YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 367 drug applications between 20 February 2023 and 26 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 52 drug names.

2023/02/20 – 2023/02/26

Period
2023/02/20 to 2023/02/26, 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
367
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
1

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

367filings, 68 of them generic

By application type

Application typeFilings
Supplement206
Generic68
New drug42
Import24
Import re-registration24
Unspecified3

By drug type

Drug typeFilings
Chemical drug270
TCM49
Therapeutic biologic40
Prophylactic biologic8

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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oseltamivir Phosphate Capsules4239
2Duloxetine Hydrochloride Enteric Capsules314
3Acetaminophen Injection211
4Levofloxacin Tablets217
5Brivaracetam Tablets2119
6Potassium Chloride Granules214
7Nicorandil for Injection211
8Gemcitabine Hydrochloride for Injection211
9Erlotinib Hydrochloride Tablets210
10Dopamine Hydrochloride Injection213

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

218 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Jun Yuan Pharma Co., Ltd. romanized16100
2Guangxi Yu Yuan Pharma Co., Ltd. romanized1290
3Chongqing Qian Fang Drug Research Co., Ltd. romanized750
4Rui Yang Pharmaceutical Co., Ltd. romanized633
5Sichuan Kelun Pharmaceutical Co., Ltd.532
6Pfizer Inc.520
7Pfizer Australia Pty Ltd510
8Guizhou Han Fang Pharma Co., Ltd. romanized440
9Boehringer Ingelheim International GmbH420
10Hunan Ke Lun Pharmaceutical Co., Ltd. romanized420

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

89 this week

AcceptedDrugApplicants
2023/02/25Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2300641 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2023/02/25Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2300640 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2023/02/25Generic · Class 3 Brivaracetam TabletsCYHS2300639 Jiangxi Qing Feng Pharma Co., Ltd. romanized
2023/02/25Generic · Class 3 Brivaracetam TabletsCYHS2300638 Jiangxi Qing Feng Pharma Co., Ltd. romanized
2023/02/25Generic · Class 3 Acetylcysteine InjectionCYHS2300637 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/02/25New drug · Class 2.2 注射用重组葡激酶 · No verified English nameCXSL2300157 Tong Hua Kang Yuan Yu Jin Pharma Co., Ltd. romanized
2023/02/25New drug · Class 1 HLX26单抗注射液 · No verified English nameCXSL2300156 Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2023/02/25New drug · Class 1 盐酸妥诺达非片 · No verified English nameCXHS2300035 Yangtze River Pharmaceutical Group Co., Ltd
2023/02/25New drug · Class 2.2 右布洛芬咀嚼片 · No verified English nameCXHL2300256 Beijing Jia Cheng Biopharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/02/25New drug · Class 2.2 右布洛芬咀嚼片 · No verified English nameCXHL2300255 Beijing Jia Cheng Biopharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/02/25New drug · Class 2.2 右布洛芬咀嚼片 · No verified English nameCXHL2300254 Beijing Jia Cheng Biopharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/02/25New drug · Class 2.2 右布洛芬咀嚼片 · No verified English nameCXHL2300253 Beijing Jia Cheng Biopharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/02/25New drug · Class 1 HRS-1893片 · No verified English nameCXHL2300252 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/02/25New drug · Class 1 HRS-1893片 · No verified English nameCXHL2300251 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/02/25New drug · Class 2.2 TAP-1502喷雾剂 · No verified English nameCXHL2300250 Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized
2023/02/25New drug · Class 1 HRS-1893片 · No verified English nameCXHL2300249 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/02/24Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2300018 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2023/02/24Import · Class 2.2 佩索利单抗注射液 · No verified English nameJXSL2300042 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/02/24Import · Class 2.2 佩索利单抗注射液 · No verified English nameJXSL2300041 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/02/24Import · Class 1 注射用舒巴坦钠/注射用度洛巴坦钠组合包装 · No verified English nameJXHS2300022 Entasis Therapeutics Inc.; MITIM S.R.L.; Lyophilization Services of New England Inc. (LSNE); Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2023/02/24Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2300034 AbbVie Inc.
2023/02/24Generic · Class 3 Ebastine Oral SolutionCYHS2300635 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/02/24Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2300633 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/02/24Generic · Class 3 Furosemide TabletsCYHS2300631 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hua Zhong Pharma Co., Ltd. romanized
2023/02/24Generic · Class 3 Fluoxetine Hydrochloride Oral SolutionCYHS2300626 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/02/24Generic · Class 3 注射用贝林司他 · No verified English nameCYHL2300029 Rui Yang Pharmaceutical Co., Ltd. romanized
2023/02/24Generic · Class 3 Methylergonovine Maleate InjectionCYHL2300028 Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized
2023/02/24New drug · Class 1 重组人源化抗Claudin 18.2单克隆抗体注射液 · No verified English nameCXSL2300155 Kai Xing Sheng Ming Technology (Shanghai) Co., Ltd. romanized; Luo Shi (Zhongguo) Investment Co., Ltd. romanized
2023/02/24New drug · Class 1 SHR-2017注射液 · No verified English nameCXSL2300154 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/02/24New drug · Class 1 HBM1020注射液 · No verified English nameCXSL2300153 He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized

59 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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