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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 485 drug applications between 31 January 2024 and 6 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 147, covering 109 drug names.

2024/01/31 – 2024/02/06

Period
2024/01/31 to 2024/02/06, 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
485
Drugs with new generic filings (by drug name, de-duplicated)
109
Accepted this week, now under review
8

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

485filings, 147 of them generic

By application type

Application typeFilings
Supplement193
Generic147
New drug85
Import35
Import re-registration13
Unspecified12

By drug type

Drug typeFilings
Chemical drug335
Therapeutic biologic79
TCM55
Prophylactic biologic11
Biologic5

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

109 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment5152
2Tadalafil Tablets4323
3Diprophylline Injection337
4Lidocaine and Prilocaine Cream3324
5Sacubitril Valsartan Sodium Tablets3170
6LevomilnacipranHydrochloride Extended-release Capsules316
7Gatifloxacin Eye Drops223
8Dronedarone Hydrochloride Tablets224
9盐酸左沙丁胺醇雾化吸入溶液 · No verified English name222
10Metoclopramide Hydrochloride Injection226

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

300 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Pfizer Inc.730
2Sichuan Yi Ke Cao Pharma Co., Ltd. romanized660
3Sichuan Kelun Pharmaceutical Co., Ltd.644
4Jiangsu En Hua Pharma Co., Ltd. romanized634
5AbbVie Inc.620
6Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized610
7Shijiazhuang No.4 Pharmaceutical Co., Ltd.553
8Bayer AG530
9Pfizer Europe MA EEIG530
10Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized535

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

184 this week

AcceptedDrugApplicants
2024/02/06Import · Class 3.1 美泊利珠单抗注射液 · No verified English nameJXSS2400010 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited
2024/02/06Import · Class 3.1 美泊利珠单抗注射液 · No verified English nameJXSS2400009 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited
2024/02/06Import · Class 3.1 注射用戈沙妥珠单抗 · No verified English nameJXSS2400008 Gilead Sciences Inc.; BSP Pharmaceuticals S.p.A.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2024/02/06Import · Class 2.2 Lebrikizumab注射液 · No verified English nameJXSL2400041 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/02/06Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2400040 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/02/06Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2400039 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/02/06Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2400038 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/02/06Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2400037 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/02/06Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2400036 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/02/06Import · Class 1 BI 1810631 片 · No verified English nameJXHL2400030 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2024/02/06Import · Class 1 BAY 2965501片 · No verified English nameJXHL2400029 Bayer AG; Bayer Healthcare Company Ltd.
2024/02/06Import · Class 1 BAY 2965501片 · No verified English nameJXHL2400028 Bayer AG; Bayer Healthcare Company Ltd.
2024/02/06Generic · Class 3 复方维生素C聚乙二醇(3350)钠钾散 · No verified English nameCYHS2400530 Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized
2024/02/06Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2400529 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/02/06Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2400528 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/02/06Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2400527 Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2024/02/06Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2400525 Jin Nuo Kang Pharma Technology (Shijiazhuang) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2024/02/06Generic · Class 3 Diprophylline InjectionCYHS2400523 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/02/06Generic · Class 3 Nicergoline TabletsCYHS2400518 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/02/06Generic · Class 3 Nicergoline TabletsCYHS2400517 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/02/06Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2400516 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/02/06Generic · Class 3 Magnesium Sulfate InjectionCYHS2400511 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2024/02/06Generic · Class 3 复方电解质注射液(Ⅴ) · No verified English nameCYHS2400510 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/02/06Generic · Class 3 盐酸羟甲唑啉滴鼻液 · No verified English nameCYHS2400509 Nanjing Hai Jing Pharma Co., Ltd. romanized
2024/02/06Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2400503 E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2024/02/06Generic · Class 3 Epinastine Hydrochloride Eye DropsCYHS2400502 Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized
2024/02/06Generic · Class 3 Ondansetron Orally Disintegrating TabletsCYHS2400501 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized
2024/02/06Generic · Class 3 Ondansetron Orally Disintegrating TabletsCYHS2400500 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized
2024/02/06Generic · Class 3 Haloperidol Lactate InjectionCYHS2400499 Yu Song Yuan Pharma Co., Ltd. romanized
2024/02/06New drug · Class 1.1 羌芩颗粒 · No verified English nameCXZL2400009 Jiangsu Kang Yuan Pharma Co., Ltd. romanized

154 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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