YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 214 drug applications between 25 February 2021 and 3 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 17 drug names.

2021/02/25 – 2021/03/03

Period
2021/02/25 to 2021/03/03, 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
214
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

214filings, 20 of them generic

By application type

Application typeFilings
Supplement92
New drug44
Import29
Unspecified22
Generic20
Import re-registration7

By drug type

Drug typeFilings
Chemical drug167
Therapeutic biologic34
TCM5
Biologic4
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

17 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Apremilast Tablets310
2Quetiapine Fumarate Extended-release Tablets210
3Dantrolene Sodium Capsules110
4Compound Ipratropium Bromide Solution For Inhalation114
5Palbociclib Capsules110
6Olmesartan Medoxomil and Amlodipine Besylate Tablets112
7孟鲁司特钠颗粒 · No verified English name110
8Levofloxacin Tablets117
9Metformin Hydrochloride Extended-release Tablets1110
10Dexmedetomidine Hydrochloride Injection110

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

122 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company720
2Bayer Inc.610
3Xian Jing Xi Shuang He Pharma Co., Ltd. romanized610
4Guo Yao Group Guo Rui Pharma Co., Ltd. romanized420
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
6Qilu Pharmaceutical (Hainan) Co., Ltd420
7Fertin Pharma A/S410
8NAPP PHARMACEUTICALS LIMITED410
9Novo Nordisk A/S410
10Shanghai Kai Mao Biopharmaceuticals 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

73 this week

AcceptedDrugApplicants
2021/03/03Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2100068 AstraZeneca AB
2021/03/03Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2100067 AstraZeneca AB
2021/03/03Generic · Class 3 Apremilast TabletsCYHS2101013 Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized
2021/03/03Generic · Class 3 Apremilast TabletsCYHS2101012 Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized
2021/03/03Generic · Class 3 Apremilast TabletsCYHS2101011 Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized
2021/03/03New drug · Class 1 宫血间充质干细胞注射液 · No verified English nameCXSL2101001 Zhejiang Sheng Chuang Jing Zhun Medical Technology Co., Ltd. romanized
2021/03/03New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSL2100080 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/03/03New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSL2100079 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/03/03New drug · Class 1 3D-229注射液 · No verified English nameCXSL2100078 Xu Zhou Si Lu Di Pharma Co., Ltd. romanized
2021/03/03New drug · Class 2.1 HECB1701301长效肌肉注射剂 · No verified English nameCXHL2101002 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/03/03New drug · Class 1 JMKX000189片 · No verified English nameCXHL2100154 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2021/03/03New drug · Class 1 JMKX000189片 · No verified English nameCXHL2100153 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2021/03/03New drug · Class 1 JMKX000189片 · No verified English nameCXHL2100152 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2021/03/02Import · Class 1 AM006 · No verified English nameJXHL2100066 Affamed Therapeutics (HK) Limited
2021/03/02Import · Class 1 AM006 · No verified English nameJXHL2100065 Affamed Therapeutics (HK) Limited
2021/03/02Generic · Class 3 Metformin Hydrochloride Extended-release TabletsCYHS2100248 Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2021/03/02Generic · Class 3 米诺地尔酊 · No verified English nameCYHS2100246 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2021/03/02Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2100245 Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized
2021/03/02New drug · Class 3.2 注射用人干扰素γ · No verified English nameCXSS2100029 Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized
2021/03/02New drug · Class 3.2 注射用人干扰素γ · No verified English nameCXSS2100028 Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized
2021/03/02New drug · Class 2.2 注射用人干扰素γ · No verified English nameCXSS2100027 Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized
2021/03/02New drug · Class 2.2 注射用人干扰素γ · No verified English nameCXSS2100026 Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized
2021/03/02New drug · Class 1 血浆生物净化柱 · No verified English nameCXSL2100077 Shanghai Wei Zhi Zhuo Bio Technology Co., Ltd. romanized
2021/03/02New drug · Class 2.4 Roxadustat CapsulesCXHL2100151 Fa Bo Jin (Zhongguo) Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/03/02New drug · Class 2.4 Roxadustat CapsulesCXHL2100150 Fa Bo Jin (Zhongguo) Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/03/02New drug · Class 2.4 Irinotecan Liposome injectionCXHL2100149 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/03/01Generic · Class 3 Olmesartan Medoxomil and Amlodipine Besylate TabletsCYHS2101010 Jilin Sheng De Shang Pharma Co., Ltd. romanized
2021/02/27Import · Class 1 注射用E6201 · No verified English nameJXHL2100064 JS INNOPHARM LIMITED
2021/02/27Generic · Class 3 Fudosteine oral solutionCYHS2100241 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2021/02/27New drug · Class 3.3 LY01015注射液 · No verified English nameCXSL2100076 Shandong Bo An Bio Technology Co., Ltd. romanized

43 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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