YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 219 drug applications between 24 February 2021 and 2 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 25 drug names.

2021/02/24 – 2021/03/02

Period
2021/02/24 to 2021/03/02, 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
219
Drugs with new generic filings (by drug name, de-duplicated)
25
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

219filings, 32 of them generic

By application type

Application typeFilings
Supplement91
New drug42
Generic32
Import27
Unspecified19
Import re-registration8

By drug type

Drug typeFilings
Chemical drug175
Therapeutic biologic33
Prophylactic biologic5
Biologic4
TCM2

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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Torsemide Injection321
2Olanzapine Orally Disintegrating Tablets210
3Quetiapine Fumarate Extended-release Tablets210
4Pregabalin Capsules2112
5Dexmedetomidine Hydrochloride Injection211
6色甘酸钠颗粒 · No verified English name210
7丙酸氟替卡松吸入粉雾剂 · No verified English name111
8Dantrolene Sodium Capsules110
9Compound Ipratropium Bromide Solution For Inhalation114
10Furosemide Injection116

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

127 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company720
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
3Bayer Inc.610
4Xian Jing Xi Shuang He Pharma Co., Ltd. romanized610
5Guo Yao Group Guo Rui Pharma Co., Ltd. romanized420
6Qilu Pharmaceutical (Hainan) Co., Ltd420
7Fertin Pharma A/S410
8NAPP PHARMACEUTICALS LIMITED410
9Novo Nordisk A/S410
10TEIJIN PHARMA LIMITED410

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

77 this week

AcceptedDrugApplicants
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
2021/02/27New drug · Class 3.3 LY01015注射液 · No verified English nameCXSL2100075 Shandong Bo An Bio Technology Co., Ltd. romanized
2021/02/27New drug · Class 3.4 托珠单抗注射液 · No verified English nameCXSL2100074 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2021/02/27New drug · Class 1 AK117注射液 · No verified English nameCXSL2100064 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/02/27New drug · Class 1 注射用重组人源化抗BCMA/CD3双特异性抗体 · No verified English nameCXSL2100063 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2021/02/27New drug · Class 1 LP-118片 · No verified English nameCXHL2100148 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2021/02/27New drug · Class 1 LP-118片 · No verified English nameCXHL2100147 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2021/02/27New drug · Class 1 ICP-332片 · No verified English nameCXHL2100146 Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/02/27New drug · Class 1 ICP-332片 · No verified English nameCXHL2100145 Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/02/27New drug · Class 1 ICP-332片 · No verified English nameCXHL2100144 Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/02/27New drug · Class 1 HS-10365胶囊 · No verified English nameCXHL2100143 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/02/27New drug · Class 1 HS-10365胶囊 · No verified English nameCXHL2100142 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/02/27New drug · Class 1 JAB-3312胶囊 · No verified English nameCXHL2100141 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/02/27New drug · Class 1 JAB-3312胶囊 · No verified English nameCXHL2100140 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized

47 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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