YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 236 drug applications between 23 May 2021 and 29 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 27 drug names.

2021/05/23 – 2021/05/29

Period
2021/05/23 to 2021/05/29, 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
236
Drugs with new generic filings (by drug name, de-duplicated)
27
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

236filings, 36 of them generic

By application type

Application typeFilings
Supplement143
Generic36
New drug28
Import19
Import re-registration7
Unspecified3

By drug type

Drug typeFilings
Chemical drug197
Therapeutic biologic25
TCM10
Prophylactic biologic4

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

27 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Escitalopram Oxalate Tablets316
2Olanzapine Orally Disintegrating Tablets210
3Ornidazole Injection210
4Potassium Chloride Granules214
5Metoprolol Succinate Sustained-release Tablets214
6Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets210
7盐酸罗哌卡因氯化钠注射液 · No verified English name210
8Moxifloxacin Hydrochloride Eye Drops214
9Sodium Valproate Concentrated Solution for Injection110
10Ethyl Iosapentate Capsules1127

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

120 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.15140
2Merck Sharp & Dohme B.V.1020
3Shuang He Pharma (Shenyang) Co., Ltd. romanized820
4Pfizer Europe MA EEIG630
5Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized630
6Janssen-Cilag International NV610
7Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized610
8Takeda Development Center Americas Inc.520
9Jiangsu Hao Sen Pharma Group Co., Ltd. romanized520
10Boehringer Ingelheim International GmbH510

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

60 this week

AcceptedDrugApplicants
2021/05/28Import · Class 1 IMGN853 · No verified English nameJXSL2101035 ImmunoGen Inc.; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO. LTD
2021/05/28Import · Class 1 ABL001片 · No verified English nameJXHL2101066 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/05/28Import · Class 1 ABL001片 · No verified English nameJXHL2101065 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/05/28Generic · Class 3 Metformin Hydrochloride Oral SolutionCYHS2101218 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2021/05/28New drug · Class 1 恩沃利单抗注射液 · No verified English nameCXSL2101099 Sichuan Si Lu Kang Rui Pharma Co., Ltd. romanized
2021/05/28New drug · Class 3.2 冻干ACYW135群脑膜炎球菌结合疫苗 · No verified English nameCXSL2101095 Suzhou Wei Chao Bio Technology Co., Ltd. romanized
2021/05/28New drug · Class 2.1 注射用HR18034 · No verified English nameCXHL2101164 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/05/28New drug · Class 1 RG001片 · No verified English nameCXHL2101154 Shanghai Ling Ji Bio Technology Co., Ltd. romanized
2021/05/28New drug · Class 1 RG001片 · No verified English nameCXHL2101153 Shanghai Ling Ji Bio Technology Co., Ltd. romanized
2021/05/27Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2101064 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/05/27Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2101063 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/05/27Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2101062 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/05/27Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2101061 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/05/27Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2101060 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/05/27Import · Class 1 注射用CEND-1 · No verified English nameJXHL2101059 Cend Therapeutics Inc.; QILU PHARMACEUTICAL CO. LTD.
2021/05/27Generic · Class 3 盐酸考尼伐坦预混型葡萄糖注射液 · No verified English nameCYHS2101216 Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized
2021/05/27Generic · Class 3 Ethyl Iosapentate CapsulesCYHS2101205 Sichuan Gowell Pharmaceutical Co., Ltd.
2021/05/27New drug · Class 1 PA3-17注射液 · No verified English nameCXSL2101097 Bo Sheng Ji Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2021/05/27New drug · Class 1 注射用重组人源化单克隆抗体MIL97 · No verified English nameCXSL2101091 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2021/05/27New drug · Class 2.2 HR19003贴剂 · No verified English nameCXHL2101163 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/05/27New drug · Class 1 HS-10376片 · No verified English nameCXHL2101162 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/05/27New drug · Class 1 HS-10376片 · No verified English nameCXHL2101161 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/05/27New drug · Class 1 Zorifertinib片 · No verified English nameCXHL2101160 Jiangsu Chen Tai Pharmaceuticals Technology Co., Ltd. romanized
2021/05/27New drug · Class 1 Zorifertinib片 · No verified English nameCXHL2101159 Jiangsu Chen Tai Pharmaceuticals Technology Co., Ltd. romanized
2021/05/27New drug · Class 1 HSK16149胶囊 · No verified English nameCXHL2101158 Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2021/05/26Import · Class 1 BRII-179 (VBI-2601) 注射液 · No verified English nameJXSL2101034 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2021/05/26Import · Class 2.4 INC280 · No verified English nameJXHL2101058 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/05/26Import · Class 2.4 INC280 · No verified English nameJXHL2101057 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/05/26Import · Class 2.4 Ponatinib TabletsJXHL2101056 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2021/05/26Import · Class 2.4 Ponatinib TabletsJXHL2101055 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd

30 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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