YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 73 drug applications between 14 February 2021 and 20 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 16, covering 12 drug names.

2021/02/14 – 2021/02/20

Period
2021/02/14 to 2021/02/20, 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
73
Drugs with new generic filings (by drug name, de-duplicated)
12
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

73filings, 16 of them generic

By application type

Application typeFilings
Supplement40
Generic16
New drug9
Import8

By drug type

Drug typeFilings
Chemical drug52
Therapeutic biologic15
TCM5
Prophylactic 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

12 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Palbociclib Capsules310
2Azithromycin For Injection2111
3Palonosetron Hydrochloride Injection211
4Etoricoxib Tablets118
5吸入用七氟烷 · No verified English name110
6Estradiol Valerate Tablets117
7Lacosamide Oral Solution110
8Lenalidomide Capsules113
9Voriconazole for Injection115
10Parecoxib Sodium for Injection112

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

43 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xian Jing Xi Shuang He Pharma Co., Ltd. romanized620
2Hebei Tian Cheng Pharma Co., Ltd. romanized440
3Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized420
4Pfizer Europe MA EEIG410
5Hubei Meng Yang Pharma Co., Ltd. romanized320
6Novo Nordisk A/S310
7Jiangxi Shan Xiang Pharma Co., Ltd. romanized313
8Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized310
9AstraZeneca AB210
10Janssen-Cilag International NV210

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

15 this week

AcceptedDrugApplicants
2021/02/20Import · Class 1 Belzutifan片 · No verified English nameJXHL2100053 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.
2021/02/20New drug · Class 1 9MW1911注射液 · No verified English nameCXSL2100060 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2021/02/20New drug · Class 1 QL1779注射液 · No verified English nameCXSL2100059 Qilu Pharmaceutical Co., Ltd.
2021/02/20New drug · Class 1 9MW1911注射液 · No verified English nameCXSL2100058 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2021/02/20New drug · Class 2.4 Lenvatinib Mesilate CapsulesCXHL2100115 Xian Sheng Pharma Co., Ltd. romanized
2021/02/20New drug · Class 1 注射用BXOS110 · No verified English nameCXHL2100113 Bai Xi Ou Si (Beijing) Bio Technology Co., Ltd. romanized
2021/02/19Import · Class 3.1 达雷妥尤单抗注射液 · No verified English nameJXSS2100016 Janssen-Cilag International NV; Cilag AG
2021/02/19Import · Class 3.1 达雷妥尤单抗注射液 · No verified English nameJXSS2100015 Janssen-Cilag International NV; Cilag AG
2021/02/19Import · Class 2.2 Semaglutide片 · No verified English nameJXSL2100028 Novo Nordisk A/S
2021/02/19Import · Class 2.2 Semaglutide片 · No verified English nameJXSL2100027 Novo Nordisk A/S
2021/02/19Import · Class 2.2 Semaglutide片 · No verified English nameJXSL2100026 Novo Nordisk A/S
2021/02/19New drug · Class 1 9MW1911注射液 · No verified English nameCXSL2100057 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2021/02/19New drug · Class 2.2 磷酸奥司他韦缓释片 · No verified English nameCXHL2100114 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/02/19New drug · Class 1 WJ01024片 · No verified English nameCXHL2100108 Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2021/02/19New drug · Class 1 WJ01024片 · No verified English nameCXHL2100107 Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized

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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