YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 622 drug applications between 10 October 2025 and 16 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 121, covering 94 drug names.
2025/10/10 – 2025/10/16
- New acceptances this week
- 622
- Drugs with new generic filings (by drug name, de-duplicated)
- 94
- Accepted this week, now under review
- 145
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
622filings, 121 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 308 |
| New drug | 125 |
| Generic | 121 |
| Import | 34 |
| Unspecified | 26 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 373 |
| TCM | 133 |
| Therapeutic biologic | 86 |
| Biologic | 19 |
| Prophylactic biologic | 7 |
| Unspecified | 3 |
| In vitro diagnostic reagent | 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
94 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Ambroxol Hydrochloride Oral Solution | 3 | 2 | 46 |
| 3 | 甘油灌肠剂 · No verified English name | 3 | 1 | 2 |
| 4 | 甲苯磺酸卢美哌隆胶囊 · No verified English name | 3 | 1 | 2 |
| 5 | LevomilnacipranHydrochloride Extended-release Capsules | 3 | 1 | 6 |
| 6 | 达普司他片 · No verified English name | 3 | 1 | 0 |
| 7 | Pemafibrate Tablets | 2 | 2 | 23 |
| 8 | Vortioxetine Hydrobromide Tablets | 2 | 2 | 10 |
| 9 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 10 | 磷酸奥司他韦颗粒 · No verified English name | 2 | 2 | 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
328 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 45 | 30 | 0 |
| 2 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 10 | 2 | 0 |
| 3 | Qilu Pharmaceutical Co., Ltd. | 9 | 5 | 3 |
| 4 | AstraZeneca AB | 9 | 4 | 0 |
| 5 | Bristol-Myers Squibb Company | 8 | 2 | 0 |
| 6 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 7 | Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 8 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 7 | 3 | 2 |
| 9 | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | 6 | 6 | 0 |
| 10 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 6 | 6 | 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
202 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/16Import · Class 3.1 | 瑞利珠单抗注射液 · No verified English nameJXSS2500133 | Alexion Europe SAS; Alexion Pharma International Operations Limited; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/10/16Import · Class 3.1 | 瑞利珠单抗注射液 · No verified English nameJXSS2500132 | Alexion Europe SAS; Alexion Pharma International Operations Limited; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/10/16Import · Class 2.2 | 度普利尤单抗注射液 · No verified English nameJXSL2500201 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/10/16Import · Class 2.4 | KarXT胶囊 · No verified English nameJXHL2500320 | Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd. |
| 2025/10/16Import · Class 2.4 | KarXT胶囊 · No verified English nameJXHL2500319 | Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd. |
| 2025/10/16Import · Class 2.4 | KarXT胶囊 · No verified English nameJXHL2500318 | Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd. |
| 2025/10/16Import · Class 2.4 | KarXT胶囊 · No verified English nameJXHL2500317 | Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd. |
| 2025/10/16Import · Class 2.4 | KarXT胶囊 · No verified English nameJXHL2500316 | Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd. |
| 2025/10/16Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2503712 | Tian Da Pharma (Zhuhai) Co., Ltd. romanized |
| 2025/10/16Generic · Class 3 | LevomilnacipranHydrochloride Extended-release CapsulesCYHS2503708 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2025/10/16Generic · Class 3 | LevomilnacipranHydrochloride Extended-release CapsulesCYHS2503707 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2025/10/16Generic · Class 3 | LevomilnacipranHydrochloride Extended-release CapsulesCYHS2503706 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2025/10/16Generic · Class 3 | Cetylpyridinium Chloride Buccal TabletsCYHS2503697 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2025/10/16Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503692 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2025/10/16Generic · Class 3 | 盐酸伊伐布雷定口服溶液 · No verified English nameCYHS2503690 | Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized |
| 2025/10/16Generic · Class 3 | Tretinoin CreamCYHL2500188 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/10/16New drug · Class 3.3 | 阿达木单抗注射液 · No verified English nameCXSS2500115 | Zhejiang Hua Hai Bio Technology Co., Ltd. romanized |
| 2025/10/16New drug · Class 1 | 注射用SIM0610 · No verified English nameCXSL2500892 | Shanghai Xian Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/16New drug · Class 2.2 | 基因减毒组分百白破联合疫苗 · No verified English nameCXSL2500891 | Suzhou Ju Wei Bio Technology Co., Ltd. romanized |
| 2025/10/16New drug · Class 1 | CG-BM1异体人骨髓间充质干细胞注射液 · No verified English nameCXSL2500890 | Guangzhou Sai Juan Bio Technology Co., Ltd. romanized |
| 2025/10/16New drug · Class 1 | 富马酸奥比特嗪肠溶微丸胶囊 · No verified English nameCXHL2501133 | Shenzhen Shi Zhen Xing Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/16New drug · Class 1 | 注射用美罗培南普莱巴坦 · No verified English nameCXHL2501132 | Qilu Pharmaceutical Co., Ltd. |
| 2025/10/16New drug · Class 1 | ABSK141片 · No verified English nameCXHL2501131 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/16New drug · Class 1 | 注射用美罗培南普莱巴坦 · No verified English nameCXHL2501130 | Qilu Pharmaceutical Co., Ltd. |
| 2025/10/16New drug · Class 1 | ABSK141片 · No verified English nameCXHL2501129 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/16New drug · Class 1 | HRS-5041片 · No verified English nameCXHL2501128 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/10/16New drug · Class 1 | HRS-5041片 · No verified English nameCXHL2501127 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/10/16New drug · Class 1 | SYH2069注射液 · No verified English nameCXHL2501126 | Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/10/16New drug · Class 1 | SYH2069注射液 · No verified English nameCXHL2501125 | Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/10/16New drug · Class 1 | SYH2069注射液 · No verified English nameCXHL2501124 | Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD. |
172 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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