YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 370 drug applications between 12 November 2025 and 18 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 59 drug names.
2025/11/12 – 2025/11/18
- New acceptances this week
- 370
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 82
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
370filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 200 |
| Generic | 82 |
| New drug | 64 |
| Import | 17 |
| Unspecified | 5 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 225 |
| TCM | 108 |
| Therapeutic biologic | 29 |
| Prophylactic biologic | 7 |
| Biologic | 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Polyvinyl Alcohol Eye Drops | 3 | 3 | 24 |
| 2 | 二甲硅油乳剂 · No verified English name | 3 | 2 | 14 |
| 3 | 奥氮平萨米多芬片 · No verified English name | 3 | 1 | 0 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | MOVICOL Ready To Take Sachet, Powder For Oral Solution | 2 | 2 | 16 |
| 6 | 氧 · No verified English name | 2 | 2 | 15 |
| 7 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 8 | 依伏卡塞片 · No verified English name | 2 | 1 | 9 |
| 9 | Furosemide Oral Solution | 2 | 1 | 8 |
| 10 | Ibuprofen Granules | 2 | 1 | 3 |
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
212 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bayer Vital GmbH | 14 | 1 | 0 |
| 2 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 8 | 3 | 2 |
| 3 | Sichuan Shu Zhong Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 7 | 4 | 1 |
| 6 | Qinghai Chun Tian Yao Yong Zi Yuan Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 6 | 3 | 0 |
| 8 | Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | AstraZeneca AB | 5 | 4 | 0 |
| 10 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 5 | 4 | 2 |
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
115 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/18Import · Class 1 | Zasocitinib (TAK-279) 胶囊 · No verified English nameJXHL2500355 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2025/11/18Generic · Class 3 | Ketorolac Trometamol TabletsCYHS2503994 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2503992 | Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2503991 | Shanghai Zhao Hui Pharma Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503990 | Hangzhou Min Sheng Drug Research Institute Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | 注射用青霉素钠/氯化钠注射液 · No verified English nameCYHS2503986 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | 注射用青霉素钠/氯化钠注射液 · No verified English nameCYHS2503985 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | Ebastine Oral SolutionCYHS2503982 | Hangzhou Min Sheng Drug Research Institute Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | Ibuprofen GranulesCYHS2503977 | Jilin Kai Man Pharma Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | Ibuprofen GranulesCYHS2503976 | Jilin Kai Man Pharma Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2503975 | Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | Buspirone Hydrochloride TabletsCYHS2503974 | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | Furosemide Oral SolutionCYHS2503973 | Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | Furosemide Oral SolutionCYHS2503972 | Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized |
| 2025/11/18Generic · Class 3 | 尿素[14C]胶囊 · No verified English nameCYHL2500205 | Wuxi Bei Ta Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/18New drug · Class 1 | RGL-270注射液 · No verified English nameCXSL2500980 | Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized; Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized |
| 2025/11/18New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500979 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/11/18New drug · Class 1.3 | 重组带状疱疹ZFA01佐剂疫苗(CHO细胞) · No verified English nameCXSL2500978 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2025/11/18New drug · Class 1 | XW003注射液 · No verified English nameCXSL2500977 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized |
| 2025/11/18New drug · Class 1 | XW003注射液 · No verified English nameCXSL2500976 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized |
| 2025/11/18New drug · Class 1 | 注射用ZG005 · No verified English nameCXSL2500975 | Name not romanized; Name not romanized |
| 2025/11/18New drug · Class 1 | TQF3250胶囊 · No verified English nameCXHL2501268 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/11/18New drug · Class 1 | TQF3250胶囊 · No verified English nameCXHL2501267 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/11/18New drug · Class 1 | TQF3250胶囊 · No verified English nameCXHL2501266 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/11/18New drug · Class 1 | IJ-25-362片 · No verified English nameCXHL2501265 | Chengdu Yin Chuang Yuan Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2025/11/18New drug · Class 2.2 | YKRH00257吸入溶液 · No verified English nameCXHL2501264 | Beijing Ying Ke Rui Innovation Drug Research Co., Ltd. romanized |
| 2025/11/17New drug · Class 1 | JNJ-95597528注射液 · No verified English nameCXSL2500974 | Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized |
| 2025/11/17New drug · Class 1 | YKYY032注射液 · No verified English nameCXHL2501263 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized |
| 2025/11/17New drug · Class 2.1; 2.4 | AP-2202片 · No verified English nameCXHL2501262 | Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/15Import · Class 1 | EPX-100口服溶液 · No verified English nameJXHL2500354 | Epygenix Therapeutics Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd |
85 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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