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
- 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 type | Filings |
|---|---|
| Supplement | 36 |
| Generic | 26 |
| New drug | 13 |
| Import | 9 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 54 |
| Therapeutic biologic | 18 |
| TCM | 12 |
| In vitro diagnostic reagent | 1 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dotinurad Tablets | 2 | 1 | 55 |
| 2 | Paracetamol Tablets | 2 | 1 | 6 |
| 3 | Lercanidipine Hydrochloride Tablets | 2 | 1 | 6 |
| 4 | Nicardipine Hydrochloride Injection | 2 | 1 | 13 |
| 5 | Calcium Folinate Injection | 1 | 1 | 4 |
| 6 | Carbetocin Injection | 1 | 1 | 6 |
| 7 | Furosemide Injection | 1 | 1 | 6 |
| 8 | Fusidic Acid Cream | 1 | 1 | 15 |
| 9 | 尿素[14C]胶囊 · No verified English name | 1 | 1 | 2 |
| 10 | Mosapride Citrate Tablets | 1 | 1 | 7 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AbbVie Deutschland GmbH & Co. KG | 4 | 1 | 0 |
| 2 | Bristol-Myers Squibb Company | 4 | 1 | 0 |
| 3 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 3 | 1 | 0 |
| 4 | Yan Tai Chuang He Bio Technology Co., Ltd. romanized | 3 | 1 | 0 |
| 5 | Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized | 2 | 2 | 2 |
| 6 | Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | 2 | 2 | 2 |
| 7 | Janssen Research & Development LLC | 2 | 1 | 0 |
| 8 | Pfizer Inc. | 2 | 1 | 0 |
| 9 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized | 2 | 1 | 0 |
| 10 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 2 | 1 | 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
29 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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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