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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 342 drug applications between 26 August 2024 and 1 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 76 drug names.

2024/08/26 – 2024/09/01

Period
2024/08/26 to 2024/09/01, 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
342
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
1

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

342filings, 101 of them generic

By application type

Application typeFilings
Supplement156
Generic101
New drug61
Import14
Unspecified8
Import re-registration2

By drug type

Drug typeFilings
Chemical drug222
TCM68
Therapeutic biologic42
Prophylactic biologic9
Biologic1

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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bumetanide Injection6313
2Rivaroxaban Tablets413
3维生素B6注射液 · No verified English name3310
4Tadalafil Tablets3123
5Gadobutrol Injection318
6Nicardipine Hydrochloride Injection2213
7Salbutamol Sulfate injection221
8Empagliflozin Tablets2118
9Sildenafil Citrate Tablets2112
10Nafamostat Mesilate for Injection2138

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

223 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized760
2Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized610
3Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized530
4Jiangsu Kang Yuan Pharma Co., Ltd. romanized520
5Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized444
6Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized440
7Guizhou Liang Ji Pharma Co., Ltd. romanized440
8Qingdao Dong Hai Pharma Co., Ltd. romanized440
9Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized424
10Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized414

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

112 this week

AcceptedDrugApplicants
2024/09/01Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2402869 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2024/09/01Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2402868 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2024/09/01Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2402867 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2024/09/01Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2402866 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2024/08/31Import · Class 2.4 Sulfur Hexafluoride Microbubbles for InjectionJXHS2400060 Bracco International B.V.; Bracco Suisse SA; Bracco Imaging Medical Technologies (Shanghai) Co. Ltd
2024/08/31Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2402865 Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/08/31Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402860 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/08/31Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2402858 Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/08/31Generic · Class 3 Revefenacin inhalation solutionCYHL2400182 Zhang Feng Pharma Co., Ltd. romanized
2024/08/31New drug · Class 1.1 玉蚕颗粒 · No verified English nameCXZL2400049 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized; Shanghai Fu Huo Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/08/31New drug · Class 1.1 膝痛颗粒 · No verified English nameCXZL2400048 Zhong Yi (Guangzhou) Technology Innovation Research Co., Ltd. romanized; Zhongguo Zhong Yi Ke College Zhong Yao Research Institute romanized
2024/08/31New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSS2400092 Cheng Da Bio (Ben Xi) Co., Ltd. romanized
2024/08/31New drug · Class 2.2 氨酚羟考酮缓释片 · No verified English nameCXHS2400088 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2024/08/31New drug · Class 1 CPI-818片 · No verified English nameCXHL2400893 Jia Xing He Ji Pharma Co., Ltd. romanized
2024/08/31New drug · Class 1 CPI-818片 · No verified English nameCXHL2400892 Jia Xing He Ji Pharma Co., Ltd. romanized
2024/08/30Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHS2402842 Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized
2024/08/30Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2402839 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized
2024/08/30Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2402838 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized
2024/08/30Generic · Class 3 Sodium Nitroprusside InjectionCYHS2402836 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/08/30Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402833 Guo Ren Health Pharmaceutical (Beijing) Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized
2024/08/30Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2402832 Ben Xi Jiang Cheng Pharmaceuticals Technology Co., Ltd. romanized; Jilin Si Huan Pharmaceutical Co., Ltd. romanized
2024/08/30Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402827 Zhejiang Jiang Bei Pharma Co., Ltd. romanized
2024/08/30Generic · Class 3 Fat-Soluble Vitamin Injection(Ⅰ)CYHS2402823 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/08/30Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2402822 Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/08/30Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2400181 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/30Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2400180 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/30Generic · Class 3 Brivaracetam Solution for InjectionCYHL2400179 Beijing Ren Zhong Pharma Co., Ltd. romanized
2024/08/30New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSS2400091 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2024/08/30New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSS2400090 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2024/08/30New drug · Class 1 PC-0003吸入溶液 · No verified English nameCXHL2400891 Jiangsu Zhang Tai Pharma Co., Ltd. romanized

82 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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