YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 363 drug applications between 11 September 2025 and 17 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 64 drug names.
2025/09/11 – 2025/09/17
- New acceptances this week
- 363
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 102
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
363filings, 84 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 174 |
| Generic | 84 |
| New drug | 53 |
| Import | 34 |
| Import re-registration | 10 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 195 |
| Therapeutic biologic | 82 |
| TCM | 75 |
| Biologic | 6 |
| Prophylactic biologic | 5 |
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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Buspirone Hydrochloride Tablets | 3 | 1 | 5 |
| 2 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 3 | Loxoprofen Sodium Oral Solution | 2 | 2 | 6 |
| 4 | 利伐沙班颗粒 · No verified English name | 2 | 1 | 2 |
| 5 | Levocarnitine Injection | 2 | 1 | 4 |
| 6 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
| 7 | Flomoxef Sodium for Injection | 2 | 1 | 9 |
| 8 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 9 | 环硅酸锆钠散 · No verified English name | 2 | 1 | 12 |
| 10 | Repaglinide Tablets | 2 | 1 | 6 |
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 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 10 | 5 | 0 |
| 2 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 10 | 4 | 0 |
| 3 | Beijing Si Huan Biopharmaceutical Co., Ltd. romanized | 10 | 1 | 0 |
| 4 | Eli Lilly and Company | 8 | 3 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 4 | 0 |
| 6 | AstraZeneca AB | 6 | 4 | 0 |
| 7 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Yunnan Yong Zi Tang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Pfizer Inc. | 5 | 4 | 0 |
| 10 | Sanofi Winthrop Industrie | 5 | 3 | 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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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. |
| 2025/09/17Generic · Class 3 | 低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2503431 | Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2025/09/17Generic · Class 3 | 低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2503430 | Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2025/09/17Generic · Class 3 | Lidocaine and Tetracaine CreamCYHL2500168 | Xizang Zhong Wei Cheng Kang Pharma Co., Ltd. romanized |
| 2025/09/17New drug · Class 1.1 | 疏肝宁心颗粒 · No verified English nameCXZL2500082 | Zhongguo Zhong Yi Ke College Zhong Yao Research Institute romanized |
| 2025/09/17New drug · Class 1.1 | 消腺止鼾口服液 · No verified English nameCXZL2500081 | Sichuan Sheng Xian Dai Zhong Yao Innovation Technology Co., Ltd. romanized; Chengdu Zhong Pharmaceuticals University romanized; Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized |
| 2025/09/17New drug · Class 2.2 | 注射用瑞康曲妥珠单抗 · No verified English nameCXSS2500094 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/17New drug · Class 1 | HX15001注射液 · No verified English nameCXSL2500800 | Hua Shen Zhi Yao Bio Technology (Suzhou) Co., Ltd. romanized |
| 2025/09/17New drug · Class 1 | SHR-2906注射液 · No verified English nameCXSL2500799 | Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/17New drug · Class 1 | QM101细胞注射液 · No verified English nameCXSL2500798 | Beijing Qi Mai Yong Hua Bio Technology Co., Ltd. romanized |
| 2025/09/17New drug · Class 1 | 注射用LBL-047 · No verified English nameCXSL2500797 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2025/09/17New drug · Class 1 | 甲苯磺酸艾贝司他片 · No verified English nameCXHS2500117 | Xu Nuo Pharma (Nanjing) Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2025/09/17New drug · Class 1 | HRS-6208胶囊 · No verified English nameCXHL2501014 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/17New drug · Class 1 | HRS-6208胶囊 · No verified English nameCXHL2501013 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/17New drug · Class 1 | HRS-6208胶囊 · No verified English nameCXHL2501012 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/17New drug · Class 1 | 注射用莱古比星 · No verified English nameCXHL2501011 | Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized |
84 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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