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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 386 drug applications between 6 September 2023 and 12 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 62 drug names.

2023/09/06 – 2023/09/12

Period
2023/09/06 to 2023/09/12, 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
386
Drugs with new generic filings (by drug name, de-duplicated)
62
Accepted this week, now under review
0

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

386filings, 75 of them generic

By application type

Application typeFilings
Supplement196
Generic75
New drug53
Import35
Import re-registration20
Unspecified7

By drug type

Drug typeFilings
Chemical drug293
TCM56
Therapeutic biologic31
Prophylactic biologic5
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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Amoxicillin Sodium for Injection310
2Lidocaine and Prilocaine Cream2224
3吸入用布地奈德混悬液 · No verified English name227
4复方聚乙二醇电解质散(儿童型) · No verified English name222
5Formoterol Fumarate Inhalation Solution225
6Pentoxifylline Injection223
7Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
8Famotidine Injection218
9Nicorandil for Injection211
10Oxacillin Sodium for Injection2113

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

212 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1NAPP PHARMACEUTICALS LIMITED1510
2Boehringer Ingelheim International GmbH1410
3Haerbin Tong Yi Tang Pharma Co., Ltd. romanized11110
4Xian Jing Xi Shuang He Pharma Co., Ltd. romanized720
5Changchun Jin Sai Pharma Co., Ltd. romanized720
6Shanxi Zhen Dong Wu He Tang Pharmaceutical Co., Ltd. romanized660
7Shen Wei Pharma Group Co., Ltd. romanized660
8Jiangsu En Hua Pharma Co., Ltd. romanized631
9Eli Lilly and Company610
10Shanghai Bai Te Medical Yong Pin Co., Ltd. romanized610

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

116 this week

AcceptedDrugApplicants
2023/09/12Import · Class 1 GSK1070806注射液 · No verified English nameJXSL2300169 GlaxoSmithKline Intellectual Property Development Limited; GlaxoSmithKline (China) Investment Co. LTD
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300223 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300222 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300221 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300220 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300219 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300218 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300217 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300216 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300215 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300214 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300213 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300212 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300211 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300210 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/12Generic · Class 3 聚乙二醇4000散(儿童型) · No verified English nameCYHS2302460 Jin Nuo Kang Pharma Technology (Shijiazhuang) Co., Ltd. romanized; Shijiazhuang Yu Hui Pharmaceutical Co., Ltd. romanized
2023/09/12Generic · Class 3 Oxacillin Sodium for InjectionCYHS2302452 Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2023/09/12Generic · Class 3 Oxacillin Sodium for InjectionCYHS2302451 Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2023/09/12Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302450 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2023/09/12Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302449 Su Zhou Yi Fan Pharma Co., Ltd. romanized
2023/09/12Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2302447 Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2023/09/12Generic · Class 3 Famotidine InjectionCYHS2302446 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/09/12Generic · Class 3 Famotidine InjectionCYHS2302445 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/09/12New drug · Class 3.2 重组人促卵泡激素-CTP融合蛋白注射液 · No verified English nameCXSL2300612 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/09/12New drug · Class 3.2 重组人促卵泡激素-CTP融合蛋白注射液 · No verified English nameCXSL2300611 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/09/12New drug · Class 2.2 重组人促卵泡激素-CTP融合蛋白注射液 · No verified English nameCXSL2300610 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/09/12New drug · Class 2.2 重组人促卵泡激素-CTP融合蛋白注射液 · No verified English nameCXSL2300609 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/09/12New drug · Class 1 LNF1802单克隆抗体注射液 · No verified English nameCXSL2300608 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/09/12New drug · Class 1 LNF1901单克隆抗体注射液 · No verified English nameCXSL2300607 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/09/12New drug · Class 1 REV001注射液 · No verified English nameCXSL2300606 Shanghai Xing Shen Bio Technology Co., Ltd. romanized

86 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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