YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 335 drug applications between 13 November 2025 and 19 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 57 drug names.
2025/11/13 – 2025/11/19
- New acceptances this week
- 335
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 85
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
335filings, 79 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| Generic | 79 |
| New drug | 55 |
| Import | 17 |
| Unspecified | 6 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 205 |
| TCM | 87 |
| Therapeutic biologic | 33 |
| Prophylactic biologic | 8 |
| 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
57 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 | 3 | 2 | 14 |
| 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 | 依伏卡塞片 · No verified English name | 2 | 1 | 9 |
| 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
205 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 | Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 7 | 4 | 1 |
| 5 | Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 6 | Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 5 | 4 | 2 |
| 8 | Qilu Pharmaceutical Co., Ltd. | 5 | 4 | 1 |
| 9 | Eli Lilly and Company | 4 | 3 | 0 |
| 10 | Takeda Development Center Americas Inc. | 4 | 2 | 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
105 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/19Import · Class 1 | 盐酸伊可白滞素片 · No verified English nameJXHS2500133 | Janssen-Cilag International NV; JANSSEN CILAG S.P.A.; Xian Janssen Pharmaceutical Ltd. |
| 2025/11/19Generic · Class 3 | 利格列汀二甲双胍缓释片(I) · No verified English nameCYHS2504008 | Jiangsu Deyuan Pharmaceutical Co.,Ltd. |
| 2025/11/19Generic · Class 3 | Tolvaptan Orally Disintegrating TabletsCYHS2504007 | TIANJIN LISHENG PHARMACEUTICAL CO., LTD; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Lisdexamfetamine Dimesylate capsulesCYHS2504006 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Tolvaptan Orally Disintegrating TabletsCYHS2504005 | TIANJIN LISHENG PHARMACEUTICAL CO., LTD; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Lisdexamfetamine Dimesylate capsulesCYHS2504004 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Lisdexamfetamine Dimesylate capsulesCYHS2504003 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Glycerol Fructose And Sodium Chloride InjectionCYHS2504002 | Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Lisdexamfetamine Dimesylate capsulesCYHS2504001 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Glycerol Fructose And Sodium Chloride InjectionCYHS2504000 | Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | 小儿复方氨基酸注射液(20AA) · No verified English nameCYHS2503999 | Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Ciclosporin Eye Drops(Ⅱ)CYHL2500206 | Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized |
| 2025/11/19New drug · Class 1 | JH021注射液 · No verified English nameCXSL2500987 | Bai Tai Bio Pharma Co., Ltd. romanized; An Bo Tai Ke Pharma Co., Ltd. romanized |
| 2025/11/19New drug · Class 1 | 注射用DB-1311 · No verified English nameCXSL2500986 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/11/19New drug · Class 1 | Pumitamig注射液 · No verified English nameCXSL2500985 | Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/11/19New drug · Class 1 | YSC001注射液 · No verified English nameCXSL2500984 | Yan Sheng Chao (Beijing) Bio Technology Co., Ltd. romanized |
| 2025/11/19New drug · Class 1.3 | 重组三价流感病毒疫苗(Sf9细胞) · No verified English nameCXSL2500983 | Chengdu Wei Si Ke Biopharmaceuticals Co., Ltd. romanized; Beijing Wei Si Ke Biopharmaceuticals Technology Co., Ltd. romanized; Wei Si Ke Biopharmaceuticals (Guangzhou) Co., Ltd. romanized |
| 2025/11/19New drug · Class 1.3 | 重组三价流感病毒疫苗(Sf9细胞) · No verified English nameCXSL2500982 | Chengdu Wei Si Ke Biopharmaceuticals Co., Ltd. romanized; Beijing Wei Si Ke Biopharmaceuticals Technology Co., Ltd. romanized; Wei Si Ke Biopharmaceuticals (Guangzhou) Co., Ltd. romanized |
| 2025/11/19New drug · Class 1 | ZL-1503注射液 · No verified English nameCXSL2500981 | Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/11/19New drug · Class 1 | BG-75098片 · No verified English nameCXHL2501273 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/11/19New drug · Class 1 | BG-75098片 · No verified English nameCXHL2501272 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/11/19New drug · Class 1 | BG-75098片 · No verified English nameCXHL2501271 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/11/19New drug · Class 1 | PAN-90806滴眼液 · No verified English nameCXHL2501270 | Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized |
| 2025/11/19New drug · Class 2.3 | 氨氯地平双叶酸片 · No verified English nameCXHL2501269 | Shenzhen Ao Sa Pharmaceutical Co., Ltd. romanized |
| 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 |
75 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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