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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 387 drug applications between 11 August 2023 and 17 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 105, covering 73 drug names.

2023/08/11 – 2023/08/17

Period
2023/08/11 to 2023/08/17, 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
387
Drugs with new generic filings (by drug name, de-duplicated)
73
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

387filings, 105 of them generic

By application type

Application typeFilings
Supplement188
Generic105
New drug55
Import re-registration21
Import13
Unspecified5

By drug type

Drug typeFilings
Chemical drug269
TCM75
Therapeutic biologic37
Prophylactic biologic4
In vitro diagnostic reagent1
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

73 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nicorandil for Injection421
2Empagliflozin Tablets3218
3Aminophylline Injection323
4恩那度司他片 · No verified English name310
5Peramivir Injection227
6氧 · No verified English name2215
7Avatrombopag Maleate Tablets220
8Lactulose Oral Solution2134
9Tacrolimus Sustained-release Capsules216
10Piracetam Injection219

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

222 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1GE Healthcare AS1410
2Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized1381
3Shenyang Qing Gong Pharma Group Co., Ltd. romanized11110
4Changsha Ai Bei Gao Pharma Co., Ltd. romanized11110
5Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized990
6Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized540
7Ren He Yi Kang Group Co., Ltd. romanized434
8Jiangsu Vanguard Pharmaceutical Co., Ltd.434
9Shandong Xin Shi Dai Pharma Co., Ltd. romanized422
10Shijiazhuang No.4 Pharmaceutical Co., Ltd.421

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

104 this week

AcceptedDrugApplicants
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
2023/08/17Generic · Class 3 恩那度司他片 · No verified English nameCYHL2300101 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2023/08/17Generic · Class 3 恩那度司他片 · No verified English nameCYHL2300100 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2023/08/17Generic · Class 3 血管紧张素II注射液 · No verified English nameCYHL2300099 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/08/17New drug · Class 3.1 苓桂术甘汤颗粒 · No verified English nameCXZS2300016 Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized
2023/08/17New drug · Class 1 STSA-1301 皮下注射液 · No verified English nameCXSL2300552 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2023/08/17New drug · Class 1.2 重组脊髓灰质炎疫苗(汉逊酵母) · No verified English nameCXSL2300551 Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized; Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/08/17New drug · Class 1 SSGJ-621注射液 · No verified English nameCXSL2300550 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2023/08/17New drug · Class 1 注射用HLX43 · No verified English nameCXSL2300549 Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2023/08/17New drug · Class 1 注射用HLX42 · No verified English nameCXSL2300548 Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2023/08/17New drug · Class 2.2 注射用N2107(纳米晶) · No verified English nameCXHL2300889 Jiangsu Hui Ju Pharma Co., Ltd. romanized
2023/08/17New drug · Class 1 THDBH110胶囊 · No verified English nameCXHL2300888 Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2023/08/17New drug · Class 1 THDBH110胶囊 · No verified English nameCXHL2300887 Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2023/08/17New drug · Class 1 THDBH110胶囊 · No verified English nameCXHL2300886 Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2023/08/17New drug · Class 1 HW091077片 · No verified English nameCXHL2300885 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized
2023/08/17New drug · Class 1 HW091077片 · No verified English nameCXHL2300884 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized
2023/08/16Import · Class 2.2 ASKC200搽剂 · No verified English nameJXHL2300185 Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD
2023/08/16Import · Class 2.2 ASKC200搽剂 · No verified English nameJXHL2300184 Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD
2023/08/16Import · Class 2.2 ASKC200搽剂 · No verified English nameJXHL2300183 Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD
2023/08/16Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2302156 Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized
2023/08/16Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2302151 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/08/16Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2302150 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized

74 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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