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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 241 drug applications between 26 May 2021 and 1 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 30, covering 23 drug names.

2021/05/26 – 2021/06/01

Period
2021/05/26 to 2021/06/01, 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
241
Drugs with new generic filings (by drug name, de-duplicated)
23
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

241filings, 30 of them generic

By application type

Application typeFilings
Supplement145
Generic30
Import28
New drug27
Import re-registration7
Unspecified4

By drug type

Drug typeFilings
Chemical drug193
TCM27
Therapeutic biologic16
Prophylactic biologic5

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

23 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Olanzapine Orally Disintegrating Tablets210
2Ornidazole Injection210
3Metoprolol Succinate Sustained-release Tablets214
4Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets210
5盐酸罗哌卡因氯化钠注射液 · No verified English name210
6Moxifloxacin Hydrochloride Eye Drops214
7Febuxostat Tablets2112
8Ethyl Iosapentate Capsules1127
9依折麦布瑞舒伐他汀钙片(III) · No verified English name110
10依折麦布瑞舒伐他汀钙片(II) · No verified English name110

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

125 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Bao Nian Tang (He Ze) Pharma Co., Ltd. romanized14130
2Shuang He Pharma (Shenyang) Co., Ltd. romanized820
3Pfizer Europe MA EEIG740
4Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized630
5Janssen-Cilag International NV610
6Shanghai Shang Yao Rui Er Medicines Co., Ltd. romanized540
7Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.540
8Takeda Development Center Americas Inc.520
9Boehringer Ingelheim International GmbH510
10Guangzhou Run Er Yan Ke Bio Technology Co., Ltd. romanized510

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

63 this week

AcceptedDrugApplicants
2021/06/01Import · Class 1 BMS-986165片 · No verified English nameJXHL2101075 Bristol-Myers Squibb Company; Name not romanized
2021/06/01Import · Class 1 BMS-986165片 · No verified English nameJXHL2101074 Bristol-Myers Squibb Company; Name not romanized
2021/06/01Import · Class 1 BMS-986165片 · No verified English nameJXHL2101073 Bristol-Myers Squibb Company; Name not romanized
2021/06/01Import · Class 2.4 Encorafenib胶囊 · No verified English nameJXHL2101071 Array BioPharma Inc a wholly owned subsidiary of Pfizer Inc; Pfizer Investment CO. Ltd.
2021/06/01Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2101224 Beijing Shi Xin Li Cheng Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/06/01New drug · Class 1 Ociperlimab注射液 · No verified English nameCXSL2101105 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2021/06/01New drug · Class 1 HB0030注射液 · No verified English nameCXSL2101104 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized
2021/06/01New drug · Class 1 注射用CU-20401 · No verified English nameCXSL2101098 Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized
2021/05/31Import · Class 1 CC-220胶囊 · No verified English nameJXHL2101070 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/05/31Import · Class 1 CC-220胶囊 · No verified English nameJXHL2101069 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/05/31Import · Class 1 CC-220胶囊 · No verified English nameJXHL2101068 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/05/31Import · Class 1 CC-220胶囊 · No verified English nameJXHL2101067 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/05/31New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101103 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/05/31New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2101102 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2021/05/31New drug · Class 1 注射用BD0801 · No verified English nameCXSL2101100 Jiangsu Xian Sheng Pharma Co., Ltd. romanized
2021/05/31New drug · Class 1 阴道用乳杆菌二联活菌胶囊 · No verified English nameCXSL2101094 Zhejiang Xin Li Fei Bio Technology Co., Ltd. romanized
2021/05/31New drug · Class 1 ASC40片 · No verified English nameCXHL2101167 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2021/05/31New drug · Class 1 ASC40片 · No verified English nameCXHL2101166 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2021/05/31New drug · Class 1 ASC40片 · No verified English nameCXHL2101165 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
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.

33 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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