YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 241 drug applications between 17 August 2021 and 23 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 31 drug names.

2021/08/17 – 2021/08/23

Period
2021/08/17 to 2021/08/23, 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
241
Drugs with new generic filings (by drug name, de-duplicated)
31
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

241filings, 40 of them generic

By application type

Application typeFilings
Supplement139
Generic40
New drug34
Unspecified15
Import13

By drug type

Drug typeFilings
Chemical drug156
TCM43
Therapeutic biologic38
Biologic3
Prophylactic biologic1

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

31 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Perampanel Tablets412
2Voglibose Tablets210
3Perindopril tert-Butylamine Tablets215
4Ornidazole Injection210
5Trelagliptin Succinate Tablets211
6Iopamidol Injection210
7Sugammadex Sodium Injection216
8Ipratropium Bromide Inhalation Solution112
9Ambroxol Hydrochloride Solution For Inhalation1110
10Celecoxib Capsules115

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

136 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Run Zhong Pharma Co., Ltd. romanized16150
2Merck Sharp & Dohme Corp.610
3Hubei Mei Si Chuang Pharma Co., Ltd. romanized550
4Qin Huang Dao Da En Pharma Co., Ltd. romanized550
5Shaanxi Bao Ling Kang Pharmaceutical Co., Ltd. romanized540
6Haerbin Han Bang Medical Technology Co., Ltd. romanized510
7Shandong Er Ye Pharmaceutical Co., Ltd. romanized510
8Yuan He Sheng (Jilin) Pharma Co., Ltd. romanized440
9Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized421
10Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420

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
2021/08/23Import · Class 3.1 雷莫西尤单抗注射液 · No verified English nameJXSS2101018 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2021/08/23Import · Class 3.1 雷莫西尤单抗注射液 · No verified English nameJXSS2101017 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2021/08/23Import · Class 1 BI655130注射液 · No verified English nameJXSL2101098 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/08/23Import · Class 2.4 ATG-010片 · No verified English nameJXHL2101168 Karyopharm Therapeutics Inc.; Antengene Corporation Co. Ltd.
2021/08/23New drug · Class 3.2 口服五价重配轮状病毒减毒活疫苗(Vero细胞) · No verified English nameCXSL2101279 Shenzhen Kang Tai Bio Zhi Pin Co., Ltd. romanized; Beijing Min Hai Bio Technology Co., Ltd. romanized
2021/08/23New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101275 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/08/23New drug · Class 1 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101270 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/08/23New drug · Class 1 ATG-008片 · No verified English nameCXHL2101427 Shanghai De Qi Pharmaceuticals Technology Co., Ltd. romanized
2021/08/23New drug · Class 1 ATG-008片 · No verified English nameCXHL2101426 Shanghai De Qi Pharmaceuticals Technology Co., Ltd. romanized
2021/08/23New drug · Class 2.4 Apatinib Mesylate TabletsCXHL2101425 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/23New drug · Class 2.4 Apatinib Mesylate TabletsCXHL2101424 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/23New drug · Class 2.4 Apatinib Mesylate TabletsCXHL2101423 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/20Generic · Class 3 Calcium Gluconate InjectionCYHS2101610 Zhejiang Rui Bang Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2021/08/20Generic · Class 3 Trelagliptin Succinate TabletsCYHS2101572 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/08/20New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2101021 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized; Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2021/08/20New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2101276 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/08/20New drug · Class 2.2 丁苯酞注射液 · No verified English nameCXHL2101422 Ao Xin Yang Guang (Beijing) Pharma Technology Co., Ltd. romanized
2021/08/20New drug · Class 1 BEBT-209胶囊 · No verified English nameCXHL2101421 Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized
2021/08/20New drug · Class 1 BEBT-209胶囊 · No verified English nameCXHL2101420 Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized
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

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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