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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 413 drug applications between 21 February 2023 and 27 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 59 drug names.

2023/02/21 – 2023/02/27

Period
2023/02/21 to 2023/02/27, 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
413
Drugs with new generic filings (by drug name, de-duplicated)
59
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

413filings, 78 of them generic

By application type

Application typeFilings
Supplement237
Generic78
New drug44
Import26
Import re-registration20
Unspecified8

By drug type

Drug typeFilings
Chemical drug298
TCM67
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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oseltamivir Phosphate Capsules4239
2Duloxetine Hydrochloride Enteric Capsules314
3Sodium Valproate Oral Solution211
4Tacrolimus Sustained-release Capsules216
5Acetaminophen Injection211
6Levofloxacin Tablets217
7Brivaracetam Tablets2119
8Potassium Chloride Granules214
9Nicorandil for Injection211
10Gemcitabine Hydrochloride for Injection211

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
1Shenyang Jun Yuan Pharma Co., Ltd. romanized16100
2Guangxi Yu Yuan Pharma Co., Ltd. romanized1290
3Guangdong Song Xia Pharma Co., Ltd. romanized11110
4Chongqing Qian Fang Drug Research Co., Ltd. romanized750
5Rui Yang Pharmaceutical Co., Ltd. romanized633
6Sichuan Kelun Pharmaceutical Co., Ltd.532
7Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized530
8Pfizer Inc.520
9Pfizer Australia Pty Ltd510
10Guizhou Han Fang Pharma Co., Ltd. romanized440

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

99 this week

AcceptedDrugApplicants
2023/02/27Import · Class 2.4 阿扎胞苷薄膜衣片 · No verified English nameJXHL2300038 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/02/27Import · Class 2.4 阿扎胞苷薄膜衣片 · No verified English nameJXHL2300037 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/02/27Import · Class 1 AZD9833片 · No verified English nameJXHL2300035 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2023/02/27Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2300654 Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized
2023/02/27Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2300648 Anhui Hai Si Mei Pharmaceuticals Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2023/02/27Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2300647 Chongqing Mai Chuan Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized
2023/02/27Generic · Class 3 Diprophylline InjectionCYHS2300643 Name not romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/02/27Generic · Class 3 Famotidine InjectionCYHS2300642 Name not romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/02/27New drug · Class 1.1 十一方药酒 · No verified English nameCXZL2300013 Guangxi Zhong Pharmaceuticals University Di Yi Fu Shu Hospital (Guangxi Zhong Yi Hospital) romanized
2023/02/27New drug · Class 2.2 苏黄止咳颗粒 · No verified English nameCXZL2300012 Beijing Dong Fang Yun Jia Technology Development Co., Ltd. romanized
2023/02/27New drug · Class 1 SHR-1654注射液 · No verified English nameCXSL2300158 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/02/27New drug · Class 1 PB-722注射液 · No verified English nameCXHL2300257 Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized
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.

69 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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