YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 208 drug applications between 19 March 2021 and 25 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 11, covering 8 drug names.

2021/03/19 – 2021/03/25

Period
2021/03/19 to 2021/03/25, 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
208
Drugs with new generic filings (by drug name, de-duplicated)
8
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

208filings, 11 of them generic

By application type

Application typeFilings
Supplement112
Import34
New drug31
Generic11
Unspecified10
Import re-registration10

By drug type

Drug typeFilings
Chemical drug158
Therapeutic biologic41
Prophylactic biologic5
TCM2
In vitro diagnostic reagent1
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

8 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Argatroban Injection222
2Saxagliptin Tablets210
3酒石酸伐尼克兰片 · No verified English name213
4头孢地尼颗粒 · No verified English name113
5特利加压素注射液 · No verified English name110
6Venlafaxine Hydrochloride Sustained-Release Capsules110
7Lanthanum Carbonate Chewable Tablets112
8Sitagliptin Phosphate Tablets112

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

109 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Si Huan Biopharmaceutical Co., Ltd. romanized1010
2Sichuan Kelun Pharmaceutical Co., Ltd.730
3AstraZeneca UK Limited620
4Astrazeneca UK Limited610
5Kyowa Kirin Co. Ltd.610
6LABORATORIOS FARMACEUTICOS ROVI S.A.510
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized430
8Loxo Oncology Inc.410
9Merck Europe B.V.410
10Mirum Pharmaceuticals Inc.410

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

55 this week

AcceptedDrugApplicants
2021/03/25Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2100042 F.Hoffmann-La Roche Ltd
2021/03/25Import · Class 1 SEP-363856片 · No verified English nameJXHL2100108 Sunovion Pharmaceuticals Inc.
2021/03/25Import · Class 1 SEP-363856片 · No verified English nameJXHL2100107 Sunovion Pharmaceuticals Inc.
2021/03/25Import · Class 1 SEP-363856片 · No verified English nameJXHL2100106 Sunovion Pharmaceuticals Inc.
2021/03/25Import · Class 1 SEP-363856片 · No verified English nameJXHL2100105 Sunovion Pharmaceuticals Inc.
2021/03/25Generic · Class 3 特利加压素注射液 · No verified English nameCYHS2100290 Shenzhen Shi Jian Xiang Biopharmaceutical Co., Ltd. romanized
2021/03/25New drug · Class 3.3 贝伐珠单抗注射液 · No verified English nameCXSL2100105 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2021/03/25New drug · Class 3.3 贝伐珠单抗注射液 · No verified English nameCXSL2100104 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2021/03/25New drug · Class 1 AK117注射液 · No verified English nameCXSL2100103 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/03/25New drug · Class 1 二甲苯磺酸萘普替尼片 · No verified English nameCXHL2100203 Shenzhen Hai Wang Pharmaceuticals Technology Research Institute Co., Ltd. romanized
2021/03/24Import · Class 1 巴替利单抗注射液 · No verified English nameJXSL2100044 Agenus Inc.
2021/03/24Import · Class 1 TransCon PTH注射液 · No verified English nameJXHL2100104 Ascendis Pharma Bone Diseases A/S
2021/03/24Import · Class 1 TransCon PTH注射液 · No verified English nameJXHL2100103 Ascendis Pharma Bone Diseases A/S
2021/03/24Import · Class 1 TransCon PTH注射液 · No verified English nameJXHL2100102 Ascendis Pharma Bone Diseases A/S
2021/03/24Import · Class 1 Linerixibat片 · No verified English nameJXHL2100101 GlaxoSmithKline (Ireland) Limited
2021/03/24New drug · Class 2.3 馥感啉口服液 · No verified English nameCXZL2101001 Yi Pin Hong Biopharmaceuticals Co., Ltd. romanized
2021/03/24New drug · Class 1 GZR18 · No verified English nameCXSL2100100 Gan Li Pharma Co., Ltd. romanized
2021/03/24New drug · Class 1 GZR18 · No verified English nameCXSL2100099 Gan Li Pharma Co., Ltd. romanized
2021/03/24New drug · Class 1 JAB-21822片 · No verified English nameCXHL2101006 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/03/24New drug · Class 1 JAB-21822片 · No verified English nameCXHL2101005 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/03/24New drug · Class 2.2 枸橼酸西地那非口溶膜 · No verified English nameCXHL2100202 Sichuan Kelun Pharmaceutical Co., Ltd.
2021/03/24New drug · Class 2.2 枸橼酸西地那非口溶膜 · No verified English nameCXHL2100201 Sichuan Kelun Pharmaceutical Co., Ltd.
2021/03/24New drug · Class 1 FWD1509 MsOH片 · No verified English nameCXHL2100200 Shenzhen Fu Wo Pharma Co., Ltd. romanized
2021/03/24New drug · Class 1 FWD1509 MsOH片 · No verified English nameCXHL2100199 Shenzhen Fu Wo Pharma Co., Ltd. romanized
2021/03/24New drug · Class 1 FWD1509 MsOH片 · No verified English nameCXHL2100198 Shenzhen Fu Wo Pharma Co., Ltd. romanized
2021/03/23Import · Class 1 注射用LNA043 · No verified English nameJXSL2100043 Novartis Pharma AG
2021/03/23Generic · Class 3 头孢地尼颗粒 · No verified English nameCYHS2100289 Hefei En Rui Te Pharma Co., Ltd. romanized; Anhui An Ke Heng Yi Pharma Co., Ltd. romanized
2021/03/23New drug · Class 3.3 重组人GLP-1-Fc融合蛋白注射液 · No verified English nameCXSL2100102 Hua Run Ang De Bio Pharma Co., Ltd. romanized
2021/03/23New drug · Class 3.3 重组人GLP-1-Fc融合蛋白注射液 · No verified English nameCXSL2100101 Hua Run Ang De Bio Pharma Co., Ltd. romanized
2021/03/23New drug · Class 1 西格列他钠片 · No verified English nameCXHL2101009 Chengdu Wei Xin Pharma Co., Ltd. romanized

25 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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