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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 355 drug applications between 2 November 2023 and 8 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 64 drug names.

2023/11/02 – 2023/11/08

Period
2023/11/02 to 2023/11/08, 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
355
Drugs with new generic filings (by drug name, de-duplicated)
64
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

355filings, 92 of them generic

By application type

Application typeFilings
Supplement169
Generic92
New drug65
Import re-registration15
Import10
Unspecified4

By drug type

Drug typeFilings
Chemical drug226
TCM86
Therapeutic biologic41
Biologic1
Prophylactic 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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Norepinephrine Bitartrate Injection429
3Benidipine Hydrochloride Tablets324
4Minoxidil Liniment3252
5中/长链脂肪乳注射液(C6~24) · No verified English name310
6Piracetam Injection319
7Potassium Phosphates Injection222
8氧 · No verified English name2215
9Potassium Chloride Injection2210
10Famotidine Injection228

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

206 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized19190
2Jiangsu Hao Sen Pharma Group Co., Ltd. romanized1030
3ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.757
4Shijiazhuang No.4 Pharmaceutical Co., Ltd.721
5Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized640
6Sanofi Winthrop Industrie620
7Guangdong Tuan Li Pharmaceutical Co., Ltd. romanized550
8Merck Sharp & Dohme B.V.510
9Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized510
10Guangxi Hong Ji Pharma Group 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

114 this week

AcceptedDrugApplicants
2023/11/08Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2300083 Merck Sharp & Dohme LLC; MSD Ireland(Carlow); MSD R&D (China) Co. Ltd.
2023/11/08Import · Class 1 Lebrikizumab注射液 · No verified English nameJXSL2300191 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/11/08Import · Class 1 BAY 2433334片 · No verified English nameJXHL2300276 Bayer AG; Bayer Healthcare Company Ltd.
2023/11/08Generic · Class 3 Bumetanide InjectionCYHS2303056 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/11/08Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2303054 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2023/11/08Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2303053 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2023/11/08Generic · Class 3 Piracetam InjectionCYHS2303050 Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Xian Yuan Da De Tian Pharma Co., Ltd. romanized
2023/11/08Generic · Class 3 Piracetam InjectionCYHS2303049 Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Xian Yuan Da De Tian Pharma Co., Ltd. romanized
2023/11/08Generic · Class 3 Piracetam InjectionCYHS2303048 Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Xian Yuan Da De Tian Pharma Co., Ltd. romanized
2023/11/08Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2303046 Zhong Run Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/11/08Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2303045 Zhong Run Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/11/08Generic · Class 3 Famotidine InjectionCYHS2303043 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized
2023/11/08Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2303041 Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized
2023/11/08Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2303040 Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized
2023/11/08New drug · Class 1 注射用RC88 · No verified English nameCXSL2300768 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/11/08New drug · Class 2.2 CG2001 · No verified English nameCXHL2301246 Beijing Chen Guang Pharmaceuticals Technology Co., Ltd. romanized; Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/11/08New drug · Class 2.2 碳[13C]美沙西汀肝脏储备功能诊断药盒 · No verified English nameCXHL2301245 Beijing Hua Gen An Bang Technology Co., Ltd. romanized
2023/11/08New drug · Class 1 HS-10509片 · No verified English nameCXHL2301244 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/08New drug · Class 1 HS-10509片 · No verified English nameCXHL2301243 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/08New drug · Class 1 HS-10509片 · No verified English nameCXHL2301242 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/08New drug · Class 1 HS-10501片 · No verified English nameCXHL2301241 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/08New drug · Class 1 HS-10501片 · No verified English nameCXHL2301240 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/08New drug · Class 1 HS-10501片 · No verified English nameCXHL2301239 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/08New drug · Class 1 HS-10501片 · No verified English nameCXHL2301238 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/08New drug · Class 1 HS-10501片 · No verified English nameCXHL2301237 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2023/11/08New drug · Class 1 HS-10501片 · No verified English nameCXHL2301236 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/08New drug · Class 1 SYN045片 · No verified English nameCXHL2301235 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/11/08New drug · Class 1 SYN045片 · No verified English nameCXHL2301234 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/11/08New drug · Class 1 SYN045片 · No verified English nameCXHL2301233 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/11/08New drug · Class 1 SYN045片 · No verified English nameCXHL2301232 Shijiazhuang No.4 Pharmaceutical Co., Ltd.

84 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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