YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 147 drug applications between 14 March 2021 and 20 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 19, covering 11 drug names.

2021/03/14 – 2021/03/20

Period
2021/03/14 to 2021/03/20, 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
147
Drugs with new generic filings (by drug name, de-duplicated)
11
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

147filings, 19 of them generic

By application type

Application typeFilings
Supplement73
Import23
Generic19
New drug15
Import re-registration9
Unspecified8

By drug type

Drug typeFilings
Chemical drug121
Therapeutic biologic13
TCM7
Prophylactic biologic3
Biologic2
In vitro diagnostic reagent1

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

11 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Argatroban Injection332
2Sodium Valproate Concentrated Solution for Injection310
3Brexpiprazole Tablets3131
4Pemetrexed Disodium for Injection214
5Febuxostat Tablets2112
6氯化钾缓释片(I) · No verified English name110
7Lormetazepam Injection110
8Metoprolol Succinate Sustained-release Tablets114
9Metformin Hydrochloride Extended-release Tablets1110
10Olprinone Hydrochloride Injection111

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

84 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized950
2Astrazeneca UK Limited610
3LABORATORIOS FARMACEUTICOS ROVI S.A.510
4AstraZeneca UK Limited410
5Loxo Oncology Inc.410
6Mirum Pharmaceuticals Inc.410
7Pfizer Healthcare Ireland410
8Novartis Pharma Schweiz AG320
9Eli Lilly and Company310
10Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized313

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

35 this week

AcceptedDrugApplicants
2021/03/20Import · Class 1 Maralixibat口服溶液 · No verified English nameJXHL2100100 Mirum Pharmaceuticals Inc.
2021/03/20Import · Class 1 Maralixibat口服溶液 · No verified English nameJXHL2100099 Mirum Pharmaceuticals Inc.
2021/03/20Import · Class 1 Maralixibat口服溶液 · No verified English nameJXHL2100098 Mirum Pharmaceuticals Inc.
2021/03/20Import · Class 1 Maralixibat口服溶液 · No verified English nameJXHL2100097 Mirum Pharmaceuticals Inc.
2021/03/20Import · Class 1 Atrasentan片 · No verified English nameJXHL2100096 Chinook Therapeutics U.S. Inc.
2021/03/20Import · Class 1 LOXO-305 · No verified English nameJXHL2100093 Loxo Oncology Inc.
2021/03/20Import · Class 1 LOXO-305 · No verified English nameJXHL2100092 Loxo Oncology Inc.
2021/03/20Import · Class 1 LOXO-305 · No verified English nameJXHL2100091 Loxo Oncology Inc.
2021/03/20Import · Class 1 LOXO-305 · No verified English nameJXHL2100090 Loxo Oncology Inc.
2021/03/20Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHL2100089 Eisai Europe Ltd.
2021/03/20Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHL2100088 Eisai Europe Ltd.
2021/03/20New drug · Class 1 阿基仑赛注射液 · No verified English nameCXSL2100098 Fu Xing Kai Te Bio Technology Co., Ltd. romanized
2021/03/19New drug · Class 2.4 Tenofovir alafenamide Fumarate TabletsCXHS2100010 Hua Bei Pharmaceutical Hua Kun Hebei Bio Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2021/03/19New drug · Class 1 ASC42片 · No verified English nameCXHL2101008 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2021/03/19New drug · Class 1 ASC42片 · No verified English nameCXHL2101007 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2021/03/18Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2101023 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/03/18Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2101022 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/03/18Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2101021 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/03/18New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2101005 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/03/18New drug · Class 1 HTD1801胶囊 · No verified English nameCXHL2100190 Shenzhen Jun Sheng Tai Bio Technology Co., Ltd. romanized
2021/03/17Generic · Class 3 Lormetazepam InjectionCYHL2100017 Jiangsu Hua Tai Chen Guang Pharma Co., Ltd. romanized
2021/03/17New drug · Class 1 阴道用四联乳杆菌活菌胶囊 · No verified English nameCXSL2101004 Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2021/03/17New drug · Class 1 阴道用四联乳杆菌活菌胶囊 · No verified English nameCXSL2101003 Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2021/03/17New drug · Class 1 ASC42片 · No verified English nameCXHL2101004 Gan Lai Pharmaceutical Co., Ltd. romanized
2021/03/17New drug · Class 1 ASC42片 · No verified English nameCXHL2101003 Gan Lai Pharmaceutical Co., Ltd. romanized
2021/03/16Generic · Class 3 氯化钾缓释片(I) · No verified English nameCYHS2100285 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/03/16Generic · Class 3 Brexpiprazole TabletsCYHS2100283 YaoPharma Co., Ltd.
2021/03/16Generic · Class 3 Brexpiprazole TabletsCYHS2100282 YaoPharma Co., Ltd.
2021/03/16Generic · Class 3 Brexpiprazole TabletsCYHS2100281 YaoPharma Co., Ltd.
2021/03/16Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2100280 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized

5 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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