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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 389 drug applications between 10 August 2025 and 16 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 120, covering 81 drug names.

2025/08/10 – 2025/08/16

Period
2025/08/10 to 2025/08/16, 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
389
Drugs with new generic filings (by drug name, de-duplicated)
81
Accepted this week, now under review
107

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

389filings, 120 of them generic

By application type

Application typeFilings
Supplement164
Generic120
New drug56
Import24
Unspecified19
Import re-registration6

By drug type

Drug typeFilings
Chemical drug271
Therapeutic biologic57
TCM49
Biologic7
Prophylactic biologic5

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

81 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets6370
2Baricitinib Tablets3232
3Trazodone Hydrochloride Sustained-release Tablets3220
4中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English name317
5中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English name317
6中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English name317
7Lactulose Oral Solution3134
8呫诺美林曲司氯铵胶囊 · No verified English name310
9Ampicillin Sodium and Sulbactam Sodium for Injection3113
10Ruxolitinib Phosphate Tablets3127

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

226 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized1559
2Qilu Pharmaceutical Co., Ltd.1063
3AstraZeneca AB940
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized930
5Henan Ling Rui Pharmaceutical Co., Ltd. romanized660
6Terumo Corporation Kofu Factory510
7Shandong Er Ye Pharmaceutical Co., Ltd. romanized510
8Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized510
9SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED441
10Shanxi Hua Kang Pharma Co., Ltd. romanized440

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

121 this week

AcceptedDrugApplicants
2025/08/16Import · Class 2.4 Rilzabrutinib片 · No verified English nameJXHL2500217 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/08/16Generic · Class 3 盐酸卡替洛尔滴眼液 · No verified English nameCYHS2503016 Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized; Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2025/08/16Generic · Class 3 洛索洛芬钠颗粒 · No verified English nameCYHS2503013 Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized
2025/08/16Generic · Class 3 Bifonazole SolutionCYHS2503009 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2025/08/16Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2503006 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/08/16Generic · Class 3 Bifonazole SolutionCYHS2503005 Hangzhou Shang He Health Technology Co., Ltd. romanized; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized
2025/08/16Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2503004 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2025/08/16Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2503003 Zhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanized
2025/08/16Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2503002 Zhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanized
2025/08/16Generic · Class 3 Amisulpride Oral SolutionCYHS2503000 Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2025/08/16New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500084 Hui Sheng Biopharmaceutical Co., Ltd. romanized
2025/08/16New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500083 Hui Sheng Biopharmaceutical Co., Ltd. romanized
2025/08/16New drug · Class 1 注射用乙型脑炎溶瘤病毒 · No verified English nameCXSL2500709 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2025/08/16New drug · Class 1 注射用乙型脑炎溶瘤病毒 · No verified English nameCXSL2500708 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2025/08/16New drug · Class 1 注射用乙型脑炎溶瘤病毒 · No verified English nameCXSL2500707 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2025/08/16New drug · Class 1 注射用乙型脑炎溶瘤病毒 · No verified English nameCXSL2500706 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2025/08/16New drug · Class 2.6 吸附无细胞百白破(组分)联合疫苗(成人及青少年用) · No verified English nameCXSL2500705 Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized
2025/08/16New drug · Class 1 SHR-1139注射液 · No verified English nameCXSL2500704 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/16New drug · Class 2.2; 2.4 XZ022 · No verified English nameCXHL2500860 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/08/16New drug · Class 1 MAX-001胶囊 · No verified English nameCXHL2500859 An Yan Da Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2025/08/16New drug · Class 1 MAX-001胶囊 · No verified English nameCXHL2500858 An Yan Da Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2025/08/16New drug · Class 2.3 HWH217片 · No verified English nameCXHL2500857 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2025/08/16New drug · Class 2.3 HWH217片 · No verified English nameCXHL2500856 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2025/08/15Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2502996 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized
2025/08/15Generic · Class 3 JP-1366片 · No verified English nameCYHS2502991 Li Zhu Pharmaceuticals Group Co., Ltd. romanized; Li Zhu Group Li Zhu Pharmaceutical Factory romanized
2025/08/15Generic · Class 3 聚乙二醇4000散 · No verified English nameCYHS2502988 Xian An Jian Pharma Co., Ltd. romanized
2025/08/15Generic · Class 3 Pregabalin Oral SolutionCYHS2502986 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2025/08/15Generic · Class 3 Pregabalin Oral SolutionCYHS2502983 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2025/08/15Generic · Class 3 Relugolix TabletsCYHL2500147 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/08/15New drug · Class 1 GenSci098注射液 · No verified English nameCXSL2500703 Changchun Jin Sai Pharma Co., Ltd. romanized

91 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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