YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 254 drug applications between 22 June 2021 and 28 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 24 drug names.

2021/06/22 – 2021/06/28

Period
2021/06/22 to 2021/06/28, 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
254
Drugs with new generic filings (by drug name, de-duplicated)
24
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

254filings, 35 of them generic

By application type

Application typeFilings
Supplement135
New drug44
Generic35
Import26
Unspecified9
Import re-registration5

By drug type

Drug typeFilings
Chemical drug173
Therapeutic biologic42
TCM38
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

24 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pregabalin Capsules3212
2Tenofovir alafenamide Fumarate Tablets220
3Selexipag Tablets2124
4Ipratropium Bromide Inhalation Solution212
5Ornidazole Injection210
6Esomeprazole Sodium for Injection211
7Epinastine Hydrochloride Tablets212
8Ropivacaine hydrochloride injection215
9Ketorolac Tromethamine Injection214
10Desmopressin Acetate Injection210

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

143 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized31280
2Janssen Research & Development LLC830
3Boehringer Ingelheim International GmbH520
4Baxalta US Inc.510
5Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized440
6Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized420
7UCB Pharma S.A.410
8Guangzhou Run Er Yan Ke Bio Technology Co., Ltd. romanized410
9Xuan Zhu Bio Technology Co., Ltd. romanized410
10CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD320

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

79 this week

AcceptedDrugApplicants
2021/06/28Import · Class 1 Talquetamab注射液 · No verified English nameJXSL2101051 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/06/28Import · Class 1 Talquetamab注射液 · No verified English nameJXSL2101050 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/06/28Import · Class 1 BI 1810631 片 · No verified English nameJXHL2101108 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/06/28Import · Class 1 BI 1810631 片 · No verified English nameJXHL2101107 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/06/28Import · Class 1 BI 1810631 片 · No verified English nameJXHL2101106 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/06/28Import · Class 1 Linerixibat 片 · No verified English nameJXHL2101105 GlaxoSmithKline(Ireland) Limited; GlaxoSmithKline(China) Investment Co. Ltd
2021/06/28Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2101347 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2021/06/28Generic · Class 3 Ornidazole InjectionCYHS2101346 Bei Da Pharmaceuticals Co., Ltd. romanized
2021/06/28Generic · Class 3 Ornidazole InjectionCYHS2101345 Bei Da Pharmaceuticals Co., Ltd. romanized
2021/06/28Generic · Class 3 Fosaprepitant Dimeglumine for InjectionCYHS2101342 Hunan Sai Long Pharma Co., Ltd. romanized
2021/06/28Generic · Class 3 地塞米松眼用植入剂(用于泪小管) · No verified English nameCYHS2101341 Beijing Nuo Kang Da Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Jin Yao Group Hebei Yong Guang Pharmaceutical Co., Ltd. romanized
2021/06/28New drug · Class 1.1 HC001颗粒 · No verified English nameCXZL2101015 Beijing Hou Cheng Pharmaceuticals Technology Co., Ltd. romanized
2021/06/28New drug · Class 2.2 三七总皂苷缓释胶囊 · No verified English nameCXZL2101014 Jiang Zhong Pharma Co., Ltd. romanized
2021/06/28New drug · Class 1.1 复方延麦搽剂 · No verified English nameCXZL2101013 Shanghai Huo Er Bio Technology Co., Ltd. romanized
2021/06/28New drug · Class 1 NBL-015注射液 · No verified English nameCXSL2101156 Shanghai Xin Shi Biopharmaceuticals Co., Ltd. romanized
2021/06/28New drug · Class 1 JS014注射液 · No verified English nameCXSL2101155 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/28New drug · Class 2.2 注射用伊尼妥单抗 · No verified English nameCXSL2101151 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/06/28New drug · Class 1 BEBT-109胶囊 · No verified English nameCXHL2101243 Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized
2021/06/28New drug · Class 1 BEBT-109胶囊 · No verified English nameCXHL2101242 Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized
2021/06/28New drug · Class 2.2 苯甲酸氨氯地平干混悬剂 · No verified English nameCXHL2101241 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2021/06/28New drug · Class 2.2 SBK003注射液 · No verified English nameCXHL2101240 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/28New drug · Class 1 BPI-23314片 · No verified English nameCXHL2101239 Bei Da Pharma Co., Ltd. romanized
2021/06/28New drug · Class 1 BPI-23314片 · No verified English nameCXHL2101238 Bei Da Pharma Co., Ltd. romanized
2021/06/28New drug · Class 1 TL938胶囊 · No verified English nameCXHL2101225 Suzhou Tao Lve Bio Technology Co., Ltd. romanized
2021/06/28New drug · Class 1 TL938胶囊 · No verified English nameCXHL2101224 Suzhou Tao Lve Bio Technology Co., Ltd. romanized
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

49 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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