YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 406 drug applications between 3 July 2025 and 9 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 115, covering 82 drug names.
2025/07/03 – 2025/07/09
- New acceptances this week
- 406
- Drugs with new generic filings (by drug name, de-duplicated)
- 82
- Accepted this week, now under review
- 93
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
406filings, 115 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 173 |
| Generic | 115 |
| New drug | 86 |
| Import | 23 |
| Import re-registration | 6 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 285 |
| Therapeutic biologic | 63 |
| TCM | 55 |
| 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
82 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 瑞维那新吸入溶液 · No verified English name | 5 | 5 | 53 |
| 2 | Dapoxetine Hydrochloride Tablets | 4 | 2 | 20 |
| 3 | Quetiapine Fumarate Extended-release Tablets | 4 | 1 | 0 |
| 4 | Cefazolin Sodium for Injection | 3 | 1 | 13 |
| 5 | Acyclovir Tablets | 3 | 1 | 6 |
| 6 | Acetylcysteine Injection | 2 | 2 | 53 |
| 7 | Pregabalin Oral Solution | 2 | 2 | 5 |
| 8 | Iguratimod Tablets | 2 | 2 | 23 |
| 9 | 蔗糖羟基氧化铁咀嚼片 · No verified English name | 2 | 2 | 0 |
| 10 | Finerenone Tablets | 2 | 2 | 69 |
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
251 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 9 | 4 | 0 |
| 2 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 8 | 7 | 0 |
| 3 | Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Celgene Corporation | 6 | 1 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | Karuna Therapeutics Inc. | 5 | 1 | 0 |
| 9 | Topfond Pharmaceutical Co., Ltd. | 4 | 4 | 0 |
| 10 | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
142 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/09Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHL2500168 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/09Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHL2500167 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/09Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHL2500166 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/09Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHL2500165 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/09Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHL2500164 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/09Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHL2500163 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/09Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2502453 | Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/07/09Generic · Class 3 | Pregabalin Oral SolutionCYHS2502452 | Zhejiang Zhi Xin Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2025/07/09Generic · Class 3 | Loxoprofen sodium hydrate gelCYHS2502451 | Shanghai Yan An Pharmaceuticals Yang Pu Co., Ltd. romanized; Shanghai Yan An Pharma (Hubei) Co., Ltd. romanized |
| 2025/07/09Generic · Class 3 | 硝酸咪康唑乳膏 · No verified English nameCYHS2502449 | Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized |
| 2025/07/09Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2502447 | Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized |
| 2025/07/09Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2502444 | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/07/09Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2502439 | Xian An Jian Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2025/07/09Generic · Class 3 | Vitamin K1 InjectionCYHS2502437 | Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/07/09Generic · Class 3 | 醋酸钠林格葡萄糖注射液(Ⅰ) · No verified English nameCYHS2502429 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2025/07/09Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHS2502428 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Jin Yao Yong Guang (Hebei) Pharmaceutical Co., Ltd. romanized |
| 2025/07/09Generic · Class 3 | Deferasirox GranulesCYHS2502427 | Yu Song Yuan Pharma Co., Ltd. romanized |
| 2025/07/09New drug · Class 1 | HC006注射液 · No verified English nameCXSL2500567 | Shanghai Hong Cheng Pharma Co., Ltd. romanized |
| 2025/07/09New drug · Class 1 | 注射用HC010 · No verified English nameCXSL2500566 | Shanghai Hong Cheng Pharma Co., Ltd. romanized |
| 2025/07/09New drug · Class 1 | VGN-R08b · No verified English nameCXSL2500565 | Shanghai Tian Ze Yun Tai Biopharmaceuticals Co., Ltd. romanized; Tian Ze Yun Tai (Shenzhen) Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/09New drug · Class 1 | Astem-101人脐带间充质干细胞(hUC-MSCs)注射液 · No verified English nameCXSL2500564 | Name not romanized |
| 2025/07/09New drug · Class 1 | VGN-R08b · No verified English nameCXSL2500563 | Shanghai Tian Ze Yun Tai Biopharmaceuticals Co., Ltd. romanized; Tian Ze Yun Tai (Shenzhen) Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/09New drug · Class 1 | 脐带间充质干细胞注射液 · No verified English nameCXSL2500562 | Shandong Bai Hong Gan Xi Bao Bio Technology Co., Ltd. romanized; Guangdong Bai Hong Gan Xi Bao Zai Sheng Yi Xue Co., Ltd. romanized; Shaanxi Bai Hong Gan Xi Bao Bio Technology Co., Ltd. romanized |
| 2025/07/09New drug · Class 1 | LBM801 · No verified English nameCXSL2500560 | Shanghai Li Kang Rui Bio Gong Cheng Co., Ltd. romanized; Shanghai Bo Sai Mei Bio Technology Co., Ltd. romanized |
| 2025/07/09New drug · Class 1 | NGGT006注射液 · No verified English nameCXSL2500559 | Suzhou Nuo Jie Bei Bio Technology Co., Ltd. romanized |
| 2025/07/09New drug · Class 1 | SHR-4298注射液 · No verified English nameCXSL2500558 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/09New drug · Class 2.2 | 硫酸阿托品滴眼液 · No verified English nameCXHS2500078 | Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized; Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized |
| 2025/07/09New drug · Class 2.4 | Fulvestrant InjectionCXHS2500077 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/07/09New drug · Class 1 | 库莫西利胶囊 · No verified English nameCXHS2500076 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/07/09New drug · Class 1 | 库莫西利胶囊 · No verified English nameCXHS2500075 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
112 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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