YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 236 drug applications between 6 August 2021 and 12 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 27 drug names.

2021/08/06 – 2021/08/12

Period
2021/08/06 to 2021/08/12, 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
236
Drugs with new generic filings (by drug name, de-duplicated)
27
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

236filings, 38 of them generic

By application type

Application typeFilings
Supplement99
New drug51
Generic38
Unspecified24
Import16
Import re-registration8

By drug type

Drug typeFilings
Chemical drug172
Therapeutic biologic46
TCM17
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

27 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pregabalin Capsules3112
2Meropenem for Injection315
3Omeprazole and Sodium Bicarbonate Capsules210
4Torsemide Injection211
5Gemcitabine Hydrochloride for Injection211
6Irinotecan Hydrochloride Injection212
7Vardenafil Hydrochloride Tablets214
8硫酸沙丁胺醇吸入溶液 · No verified English name210
9草酸艾司西酞普兰口服溶液 · No verified English name2111
10丙酸氟替卡松吸入粉雾剂 · No verified English name111

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

130 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Er Ye Pharmaceutical Co., Ltd. romanized1130
2AstraZeneca AB830
3Oncotec Pharma Produktion GmbH810
4Eurofins Analytical Science Laboratories Inc.660
5Chengdu Rong Sheng Pharma Co., Ltd. romanized630
6Novartis Pharma Schweiz AG620
7Huang Shi Wei Sheng Cai Liao Pharma Co., Ltd. romanized550
8Pfizer Europe MA EEIG520
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized510
10Upjohn EESV410

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

81 this week

AcceptedDrugApplicants
2021/08/12Import · Class 1 Ziltivekimab 注射液 · No verified English nameJXSL2101092 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2021/08/12Import · Class 1 ricolinostat · No verified English nameJXHL2101163 Beijing B3R Pharmaceutical Technology HK Limited; PAREXEL CHINA CO. LTD
2021/08/12Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2101565 Zhejiang Hua Yuan Pharma Co., Ltd. romanized
2021/08/12Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2101564 Zhejiang Hua Yuan Pharma Co., Ltd. romanized
2021/08/12Generic · Class 3 Metronidazole and Sodium Chloride InjectionCYHS2101559 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2021/08/12New drug · Class 1 QX002N注射液 · No verified English nameCXSL2101259 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2021/08/12New drug · Class 1 GZR18 · No verified English nameCXSL2101258 Gan Li Pharma Co., Ltd. romanized
2021/08/12New drug · Class 1 GZR18 · No verified English nameCXSL2101257 Gan Li Pharma Co., Ltd. romanized
2021/08/12New drug · Class 1 GZR18 · No verified English nameCXSL2101256 Gan Li Pharma Co., Ltd. romanized
2021/08/12New drug · Class 1 GZR18 · No verified English nameCXSL2101255 Gan Li Pharma Co., Ltd. romanized
2021/08/12New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2101241 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/08/12New drug · Class 1 注射用HTPEP-001 · No verified English nameCXHL2101396 Chengdu Hui Tai Biopharmaceuticals Co., Ltd. romanized
2021/08/12New drug · Class 2.4; 2.2 BH011注射液 · No verified English nameCXHL2101395 Zhuhai Bei Hai Bio Technology Co., Ltd. romanized
2021/08/11Import · Class 1 CC-99677胶囊 · No verified English nameJXHL2101162 Celgene Corporation; Name not romanized
2021/08/11Import · Class 1 CC-99677胶囊 · No verified English nameJXHL2101161 Celgene Corporation; Name not romanized
2021/08/11Generic · Class 3 Peramivir InjectionCYHS2101558 Yunnan Xian Shi Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2021/08/11Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2101554 Zhejiang Guo Jing Pharma Co., Ltd. romanized
2021/08/11Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2101553 Zhejiang Guo Jing Pharma Co., Ltd. romanized
2021/08/11New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSL2101254 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/08/11New drug · Class 2.2 重组GLP-1受体激动剂注射液 · No verified English nameCXSL2101253 Beijing Le Pu Pharmaceuticals Technology Co., Ltd. romanized
2021/08/11New drug · Class 1 9MW2821 · No verified English nameCXSL2101252 Jiangsu Mai Wei Kang Xin Yao Research and Development Co., Ltd. romanized
2021/08/11New drug · Class 2.2 PTBC胶囊 · No verified English nameCXHL2101394 Xiamen En Cheng Pharmaceutical Co., Ltd. romanized
2021/08/11New drug · Class 2.2 枸橼酸托法替布多释片 · No verified English nameCXHL2101393 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2021/08/11New drug · Class 1 苹果酸法米替尼胶囊 · No verified English nameCXHL2101392 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/11New drug · Class 1 苹果酸法米替尼胶囊 · No verified English nameCXHL2101391 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/10Import · Class 1 LNP023胶囊 · No verified English nameJXHL2101160 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/08/10Import · Class 1 BMS-986278-01片 · No verified English nameJXHL2101159 Bristol Myers Squibb Company; Name not romanized
2021/08/10Import · Class 1 BMS-986278-01片 · No verified English nameJXHL2101158 Bristol Myers Squibb Company; Name not romanized
2021/08/10Generic · Class 3 硫酸沙丁胺醇吸入溶液 · No verified English nameCYHS2101552 Jinan Jing Sheng Technology Co., Ltd. romanized; Wei Fang Zhong Shi Pharmaceutical Co., Ltd. romanized
2021/08/10Generic · Class 3 硫酸沙丁胺醇吸入溶液 · No verified English nameCYHS2101551 Jinan Jing Sheng Technology Co., Ltd. romanized; Wei Fang Zhong Shi Pharmaceutical Co., Ltd. romanized

51 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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