YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 426 drug applications between 12 August 2023 and 18 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 116, covering 79 drug names.

2023/08/12 – 2023/08/18

Period
2023/08/12 to 2023/08/18, 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
426
Drugs with new generic filings (by drug name, de-duplicated)
79
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

426filings, 116 of them generic

By application type

Application typeFilings
Supplement202
Generic116
New drug62
Import23
Import re-registration20
Unspecified3

By drug type

Drug typeFilings
Chemical drug299
TCM74
Therapeutic biologic47
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

79 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nicorandil for Injection421
2Gadoteridol Injection413
3Empagliflozin Tablets3218
4Aminophylline Injection323
5Urapidil Hydrochloride Injection326
6恩那度司他片 · No verified English name310
7氧 · No verified English name2215
8Mupirocin Ointment2230
9Avatrombopag Maleate Tablets220
10Lactulose Oral Solution2134

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

241 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized15101
2GE Healthcare AS1410
3Changsha Ai Bei Gao Pharma Co., Ltd. romanized11110
4Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized990
5Shenyang Qing Gong Pharma Group Co., Ltd. romanized880
6Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized540
7Myokardia Inc.510
8Ren He Yi Kang Group Co., Ltd. romanized434
9Jiangsu Vanguard Pharmaceutical Co., Ltd.434
10Janssen Research & Development LLC420

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

124 this week

AcceptedDrugApplicants
2023/08/18Import · Class 2.2 Guselkumab Final Vialed Product for Intravenous Infusion (FVP(IV)) · No verified English nameJXSL2300156 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/18Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2300155 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/18Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2300154 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/18Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2300153 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/18Import · Class 1 BION-1301注射液 · No verified English nameJXSL2300152 Chinook Therapeutics Inc.; SanReno Therapeutics (Shanghai) Limited
2023/08/18Import · Class 2.4 Mavacamten胶囊 · No verified English nameJXHL2300190 Myokardia Inc.; Shanghai LianBio Development Co. Ltd.
2023/08/18Import · Class 2.4 Mavacamten胶囊 · No verified English nameJXHL2300189 Myokardia Inc.; Shanghai LianBio Development Co. Ltd.
2023/08/18Import · Class 2.4 Mavacamten胶囊 · No verified English nameJXHL2300188 Myokardia Inc.; Shanghai LianBio Development Co. Ltd.
2023/08/18Import · Class 2.4 Mavacamten胶囊 · No verified English nameJXHL2300187 Myokardia Inc.; Shanghai LianBio Development Co. Ltd.
2023/08/18Import · Class 2.4 Mavacamten胶囊 · No verified English nameJXHL2300186 Myokardia Inc.; Shanghai LianBio Development Co. Ltd.
2023/08/18Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2302190 Hua Run Shuang He Pharma Co., Ltd. romanized
2023/08/18Generic · Class 3 Methocarbamol InjectionCYHS2302187 Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2023/08/18Generic · Class 3 Metaraminol Tartrate InjectionCYHS2302186 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2023/08/18Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2302181 Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/08/18New drug · Class 1 VT-101注射液 · No verified English nameCXSL2300558 Jiangsu Wan Rong Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Wan Bang Pharmaceuticals Technology Co., Ltd. romanized
2023/08/18New drug · Class 3.3 司库奇尤单抗注射液 · No verified English nameCXSL2300557 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2023/08/18New drug · Class 1 CM313(SC)注射液 · No verified English nameCXSL2300556 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2023/08/18New drug · Class 1 自体抗CLL-1嵌合抗原受体T细胞注射液 · No verified English nameCXSL2300555 Guangzhou Bai Ji Ji Yin Technology Co., Ltd. romanized
2023/08/18New drug · Class 1 注射用IMM2510 · No verified English nameCXSL2300554 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/08/18New drug · Class 1 IMM27M注射液 · No verified English nameCXSL2300553 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/08/18New drug · Class 1 注射用HRS-9057 · No verified English nameCXHL2300890 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/08/17Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2302178 Sui Cheng Pharma Co., Ltd. romanized
2023/08/17Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2302177 Sui Cheng Pharma Co., Ltd. romanized
2023/08/17Generic · Class 3 Nicorandil for InjectionCYHS2302173 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2023/08/17Generic · Class 3 Nicorandil for InjectionCYHS2302172 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2023/08/17Generic · Class 3 Thiotepa for InjectionCYHS2302164 Name not romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2023/08/17Generic · Class 3 Thiotepa for InjectionCYHS2302163 Name not romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2023/08/17Generic · Class 3 Calcium Folinate InjectionCYHS2302161 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2023/08/17Generic · Class 3 Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2302159 Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/08/17Generic · Class 3 恩那度司他片 · No verified English nameCYHL2300102 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized

94 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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