YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 361 drug applications between 5 November 2025 and 11 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 49 drug names.
2025/11/05 – 2025/11/11
- New acceptances this week
- 361
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- Accepted this week, now under review
- 90
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
361filings, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 182 |
| Generic | 66 |
| New drug | 53 |
| Import | 29 |
| Import re-registration | 21 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 214 |
| TCM | 81 |
| Therapeutic biologic | 58 |
| Prophylactic biologic | 5 |
| Biologic | 3 |
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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cefditoren Pivoxil Granules | 4 | 2 | 18 |
| 2 | Finerenone Tablets | 3 | 2 | 69 |
| 3 | 氟比洛芬凝胶贴膏 · No verified English name | 2 | 2 | 16 |
| 4 | 利伐沙班干混悬剂 · No verified English name | 2 | 1 | 2 |
| 5 | Carboplatin Injection | 2 | 1 | 10 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Lamotrigine Dispersible Tablets | 2 | 1 | 2 |
| 8 | 氯化钾氯化钠注射液 · No verified English name | 2 | 1 | 4 |
| 9 | 注射用头孢曲松钠/氯化钠注射液 · No verified English name | 2 | 1 | 3 |
| 10 | Dapoxetine Hydrochloride Tablets | 2 | 1 | 20 |
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
219 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 2 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 3 | Bayer AG | 5 | 4 | 0 |
| 4 | Takeda Development Center Americas Inc. | 5 | 2 | 0 |
| 5 | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Eisai Co. Ltd. | 5 | 1 | 0 |
| 7 | Novo Nordisk A/S | 5 | 1 | 0 |
| 8 | Sanofi-Aventis Recherche & Développement | 4 | 4 | 0 |
| 9 | Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Chongqing Ke Rui Nan Hai Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/11Import · Class 1 | 注射用BAY 3547922 · No verified English nameJXSL2500220 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2025/11/11Import · Class 1 | BAY 3547926 注射液 · No verified English nameJXSL2500219 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2025/11/11Import · Class 1 | PF-08049820水合物片 · No verified English nameJXHL2500349 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2025/11/11Import · Class 1 | PF-08049820水合物片 · No verified English nameJXHL2500348 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2025/11/11Import · Class 1 | Zasocitinib (TAK-279) 片 · No verified English nameJXHL2500347 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2025/11/11Import · Class 1 | Zasocitinib (TAK-279) 片 · No verified English nameJXHL2500346 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2025/11/11Import · Class 1 | Zasocitinib(TAK-279)片 · No verified English nameJXHL2500345 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2025/11/11Generic · Class 3 | Bifonazole SolutionCYHS2503921 | Guo Ming Pharmaceutical (Hainan) Co., Ltd. romanized; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized |
| 2025/11/11Generic · Class 3 | 复方电解质注射液(V) · No verified English nameCYHS2503918 | Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2025/11/11Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2503916 | Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/11/11Generic · Class 3 | 青霉胺胶囊 · No verified English nameCYHS2503913 | Shanghai Shang Yao Rui Er Medicines Co., Ltd. romanized; Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized |
| 2025/11/11Generic · Class 3 | Esflurbiprofen PatchesCYHL2500198 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2025/11/11New drug · Class 2.3 | 天丹通络片 · No verified English nameCXZL2500109 | Shandong Feng Huang Pharmaceutical Co., Ltd. romanized |
| 2025/11/11New drug · Class 3.3 | 帕妥珠单抗注射液 · No verified English nameCXSS2500123 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/11/11New drug · Class 1 | 注射用DB-1317 · No verified English nameCXSL2500963 | Ying En Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/11/11New drug · Class 2.2 | 冻干水痘灭活疫苗 · No verified English nameCXSL2500962 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2025/11/11New drug · Class 1.2 | 带状疱疹mRNA疫苗 · No verified English nameCXSL2500961 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2025/11/11New drug · Class 1 | 注射用ZG005 · No verified English nameCXSL2500960 | Name not romanized; Name not romanized |
| 2025/11/11New drug · Class 1 | 注射用ZGGS18 · No verified English nameCXSL2500959 | Name not romanized; Name not romanized |
| 2025/11/11New drug · Class 1 | SENL103自体T细胞注射液 · No verified English nameCXSL2500958 | Hebei Sen Lang Bio Technology Co., Ltd. romanized |
| 2025/11/11New drug · Class 2.2; 2.4 | LT001 · No verified English nameCXHL2501235 | Guangdong Li Tai Pharmaceutical Co., Ltd. romanized |
| 2025/11/11New drug · Class 1 | JYP0015片 · No verified English nameCXHL2501228 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/11New drug · Class 1 | JYP0015片 · No verified English nameCXHL2501227 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/11New drug · Class 1 | JYP0015片 · No verified English nameCXHL2501226 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/11New drug · Class 1 | RA1115-B1滴眼液 · No verified English nameCXHL2501225 | Suzhou Rui Ming Xin Yao Research and Development Co., Ltd. romanized |
| 2025/11/11New drug · Class 1 | RA1115-B1滴眼液 · No verified English nameCXHL2501224 | Suzhou Rui Ming Xin Yao Research and Development Co., Ltd. romanized |
| 2025/11/10New drug · Class 1 | SPGL008注射液 · No verified English nameCXSL2500957 | Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized |
| 2025/11/08Import · Class 1 | ABBV-706注射用冻干粉 · No verified English nameJXSL2500213 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/11/08Import · Class 1 | CID-103注射液 · No verified English nameJXSL2500212 | CASI Pharmaceuticals Inc.; CASI Pharmaceuticals (China) Co. Ltd. |
| 2025/11/08Import · Class 1 | Frexalimab注射液 · No verified English nameJXSL2500211 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
71 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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