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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 392 drug applications between 5 April 2025 and 11 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 114, covering 82 drug names.

2025/04/05 – 2025/04/11

Period
2025/04/05 to 2025/04/11, 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
392
Drugs with new generic filings (by drug name, de-duplicated)
82
Accepted this week, now under review
39

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

392filings, 114 of them generic

By application type

Application typeFilings
Supplement182
Generic114
New drug61
Import23
Unspecified7
Import re-registration5

By drug type

Drug typeFilings
Chemical drug261
TCM82
Therapeutic biologic44
Prophylactic biologic4
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

82 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets5360
2Dopamine Hydrochloride Injection423
3Finerenone Tablets3269
4Brexpiprazole Tablets3131
5Oxacillin Sodium for Injection3113
6复方聚乙二醇(3350)电解质散 · No verified English name223
7Rosuvastatin Calcium and Ezetimibe Tablets (I)225
8Ilaprazole Enteric-coated Tablets2226
9Iron Proteinsuccinylate Oral Solution2226
10Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)225

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

248 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guo Yao Group Beijing Hua Miao Pharma Co., Ltd. romanized11100
2Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized10100
3Shenyang Dong Xin Pharma Co., Ltd. romanized640
4AstraZeneca AB630
5Bayer Inc.610
6Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized550
7Shandong Er Ye Pharmaceutical Co., Ltd. romanized540
8Boehringer Ingelheim International GmbH530
9Merck Healthcare KGaA530
10Sichuan Kelun Pharmaceutical Co., Ltd.510

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

123 this week

AcceptedDrugApplicants
2025/04/11Import · Class 1.4 21价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2500058 Sanofi Pasteur Inc.; Shenzhen Sanofi Pasteur Biological Products Co. Ltd.
2025/04/11Generic · Class 3 Vitamin K1 InjectionCYHS2501407 Hainan Quan Ying Pharma Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2025/04/11Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2501406 Chongqing Sai Nuo Bio Pharma Co., Ltd. romanized; Chongqing He Ping Pharmaceutical Co., Ltd. romanized
2025/04/11Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2501404 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2025/04/11Generic · Class 3 Acetylcysteine TabletsCYHS2501401 Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2025/04/11Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2501398 Hefei Yuan Feng Shun Pharmaceuticals Technology Co., Ltd. romanized; Beng Bu Feng Yuan Tu Shan Pharmaceutical Co., Ltd. romanized
2025/04/11Generic · Class 3 聚乙二醇4000散 · No verified English nameCYHS2501395 Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized
2025/04/11Generic · Class 3 Piracetam InjectionCYHS2501394 Ya Bang Pharmaceuticals Co., Ltd. romanized
2025/04/11New drug · Class 1 注射用HY0001a · No verified English nameCXSL2500294 Name not romanized
2025/04/11New drug · Class 1 CRG-B191注射液 · No verified English nameCXSL2500293 Shanghai Ke Rui Ke Pharmaceuticals Technology Co., Ltd. romanized
2025/04/11New drug · Class 1 XKH001注射液 · No verified English nameCXSL2500292 Zhejiang Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized
2025/04/11New drug · Class 1 XKH001注射液 · No verified English nameCXSL2500291 Zhejiang Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized
2025/04/11New drug · Class 1 PM1300注射用冻干制剂 · No verified English nameCXSL2500290 Zhuhai Pu Mi Si Bio Technology Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/04/11New drug · Class 3.3 人生长激素注射液 · No verified English nameCXSL2500289 Yi Fan Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/04/11New drug · Class 1 QX029N注射液 · No verified English nameCXSL2500288 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2025/04/11New drug · Class 2.3 PXT3003 · No verified English nameCXHS2500027 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized
2025/04/11New drug · Class 2.4 盐酸羟钴胺注射液 · No verified English nameCXHL2500382 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2025/04/11New drug · Class 1 抗菌肽PL-3301口腔凝胶 · No verified English nameCXHL2500381 Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized; Nanjing Di Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2025/04/11New drug · Class 1 抗菌肽PL-3301口腔凝胶 · No verified English nameCXHL2500380 Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized; Nanjing Di Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2025/04/11New drug · Class 1 HRS-8829注射用浓溶液 · No verified English nameCXHL2500379 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/04/11New drug · Class 1 艾本那肽注射液 · No verified English nameCXHL2500378 Chang Shan Kai Jie Jian Bio Drug Research and Development (Hebei) Co., Ltd. romanized; Hebei Chang Shan Sheng Hua Pharma Co., Ltd. romanized
2025/04/11New drug · Class 1 HRS-9821吸入粉雾剂 · No verified English nameCXHL2500377 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/04/10Generic · Class 3 Bumetanide InjectionCYHS2501389 Hefei Yuan Feng Shun Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2025/04/10Generic · Class 3 Celecoxib TabletsCYHS2501388 Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized
2025/04/10Generic · Class 3 Minodronic acid TabletsCYHS2501386 Anhui Bo Nuo Mei Ke Biopharmaceuticals Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized
2025/04/10Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2501384 Guangdong Nan Guo Pharma Co., Ltd. romanized
2025/04/10Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2501383 Guangdong Nan Guo Pharma Co., Ltd. romanized
2025/04/10Generic · Class 3 Ferrous Succinate TabletsCYHS2501379 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/04/10New drug · Class 1.1 健脾解毒丸 · No verified English nameCXZL2500021 Xinjiang Wei Wu Er Zi Zhi Qu Zhong Yi Hospital romanized
2025/04/10New drug · Class 1 LNF2102注射液 · No verified English nameCXSL2500287 Shandong Xin Shi Dai Pharma Co., Ltd. romanized

93 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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