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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 82 drug applications between 2 December 2022 and 8 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 8 drug names.

2022/12/02 – 2022/12/08

Period
2022/12/02 to 2022/12/08, 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
82
Drugs with new generic filings (by drug name, de-duplicated)
8
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

82filings, 10 of them generic

By application type

Application typeFilings
Supplement48
New drug12
Generic10
Import re-registration6
Import4
Unspecified2

By drug type

Drug typeFilings
Chemical drug61
Therapeutic biologic14
TCM7

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

8 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tedizolid Phosphate Tablets221
2Elagolix Sodium Tablets212
3Salbutamol Sulfate Inhalation Solution112
4Desloratadine Tablets110
5帕拉米韦氯化钠注射液 · No verified English name1117
6Atomoxetine Hydrochloride Oral Solution110
7Moxifloxacin Hydrochloride Tablets1111
8Minoxidil Topical Solution110

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

42 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Wei Gao Shu Xue Technology Zhuang Bei Co., Ltd. romanized1120
2Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized840
3Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized410
4Atlantic Laboratories Corporation Ltd.310
5Janssen Research & Development LLC310
6Santen Pharmaceutical Co. Ltd.310
7Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized310
8Hebei Wu Luo Pharma Co., Ltd. romanized310
9Aristo Pharma GmbH210
10F.Hoffmann-La Roche Ltd210

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

18 this week

AcceptedDrugApplicants
2022/12/08Generic · Class 3 Minoxidil Topical SolutionCYHS2202039 Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized
2022/12/08Generic · Class 3 Elagolix Sodium TabletsCYHL2200108 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2022/12/08Generic · Class 3 Elagolix Sodium TabletsCYHL2200107 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2022/12/08New drug · Class 1 重组人IL12/15-PDL1B单纯疱疹Ⅰ型溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2200593 Zhong Sheng Fu Nuo Jian Bio Technology (Shanghai) Co., Ltd. romanized
2022/12/08New drug · Class 1 KD-025细胞注射液 · No verified English nameCXSL2200592 Nanjing Kai Di Medical Technology Co., Ltd. romanized
2022/12/08New drug · Class 1 齐瑞索韦肠溶胶囊 · No verified English nameCXHS2200063 Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2022/12/08New drug · Class 1 齐瑞索韦肠溶胶囊 · No verified English nameCXHS2200062 Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2022/12/08New drug · Class 1 NB004片 · No verified English nameCXHL2200927 Ningbo Xin Wan Technology Development Co., Ltd. romanized
2022/12/08New drug · Class 1 ABSK121-NX片 · No verified English nameCXHL2200926 Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/12/08New drug · Class 1 ABSK121-NX片 · No verified English nameCXHL2200925 Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/12/08New drug · Class 1 ABSK121-NX片 · No verified English nameCXHL2200924 Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/12/07Import · Class 1 GDC-0077 · No verified English nameJXHL2200344 F.Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/12/07Import · Class 1 GDC-0077 · No verified English nameJXHL2200343 F.Hoffmann-La Roche Ltd
2022/12/07Generic · Class 3 帕拉米韦氯化钠注射液 · No verified English nameCYHS2202034 Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2022/12/07New drug · Class 1 NBL-020注射液 · No verified English nameCXSL2200591 Shanghai Xin Shi Biopharmaceuticals Co., Ltd. romanized
2022/12/07New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2200590 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/12/07New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2200589 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/12/07New drug · Class 1 注射用TSN222 · No verified English nameCXHL2200923 Tai Li Bio Technology (Shanghai) 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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