YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 380 drug applications between 12 September 2025 and 18 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 74 drug names.
2025/09/12 – 2025/09/18
- New acceptances this week
- 380
- Drugs with new generic filings (by drug name, de-duplicated)
- 74
- Accepted this week, now under review
- 112
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
380filings, 96 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 186 |
| Generic | 96 |
| New drug | 48 |
| Import | 34 |
| Import re-registration | 9 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 203 |
| TCM | 90 |
| Therapeutic biologic | 75 |
| Prophylactic biologic | 6 |
| Biologic | 5 |
| 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
74 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Safinamide Methansulfonate Tablets | 4 | 2 | 20 |
| 2 | Buspirone Hydrochloride Tablets | 3 | 1 | 5 |
| 3 | 注射用盐酸地尔硫? · No verified English nameThe source text contains a character that cannot be displayed. | 2 | 2 | 9 |
| 4 | 利伐沙班颗粒 · No verified English name | 2 | 1 | 2 |
| 5 | Levocarnitine Injection | 2 | 1 | 4 |
| 6 | Brexpiprazole Orally Disintegrating Tablets | 2 | 1 | 10 |
| 7 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
| 8 | Flomoxef Sodium for Injection | 2 | 1 | 9 |
| 9 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 10 | 环硅酸锆钠散 · No verified English name | 2 | 1 | 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
215 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 10 | 5 | 0 |
| 2 | Beijing Si Huan Biopharmaceutical Co., Ltd. romanized | 10 | 1 | 0 |
| 3 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 8 | 3 | 0 |
| 4 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | Gansu Fu Zheng Pharma Technology Co., Ltd. romanized | 7 | 6 | 0 |
| 6 | AstraZeneca AB | 7 | 5 | 0 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 4 | 0 |
| 8 | Eli Lilly and Company | 7 | 2 | 0 |
| 9 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 6 | 1 | 0 |
| 10 | Yunnan Yong Zi Tang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 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
112 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/18Import · Class 1 | CVM-1118胶囊 · No verified English nameJXHL2500294 | TaiRx Inc.; TaiRx Pharmaceutical (Kunshan). Ltd. |
| 2025/09/18Import · Class 2.2; 2.4 | 双醋瑞因软膏 · No verified English nameJXHL2500293 | TWi Biotechnology Inc.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2025/09/18Generic · Class 3 | Nefopam Hydrochloride InjectionCYHS2503457 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2503453 | Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2503451 | Yan Tai Ju Xian Pharma Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2503450 | Yan Tai Ju Xian Pharma Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | Trihexyphenidyl Hydrochloride TabletsCYHS2503445 | Yun Peng Pharmaceuticals Group Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2503444 | Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | 盐酸羟甲唑啉滴眼液 · No verified English nameCYHL2500170 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | 酮洛芬凝胶贴膏 · No verified English nameCYHL2500169 | Fu Yuan Pharma Co., Ltd. romanized |
| 2025/09/18New drug · Class 3.1 | 半夏白术天麻颗粒 · No verified English nameCXZS2500040 | Hainan Si Da Pharmaceutical Co., Ltd. romanized; Anhui Hong Xin Pharma Development Co., Ltd. romanized |
| 2025/09/18New drug · Class 3.1 | 芍药甘草颗粒 · No verified English nameCXZS2500039 | Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized |
| 2025/09/18New drug · Class 2 | 人细小病毒B19核酸检测试剂盒(PCR-荧光法) · No verified English nameCXSS2500095 | Beijing Wan Tai Bio Pharma Co., Ltd. romanized |
| 2025/09/18New drug · Class 1 | VBC103 · No verified English nameCXSL2500801 | Shanghai Cheng Fan Pharmaceuticals Co., Ltd. romanized |
| 2025/09/18New drug · Class 1 | 177Lu-PSMA-VG01注射液 · No verified English nameCXHL2501015 | Shandong Wei Zhi Zhi Ke Pharma Co., Ltd. romanized |
| 2025/09/17Import · Class 1 | prasinezumab注射液 · No verified English nameJXSL2500181 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2025/09/17Import · Class 2.2 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2500180 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/09/17Import · Class 2.2 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2500178 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/09/17Import · Class 2.4 | 布地格福吸入气雾剂 · No verified English nameJXHS2500105 | AstraZeneca AB; ASTRAZENECA DUNKERQUE PRODUCTION; AstraZeneca Investment (China) Co. Ltd. |
| 2025/09/17Import · Class 2.4 | 布地格福吸入气雾剂 · No verified English nameJXHS2500104 | AstraZeneca AB; ASTRAZENECA DUNKERQUE PRODUCTION; AstraZeneca Investment (China) Co. Ltd. |
| 2025/09/17Import · Class 1 | Gadoquatrane 注射液 · No verified English nameJXHS2500103 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2025/09/17Import · Class 1 | Gadoquatrane 注射液 · No verified English nameJXHS2500102 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2025/09/17Import · Class 2.4 | 达罗他胺片 · No verified English nameJXHL2500292 | Bayer HealthCare Pharmaceuticals Inc.; Bayer Healthcare Company Ltd. |
| 2025/09/17Import · Class 1 | Olomorasib胶囊 · No verified English nameJXHL2500291 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/17Import · Class 1 | Olomorasib胶囊 · No verified English nameJXHL2500290 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/17Import · Class 1 | DZR123片 · No verified English nameJXHL2500289 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/09/17Import · Class 1 | JSB462片 · No verified English nameJXHL2500288 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/09/17Import · Class 1 | DZR123片 · No verified English nameJXHL2500287 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/09/17Import · Class 1 | DZR123片 · No verified English nameJXHL2500286 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/09/17Import · Class 1 | DZR123片 · No verified English nameJXHL2500285 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
82 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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