YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 212 drug applications between 21 June 2021 and 27 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 28, covering 17 drug names.

2021/06/21 – 2021/06/27

Period
2021/06/21 to 2021/06/27, 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
212
Drugs with new generic filings (by drug name, de-duplicated)
17
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

212filings, 28 of them generic

By application type

Application typeFilings
Supplement112
New drug36
Import29
Generic28
Unspecified4
Import re-registration3

By drug type

Drug typeFilings
Chemical drug156
Therapeutic biologic40
TCM15
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

17 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Celecoxib Capsules415
2Pregabalin Capsules3212
3Tenofovir alafenamide Fumarate Tablets220
4Selexipag Tablets2124
5Ipratropium Bromide Inhalation Solution212
6Esomeprazole Sodium for Injection211
7Valsartan Film-Coated Tablets210
8Ketorolac Tromethamine Injection214
9Itraconazole Oral Solution111
10Warfarin Sodium Tablets111

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

129 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1The Wellcome Foundation Limited720
2Janssen Research & Development LLC620
3Qilu Pharmaceutical Co., Ltd.530
4Baxalta US Inc.510
5IPSEN PHARMA510
6Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized440
7UCB Pharma S.A.410
8Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized414
9Guangzhou Run Er Yan Ke Bio Technology Co., Ltd. romanized410
10Xuan Zhu Bio Technology Co., Ltd. romanized410

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

70 this week

AcceptedDrugApplicants
2021/06/25Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSS2101012 Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd
2021/06/25Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSS2101011 Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd
2021/06/25Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSS2101010 Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd
2021/06/25Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSS2101009 Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd
2021/06/25Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSS2101008 Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd
2021/06/25Import · Class 1 SAR439459注射用粉针 · No verified English nameJXSL2101049 sanofi-aventis recherche & développement; Sanofi (China) Investment Co. Ltd.
2021/06/25Import · Class 1 RO7112689 · No verified English nameJXSL2101048 F.Hoffmann-La Roche Ltd.; Roche(China)Holding Ltd.
2021/06/25Import · Class 1 Zenocutuzumab注射液 · No verified English nameJXSL2101046 Merus N.V.; Hangzhou Tigermed Consulting Co. Ltd.
2021/06/25Import · Class 1 Relatlimab注射液 · No verified English nameJXSL2101045 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2021/06/25Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHL2101104 Eisai Europe Ltd.
2021/06/25Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHL2101103 Eisai Europe Ltd.
2021/06/25Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHL2101102 Eisai Europe Ltd.
2021/06/25Import · Class 2.4 ATG-010片 · No verified English nameJXHL2101101 Karyopharm Therapeutics Inc.; Antengene Corporation Co. Ltd.
2021/06/25Import · Class 2.2 盐酸毛果芸香碱微量眼用溶液 · No verified English nameJXHL2101100 Arctic Vision (Hong Kong) Limited; Arctic Vision (Shanghai) Biotechnology Co Ltd
2021/06/25Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2101349 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2021/06/25Generic · Class 3 Warfarin Sodium TabletsCYHS2101348 Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
2021/06/25Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2101332 Zhejiang Er Ying Medicines Co., Ltd. romanized; Zhejiang Jian Feng Pharma Co., Ltd. romanized
2021/06/25Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2101321 Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized
2021/06/25Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2101320 Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized
2021/06/25New drug · Class 1 AK112注射液 · No verified English nameCXSL2101154 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/06/25New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101147 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/06/25New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2101146 Shanghai Hui Cun Medical Technology Co., Ltd. romanized
2021/06/25New drug · Class 1 注射用IMM01 · No verified English nameCXSL2101143 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/06/25New drug · Class 1 TQB3617胶囊 · No verified English nameCXHL2101237 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/06/25New drug · Class 1 TQB3617胶囊 · No verified English nameCXHL2101236 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/06/25New drug · Class 1 SPH6516片 · No verified English nameCXHL2101235 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2021/06/25New drug · Class 1 SPH6516片 · No verified English nameCXHL2101234 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2021/06/25New drug · Class 1 ADC189片 · No verified English nameCXHL2101233 An Di Kang (Wuxi) Bio Technology Co., Ltd. romanized
2021/06/25New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2101232 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/06/25New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2101231 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized

40 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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