YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 85 drug applications between 4 October 2025 and 10 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 26, covering 22 drug names.

2025/10/04 – 2025/10/10

Period
2025/10/04 to 2025/10/10, 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
85
Drugs with new generic filings (by drug name, de-duplicated)
22
Accepted this week, now under review
30

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

85filings, 26 of them generic

By application type

Application typeFilings
Supplement36
Generic26
New drug13
Import9
Import re-registration1

By drug type

Drug typeFilings
Chemical drug54
Therapeutic biologic18
TCM12
In vitro diagnostic reagent1

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

22 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dotinurad Tablets2155
2Paracetamol Tablets216
3Lercanidipine Hydrochloride Tablets216
4Nicardipine Hydrochloride Injection2113
5Calcium Folinate Injection114
6Carbetocin Injection116
7Furosemide Injection116
8Fusidic Acid Cream1115
9尿素[14C]胶囊 · No verified English name112
10Mosapride Citrate Tablets117

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

62 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AbbVie Deutschland GmbH & Co. KG410
2Bristol-Myers Squibb Company410
3Shandong Er Ye Pharmaceutical Co., Ltd. romanized310
4Yan Tai Chuang He Bio Technology Co., Ltd. romanized310
5Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized222
6Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized222
7Janssen Research & Development LLC210
8Pfizer Inc.210
9Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized210
10Xin Da Biopharmaceutical (Suzhou) 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

29 this week

AcceptedDrugApplicants
2025/10/10Import · Class 1 Pasritamig注射液 · No verified English nameJXSL2500195 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/10/10Import · Class 1 Pasritamig注射液 · No verified English nameJXSL2500194 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/10/10Import · Class 1 AZD2936 · No verified English nameJXSL2500193 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/10/10Import · Class 1 PF-07328948片 · No verified English nameJXHL2500311 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd
2025/10/10Import · Class 1 PF-07328948片 · No verified English nameJXHL2500310 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd
2025/10/10Import · Class 2.2 BMS-986519肠溶胶囊 · No verified English nameJXHL2500308 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/10/10Import · Class 2.2 BMS-986519肠溶胶囊 · No verified English nameJXHL2500307 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/10/10Import · Class 2.2 BMS-986519肠溶胶囊 · No verified English nameJXHL2500306 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/10/10Import · Class 2.2 BMS-986519肠溶胶囊 · No verified English nameJXHL2500305 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/10/10Generic · Class 3 Sodium Cromoglicate Eye DropsCYHS2503616 Wuhan Xin Rui Pharmaceuticals Technology Co., Ltd. romanized; Wuhan Wu Jing Pharma Co., Ltd. romanized
2025/10/10Generic · Class 3 Methocarbamol InjectionCYHS2503609 Shandong Yi Jian Pharma Co., Ltd. romanized
2025/10/10Generic · Class 3 Paracetamol TabletsCYHS2503606 Rui Yang Pharmaceutical Co., Ltd. romanized
2025/10/10Generic · Class 3 Paracetamol TabletsCYHS2503605 Rui Yang Pharmaceutical Co., Ltd. romanized
2025/10/10Generic · Class 3 马沙骨化醇注射液 · No verified English nameCYHL2500178 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/10/10Generic · Class 3 尿素[14C]胶囊 · No verified English nameCYHL2500177 Chengdu Xin Ke Pharmaceuticals Co., Ltd. romanized
2025/10/10New drug · Class 1 IBNI617肠溶胶囊 · No verified English nameCXSL2500867 Hefei Han Wei Bio Technology Co., Ltd. romanized
2025/10/10New drug · Class 1 IBNI617肠溶胶囊 · No verified English nameCXSL2500866 Hefei Han Wei Bio Technology Co., Ltd. romanized
2025/10/10New drug · Class 3.4 静注人免疫球蛋白 · No verified English nameCXSL2500861 Guangdong Wei Lun Biopharmaceutical Co., Ltd. romanized
2025/10/10New drug · Class 1 IBI363 · No verified English nameCXSL2500860 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/10/10New drug · Class 1 IBI363 · No verified English nameCXSL2500859 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/10/10New drug · Class 1 注射用ISH0613 · No verified English nameCXSL2500858 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2025/10/10New drug · Class 2.2 注射用左炔诺孕酮微球 · No verified English nameCXHL2501065 Shanghai Shi Biopharmaceuticals Technology Research Institute romanized
2025/10/10New drug · Class 1 LPM6690176胶囊 · No verified English nameCXHL2501064 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2025/10/10New drug · Class 1 LPM6690176胶囊 · No verified English nameCXHL2501063 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2025/10/10New drug · Class 1 LPM6690176胶囊 · No verified English nameCXHL2501062 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2025/10/10New drug · Class 1 DII235注射液 · No verified English nameCXHL2501061 Nuo Hua (Zhongguo) Bio Yi Xue Research Co., Ltd. romanized
2025/10/09Generic · Class 3 Furosemide InjectionCYHS2503598 Henan Pu Rui Pharma Co., Ltd. romanized
2025/10/09New drug · Class 1 HSK36357胶囊 · No verified English nameCXHL2501060 Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized
2025/10/09New drug · Class 1 HSK36357胶囊 · No verified English nameCXHL2501059 Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology 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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