YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 229 drug applications between 13 August 2021 and 19 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 28 drug names.

2021/08/13 – 2021/08/19

Period
2021/08/13 to 2021/08/19, 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
229
Drugs with new generic filings (by drug name, de-duplicated)
28
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

229filings, 35 of them generic

By application type

Application typeFilings
Supplement124
Generic35
New drug35
Unspecified15
Import15
Import re-registration5

By drug type

Drug typeFilings
Chemical drug148
TCM39
Therapeutic biologic39
Biologic3

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

28 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ornidazole Injection420
2Rivaroxaban Tablets323
3Iopamidol Injection210
4Sugammadex Sodium Injection216
5Tadalafil Tablets1123
6Ambroxol Hydrochloride Solution For Inhalation1110
7Omeprazole and Sodium Bicarbonate Capsules110
8Quetiapine Fumarate Tablets110
9Levofloxacin Tablets117
10Lacosamide Injection110

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

138 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Run Zhong Pharma Co., Ltd. romanized16150
2Jilin Hua Kang Pharma Co., Ltd. romanized550
3Janssen Research & Development LLC530
4Boehringer Ingelheim International GmbH510
5Haerbin Han Bang Medical Technology Co., Ltd. romanized510
6Shandong Er Ye Pharmaceutical Co., Ltd. romanized510
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized430
8Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized421
9Merck Sharp & Dohme Corp.410
10Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized410

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

62 this week

AcceptedDrugApplicants
2021/08/19Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSL2101099 MedImmune LLC; AstraZeneca Investment (China) Co. Limited
2021/08/19Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2101604 Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2021/08/19New drug · Class 1 AK112注射液 · No verified English nameCXSL2101274 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/08/19New drug · Class 1 YH003注射液 · No verified English nameCXSL2101273 Name not romanized
2021/08/19New drug · Class 2.2 克来夫定胶囊 · No verified English nameCXHL2101419 Guangxi Hui Bao Yuan Pharmaceuticals Technology Co., Ltd. romanized
2021/08/19New drug · Class 2.2 克来夫定胶囊 · No verified English nameCXHL2101418 Guangxi Hui Bao Yuan Pharmaceuticals Technology Co., Ltd. romanized
2021/08/19New drug · Class 1 ENN0403 胶囊 · No verified English nameCXHL2101417 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized
2021/08/19New drug · Class 1 ENN0403 胶囊 · No verified English nameCXHL2101416 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized
2021/08/19New drug · Class 1 ENN0403 胶囊 · No verified English nameCXHL2101415 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized
2021/08/19New drug · Class 1 JAB-21822片 · No verified English nameCXHL2101414 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/08/19New drug · Class 1 JAB-21822片 · No verified English nameCXHL2101413 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/08/19New drug · Class 1 JAB-21822片 · No verified English nameCXHL2101406 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/08/19New drug · Class 1 JAB-21822片 · No verified English nameCXHL2101405 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/08/18Import · Class 1 LNP023胶囊 · No verified English nameJXHL2101167 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/08/18Generic · Class 3 Tofacitinib Citrate Extended Release tabletsCYHS2101602 Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2021/08/18New drug · Class 1 QX005N注射液 · No verified English nameCXSL2101272 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2021/08/18New drug · Class 2.2 丁苯酞注射液 · No verified English nameCXHL2101404 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/08/18New drug · Class 1 ICP-189片 · No verified English nameCXHL2101337 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/08/17Import · Class 1 Relatlimab/Nivolumab固定剂量复方注射液 · No verified English nameJXSL2101097 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2021/08/17Import · Class 1 JNJ-63733657注射液 · No verified English nameJXSL2101091 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/08/17Import · Class 1 注射用普那布林浓溶液 · No verified English nameJXHS2101041 BeyondSpring Pharmaceuticals Inc.; Pharmaceutics International Incorporated(Pii); Dalian Wanchun Bulin Pharmaceutical Co. Ltd.
2021/08/17Import · Class 1 Difelikefalin注射液 · No verified English nameJXHL2101166 Vifor Fresenius Medical Care Renal Pharma Ltd.; Hangzhou Tigermed Consulting Co. Ltd.
2021/08/17Generic · Class 3 Paracetamol and Caffeine TabletsCYHS2101600 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2021/08/17Generic · Class 3 Ornidazole InjectionCYHS2101599 Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/08/17Generic · Class 3 Ornidazole InjectionCYHS2101598 Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/08/17Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2101595 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2021/08/17Generic · Class 3 Iopamidol InjectionCYHS2101594 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2021/08/17Generic · Class 3 Iopamidol InjectionCYHS2101593 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2021/08/17Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2101590 Hebei Xin Rui Wei Lai Technology Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2021/08/17Generic · Class 3 Trelagliptin Succinate TabletsCYHS2101573 CSPC OUYI PHARMACEUTICAL CO., LTD.

32 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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