YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 271 drug applications between 17 January 2021 and 23 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 31 drug names.

2021/01/17 – 2021/01/23

Period
2021/01/17 to 2021/01/23, 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
271
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

271filings, 38 of them generic

By application type

Application typeFilings
Supplement148
New drug40
Generic38
Import24
Unspecified13
Import re-registration8

By drug type

Drug typeFilings
Chemical drug214
Therapeutic biologic41
TCM9
Prophylactic biologic5
In vitro diagnostic reagent2

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
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
3Sodium Valproate Concentrated Solution for Injection210
4Canagliflozin Tablets218
5Levocarnitine Injection214
6Temozolomide Capsules210
7Cisatracurium Besylate Injection214
8依托咪酯乳状注射液 · No verified English name111
9Linezolid and Glucose Injection113
10Ambroxol Hydrochloride Solution For Inhalation1110

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

149 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hunan Ke Lun Pharmaceutical Co., Ltd. romanized822
2AstraZeneca AB720
3Pfizer Europe MA EEIG630
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
5Qilu Pharmaceutical Co., Ltd.542
6Sichuan Kelun Pharmaceutical Co., Ltd.533
7Changchun Jin Sai Pharma Co., Ltd. romanized520
8Guilin Pharmaceutical Co. Ltd China510
9Boehringer Ingelheim International GmbH420
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

67 this week

AcceptedDrugApplicants
2021/01/23Import · Class 2.4 Dapagliflozin TabletsJXHS2100010 AstraZeneca AB; AstraZeneca Pharmaceuticals LP
2021/01/23Import · Class 2.4 Dapagliflozin TabletsJXHS2100009 AstraZeneca AB; AstraZeneca Pharmaceuticals LP
2021/01/23Import · Class 2.2; 2.4 硫酸阿托品滴眼液 · No verified English nameJXHL2100026 Santen Pharmaceutical Co. Ltd.
2021/01/23Import · Class 2.2 硫酸阿托品滴眼液 · No verified English nameJXHL2100025 Santen Pharmaceutical Co. Ltd.
2021/01/23Import · Class 2.2; 2.4 硫酸阿托品滴眼液 · No verified English nameJXHL2100024 Santen Pharmaceutical Co. Ltd.
2021/01/23Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2100101 Chengdu Li Er Pharma Co., Ltd. romanized
2021/01/23Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2100100 Chengdu Li Er Pharma Co., Ltd. romanized
2021/01/23Generic · Class 3 Delafloxacin for InjectionCYHL2100004 Yangtze River Pharmaceutical Group Co., Ltd
2021/01/23New drug · Class 1 IBI318 · No verified English nameCXSL2100029 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/01/23New drug · Class 1 盐酸依地西汀片 · No verified English nameCXHL2100055 Suzhou Xi Ke Luo Pharmaceutical Co., Ltd. romanized
2021/01/23New drug · Class 1 盐酸依地西汀片 · No verified English nameCXHL2100054 Suzhou Xi Ke Luo Pharmaceutical Co., Ltd. romanized
2021/01/23New drug · Class 1 盐酸依地西汀片 · No verified English nameCXHL2100053 Suzhou Xi Ke Luo Pharmaceutical Co., Ltd. romanized
2021/01/23New drug · Class 1 盐酸依地西汀片 · No verified English nameCXHL2100052 Suzhou Xi Ke Luo Pharmaceutical Co., Ltd. romanized
2021/01/23New drug · Class 1 HSK29116散 · No verified English nameCXHL2100051 Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2021/01/23New drug · Class 1 HSK29116散 · No verified English nameCXHL2100050 Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2021/01/23New drug · Class 1 HSK29116散 · No verified English nameCXHL2100049 Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
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

37 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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