YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 31 drug applications between 1 October 2022 and 7 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 6, covering 5 drug names.

2022/10/01 – 2022/10/07

Period
2022/10/01 to 2022/10/07, 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
31
Drugs with new generic filings (by drug name, de-duplicated)
5
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

31filings, 6 of them generic

By application type

Application typeFilings
Supplement12
New drug7
Generic6
Import4
Unspecified2

By drug type

Drug typeFilings
Chemical drug20
Therapeutic biologic7
TCM2
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

5 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Doxofylline Injection215
2Imidapril Hydrochloride Tablets110
3Clopidogrel Hydrogen Sulphate Tablets116
4酮洛芬凝胶 · No verified English name117
5Felodipine Sustained Release Tablets111

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

20 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen Research & Development LLC420
2FUJIFILM Diosynth Biotechnologies UK Ltd220
3MERCK SANTE s.a.s.210
4Tianjin Drug Research Institute Co., Ltd. romanized210
5Shandong Hua Su Pharmaceutical Co., Ltd. romanized210
6Shandong Luo Xin Pharma Group Co., Ltd. romanized210
7Henan Pu Rui Pharmaceutical Co., Ltd. romanized210
8Hubei Mei Lin Pharma Co., Ltd. romanized212
9Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized210
10Bayer S.A.110

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

11 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

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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