞普兰口服溶液 · No verified English name2111
10Sodium Valproate Sustained-release Tablets(I)114

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

173 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
3Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized660
4Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized660
5Shanghai Bei Jie Group Guan Dong Pharma Co., Ltd. romanized440
6Boehringer Ingelheim International GmbH430
7AstraZeneca AB420
8AstraZeneca UK Limited410
9Baxter Holding B.V.330
10Daiichi Sankyo Inc.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

81 this week

AcceptedDrugApplicants
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.
2025/02/25Import · Class 2.2 特泽利尤单抗注射液 · No verified English nameJXSS2500019 AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd.
2025/02/25Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSS2500018 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/02/25Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSS2500017 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/02/25Import · Class 1 那米司特片 · No verified English nameJXHS2500030 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/02/25Import · Class 1 那米司特片 · No verified English nameJXHS2500029 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/02/25Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2500844 Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2025/02/25Generic · Class 3 Potassium Chloride Oral SolutionCYHS2500843 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2025/02/25Generic · Class 3 Polaprezinc GranulesCYHS2500839 Yan Tai Wan Run Pharma Co., Ltd. romanized
2025/02/25Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2500835 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/02/25Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2500834 Hubei Min Kang Pharma Group Co., Ltd. romanized; Hubei Mei Lin Pharma Co., Ltd. romanized
2025/02/25Generic · Class 3 卡格列净二甲双胍缓释片 · No verified English nameCYHS2500830 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/02/25Generic · Class 3 Desonide OintmentCYHS2500829 Hunan Ming Rui Pharmaceutical Co., Ltd. romanized
2025/02/25Generic · Class 3 贝美前列素涂剂 · No verified English nameCYHL2500051 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/02/25New drug · Class 3.1 二冬汤颗粒 · No verified English nameCXZS2500009 Shanghai Jin Cun Pharmaceutical Co., Ltd. romanized
2025/02/25New drug · Class 2 人细小病毒(B19)核酸检测试剂盒 (PCR-荧光法) · No verified English nameCXSS2500033 Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized
2025/02/25New drug · Class 1 BNT323 · No verified English nameCXSL2500174 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized

51 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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