YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 304 drug applications between 29 October 2025 and 4 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 38 drug names.
2025/10/29 – 2025/11/04
- New acceptances this week
- 304
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- Accepted this week, now under review
- 61
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
304filings, 44 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 180 |
| Generic | 44 |
| New drug | 40 |
| Unspecified | 18 |
| Import re-registration | 14 |
| Import | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 182 |
| TCM | 81 |
| Therapeutic biologic | 28 |
| Biologic | 11 |
| Prophylactic biologic | 2 |
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
38 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Crisaborole Ointment | 2 | 2 | 26 |
| 2 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 3 | Pregabalin Capsules | 2 | 1 | 12 |
| 4 | 注射用托伐普坦磷酸钠 · No verified English name | 2 | 1 | 15 |
| 5 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 2 | 1 | 12 |
| 6 | Finerenone Tablets | 2 | 1 | 69 |
| 7 | Upadacitinib Sustained-release Tablets | 1 | 1 | 43 |
| 8 | Tafluprost Eye Drops | 1 | 1 | 3 |
| 9 | Pemafibrate Tablets | 1 | 1 | 23 |
| 10 | Carbidopa and Levodopa Sustained-release Tablets | 1 | 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
195 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bao Long Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 2 | Novartis Pharma Schweiz AG | 5 | 4 | 0 |
| 3 | Bayer Vital GmbH | 5 | 2 | 0 |
| 4 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Eli Lilly and Company | 4 | 3 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Biogen Netherlands B.V. | 4 | 1 | 0 |
| 8 | GUERBET | 4 | 1 | 0 |
| 9 | Beijing Yin Gu Pharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Ferring GmbH | 3 | 3 | 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
63 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/04Import · Class 2.4 | 镥[177Lu] 特昔维匹肽注射液 · No verified English nameJXHS2500125 | Novartis Pharma Schweiz AG; Advanced Accelerator Applications (Italy) S.R.L.; Beijing Novartis Pharma Co. Ltd. |
| 2025/11/04Generic · Class 3 | Furosemide Oral SolutionCYHS2503859 | Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2025/11/04Generic · Class 3 | Ketorolac Trometamol TabletsCYHS2503856 | Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/04Generic · Class 3 | 氟[1?F]贝他苯注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2503855 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Xian Tong Fen Zi Ying Xiang Technology Co., Ltd. romanized; Jiangsu Xian Tong Fen Zi Ying Xiang Technology Co., Ltd. romanized; Beijing Shan Wei Zheng Zi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | 重组人IL12/15单纯疱疹I型双调控溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2500942 | Shanghai Fu Nuo Jian Bio Technology Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | 自体NK细胞注射液 · No verified English nameCXSL2500941 | Guangxi Tai Mei Ren Sheng Bio Technology Co., Ltd. romanized |
| 2025/11/04New drug · Class 2.2 | 依沃西单抗注射液 · No verified English nameCXSL2500940 | Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | 注射用SHR-9839(sc) · No verified English nameCXSL2500939 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | IMM2510 · No verified English nameCXSL2500938 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2500937 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | IMM01 · No verified English nameCXSL2500936 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2501205 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2501204 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | KR23335片 · No verified English nameCXHL2501203 | Shanghai Qing Run Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | KR23335片 · No verified English nameCXHL2501202 | Shanghai Qing Run Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/03Import · Class 1 | Solbinsiran注射液 · No verified English nameJXHL2500336 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 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 |
33 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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