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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 132 drug applications between 30 April 2023 and 6 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 28, covering 23 drug names.

2023/04/30 – 2023/05/06

Period
2023/04/30 to 2023/05/06, 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
132
Drugs with new generic filings (by drug name, de-duplicated)
23
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

132filings, 28 of them generic

By application type

Application typeFilings
Supplement59
New drug32
Generic28
Import re-registration7
Import5
Unspecified1

By drug type

Drug typeFilings
Chemical drug78
Therapeutic biologic29
TCM25

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

23 drugs with new generic filings; top 10 listed

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

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

82 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shaanxi Qing Hua Zi Guang Bio Technology Co., Ltd. romanized660
2Novo Nordisk A/S510
3Sichuan He Li Xin Jian Pharma Co., Ltd. romanized440
4McNeil Sweden AB410
5Ha Yao Group Pharmaceutical Factory romanized410
6Heilongjiang Jia Yue Ze Medical Technology Co., Ltd. romanized330
7Ren He Yi Kang Group Co., Ltd. romanized323
8Eli Lilly and Company310
9Janssen Research & Development LLC310
10Shanghai Han Dou Pharmaceuticals Technology Co., Ltd. romanized310

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

49 this week

AcceptedDrugApplicants
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
2023/05/06New drug · Class 1.1 小儿银连颗粒 · No verified English nameCXZL2300032 Yi Li Pharmaceutical (Luo Ding) Co., Ltd. romanized
2023/05/06New drug · Class 1 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2300315 Shanghai Bang Yao Bio Technology Co., Ltd. romanized
2023/05/06New drug · Class 1 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2300314 Shanghai Bang Yao Bio Technology Co., Ltd. romanized
2023/05/06New drug · Class 1 注射用XJ101 · No verified English nameCXSL2300313 Xing Ji Bio (Suzhou) Co., Ltd. romanized
2023/05/06New drug · Class 1 BPR-101胶囊 · No verified English nameCXSL2300312 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2023/05/06New drug · Class 1 BPR-101胶囊 · No verified English nameCXSL2300311 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2023/05/06New drug · Class 1 BPR-101胶囊 · No verified English nameCXSL2300310 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2023/05/06New drug · Class 1 QN-019a细胞注射液 · No verified English nameCXSL2300309 Hangzhou Qi Han Bio Technology Co., Ltd. romanized
2023/05/06New drug · Class 1 HB0030注射液 · No verified English nameCXSL2300308 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/05/06New drug · Class 1 HB0025注射液 · No verified English nameCXSL2300307 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized
2023/05/06New drug · Class 2.2; 2.4 吸入用H057 · No verified English nameCXHL2300468 Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized
2023/05/06New drug · Class 2.2; 2.4 吸入用H057 · No verified English nameCXHL2300467 Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized
2023/05/06New drug · Class 1 TJ0113胶囊 · No verified English nameCXHL2300466 Hangzhou Tian Ji Ji Shi Bio Technology Co., Ltd. romanized
2023/05/06New drug · Class 1 TJ0113胶囊 · No verified English nameCXHL2300465 Hangzhou Tian Ji Ji Shi Bio Technology Co., Ltd. romanized
2023/05/06New drug · Class 2.2 左旋多巴口腔控释片/卡左双多巴片 · No verified English nameCXHL2300464 Shanghai Han Dou Pharmaceuticals Technology Co., Ltd. romanized
2023/05/06New drug · Class 2.2 左旋多巴口腔控释片/卡左双多巴片 · No verified English nameCXHL2300463 Shanghai Han Dou Pharmaceuticals Technology Co., Ltd. romanized
2023/05/06New drug · Class 2.2 左旋多巴口腔控释片/卡左双多巴片 · No verified English nameCXHL2300462 Shanghai Han Dou Pharmaceuticals Technology Co., Ltd. romanized
2023/05/06New drug · Class 1 XH-S003胶囊 · No verified English nameCXHL2300461 Zhejiang Xing Hao Peng Bo Pharmaceuticals Co., Ltd. romanized
2023/05/06New drug · Class 1 XH-S003胶囊 · No verified English nameCXHL2300460 Zhejiang Xing Hao Peng Bo Pharmaceuticals Co., Ltd. romanized

19 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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