YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 194 drug applications between 26 March 2021 and 1 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 19, covering 11 drug names.

2021/03/26 – 2021/04/01

Period
2021/03/26 to 2021/04/01, 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
194
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

194filings, 19 of them generic

By application type

Application typeFilings
Supplement110
New drug27
Import22
Generic19
Import re-registration12
Unspecified4

By drug type

Drug typeFilings
Chemical drug136
Therapeutic biologic34
TCM17
Prophylactic biologic6
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
1Memantine Hydrochloride Tablets412
2Celecoxib Capsules215
3Levofloxacin Tablets217
4Dapagliflozin Tablets2184
5Metoprolol Tartrate Tablets213
6Ranolazine Prolonged-Release Tablets213
7丙泊酚乳状注射液 · No verified English name113
8Tenofovir alafenamide Fumarate Tablets110
9Fluconazole and Sodium Chloride Injection111
10Flurbiprofen Axetil Injection110

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

111 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hainan Sai Li Ke Pharma Co., Ltd. romanized11110
2Sichuan Kelun Pharmaceutical Co., Ltd.930
3Fresenius Kabi Austria GmbH610
4Janssen-Cilag International NV610
5Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized510
6Novartis Pharma AG430
7Janssen Research & Development LLC420
8Pfizer Europe MA EEIG420
9Chengdu Brilliant Pharmaceutical Co., Ltd.422
10Aurobindo Pharma Limited410

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

44 this week

AcceptedDrugApplicants
2021/04/01Import · Class 3.1 贝伐珠单抗注射液 · No verified English nameJXSS2100021 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH
2021/04/01Import · Class 1 Teclistamab 注射液 · No verified English nameJXSL2101003 Janssen Research & Development LLC; Johnson & Jonson (China)Investment Ltd.
2021/04/01Import · Class 1 Teclistamab 注射液 · No verified English nameJXSL2101002 Janssen Research & Development, LLC; Johnson & Johnson (China)Investment Ltd
2021/04/01Import · Class 3.1 Nonacog beta pegol · No verified English nameJXSL2100050 Novo Nordisk A/S
2021/04/01Import · Class 3.1 Nonacog beta pegol · No verified English nameJXSL2100049 Novo Nordisk A/S
2021/04/01Import · Class 3.1 Nonacog beta pegol · No verified English nameJXSL2100048 Novo Nordisk A/S
2021/04/01Import · Class 1 注射用LNA043 · No verified English nameJXSL2100047 Novartis Pharma AG
2021/04/01Import · Class 2.2 ACZ885注射液 · No verified English nameJXSL2100046 Novartis Pharma AG
2021/04/01Import · Class 2.4 注射用Trilaciclib · No verified English nameJXHL2100110 G1 THERAPEUTICS INC.
2021/04/01Generic · Class 3 Ranolazine Prolonged-Release TabletsCYHL2100020 Yangtze River Pharmaceutical Group Co., Ltd
2021/04/01Generic · Class 3 Ranolazine Prolonged-Release TabletsCYHL2100019 Yangtze River Pharmaceutical Group Co., Ltd
2021/04/01New drug · Class 1.1 小儿连花清感颗粒 · No verified English nameCXZL2101003 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2021/04/01New drug · Class 2.3 痰热清胶囊 · No verified English nameCXZL2101002 Shanghai Kai Bao Pharma Co., Ltd. romanized
2021/04/01New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSL2101008 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2021/04/01New drug · Class 1 JS007注射液 · No verified English nameCXSL2100110 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/03/31Import · Class 3.1 注射用贝林妥欧单抗 · No verified English nameJXSS2100020 Amgen Inc.; Amgen Technology (Ireland) Unlimited Company
2021/03/31Import · Class 1 LY3471851注射液 · No verified English nameJXSL2100045 Eli Lilly and Company
2021/03/31New drug · Class 2 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) · No verified English nameCXSS2100033 Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized
2021/03/31New drug · Class 1 MY004567片 · No verified English nameCXHL2100213 Shanghai Mei Yue Bio Technology Development Co., Ltd. romanized
2021/03/31New drug · Class 1 MY004567片 · No verified English nameCXHL2100212 Shanghai Mei Yue Bio Technology Development Co., Ltd. romanized
2021/03/31New drug · Class 1 赛沃替尼片 · No verified English nameCXHL2100211 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/03/31New drug · Class 1 赛沃替尼片 · No verified English nameCXHL2100210 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/03/30Import · Class 1 Balixafortide · No verified English nameJXHL2100109 Polyphor Ltd
2021/03/30New drug · Class 1 AK104注射液 · No verified English nameCXSL2100109 Kang Fang Pharma Co., Ltd. romanized
2021/03/30New drug · Class 1 重组抗CD20人源化单克隆抗体注射液 · No verified English nameCXSL2100108 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2021/03/29Import · Class 2.4 BYL719 · No verified English nameJXHL2101001 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/03/29Import · Class 2.4 BYL719 · No verified English nameJXHL2101000 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/03/29New drug · Class 1 SH3765片 · No verified English nameCXHL2101015 Nanjing Hui Cheng Pharmaceutical Co., Ltd. romanized
2021/03/29New drug · Class 1 SH3765片 · No verified English nameCXHL2101014 Nanjing Hui Cheng Pharmaceutical Co., Ltd. romanized
2021/03/29New drug · Class 2.2 吡非尼酮双释片 · No verified English nameCXHL2101012 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized

14 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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