YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 75 drug applications between 30 September 2022 and 6 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 13, covering 11 drug names.

2022/09/30 – 2022/10/06

Period
2022/09/30 to 2022/10/06, 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
75
Drugs with new generic filings (by drug name, de-duplicated)
11
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

75filings, 13 of them generic

By application type

Application typeFilings
Supplement38
New drug15
Generic13
Import6
Unspecified2
Import re-registration1

By drug type

Drug typeFilings
Chemical drug55
Therapeutic biologic13
TCM5
Biologic2

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

11 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Aspirin Enteric-coated Tablets2210
2Doxofylline Injection215
3Linezolid and Glucose Injection113
4Folic Acid Tablets1112
5Ursodeoxycholic Acid Capsules112
6Imidapril Hydrochloride Tablets110
7Clopidogrel Hydrogen Sulphate Tablets116
8Eltrombopag Olamine Tablets111
9Ketorolac Trometamol Tablets118
10酮洛芬凝胶 · No verified English name117

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

48 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Ya Dong Biopharmaceutical Co., Ltd. romanized11110
2Janssen Research & Development LLC420
3Henan Li Xin Pharmaceutical Co., Ltd. romanized310
4FUJIFILM Diosynth Biotechnologies UK Ltd220
5Jilin Shi Wu Tai Gan Kang Pharma Co., Ltd. romanized220
6Hebei Chen Huan Bio Technology Co., Ltd. romanized220
7MERCK SANTE s.a.s.210
8Xiamen Gan Bao Li Biopharmaceuticals Co., Ltd. romanized210
9Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized210
10Tianjin Drug Research Institute Co., Ltd. romanized210

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

23 this week

AcceptedDrugApplicants
2022/10/01Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2200178 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/01Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2200177 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/01Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2200176 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/01Import · Class 2.4 Lazertinib片 · No verified English nameJXHL2200296 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/01New drug · Class 3.1 苓桂术甘颗粒 · No verified English nameCXZS2200011 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/10/01New drug · Class 1 IBI343 · No verified English nameCXSL2200501 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/10/01New drug · Class 1 IBR733细胞注射液 · No verified English nameCXSL2200500 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2022/10/01New drug · Class 1 IBR733细胞注射液 · No verified English nameCXSL2200499 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2022/10/01New drug · Class 2.2 艾司奥美拉唑镁碳酸氢钠胶囊 · No verified English nameCXHS2200049 Xiamen En Cheng Pharmaceutical Co., Ltd. romanized
2022/10/01New drug · Class 1 TY705注射液 · No verified English nameCXHL2200752 Tianjin Drug Research Institute Co., Ltd. romanized
2022/10/01New drug · Class 1 TY705注射液 · No verified English nameCXHL2200751 Tianjin Drug Research Institute Co., Ltd. romanized
2022/09/30Import · Class 1 VAY736注射液 · No verified English nameJXSL2200175 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/09/30Import · Class 1 DS-1062a · No verified English nameJXSL2200174 ASTRAZENECA AB; AstraZeneca Investment (China) Co. Limited
2022/09/30Generic · Class 3 Ketorolac Trometamol TabletsCYHS2201655 Chengdu Brilliant Pharmaceutical Co., Ltd.
2022/09/30Generic · Class 3 Folic Acid TabletsCYHS2201652 Zhejiang Nord Pharmaceutical Co., Ltd
2022/09/30New drug · Class 3.4 人纤维蛋白粘合剂 · No verified English nameCXSL2200498 Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized
2022/09/30New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2200497 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2022/09/30New drug · Class 1 RB0011注射液 · No verified English nameCXSL2200496 Rui Yang (Suzhou) Bio Technology Co., Ltd. romanized
2022/09/30New drug · Class 2.2 右布洛芬缓控释双层片 · No verified English nameCXHL2200750 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2022/09/30New drug · Class 2.2 枸橼酸坦度螺酮缓释片 · No verified English nameCXHL2200749 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2022/09/30New drug · Class 2.2 枸橼酸坦度螺酮缓释片 · No verified English nameCXHL2200748 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2022/09/30New drug · Class 1 Kylo-0603胶囊 · No verified English nameCXHL2200747 Xiamen Gan Bao Li Biopharmaceuticals Co., Ltd. romanized
2022/09/30New drug · Class 1 Kylo-0603胶囊 · No verified English nameCXHL2200746 Xiamen Gan Bao Li Biopharmaceuticals Co., Ltd. romanized

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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