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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 422 drug applications between 6 August 2025 and 12 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 122, covering 83 drug names.

2025/08/06 – 2025/08/12

Period
2025/08/06 to 2025/08/12, 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
422
Drugs with new generic filings (by drug name, de-duplicated)
83
Accepted this week, now under review
115

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

422filings, 122 of them generic

By application type

Application typeFilings
Supplement190
Generic122
New drug67
Import re-registration18
Import15
Unspecified10

By drug type

Drug typeFilings
Chemical drug267
TCM84
Therapeutic biologic63
Biologic5
Prophylactic 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

83 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets4270
2苯磺酸左氨氯地平片 · No verified English name4245
3替尔泊肽注射液 · No verified English name4122
4Acetylcysteine Injection3353
5Finerenone Tablets3269
6中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name317
7中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English name317
8呫诺美林曲司氯铵胶囊 · No verified English name310
9Ampicillin Sodium and Sulbactam Sodium for Injection3113
10Adapalene Gel2230

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

234 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shen Yao He Ze Pharma (Shandong) Co., Ltd. romanized1560
2Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized1246
3Shanxi Hua Kang Pharma Co., Ltd. romanized11100
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized1080
5Hunan Ke Lun Pharmaceutical Co., Ltd. romanized966
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized740
7Henan Ling Rui Pharmaceutical Co., Ltd. romanized640
8Bayer Inc.610
9Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized550
10Hua Run Zi Zhu Pharma Co., Ltd. romanized542

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

120 this week

AcceptedDrugApplicants
2025/08/12Import · Class 2.1 艾沙妥昔单抗注射液(皮下注射) · No verified English nameJXSS2500108 Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH
2025/08/12Import · Class 1 注射用SAR446523 · No verified English nameJXSL2500144 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/08/12Generic · Class 3 Sodium Cromoglicate Eye DropsCYHS2502936 Suzhou Le Zhu Pharmaceutical Co., Ltd. romanized
2025/08/12Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502930 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/12Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502929 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/12Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502928 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/12Generic · Class 3 磷/碳酸氢钠血滤置换液(4mmol/L钾、1.25mmol/L钙) · No verified English nameCYHS2502922 Ningbo Tian Yi Pharma Technology Co., Ltd. romanized
2025/08/12Generic · Class 3 Peramivir InjectionCYHS2502916 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2025/08/12Generic · Class 3 甲磺酸酚妥拉明滴眼液 · No verified English nameCYHL2500143 Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized
2025/08/12Generic · Class 3 呫诺美林曲司氯铵胶囊 · No verified English nameCYHL2500142 Jiangsu En Hua Pharma Co., Ltd. romanized
2025/08/12Generic · Class 3 呫诺美林曲司氯铵胶囊 · No verified English nameCYHL2500141 Jiangsu En Hua Pharma Co., Ltd. romanized
2025/08/12Generic · Class 3 呫诺美林曲司氯铵胶囊 · No verified English nameCYHL2500140 Jiangsu En Hua Pharma Co., Ltd. romanized
2025/08/12New drug · Class 1.1 小儿胆青双解颗粒 · No verified English nameCXZL2500065 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2025/08/12New drug · Class 1.2 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2500691 Beijing Hua Nuo Tai Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Hua Nuo Tai Biopharmaceuticals Technology Co., Ltd. romanized; Hua Nuo Tai Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/08/12New drug · Class 1 注射用QLC5513 · No verified English nameCXSL2500690 Qilu Pharmaceutical Co., Ltd.
2025/08/12New drug · Class 2.4 吡非尼酮胶囊 · No verified English nameCXHL2500836 Beijing Kang Di Ni Pharma Co., Ltd. romanized
2025/08/12New drug · Class 1 ARTS-023片 · No verified English nameCXHL2500835 An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2025/08/12New drug · Class 1 ARTS-023片 · No verified English nameCXHL2500834 An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2025/08/12New drug · Class 2.4 结合雌激素乳膏 · No verified English nameCXHL2500833 Xinjiang Xin Zi Yuan Biopharmaceutical Co., Ltd. romanized
2025/08/11Import · Class 1 Icotrokinra片 · No verified English nameJXHL2500213 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/08/11Import · Class 2.4; 2.2 马立巴韦干混悬剂 · No verified English nameJXHL2500212 Takeda Pharmaceuticals U.S.A. Inc; Takeda(China) International Company Ltd.
2025/08/11Import · Class 2.4; 2.2 马立巴韦干混悬剂 · No verified English nameJXHL2500211 Takeda Pharmaceuticals U.S.A. Inc.; Takeda(China) International Company Ltd.
2025/08/11New drug · Class 2.4 海曲泊帕乙醇胺片 · No verified English nameCXHS2500094 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/11New drug · Class 2.4 海曲泊帕乙醇胺片 · No verified English nameCXHS2500093 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/11New drug · Class 2.4 海曲泊帕乙醇胺片 · No verified English nameCXHS2500092 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/09Generic · Class 3 Glycopyrrolate InjectionCYHS2502894 Henan Pu Rui Pharma Co., Ltd. romanized
2025/08/09Generic · Class 3 Glycopyrrolate InjectionCYHS2502893 Henan Pu Rui Pharma Co., Ltd. romanized
2025/08/09Generic · Class 3 Elagolix Sodium TabletsCYHS2502892 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/08/09Generic · Class 3 Elagolix Sodium TabletsCYHS2502891 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/08/09Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2502890 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized

90 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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