YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 247 drug applications between 16 January 2021 and 22 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 31, covering 25 drug names.

2021/01/16 – 2021/01/22

Period
2021/01/16 to 2021/01/22, 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
247
Drugs with new generic filings (by drug name, de-duplicated)
25
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

247filings, 31 of them generic

By application type

Application typeFilings
Supplement138
New drug37
Generic31
Import23
Unspecified13
Import re-registration5

By drug type

Drug typeFilings
Chemical drug190
Therapeutic biologic42
TCM7
Prophylactic biologic5
In vitro diagnostic reagent3

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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oseltamivir Phosphate Capsules2239
2ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液 · No verified English name210
3Canagliflozin Tablets218
4Levocarnitine Injection214
5Duloxetine Hydrochloride Enteric Capsules214
6Cisatracurium Besylate Injection214
7依托咪酯乳状注射液 · No verified English name111
8Ambroxol Hydrochloride Solution For Inhalation1110
9Ornidazole Injection110
10Nimodipine Oral Solution114

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

135 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Pfizer Europe MA EEIG840
2Hunan Ke Lun Pharmaceutical Co., Ltd. romanized822
3AstraZeneca AB730
4Qilu Pharmaceutical Co., Ltd.542
5Boehringer Ingelheim International GmbH530
6Sichuan Kelun Pharmaceutical Co., Ltd.532
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
8Changchun Jin Sai Pharma Co., Ltd. romanized520
9Guilin Pharmaceutical Co. Ltd China510
10Dong Guan Shi Dong Yang Guang Bio Yao Research and Development 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

59 this week

AcceptedDrugApplicants
2021/01/22Generic · Class 3 ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液 · No verified English nameCYHS2100094 Sichuan Kelun Pharmaceutical Co., Ltd.
2021/01/22Generic · Class 3 ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液 · No verified English nameCYHS2100093 Sichuan Kelun Pharmaceutical Co., Ltd.
2021/01/22New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2100028 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/01/22New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2100027 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/01/22New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2100026 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/01/22New drug · Class 1.2 重组肠道病毒71型疫苗(汉逊酵母) · No verified English nameCXSL2100025 Chongqing Bo Wei Bai Tai Biopharmaceutical Co., Ltd. romanized
2021/01/22New drug · Class 2.2 注射用双羟萘酸曲普瑞林微球 · No verified English nameCXHL2100048 Li Zhu Pharmaceuticals Group Co., Ltd. romanized
2021/01/22New drug · Class 1 BPI-421286胶囊 · No verified English nameCXHL2100047 Bei Da Pharma Co., Ltd. romanized
2021/01/22New drug · Class 1 BPI-421286胶囊 · No verified English nameCXHL2100046 Bei Da Pharma Co., Ltd. romanized
2021/01/21Import · Class 3.1 Ramucirumab注射液 · No verified English nameJXSS2100007 Eli Lilly and Company
2021/01/21Import · Class 3.1 Ramucirumab注射液 · No verified English nameJXSS2100006 Eli Lilly and Company
2021/01/21Generic · Class 3 Memantine Hydrochloride OD TabletsCYHS2100090 Wan Quan Wan Te Pharmaceutical Jiangsu Co., Ltd. romanized
2021/01/21Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2100089 CISEN PHARMACEUTICAL CO., LTD.
2021/01/21Generic · Class 3 Pregabalin Oral SolutionCYHS2100087 Jiangxi Qing Feng Pharma Co., Ltd. romanized
2021/01/21Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2100086 Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2021/01/21New drug · Class 2.1; 2.2 硫酸氢伊伐布雷定缓释片 · No verified English nameCXHL2100045 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/21New drug · Class 2.1; 2.2 硫酸氢伊伐布雷定缓释片 · No verified English nameCXHL2100044 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/21New drug · Class 2.1; 2.2 硫酸氢伊伐布雷定缓释片 · No verified English nameCXHL2100043 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/21New drug · Class 1 HS-10360片 · No verified English nameCXHL2100042 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/01/21New drug · Class 1 HS-10360片 · No verified English nameCXHL2100041 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/01/21New drug · Class 1 RO7020531片 · No verified English nameCXHL2100040 Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized
2021/01/21New drug · Class 1 RO7020531片 · No verified English nameCXHL2100039 Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized
2021/01/20Import · Class 3.1 注射用司妥昔单抗 · No verified English nameJXSS2100005 EUSA Pharma (Netherlands) B.V.; Cilag AG
2021/01/20Import · Class 3.1 注射用司妥昔单抗 · No verified English nameJXSS2100004 EUSA Pharma (Netherlands) B.V.; Cilag AG
2021/01/20Import · Class 1 IMGN853 · No verified English nameJXSL2100009 ImmunoGen Inc.
2021/01/20Import · Class 1 RO7445482注射液 · No verified English nameJXHL2100021 F. Hoffmann-La Roche Ltd.
2021/01/20New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSL2100024 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized
2021/01/20New drug · Class 1 异体内皮祖细胞(EPCs)注射液 · No verified English nameCXSL2100023 Cheng Nuo Zai Sheng Yi Xue Technology (Zhuhai Heng Qin Xin Qu) Co., Ltd. romanized
2021/01/20New drug · Class 1 JMT601注射液 · No verified English nameCXSL2100022 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2021/01/20New drug · Class 1 HEC88473注射液 · No verified English nameCXSL2100021 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized

29 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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