YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 340 drug applications between 26 October 2025 and 1 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 51 drug names.
2025/10/26 – 2025/11/01
- New acceptances this week
- 340
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- Accepted this week, now under review
- 76
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
340filings, 62 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 183 |
| Generic | 62 |
| New drug | 59 |
| Unspecified | 12 |
| Import | 12 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 231 |
| TCM | 72 |
| Therapeutic biologic | 31 |
| Biologic | 3 |
| Prophylactic biologic | 2 |
| Unspecified | 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
51 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Finerenone Tablets | 4 | 2 | 69 |
| 2 | Pemafibrate Tablets | 2 | 2 | 23 |
| 3 | Crisaborole Ointment | 2 | 2 | 26 |
| 4 | Lidocaine and Tetracaine Cream | 2 | 2 | 2 |
| 5 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 6 | Pregabalin Capsules | 2 | 1 | 12 |
| 7 | 注射用托伐普坦磷酸钠 · No verified English name | 2 | 1 | 15 |
| 8 | Rosuvastatin Calcium Tablets | 2 | 1 | 18 |
| 9 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 2 | 1 | 12 |
| 10 | Fluticasone Propionate Cream | 1 | 1 | 12 |
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
223 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xinjiang Hua Shi Dan Pharma Co., Ltd. romanized | 7 | 1 | 0 |
| 2 | Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 3 | Bayer Vital GmbH | 5 | 2 | 0 |
| 4 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 5 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Shi Yao Group En Bi Pu Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Ferring GmbH | 4 | 4 | 0 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Novartis Pharma Schweiz AG | 4 | 3 | 0 |
| 10 | Biogen Netherlands B.V. | 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
88 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/01Generic · Class 3 | Potassium Chloride GranulesCYHS2503852 | Fujian Rui Tai Lai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Jia He Pharma Co., Ltd. romanized |
| 2025/11/01Generic · Class 3 | Sucralfate Oral SuspensionCYHS2503851 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2025/11/01Generic · Class 3 | Lanthanum Carbonate Hydrate GranulesCYHS2503849 | Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized |
| 2025/11/01New drug · Class 1.2 | FS2303分散片 · No verified English nameCXZL2500107 | Da Lian Fu Sheng Tian Ran Drug Kai Fa Co., Ltd. romanized |
| 2025/11/01New drug · Class 1 | 阴道用卷曲乳杆菌活菌胶囊 · No verified English nameCXSS2500117 | Suzhou Ou Sai Wei Ke Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/01New drug · Class 2.2 | 兰索拉唑碳酸氢钠干混悬剂 · No verified English nameCXHS2500135 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/11/01New drug · Class 2.2 | CB446 · No verified English nameCXHL2501201 | Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/01New drug · Class 2.2 | ASECG肠溶干混悬剂 · No verified English nameCXHL2501200 | Beijing Tian Heng Drug Research Institute Co., Ltd. romanized |
| 2025/10/31Import · Class 2.4 | 宗艾替尼片 · No verified English nameJXHS2500124 | Boehringer Ingelheim International GmbH; Hovione Farmaciencia S.A.; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2025/10/31Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2503846 | Henan Zhong Jie Pharma Co., Ltd. romanized |
| 2025/10/31Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2503845 | Henan Zhong Jie Pharma Co., Ltd. romanized |
| 2025/10/31Generic · Class 3 | Clindamycin Palmitate Hydrochloride GranulesCYHS2503842 | Shandong Rui Yi Pharmaceuticals Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/10/31Generic · Class 3 | 复方聚乙二醇(3350)电解质维C散 · No verified English nameCYHS2503841 | Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized |
| 2025/10/31Generic · Class 3 | Galanthamine Hydrobromide Oral SolutionCYHS2503839 | Shanghai Bao Long Bio Technology Co., Ltd. romanized; Shanghai Mei You Pharmaceutical Co., Ltd. romanized |
| 2025/10/31Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2503835 | Hubei Bang Ze Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2025/10/31Generic · Class 3 | Regadenoson InjectionCYHL2500195 | Hebei Sai Pu Yi Hui Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/31New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2500935 | Hua Lan Bio Yi Miao Co., Ltd. romanized |
| 2025/10/31New drug · Class 1 | NWRD18 · No verified English nameCXHL2501199 | Nuo Wei Bio Technology (Wuxi) Co., Ltd. romanized; Nuo Wei Technology (Beijing) Co., Ltd. romanized; Nuo Wei Bio Technology (Tianjin) Co., Ltd. romanized |
| 2025/10/31New drug · Class 2.2; 2.4 | SY-606滴眼液 · No verified English nameCXHL2501198 | Beijing Yin Gu Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/31New drug · Class 2.2; 2.4 | SY-606滴眼液 · No verified English nameCXHL2501197 | Beijing Yin Gu Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/31New drug · Class 2.2; 2.4 | SY-606滴眼液 · No verified English nameCXHL2501196 | Beijing Yin Gu Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/31New drug · Class 2.2; 2.4 | SY-606滴眼液 · No verified English nameCXHL2501195 | Beijing Yin Gu Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/30Import · Class 3.1 | Nemolizumab注射液 · No verified English nameJXSL2500208 | Galderma SA; Q-Med International Trading (Shanghai) Co. Ltd |
| 2025/10/30Import · Class 1 | GSK6042981片 · No verified English nameJXHL2500334 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2025/10/30New drug · Class 1.2 | 栀子西红花酸提取物(C2235) · No verified English nameCXZL2500106 | Zhejiang Jian Feng Pharma Co., Ltd. romanized |
| 2025/10/30New drug · Class 1 | 柯美奇拜单抗注射液 · No verified English nameCXSS2500116 | Shanghai Mai Ji Pharmaceuticals Co., Ltd. romanized; Ding Kang (Wuhan) Biopharmaceuticals Co., Ltd. romanized |
| 2025/10/30New drug · Class 1 | 注射用QLS5316 · No verified English nameCXSL2500934 | Qilu Pharmaceutical Co., Ltd. |
| 2025/10/30New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500133 | Gansu Pu An Pharmaceutical Co., Ltd. romanized |
| 2025/10/30New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500132 | Gansu Pu An Pharmaceutical Co., Ltd. romanized |
| 2025/10/30New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500131 | Gansu Pu An Pharmaceutical Co., Ltd. romanized |
58 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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