YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 309 drug applications between 15 November 2025 and 21 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 52 drug names.
2025/11/15 – 2025/11/21
- New acceptances this week
- 309
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 80
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
309filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 68 |
| New drug | 62 |
| Unspecified | 12 |
| Import re-registration | 10 |
| Import | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 174 |
| TCM | 74 |
| Therapeutic biologic | 46 |
| Biologic | 10 |
| Prophylactic biologic | 5 |
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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lisdexamfetamine Dimesylate capsules | 4 | 1 | 4 |
| 2 | Polyvinyl Alcohol Eye Drops | 3 | 3 | 24 |
| 3 | 二甲硅油乳剂 · No verified English name | 2 | 1 | 14 |
| 4 | Furosemide Oral Solution | 2 | 1 | 8 |
| 5 | Ibuprofen Granules | 2 | 1 | 3 |
| 6 | Tolvaptan Orally Disintegrating Tablets | 2 | 1 | 5 |
| 7 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 8 | 氯雷他定糖浆 · No verified English name | 2 | 1 | 7 |
| 9 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 10 | 注射用青霉素钠/氯化钠注射液 · No verified English name | 2 | 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
190 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bayer Vital GmbH | 14 | 1 | 0 |
| 2 | Qinghai Jiu Mei Cang Pharmaceuticals Technology Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Qilu Pharmaceutical Co., Ltd. | 7 | 6 | 1 |
| 4 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 7 | 5 | 4 |
| 5 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 5 | 2 | 2 |
| 6 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 2 | 0 |
| 8 | Terumo Corporation Kofu Factory | 4 | 1 | 0 |
| 9 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Hangzhou Jing Yao Bio Technology Co., Ltd. romanized | 4 | 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/21Generic · Class 3 | Amifostine For InjectionCYHS2504020 | Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized; Mei Luo Pharma Co., Ltd. romanized |
| 2025/11/21New drug · Class 2.3 | 湿润烧伤膏 · No verified English nameCXZL2500117 | Shan Tou Shi Mei Bao Pharmaceutical Co., Ltd. romanized |
| 2025/11/21New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSS2500124 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized |
| 2025/11/21New drug · Class 1 | 注射用SKB518 · No verified English nameCXSL2500997 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/21New drug · Class 1 | 注射用HLX43 · No verified English nameCXSL2500996 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/21New drug · Class 1 | 重组抗EGFR人源化单克隆抗体注射液 · No verified English nameCXSL2500995 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/21New drug · Class 1 | 注射用JSKN003 · No verified English nameCXSL2500994 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2025/11/21New drug · Class 1 | QLP2117注射液 · No verified English nameCXSL2500993 | Qilu Pharmaceutical Co., Ltd. |
| 2025/11/21New drug · Class 2.2 | QL2107注射液 · No verified English nameCXSL2500992 | Qilu Pharmaceutical Co., Ltd. |
| 2025/11/21New drug · Class 3.3 | 水痘减毒活疫苗 · No verified English nameCXSL2500991 | Yunnan Wo Sen Bio Technology Co., Ltd. romanized; Yunnan Yi Miao Laboratory Co., Ltd. romanized; Beijing Wo Sen Innovation Bio Technology Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized |
| 2025/11/21New drug · Class 2.2 | 氢溴酸伏硫西汀口崩片 · No verified English nameCXHS2500138 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2025/11/21New drug · Class 2.2 | 氢溴酸伏硫西汀口崩片 · No verified English nameCXHS2500137 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2025/11/21New drug · Class 1 | BPI-572270胶囊 · No verified English nameCXHL2501287 | Hangzhou Jing Yao Bio Technology Co., Ltd. romanized |
| 2025/11/21New drug · Class 1 | BPI-572270胶囊 · No verified English nameCXHL2501286 | Hangzhou Jing Yao Bio Technology Co., Ltd. romanized |
| 2025/11/21New drug · Class 1 | BPI-572270胶囊 · No verified English nameCXHL2501285 | Hangzhou Jing Yao Bio Technology Co., Ltd. romanized |
| 2025/11/21New drug · Class 1 | BPI-572270胶囊 · No verified English nameCXHL2501284 | Hangzhou Jing Yao Bio Technology Co., Ltd. romanized |
| 2025/11/20Import · Class 1 | AMO959硬胶囊 · No verified English nameJXHL2500359 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/11/20Import · Class 2.4 | 镥(177Lu)vipivotide tetraxetan注射液 · No verified English nameJXHL2500358 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/11/20Import · Class 1 | AMO959硬胶囊 · No verified English nameJXHL2500357 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/11/20Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2504012 | Zhong Shan Ke Ke Kang Pharmaceutical Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | SHR-1894注射液 · No verified English nameCXSL2500990 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | EHT102注射液 · No verified English nameCXSL2500989 | Shanghai You Yin Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | SYS6010 · No verified English nameCXSL2500988 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/11/20New drug · Class 2.4 | 芦沃美替尼片 · No verified English nameCXHS2500140 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2025/11/20New drug · Class 2.4 | 芦沃美替尼片 · No verified English nameCXHS2500139 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | HSK42360-Na片 · No verified English nameCXHL2501283 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | CKBA乳膏 · No verified English nameCXHL2501282 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | CKBA乳膏 · No verified English nameCXHL2501281 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | CKBA乳膏 · No verified English nameCXHL2501280 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | ASP3082注射液 · No verified English nameCXHL2501279 | An Si Tai Lai (Zhongguo) Investment Co., Ltd. romanized |
67 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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