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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 182 drug applications between 1 May 2023 and 7 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 37, covering 31 drug names.

2023/05/01 – 2023/05/07

Period
2023/05/01 to 2023/05/07, 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
182
Drugs with new generic filings (by drug name, de-duplicated)
31
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

182filings, 37 of them generic

By application type

Application typeFilings
Supplement84
New drug41
Generic37
Import11
Import re-registration7
Unspecified2

By drug type

Drug typeFilings
Chemical drug112
Therapeutic biologic40
TCM29
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

31 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Arginine and Ibuprofen Granules3111
2Fluorouracil Injection216
3Nicorandil for Injection211
4硝酸甘油葡萄糖注射液 · No verified English name210
5Amikacin Sulfate injection214
6Tadalafil Tablets1123
7Voriconazole for Oral Suspension111
8Epalrestat Tablets111
9Indobufen Tablets116
10吸入用布地奈德混悬液 · No verified English name117

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

108 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized980
2Novo Nordisk A/S820
3Shaanxi Qing Hua Zi Guang Bio Technology Co., Ltd. romanized660
4Sichuan He Li Xin Jian Pharma Co., Ltd. romanized440
5McNeil Sweden AB410
6Ha Yao Group Pharmaceutical Factory romanized410
7Jin Zhou Ao Hong Pharma Co., Ltd. romanized410
8Heilongjiang Jia Yue Ze Medical Technology Co., Ltd. romanized330
9Ren He Yi Kang Group Co., Ltd. romanized323
10Hui Sheng Biopharmaceutical Co., Ltd. romanized321

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

68 this week

AcceptedDrugApplicants
2023/05/07Import · Class 1 依柯胰岛素注射液 · No verified English nameJXSS2300036 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2023/05/07Import · Class 1 依柯胰岛素注射液 · No verified English nameJXSS2300035 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2023/05/07Import · Class 1 依柯胰岛素注射液 · No verified English nameJXSS2300034 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2023/05/07Import · Class 1 VAY736注射液 · No verified English nameJXSL2300091 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/05/07Import · Class 2.2 (decitabine and cedazuridine)片 · No verified English nameJXHL2300103 Otsuka Pharmaceutical Co. Ltd; Otsuka Beijing Research Institute
2023/05/07Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2301237 Anhui Hai Si Mei Pharmaceuticals Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2023/05/07Generic · Class 3 Fluorouracil InjectionCYHS2301235 Hubei Min Kang Pharma Group Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized
2023/05/07Generic · Class 3 Fluorouracil InjectionCYHS2301234 Hubei Min Kang Pharma Group Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized
2023/05/07Generic · Class 3 Minoxidil LinimentCYHS2301232 Name not romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/05/07Generic · Class 3 Esketamine Hydrochloride InjectionCYHL2300070 Chengdu Brilliant Pharmaceutical Co., Ltd.
2023/05/07New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSS2300029 Hui Sheng Biopharmaceutical Co., Ltd. romanized
2023/05/07New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSS2300028 Hui Sheng Biopharmaceutical Co., Ltd. romanized
2023/05/07New drug · Class 3.3 注射用BLB101 · No verified English nameCXSL2300317 Beijing Li Bang Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/07New drug · Class 3.3 GLR1023注射液 · No verified English nameCXSL2300316 Gan Li Pharma Co., Ltd. romanized
2023/05/07New drug · Class 1 FCN-437c胶囊 · No verified English nameCXHL2300473 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2023/05/07New drug · Class 1 FCN-437c胶囊 · No verified English nameCXHL2300472 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2023/05/07New drug · Class 1 FCN-437c胶囊 · No verified English nameCXHL2300471 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2023/05/07New drug · Class 1 FCN-437c胶囊 · No verified English nameCXHL2300470 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2023/05/07New drug · Class 2.2 盐酸达泊西汀口溶膜 · No verified English nameCXHL2300469 Sichuan Kelun Pharmaceutical Co., Ltd.
2023/05/06Import · Class 1 Mim8 · No verified English nameJXSL2300090 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/05/06Import · Class 1 Mim8 · No verified English nameJXSL2300089 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/05/06Import · Class 1 Mim8 · No verified English nameJXSL2300088 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/05/06Import · Class 1 Mim8 · No verified English nameJXSL2300087 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/05/06Import · Class 1 Mim8 · No verified English nameJXSL2300086 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/05/06Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2301228 Anhui Huan Qiu Pharma Co., Ltd. romanized
2023/05/06Generic · Class 3 硝酸甘油葡萄糖注射液 · No verified English nameCYHS2301227 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/05/06Generic · Class 3 硝酸甘油葡萄糖注射液 · No verified English nameCYHS2301226 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/05/06Generic · Class 3 Nicorandil for InjectionCYHS2301224 Guangdong Hai He Biopharmaceuticals Technology Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2023/05/06Generic · Class 3 Nicorandil for InjectionCYHS2301223 Guangdong Hai He Biopharmaceuticals Technology Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2023/05/06Generic · Class 3 Epalrestat TabletsCYHS2301215 Hui Sheng Biopharmaceutical Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized

38 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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