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
- 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 type | Filings |
|---|---|
| Supplement | 66 |
| Generic | 36 |
| New drug | 31 |
| Import | 15 |
| Unspecified | 5 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 103 |
| Therapeutic biologic | 29 |
| TCM | 20 |
| Prophylactic biologic | 2 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 2 | 1 | 23 |
| 2 | Dotinurad Tablets | 2 | 1 | 55 |
| 3 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 4 | 氯雷他定糖浆 · No verified English name | 2 | 1 | 7 |
| 5 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
| 6 | Rosuvastatin Calcium Tablets | 2 | 1 | 18 |
| 7 | Neostigmine Methylsulfate Injection | 2 | 1 | 4 |
| 8 | Dapoxetine Hydrochloride Tablets | 2 | 1 | 20 |
| 9 | Lactulose Oral Solution | 1 | 1 | 34 |
| 10 | 低钙腹膜透析液(乳酸盐-G1.76%) · No verified English name | 1 | 1 | 2 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Takeda Development Center Americas Inc. | 6 | 2 | 0 |
| 2 | Luo Yang Shun Shi Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 3 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 5 | 2 | 0 |
| 4 | Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 3 | 0 |
| 7 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Celgene International Sarl | 4 | 1 | 0 |
| 9 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 10 | Merck Sharp & Dohme LLC | 3 | 2 | 0 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 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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