YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 278 drug applications between 10 October 2021 and 16 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 37, covering 26 drug names.

2021/10/10 – 2021/10/16

Period
2021/10/10 to 2021/10/16, 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
278
Drugs with new generic filings (by drug name, de-duplicated)
26
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

278filings, 37 of them generic

By application type

Application typeFilings
Supplement165
New drug53
Generic37
Import9
Unspecified8
Import re-registration6

By drug type

Drug typeFilings
Chemical drug140
TCM98
Therapeutic biologic35
Biologic5

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

26 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1阿普米司特片 · No verified English name623
2Sitagliptin Phosphate Tablets312
3氧 · No verified English name2215
4Ornidazole Injection210
5磷酸奥司他韦干糖浆 · No verified English name210
6Esomeprazole Magnesium Enteric-Coated Capsules214
7依托咪酯乳状注射液 · No verified English name111
8Lidocaine Cataplasms117
9Desonide Cream110
10Doxofylline Injection115

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

131 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Wan Hui Pharmaceutical Co., Ltd. romanized64480
2CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD840
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized740
4Novo Nordisk A/S540
5Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized510
6Jiangxi Di Kang Pharma Co., Ltd. romanized440
7Pfizer Europe MA EEIG420
8Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized421
9Hebei Yao Wang Group Co., Ltd. romanized420
10Qilu Pharmaceutical Co., Ltd.423

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

71 this week

AcceptedDrugApplicants
2021/10/15Generic · Class 3 Minodronic acid TabletsCYHL2101030 Nanjing Healthnice Pharmaceutical Technology Co., Ltd
2021/10/15New drug · Class 1.1 巴蜀颗粒 · No verified English nameCXZL2101030 Xinjiang Hua Shi Dan Drug Research Co., Ltd. romanized
2021/10/15New drug · Class 1.1 清肠温中片 · No verified English nameCXZL2101029 Yang Zi Jiang Pharma Group Jiangsu Long Feng Tang Zhong Yao Co., Ltd. romanized
2021/10/15New drug · Class 1 HRS-3738片 · No verified English nameCXHL2101572 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/15New drug · Class 1 HRS-3738片 · No verified English nameCXHL2101571 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/15New drug · Class 1 HRS-3738片 · No verified English nameCXHL2101570 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/15New drug · Class 1 HRS5685片 · No verified English nameCXHL2101569 Rui Ke Di (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2021/10/15New drug · Class 1 HRS5685片 · No verified English nameCXHL2101568 Rui Ke Di (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2021/10/15New drug · Class 1 IN10018 片 · No verified English nameCXHL2101567 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2021/10/15New drug · Class 1 IN10018片 · No verified English nameCXHL2101566 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2021/10/15New drug · Class 2.3 HRG2005吸入剂 · No verified English nameCXHL2101565 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/15New drug · Class 1 IMP4297胶囊 · No verified English nameCXHL2101564 Shanghai Jun Pai Ying Shi Pharma Co., Ltd. romanized
2021/10/15New drug · Class 2.4 盐酸氨酮戊酸外用散 · No verified English nameCXHL2101563 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2021/10/15New drug · Class 1 注射用MB07133 · No verified English nameCXHL2101561 Xian Xin Tong Drug Research Co., Ltd. romanized
2021/10/14Import · Class 1 Rozanolixizumab注射液 · No verified English nameJXSL2101117 UCB Pharma SA; UCB Trading (Shanghai) Co. Ltd
2021/10/14Import · Class 1 TAK-935片 · No verified English nameJXHL2101200 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2021/10/14Import · Class 1 TAK-935片 · No verified English nameJXHL2101199 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2021/10/14Generic · Class 3 Desonide CreamCYHS2101866 Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized
2021/10/14Generic · Class 3 Haloperidol Oral SolutionCYHS2101865 Xinjiang Te Feng Pharma Co., Ltd. romanized
2021/10/14Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2101861 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2021/10/14Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2101860 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2021/10/14Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2101856 Qilu Pharmaceutical (Hainan) Co., Ltd
2021/10/14Generic · Class 3 Tranexamic Acid InjectionCYHS2101833 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2021/10/14New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSS2101033 Shandong Bo An Bio Technology Co., Ltd. romanized
2021/10/14New drug · Class 1 注射用DNV3 · No verified English nameCXSL2101369 Zhejiang Shi Mai Pharma Co., Ltd. romanized
2021/10/14New drug · Class 1 Ociperlimab注射液 · No verified English nameCXSL2101368 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2021/10/14New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2101367 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/10/14New drug · Class 3.2 静注人免疫球蛋白(10%) · No verified English nameCXSL2101366 Bo Ya Biopharmaceutical Group Co., Ltd. romanized
2021/10/14New drug · Class 1 SSGJ-706注射液 · No verified English nameCXSL2101365 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/10/14New drug · Class 1 SSGJ-706注射液 · No verified English nameCXSL2101364 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized

41 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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