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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 108 drug applications between 15 February 2021 and 21 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 16 drug names.

2021/02/15 – 2021/02/21

Period
2021/02/15 to 2021/02/21, 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
108
Drugs with new generic filings (by drug name, de-duplicated)
16
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

108filings, 20 of them generic

By application type

Application typeFilings
Supplement65
Generic20
New drug14
Import9

By drug type

Drug typeFilings
Chemical drug81
Therapeutic biologic17
TCM8
Prophylactic biologic2

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

16 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
6Brivaracetam Solution for Injection110
7Estradiol Valerate Tablets117
8Lacosamide Oral Solution110
9Lenalidomide Capsules113
10Voriconazole for Injection115

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

66 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
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized321
6Hubei Meng Yang Pharma Co., Ltd. romanized320
7H. Lundbeck A/S310
8Novo Nordisk A/S310
9Pfizer Australia Pty Ltd310
10Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized310

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

22 this week

AcceptedDrugApplicants
2021/02/21Generic · Class 3 Doxepin Hydrochloride TabletsCYHS2100214 Shenyang Hua Tai Drug Research Co., Ltd. romanized; Shenyang Fu Ning Pharma Co., Ltd. romanized
2021/02/21Generic · Class 3 Brivaracetam Solution for InjectionCYHS2100213 Yang Zi Jiang Pharma Group Sichuan Hai Rong Pharma Co., Ltd. romanized
2021/02/21New drug · Class 1 JMKX000189片 · No verified English nameCXHL2100120 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2021/02/21New drug · Class 1 JMKX000189片 · No verified English nameCXHL2100119 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2021/02/21New drug · Class 1 JMKX000189片 · No verified English nameCXHL2100118 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2021/02/21New drug · Class 1 FM888胶囊 · No verified English nameCXHL2100117 Qingdao Yong Zhan Pharmaceuticals Technology Co., Ltd. romanized
2021/02/21New drug · Class 1 FM888胶囊 · No verified English nameCXHL2100116 Qingdao Yong Zhan Pharmaceuticals Technology Co., Ltd. romanized
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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