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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 325 drug applications between 7 June 2023 and 13 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 59 drug names.

2023/06/07 – 2023/06/13

Period
2023/06/07 to 2023/06/13, 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
325
Drugs with new generic filings (by drug name, de-duplicated)
59
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

325filings, 87 of them generic

By application type

Application typeFilings
Supplement141
Generic87
New drug61
Unspecified16
Import15
Import re-registration5

By drug type

Drug typeFilings
Chemical drug224
Therapeutic biologic51
TCM40
Biologic6
Prophylactic biologic4

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
1Potassium Chloride Injection3310
2Minoxidil Topical Solution320
3Lactulose Oral Solution3134
4注射用头孢哌酮钠舒巴坦钠(2:1) · No verified English name312
5Neostigmine Methylsulfate Injection314
6Nitroglycerin Sublingual Tablets313
7Methocarbamol Injection223
8Phloroglucinol Injection222
9ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name210
10Procaterol Hydrochloride Solution for Inhalation212

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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized610
2Chengdu Brilliant Pharmaceutical Co., Ltd.522
3Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized440
4Qilu Pharmaceutical Co., Ltd.431
5Janssen Research & Development LLC420
6Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized423
7Xin Dong Sheng Ji Co., Ltd. romanized410
8GlaxoSmithKline Biologicals SA330
9Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized330
10Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized330

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

108 this week

AcceptedDrugApplicants
2023/06/13Import · Class 1 STRO-002注射液(暂用) · No verified English nameJXSL2300106 Sutro Biopharma Inc.
2023/06/13Generic · Class 3 ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English nameCYHS2301614 Sichuan Kelun Pharmaceutical Co., Ltd.
2023/06/13Generic · Class 3 ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English nameCYHS2301613 Sichuan Kelun Pharmaceutical Co., Ltd.
2023/06/13Generic · Class 3 Methocarbamol InjectionCYHS2301612 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2023/06/13Generic · Class 3 Ornidazole InjectionCYHS2301608 Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
2023/06/13Generic · Class 3 Furosemide InjectionCYHS2301607 Wuhan Jiu An Pharma Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/06/13Generic · Class 3 Furosemide InjectionCYHS2301606 Wuhan Jiu An Pharma Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/06/13New drug · Class 1.3 马甲子胶囊 · No verified English nameCXZL2300040 Chengdu Ma Jia Zi Bio Technology Co., Ltd. romanized
2023/06/13New drug · Class 1 注射用SMP-656 · No verified English nameCXSL2300413 Chengdu Ke Ling Yuan Pharmaceuticals Technology Co., Ltd. romanized
2023/06/13New drug · Class 2.2 恩沃利单抗注射液 · No verified English nameCXSL2300412 Sichuan Si Lu Kang Rui Pharma Co., Ltd. romanized
2023/06/13New drug · Class 1 IBI355 · No verified English nameCXSL2300411 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/06/13New drug · Class 1 IBI355 · No verified English nameCXSL2300410 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/06/13New drug · Class 1 XNW21015片 · No verified English nameCXHL2300640 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/06/13New drug · Class 1 XNW21015片 · No verified English nameCXHL2300639 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/06/13New drug · Class 1 XNW21015片 · No verified English nameCXHL2300638 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/06/12New drug · Class 1.3 冻干人用CpG佐剂狂犬病疫苗(Vero细胞) · No verified English nameCXSL2300409 Changchun Zhuo Yi Bio Co., Ltd. romanized
2023/06/12New drug · Class 2.2; 2.4 注射用醋酸丙氨瑞林微球 · No verified English nameCXHL2300637 Shanghai Li Zhu Pharmaceutical Co., Ltd. romanized
2023/06/10Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2301598 Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/06/10Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2301597 Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/06/10Generic · Class 3 Potassium Chloride InjectionCYHS2301596 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/06/10Generic · Class 3 Perospirone Hydrochloride TabletsCYHS2301594 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2023/06/10Generic · Class 3 Perospirone Hydrochloride TabletsCYHS2301593 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2023/06/10Generic · Class 3 Nitroglycerin InjectionCYHS2301592 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/06/10Generic · Class 3 Nitroglycerin InjectionCYHS2301591 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/06/10Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2301590 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/06/10Generic · Class 3 Potassium Chloride GranulesCYHS2301588 Ji Chuan Pharma Group Co., Ltd. romanized
2023/06/10Generic · Class 3 Potassium Chloride GranulesCYHS2301587 Ji Chuan Pharma Group Co., Ltd. romanized
2023/06/10Generic · Class 3 Bumetanide InjectionCYHS2301586 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2023/06/10Generic · Class 3 Nicergoline TabletsCYHS2301585 Beijing Jiu Neng Tian Yuan Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2023/06/10New drug · Class 1 TAVO412注射液 · No verified English nameCXSL2300408 Tuo Chuang Bio Technology (Jiangsu) Co., Ltd. romanized

78 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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