YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 199 drug applications between 7 October 2025 and 13 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 42 drug names.
2025/10/07 – 2025/10/13
- New acceptances this week
- 199
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- Accepted this week, now under review
- 55
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
199filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 96 |
| Generic | 48 |
| New drug | 37 |
| Import | 13 |
| Import re-registration | 4 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 113 |
| TCM | 49 |
| Therapeutic biologic | 35 |
| In vitro diagnostic reagent | 1 |
| 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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Furosemide Injection | 2 | 2 | 6 |
| 2 | Dotinurad Tablets | 2 | 1 | 55 |
| 3 | Paracetamol Tablets | 2 | 1 | 6 |
| 4 | 枸橼酸西地那非口溶膜 · No verified English name | 2 | 1 | 8 |
| 5 | Lercanidipine Hydrochloride Tablets | 2 | 1 | 6 |
| 6 | Nicardipine Hydrochloride Injection | 2 | 1 | 13 |
| 7 | Fluticasone Propionate Cream | 1 | 1 | 12 |
| 8 | Calcium Folinate Injection | 1 | 1 | 4 |
| 9 | Pemafibrate Tablets | 1 | 1 | 23 |
| 10 | Crisaborole Ointment | 1 | 1 | 26 |
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
137 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 2 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 4 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | AbbVie Deutschland GmbH & Co. KG | 4 | 1 | 0 |
| 7 | Bristol-Myers Squibb Company | 4 | 1 | 0 |
| 8 | Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Sichuan Tai Hua Tang Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized | 3 | 3 | 3 |
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
62 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/13Import · Class 1 | 注射用E型肉毒毒素 · No verified English nameJXSS2500131 | AbbVie Limited; Allergan Pharmaceuticals Ireland Unlimited Company; Allergan Information Consulting (Shanghai) Co. Ltd |
| 2025/10/13New drug · Class 1 | 注射用BG-C0902 · No verified English nameCXSL2500877 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2025/10/13New drug · Class 2.2 | GLX002 · No verified English nameCXHL2501089 | Beijing Ya Bao Bio Pharma Co., Ltd. romanized |
| 2025/10/12New drug · Class 1.1 | 复方南藤胶囊 · No verified English nameCXZL2500094 | Nanjing Zhong Pharmaceuticals University romanized; Jiangsu Jin Shi Dan Technology Co., Ltd. romanized |
| 2025/10/12New drug · Class 3.4 | 抗五步蛇毒血清 · No verified English nameCXSL2500869 | Jiangxi Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2025/10/12New drug · Class 2.2 | 注射用硼[10B]法仑 · No verified English nameCXHL2501079 | Shenzhen Shi Zhong He Hai De Wei Bio Technology Co., Ltd. romanized |
| 2025/10/12New drug · Class 1 | 注射用HSK55718 · No verified English nameCXHL2501078 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/12New drug · Class 1 | 注射用HSK55718 · No verified English nameCXHL2501077 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/12New drug · Class 1 | RTX-117片 · No verified English nameCXHL2501076 | Xi Li Technology (Shenzhen) Co., Ltd. romanized |
| 2025/10/12New drug · Class 1 | RTX-117片 · No verified English nameCXHL2501075 | Xi Li Technology (Shenzhen) Co., Ltd. romanized |
| 2025/10/12New drug · Class 1 | ICP-332 · No verified English nameCXHL2501074 | Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/11Import · Class 3.4 | 注射用A型肉毒毒素 · No verified English nameJXSS2500130 | Daewoong Pharmaceutical Co. Ltd.; Beijing Daewoong Pharmaceutical R&D Center Co. Ltd. |
| 2025/10/11Import · Class 2.4 | Entrectinib胶囊 · No verified English nameJXHL2500309 | F. Hoffmann-La Roche Ltd |
| 2025/10/11Generic · Class 3 | Doxofylline TabletsCYHS2503631 | Hefei He Yuan Pharma Co., Ltd. romanized |
| 2025/10/11Generic · Class 3 | 枸橼酸西地那非口溶膜 · No verified English nameCYHS2503629 | Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized; Hefei Si Pu Rui Pharma Co., Ltd. romanized |
| 2025/10/11Generic · Class 3 | 枸橼酸西地那非口溶膜 · No verified English nameCYHS2503628 | Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized; Hefei Si Pu Rui Pharma Co., Ltd. romanized |
| 2025/10/11Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2503624 | Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/10/11Generic · Class 3 | Furosemide InjectionCYHS2503622 | Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2025/10/11Generic · Class 3 | Ketoprofen PatchesCYHL2500179 | Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2025/10/11New drug · Class 2.2 | TQA凝胶贴膏 · No verified English nameCXZL2500093 | Sai Ling Pharma Technology Group Co., Ltd. romanized |
| 2025/10/11New drug · Class 1 | 注射用ISH0688 · No verified English nameCXSL2500868 | Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized |
| 2025/10/11New drug · Class 1 | YF-3注射液 · No verified English nameCXSL2500865 | Suzhou Yong Xin Bio Technology Co., Ltd. romanized |
| 2025/10/11New drug · Class 1 | 人前/中脑神经前体细胞注射液 · No verified English nameCXSL2500864 | Zhejiang Quan Sheng Bio Technology Co., Ltd. romanized |
| 2025/10/11New drug · Class 1 | 注射用SHR-4394 · No verified English nameCXSL2500863 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/10/11New drug · Class 1 | 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2500862 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2025/10/11New drug · Class 1 | HSK45019片 · No verified English nameCXHL2501073 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/11New drug · Class 1 | HSK45019片 · No verified English nameCXHL2501072 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/11New drug · Class 1 | HRL1101散 · No verified English nameCXHL2501071 | Beijing Hua Rui Ding Xin Technology Co., Ltd. romanized; Hunan Ming Rui Pharmaceutical Co., Ltd. romanized |
| 2025/10/11New drug · Class 2.2 | 1861B · No verified English nameCXHL2501070 | Pu Zhao Guo Kang (Hubei) Pharma Co., Ltd. romanized |
| 2025/10/11New drug · Class 2.4 | 泽美妥司他片 · No verified English nameCXHL2501069 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
32 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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