YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 202 drug applications between 5 June 2021 and 11 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 27 drug names.

2021/06/05 – 2021/06/11

Period
2021/06/05 to 2021/06/11, 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
202
Drugs with new generic filings (by drug name, de-duplicated)
27
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

202filings, 40 of them generic

By application type

Application typeFilings
Supplement100
Generic40
New drug39
Import re-registration11
Import10
Unspecified2

By drug type

Drug typeFilings
Chemical drug147
Therapeutic biologic27
TCM22
Prophylactic biologic6

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

27 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oxcarbazepine Tablets314
2Ipratropium Bromide Inhalation Solution212
3Ornidazole Injection210
4Obeticholic Acid Tablets210
5Levofloxacin Tablets217
6Sacubitril Valsartan Sodium Tablets2170
7注射用头孢美唑钠/氯化钠注射液 · No verified English name211
8Daptomycin for Injection211
9Epinastine Hydrochloride Granules210
10盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212

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

112 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1NAPP PHARMACEUTICALS LIMITED910
2Tong Yong Dian Qi Pharma (Shanghai) Co., Ltd. romanized710
3AstraZeneca AB630
4Bristol-Myers Squibb Pharma EEIG510
5Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized430
6Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized430
7Shijiazhuang No.4 Pharmaceutical Co., Ltd.433
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
9Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized410
10Beijing Bao Nian Tang (He Ze) Pharma 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

57 this week

AcceptedDrugApplicants
2021/06/11Generic · Class 3 Epinastine Hydrochloride GranulesCYHS2101293 Jiao Zuo Shi Ming Ren Tian Ran Drug Co., Ltd. romanized
2021/06/11Generic · Class 3 Epinastine Hydrochloride GranulesCYHS2101292 Jiao Zuo Shi Ming Ren Tian Ran Drug Co., Ltd. romanized
2021/06/11Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2101291 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/06/11Generic · Class 3 注射用头孢美唑钠/氯化钠注射液 · No verified English nameCYHS2101251 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2021/06/11Generic · Class 3 注射用头孢美唑钠/氯化钠注射液 · No verified English nameCYHS2101250 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2021/06/11New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2101131 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/06/11New drug · Class 3.4 卡介菌纯蛋白衍生物 · No verified English nameCXSL2101114 Chengdu Ke En Bio Technology Co., Ltd. romanized
2021/06/11New drug · Class 1 盐酸安舒法辛缓释片 · No verified English nameCXHS2101024 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2021/06/11New drug · Class 1 盐酸安舒法辛缓释片 · No verified English nameCXHS2101023 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2021/06/11New drug · Class 1 VC005片 · No verified English nameCXHL2101199 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2021/06/11New drug · Class 1 VC005片 · No verified English nameCXHL2101198 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2021/06/11New drug · Class 1 VC005片 · No verified English nameCXHL2101197 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2021/06/11New drug · Class 1 VC005片 · No verified English nameCXHL2101196 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2021/06/10New drug · Class 1 注射用IMM01 · No verified English nameCXSL2101130 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/06/10New drug · Class 1 QL1706注射液 · No verified English nameCXSL2101122 Qilu Pharmaceutical Co., Ltd.
2021/06/10New drug · Class 1.4 24价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2101113 Jiangsu Kun Li Biopharmaceutical Co., Ltd. romanized; Shandong Kun Li Biopharmaceutical Co., Ltd. romanized
2021/06/10New drug · Class 2.2 小儿水合氯醛糖浆 · No verified English nameCXHL2101193 Hainan Peng Kang Pharma Co., Ltd. romanized
2021/06/10New drug · Class 1 HEC93077片 · No verified English nameCXHL2101192 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/06/10New drug · Class 1 HEC93077片 · No verified English nameCXHL2101191 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/06/10New drug · Class 1 HEC93077片 · No verified English nameCXHL2101190 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/06/10New drug · Class 1 HRS2300片 · No verified English nameCXHL2101189 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/06/10New drug · Class 1 HRS2300片 · No verified English nameCXHL2101188 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/06/10New drug · Class 1 LNK01001胶囊 · No verified English nameCXHL2101186 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2021/06/10New drug · Class 1 LNK01001胶囊 · No verified English nameCXHL2101185 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2021/06/09Import · Class 1 BI 425809 片 · No verified English nameJXHL2101086 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/06/09Generic · Class 3 Obeticholic Acid TabletsCYHL2101014 Yangtze River Pharmaceutical Group Co., Ltd
2021/06/09Generic · Class 3 Obeticholic Acid TabletsCYHL2101013 Yangtze River Pharmaceutical Group Co., Ltd
2021/06/09New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101128 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/06/09New drug · Class 1 IBI110 · No verified English nameCXSL2101127 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/06/09New drug · Class 2.2 HRG2010胶囊 · No verified English nameCXHL2101178 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

27 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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