YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 403 drug applications between 9 August 2025 and 15 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 124, covering 80 drug names.

2025/08/09 – 2025/08/15

Period
2025/08/09 to 2025/08/15, 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
403
Drugs with new generic filings (by drug name, de-duplicated)
80
Accepted this week, now under review
103

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

403filings, 124 of them generic

By application type

Application typeFilings
Supplement167
Generic124
New drug66
Import24
Unspecified19
Import re-registration3

By drug type

Drug typeFilings
Chemical drug269
Therapeutic biologic67
TCM56
Biologic7
Prophylactic biologic4

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

80 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets6370
2Lactulose Oral Solution5234
3苯磺酸左氨氯地平片 · No verified English name4245
4Baricitinib Tablets3232
5Finerenone Tablets3269
6中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English name317
7中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English name317
8中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English name317
9呫诺美林曲司氯铵胶囊 · No verified English name310
10Ampicillin Sodium and Sulbactam Sodium for Injection3113

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

230 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
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized1040
4AstraZeneca AB940
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized760
6Henan Ling Rui Pharmaceutical Co., Ltd. romanized660
7Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized630
8Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized540
9Terumo Corporation Kofu Factory510
10Shandong Er Ye Pharmaceutical Co., Ltd. romanized510

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

129 this week

AcceptedDrugApplicants
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
2025/08/15New drug · Class 1 Cizutamig注射液 · No verified English nameCXSL2500702 Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized
2025/08/15New drug · Class 1 注射用YP004 · No verified English nameCXSL2500701 Yuan Pu Bio Technology (Wuhan) Co., Ltd. romanized
2025/08/15New drug · Class 1 VBC101 · No verified English nameCXSL2500700 Shanghai Cheng Fan Pharmaceuticals Co., Ltd. romanized
2025/08/15New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2500699 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2025/08/15New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2500698 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2025/08/15New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2500697 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2025/08/15New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2500696 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2025/08/15New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2500695 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2025/08/15New drug · Class 1 HSK39297片 · No verified English nameCXHL2500855 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/08/15New drug · Class 1 HSK39297片 · No verified English nameCXHL2500854 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/08/15New drug · Class 1 HSK39297片 · No verified English nameCXHL2500853 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/08/15New drug · Class 1 HSK39297片 · No verified English nameCXHL2500852 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/08/15New drug · Class 2.4 注射用戈舍瑞林微球 · No verified English nameCXHL2500851 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2025/08/15New drug · Class 1 TGRX-678片 · No verified English nameCXHL2500850 Shenzhen Shi Ta Ji Rui Biopharmaceuticals Co., Ltd. romanized
2025/08/15New drug · Class 1 D-2570片 · No verified English nameCXHL2500849 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2025/08/14Import · Class 2.2 注射用替奈普酶 · No verified English nameJXSL2500155 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/08/14Import · Class 1 AZD0486 · No verified English nameJXSL2500154 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/14Import · Class 1 AZD0486 · No verified English nameJXSL2500153 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/14Import · Class 1 AZD0486 · No verified English nameJXSL2500152 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/14Import · Class 1 AZD0486 · No verified English nameJXSL2500151 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/14Import · Class 1 AZD0486 · No verified English nameJXSL2500150 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/14Import · Class 1 BCD-261注射液 · No verified English nameJXSL2500149 SPH-BIOCAD (HK) LIMITED; SPH-BIOCAD Biopharmaceuticals (SH) Co. Ltd.
2025/08/14Import · Class 1 MEDI5752 · No verified English nameJXSL2500148 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.

99 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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