YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 183 drug applications between 27 March 2021 and 2 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 12 drug names.

2021/03/27 – 2021/04/02

Period
2021/03/27 to 2021/04/02, 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
183
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

183filings, 20 of them generic

By application type

Application typeFilings
Supplement104
New drug24
Generic20
Import18
Import re-registration13
Unspecified4

By drug type

Drug typeFilings
Chemical drug133
Therapeutic biologic35
TCM8
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

12 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Memantine Hydrochloride Tablets412
2Olanzapine Tablets214
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
9Torsemide Injection111
10Glycopyrronium Bromide and Neostigmine Metilsulfate Injection113

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

112 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fresenius Kabi Austria GmbH610
2Janssen-Cilag International NV610
3Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized510
4Bao Ding Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized440
5Novartis Pharma AG430
6Janssen Research & Development LLC420
7Pfizer Europe MA EEIG420
8Chengdu Brilliant Pharmaceutical Co., Ltd.422
9Sichuan Kelun Pharmaceutical Co., Ltd.410
10Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized414

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
2021/04/02Import · Class 3.3 注射用英夫利西单抗 · No verified English nameJXSS2100022 CELLTRION Inc.
2021/04/02Import · Class 1 注射用阿帕拉格鲁肽 · No verified English nameJXHL2100112 VectivBio AG
2021/04/02Generic · Class 3 Torsemide InjectionCYHS2100309 Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd
2021/04/02Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2100018 Rui Yang Pharmaceutical Co., Ltd. romanized
2021/04/02New drug · Class 1.1 川芎定痛颗粒 · No verified English nameCXZL2100004 Beijing Yang Guang He He Zhong Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/04/02New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSL2100112 Jilin Hui Sheng Biopharmaceutical Co., Ltd. romanized
2021/04/02New drug · Class 1 LM-102 注射液 · No verified English nameCXSL2100111 Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized
2021/04/02New drug · Class 1 HS-10374片 · No verified English nameCXHL2100217 Changzhou Heng Bang Pharma Co., Ltd. romanized
2021/04/02New drug · Class 1 HS-10374片 · No verified English nameCXHL2100216 Changzhou Heng Bang Pharma Co., Ltd. romanized
2021/04/02New drug · Class 1 PG-011凝胶 · No verified English nameCXHL2100215 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2021/04/02New drug · Class 1 PG-011凝胶 · No verified English nameCXHL2100214 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
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

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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