YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 321 drug applications between 18 November 2025 and 24 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 62 drug names.
2025/11/18 – 2025/11/24
- New acceptances this week
- 321
- Drugs with new generic filings (by drug name, de-duplicated)
- 62
- Accepted this week, now under review
- 88
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
321filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 141 |
| Generic | 82 |
| New drug | 61 |
| Unspecified | 14 |
| Import re-registration | 12 |
| Import | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 173 |
| TCM | 85 |
| Therapeutic biologic | 48 |
| 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
62 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 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 4 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 5 | 非那雄胺喷雾剂 · No verified English name | 2 | 2 | 4 |
| 6 | 二甲硅油乳剂 · No verified English name | 2 | 1 | 14 |
| 7 | Folic Acid Tablets | 2 | 1 | 12 |
| 8 | Furosemide Oral Solution | 2 | 1 | 8 |
| 9 | Ibuprofen Granules | 2 | 1 | 3 |
| 10 | Tolvaptan Orally Disintegrating Tablets | 2 | 1 | 5 |
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
213 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Qinghai Jiu Mei Cang Pharmaceuticals Technology Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 7 | 6 | 1 |
| 3 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 4 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Sichuan Shu Zhong Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 6 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/24Import · Class 1 | 注射用IPN10200 · No verified English nameJXSL2500225 | Ipsen Innovation; Ipsen (Shanghai) Innovation Pharmaceutical Co. Ltd |
| 2025/11/24Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2504045 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/11/24Generic · Class 3 | Folic Acid TabletsCYHS2504044 | Beijing Foyou Pharma CO.,LTD |
| 2025/11/24Generic · Class 3 | Folic Acid TabletsCYHS2504043 | Beijing Foyou Pharma CO.,LTD |
| 2025/11/24New drug · Class 1 | EP-0210单抗注射液 · No verified English nameCXSL2501001 | Chengdu You Luo Bio Technology Co., Ltd. romanized |
| 2025/11/24New drug · Class 1 | R01注射液 · No verified English nameCXSL2501000 | Hangzhou Niu An Jin Bio Technology Co., Ltd. romanized |
| 2025/11/22Import · Class 1 | Itepekimab注射液 · No verified English nameJXSL2500224 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/11/22Import · Class 1 | Omecamtiv Mecarbil缓释片 · No verified English nameJXHL2500362 | Cytokinetics Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2025/11/22Import · Class 1 | Omecamtiv Mecarbil缓释片 · No verified English nameJXHL2500361 | Cytokinetics Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2025/11/22Import · Class 1 | Omecamtiv Mecarbil缓释片 · No verified English nameJXHL2500360 | Cytokinetics, Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2025/11/22Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHS2504037 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hui Cheng Pharma Co., Ltd. romanized |
| 2025/11/22Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2504035 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2025/11/22New drug · Class 3.4 | 注射用重组人凝血因子Ⅷ · No verified English nameCXSS2500125 | Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized; Nanjing Peng Bo Bio Technology Co., Ltd. romanized |
| 2025/11/22New drug · Class 1 | 注射用LM-24C5 · No verified English nameCXSL2500999 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/11/22New drug · Class 3.2 | 流感病毒裂解疫苗(高剂量) · No verified English nameCXSL2500998 | Cheng Da Bio (Ben Xi) Co., Ltd. romanized; Liaoning Cheng Da Bio Co., Ltd. romanized |
| 2025/11/22New drug · Class 2.4 | 硫酸艾玛昔替尼片 · No verified English nameCXHS2500141 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/11/22New drug · Class 1 | HYP-6589片 · No verified English nameCXHL2501289 | Name not romanized |
| 2025/11/22New drug · Class 1 | HYP-6589片 · No verified English nameCXHL2501288 | Name not romanized |
| 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 |
73 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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