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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 396 drug applications between 7 September 2023 and 13 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 66 drug names.

2023/09/07 – 2023/09/13

Period
2023/09/07 to 2023/09/13, 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
396
Drugs with new generic filings (by drug name, de-duplicated)
66
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

396filings, 83 of them generic

By application type

Application typeFilings
Supplement194
Generic83
New drug60
Import31
Import re-registration19
Unspecified9

By drug type

Drug typeFilings
Chemical drug298
TCM54
Therapeutic biologic37
Prophylactic biologic6
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

66 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
4Formoterol Fumarate Inhalation Solution225
5Levocarnitine Oral Solution229
6Pentoxifylline Injection223
7Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
8利伐沙班颗粒 · No verified English name212
9Pregabalin Oral Solution215
10Famotidine Injection218

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

224 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1NAPP PHARMACEUTICALS LIMITED1510
2Boehringer Ingelheim International GmbH1410
3Xian Jing Xi Shuang He Pharma Co., Ltd. romanized920
4Changchun Jin Sai Pharma Co., Ltd. romanized720
5Haerbin Tong Yi Tang Pharma Co., Ltd. romanized660
6Shanxi Zhen Dong Wu He Tang Pharmaceutical Co., Ltd. romanized660
7Shen Wei Pharma Group Co., Ltd. romanized660
8Eli Lilly and Company610
9Shanghai Bai Te Medical Yong Pin Co., Ltd. romanized610
10Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized550

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

125 this week

AcceptedDrugApplicants
2023/09/13Generic · Class 3 利伐沙班颗粒 · No verified English nameCYHS2302484 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/09/13Generic · Class 3 利伐沙班颗粒 · No verified English nameCYHS2302483 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/09/13Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2302481 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2023/09/13Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2302480 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2023/09/13Generic · Class 3 Fudosteine oral solutionCYHS2302476 Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized
2023/09/13Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2302475 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanized
2023/09/13Generic · Class 3 Pregabalin Oral SolutionCYHS2302471 Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/09/13Generic · Class 3 Pregabalin Oral SolutionCYHS2302470 Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/09/13Generic · Class 3 Adenosine InjectionCYHS2302469 Sui Cheng Pharma Co., Ltd. romanized
2023/09/13Generic · Class 3 Adenosine InjectionCYHS2302468 Sui Cheng Pharma Co., Ltd. romanized
2023/09/13Generic · Class 3 Carbazochrome Sodium Sulfonate TabletsCYHS2302466 Chengdu Brilliant Pharmaceutical Co., Ltd.
2023/09/13Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2302462 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2023/09/13New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2300618 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/09/13New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2300617 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/09/13New drug · Class 1 F012 · No verified English nameCXSL2300616 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/09/13New drug · Class 2.5 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2300615 Changchun Bai Ke Bio Technology Shareholding Company romanized
2023/09/13New drug · Class 1 注射用重组人FGF21-Fc融合蛋白 · No verified English nameCXSL2300614 An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/09/13New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2300613 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/09/13New drug · Class 1 HSK16149胶囊 · No verified English nameCXHS2300081 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/09/13New drug · Class 1 安脑三醇注射液 · No verified English nameCXHL2300995 Guangzhou Shi Sai Pu Te Pharmaceuticals Technology Co., Ltd. romanized
2023/09/13New drug · Class 2.2 OD-03 · No verified English nameCXHL2300994 Chongqing Ben Li Fang Pharmaceuticals Technology Co., Ltd. romanized
2023/09/13New drug · Class 1 SH-337片 · No verified English nameCXHL2300993 Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized; Nanjing Shuo Hui Pharmaceuticals Technology Co., Ltd. romanized
2023/09/13New drug · Class 2.4 脯氨酸恒格列净片 · No verified English nameCXHL2300992 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/13New drug · Class 2.4 脯氨酸恒格列净片 · No verified English nameCXHL2300991 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/13New drug · Class 1 HRS-8080片 · No verified English nameCXHL2300990 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/09/13New drug · Class 1 HRS-8080片 · No verified English nameCXHL2300989 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/09/13New drug · Class 1 注射用QD202 · No verified English nameCXHL2300988 Shanghai Kui Te Di Bio Technology Co., Ltd. romanized
2023/09/13New drug · Class 1 D-2570片 · No verified English nameCXHL2300987 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
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.

95 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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