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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 297 drug applications between 10 August 2022 and 16 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 37 drug names.

2022/08/10 – 2022/08/16

Period
2022/08/10 to 2022/08/16, 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
297
Drugs with new generic filings (by drug name, de-duplicated)
37
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

297filings, 53 of them generic

By application type

Application typeFilings
Supplement175
Generic53
New drug33
Import19
Import re-registration10
Unspecified6
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug211
TCM45
Therapeutic biologic38
Prophylactic biologic2
In vitro diagnostic reagent1

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

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1泊马度胺胶囊 · No verified English name414
2Minoxidil Liniment3252
3Midazolam Injection310
4Piperacillin Sodium And Tazobactam Sodium For Injection315
5Acetylcysteine Solution For Inhalation224
6Empagliflozin Tablets2118
7Temozolomide Capsules210
8Vortioxetine Hydrobromide Tablets2110
9Ambroxol Hydrochloride Oral Solution2146
10Sevelamer Carbonate Powder for oral suspension213

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

173 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Yu Sheng Tang Group Shijiazhuang Pharmaceutical Co., Ltd. romanized990
2Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized947
3Roche Pharma (Schweiz) AG730
4Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized660
5Merck Sharp & Dohme B.V.640
6Shanxi Fen He Pharmaceutical Co., Ltd. romanized550
7Qilu Pharmaceutical Co., Ltd.525
8Shanxi Tong Da Pharma Co., Ltd. romanized440
9Hebei Wu Luo Pharma Co., Ltd. romanized440
10Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.440

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

68 this week

AcceptedDrugApplicants
2022/08/16Import · Class 1 STN1013400滴眼液 · No verified English nameJXHL2200243 Santen Pharmaceutical Co. Ltd.
2022/08/16Import · Class 1 STN1013400滴眼液 · No verified English nameJXHL2200242 Santen Pharmaceutical Co. Ltd.
2022/08/16Import · Class 1 STN1013400滴眼液 · No verified English nameJXHL2200241 Santen Pharmaceutical Co. Ltd.
2022/08/16Import · Class 1 INCB000928片 · No verified English nameJXHL2200240 Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd.
2022/08/16Generic · Class 3 Minoxidil LinimentCYHS2201319 Anhui Pioneer Pharmaceutical Co., Ltd
2022/08/16Generic · Class 3 Minoxidil LinimentCYHS2201318 Anhui Pioneer Pharmaceutical Co., Ltd
2022/08/16Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2201313 Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/08/16Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2201312 Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/08/16Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2201310 Qilu Pharmaceutical Co., Ltd.
2022/08/16Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2201308 Qilu Pharmaceutical Co., Ltd.
2022/08/16Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2201307 Qilu Pharmaceutical Co., Ltd.
2022/08/16Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2201306 Qilu Pharmaceutical Co., Ltd.
2022/08/16Generic · Class 3 Nifedipine Extended-Release TabletsCYHS2201304 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/08/16Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201301 Shandong Qidu Pharmaceutical Co., Ltd.
2022/08/16Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201300 Shandong Qidu Pharmaceutical Co., Ltd.
2022/08/16Generic · Class 3 盐酸氨酮戊酸口服溶液用粉末 · No verified English nameCYHL2200065 Zhao Ke Pharma (Hefei) Co., Ltd. romanized
2022/08/16Generic · Class 3 Clobazam Oral SuspensionCYHL2200064 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/08/16New drug · Class 3.3 特立帕肽注射液 · No verified English nameCXSS2200073 Wuxi He Bang Bio Technology Co., Ltd. romanized
2022/08/16New drug · Class 1 HBG基因修饰的自体CD34+造血干细胞注射液 · No verified English nameCXSL2200378 Guangzhou Rui Feng Bio Technology Co., Ltd. romanized
2022/08/16New drug · Class 1 JCXH-211注射液 · No verified English nameCXSL2200377 Jia Chen Xi Hai (Hangzhou) Bio Technology Co., Ltd. romanized
2022/08/16New drug · Class 1 注射用JSKN003 · No verified English nameCXSL2200376 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2022/08/16New drug · Class 2.2 注射用醋酸戈舍瑞林缓释微球 · No verified English nameCXHS2200045 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2022/08/15Import · Class 2.2 Amivantamab注射液 · No verified English nameJXSL2200133 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/08/15Generic · Class 3 甲硝唑凝胶 · No verified English nameCYHS2201296 Wuxi Lang Run Pharmaceuticals Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd.
2022/08/15Generic · Class 3 Pentazocine InjectionCYHS2201295 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2022/08/15Generic · Class 3 Peramivir InjectionCYHS2201294 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2022/08/15New drug · Class 1.1 双根口服液 · No verified English nameCXZL2200038 Zhongguo Ren Min Jie Fang Jun Zong Hospital Di Wu Yi Xue Center romanized
2022/08/15New drug · Class 1 U16注射液 · No verified English nameCXSL2200375 Shanghai You Ka Di Zhi Zao Sheng Ming Technology Co., Ltd. romanized; Shanghai You Ka Di Biopharmaceuticals Technology Co., Ltd. romanized
2022/08/15New drug · Class 2.1 人干扰素α2b喷雾剂 · No verified English nameCXSL2200374 Ke Xing Biopharmaceutical Co., Ltd. romanized
2022/08/15New drug · Class 2.4 奥布替尼片 · No verified English nameCXHS2200044 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized

38 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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