YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 154 drug applications between 19 February 2026 and 25 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 28 drug names.

2026/02/19 – 2026/02/25

Period
2026/02/19 to 2026/02/25, 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
154
Drugs with new generic filings (by drug name, de-duplicated)
28
Accepted this week, now under review
55

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

154filings, 36 of them generic

By application type

Application typeFilings
Supplement66
Generic36
New drug31
Import15
Unspecified5
Import re-registration1

By drug type

Drug typeFilings
Chemical drug103
Therapeutic biologic29
TCM20
Prophylactic 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

28 drugs with new generic filings; top 10 listed

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

92 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Takeda Development Center Americas Inc.620
2Luo Yang Shun Shi Pharma Co., Ltd. romanized550
3Sichuan Pharmaceutical Formulations Co., Ltd. romanized520
4Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized510
5Guizhou Rui He Pharmaceutical Co., Ltd. romanized440
6Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized430
7Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized430
8Celgene International Sarl410
9Eli Lilly Nederland B.V.410
10Merck Sharp & Dohme LLC320

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

58 this week

AcceptedDrugApplicants
2026/02/25Import · Class 1 FUB523注射液 · No verified English nameJXSL2600055 Novartis Pharma AG; China Novartis Institutes for BioMedical Research
2026/02/25Import · Class 1 利奈昔巴特片 · No verified English nameJXHS2600028 GlaxoSmithKline Trading Services Limited; GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS
2026/02/25Import · Class 1 S095035 · No verified English nameJXHL2600065 Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development Co. LTD
2026/02/25Import · Class 1 S095035 · No verified English nameJXHL2600064 Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development Co. LTD
2026/02/25Import · Class 1 Nemtabrutinib片 · No verified English nameJXHL2600063 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2026/02/25Import · Class 1 Nemtabrutinib片 · No verified English nameJXHL2600062 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2026/02/25Import · Class 1 Nemtabrutinib片 · No verified English nameJXHL2600061 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2026/02/25Import · Class 1 TAK-360片 · No verified English nameJXHL2600060 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/02/25Import · Class 1 TAK-360片 · No verified English nameJXHL2600059 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/02/25Import · Class 1 TAK-360片 · No verified English nameJXHL2600058 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/02/25Import · Class 1 TAK-360片 · No verified English nameJXHL2600057 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/02/25Import · Class 1 TAK-360片 · No verified English nameJXHL2600056 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/02/25Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide Tablets(II)CYHS2600527 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized
2026/02/25Generic · Class 3 Calcitriol Oral SolutionCYHS2600523 Shanxi Hui Da Lin Xi Pharmaceuticals Technology Co., Ltd. romanized; Lin Fen Bao Zhu Pharmaceutical Co., Ltd. romanized
2026/02/25Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2600513 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized
2026/02/25Generic · Class 3 Peramivir InjectionCYHS2600509 Kai Feng Ming Ren Pharma Co., Ltd. romanized; Fu Ren Pharma Group Co., Ltd. romanized
2026/02/25Generic · Class 3 低钙腹膜透析液(乳酸盐-G1.76%) · No verified English nameCYHS2600507 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2026/02/25Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2600503 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/02/25Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2600502 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/02/25Generic · Class 3 盐酸卡替洛尔滴眼液 · No verified English nameCYHS2600499 Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized; Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2026/02/25Generic · Class 3 Vincriscristine Sulfate InjectionCYHS2600496 Ren He Xi De Long Pharma Co., Ltd. romanized
2026/02/25Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2600028 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2026/02/25Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2600027 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2026/02/25Generic · Class 3 Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2600026 Hangzhou Bei Te Biopharmaceuticals Co., Ltd. romanized
2026/02/25New drug · Class 1.1 芪志片 · No verified English nameCXZL2600023 Beijing Fu Nuo Ming Pharmaceuticals Technology Co., Ltd. romanized
2026/02/25New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600029 Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized
2026/02/25New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600028 Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized
2026/02/25New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600027 Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized
2026/02/25New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600026 Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized
2026/02/25New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600025 Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized

28 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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