YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 301 drug applications between 19 October 2025 and 25 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 45 drug names.
2025/10/19 – 2025/10/25
- New acceptances this week
- 301
- Drugs with new generic filings (by drug name, de-duplicated)
- 45
- 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
301filings, 58 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 170 |
| Generic | 58 |
| New drug | 51 |
| Import | 11 |
| Import re-registration | 8 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 206 |
| TCM | 59 |
| Therapeutic biologic | 33 |
| Prophylactic biologic | 2 |
| Biologic | 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
45 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 2 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 3 | Clindamycin Injection | 2 | 1 | 4 |
| 4 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 5 | Levothyroxine Sodium Tablets | 2 | 1 | 12 |
| 6 | Imipenem and Cilastatin Sodium for Injection | 2 | 1 | 6 |
| 7 | 注射用托伐普坦磷酸钠 · No verified English name | 2 | 1 | 15 |
| 8 | Fosfomycin Sodium For Injection | 2 | 1 | 16 |
| 9 | Safinamide Methansulfonate Tablets | 2 | 1 | 20 |
| 10 | Promethazine Hydrochloride Injection | 2 | 1 | 11 |
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
172 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 14 | 14 | 0 |
| 2 | Xinjiang Hua Shi Dan Pharma Co., Ltd. romanized | 12 | 1 | 0 |
| 3 | Jiangsu Si Jia Wei Kang Pharmaceuticals Technology Co., Ltd. romanized | 9 | 1 | 0 |
| 4 | Qilu Pharmaceutical (Hainan) Co., Ltd | 8 | 3 | 0 |
| 5 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 7 | 6 | 0 |
| 6 | Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 2 | 0 |
| 8 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Tong Hua Si Wei Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Pfizer Europe MA EEIG | 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
84 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/24Import · Class 2.4 | 伊那利塞片 · No verified English nameJXHL2500327 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2025/10/24Import · Class 2.4 | 伊那利塞片 · No verified English nameJXHL2500326 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2025/10/24Import · Class 1 | Nucresiran注射液 · No verified English nameJXHL2500325 | Alnylam Pharmaceuticals Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd. |
| 2025/10/24Import · Class 1 | TAK-279胶囊 · No verified English nameJXHL2500324 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2025/10/24Import · Class 1 | TAK-279胶囊 · No verified English nameJXHL2500323 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2025/10/24Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2503795 | Jiangsu Deyuan Pharmaceutical Co.,Ltd. |
| 2025/10/24Generic · Class 3 | Olopatadine Hydrochloride GranulesCYHS2503792 | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized |
| 2025/10/24Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2503790 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/10/24Generic · Class 3 | Fosfomycin Sodium For InjectionCYHS2503789 | Hebei Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized; Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanized |
| 2025/10/24Generic · Class 3 | Fosfomycin Sodium For InjectionCYHS2503788 | Hebei Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized; Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanized |
| 2025/10/24New drug · Class 1 | B023细胞注射液 · No verified English nameCXSL2500924 | Shanghai Pharmaceuticals Group Bio Zhi Liao Technology Co., Ltd. romanized |
| 2025/10/24New drug · Class 1 | 注射用MK-1045 · No verified English nameCXSL2500923 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/10/24New drug · Class 1 | 注射用MK-1045 · No verified English nameCXSL2500922 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/10/24New drug · Class 1 | SV-1993 胶囊 · No verified English nameCXHL2501166 | Beijing Sen Miao Bio Technology Co., Ltd. romanized |
| 2025/10/24New drug · Class 1 | SV-1993 胶囊 · No verified English nameCXHL2501165 | Beijing Sen Miao Bio Technology Co., Ltd. romanized |
| 2025/10/23Import · Class 1 | BI764198 片 · No verified English nameJXHL2500328 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2025/10/23Import · Class 1 | Balinatunfib · No verified English nameJXHL2500322 | Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd. |
| 2025/10/23Import · Class 1 | Balinatunfib · No verified English nameJXHL2500321 | Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd. |
| 2025/10/23Generic · Class 3 | 托吡酯口服溶液 · No verified English nameCYHS2503777 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/10/23Generic · Class 3 | Oxytocin InjectionCYHS2503776 | Wuhan Ren Fu Pharma Co., Ltd. romanized |
| 2025/10/23Generic · Class 3 | Oxytocin InjectionCYHS2503775 | Wuhan Ren Fu Pharma Co., Ltd. romanized |
| 2025/10/23Generic · Class 3 | Clindamycin InjectionCYHS2503768 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2025/10/23Generic · Class 3 | Clindamycin InjectionCYHS2503767 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2025/10/23Generic · Class 3 | 利非司特滴眼液 · No verified English nameCYHL2500190 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2025/10/23New drug · Class 1 | 注射用QLS2313 · No verified English nameCXSL2500921 | Qilu Pharmaceutical Co., Ltd. |
| 2025/10/23New drug · Class 1.2 | RSV mRNA疫苗(JCXH-108注射液) · No verified English nameCXSL2500920 | Jia Chen Xi Hai (Hangzhou) Bio Technology Co., Ltd. romanized |
| 2025/10/23New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2500919 | Jiangsu Sai Yi Bio Technology Co., Ltd. romanized |
| 2025/10/23New drug · Class 2.2 | 复方α-酮酸颗粒 · No verified English nameCXHS2500128 | Beijing Fei Sen You Si Ka Bi Pharmaceuticals Co., Ltd. romanized |
| 2025/10/23New drug · Class 1 | HS-10365胶囊 · No verified English nameCXHS2500127 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2025/10/23New drug · Class 1 | 注射用RAB001 · No verified English nameCXHL2501164 | Zhong Shan Lai Bo Rui Chen Biopharmaceuticals Co., Ltd. romanized |
54 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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