YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 357 drug applications between 24 July 2025 and 30 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 89, covering 72 drug names.
2025/07/24 – 2025/07/30
- New acceptances this week
- 357
- Drugs with new generic filings (by drug name, de-duplicated)
- 72
- Accepted this week, now under review
- 81
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
357filings, 89 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 89 |
| New drug | 72 |
| Import | 29 |
| Import re-registration | 7 |
| Unspecified | 2 |
| Drug-device combination product | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 224 |
| TCM | 76 |
| Therapeutic biologic | 53 |
| Unspecified | 3 |
| Prophylactic 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
72 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lidocaine and Prilocaine Cream | 3 | 2 | 24 |
| 2 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 3 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 4 | Pemafibrate Tablets | 2 | 2 | 23 |
| 5 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 2 | 2 | 9 |
| 6 | Mecobalamin Tablets | 2 | 2 | 16 |
| 7 | Fruquintinib Capsules | 2 | 1 | 4 |
| 8 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Vardenafil Hydrochloride Tablets | 2 | 1 | 4 |
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
226 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 7 | 3 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 3 | 0 |
| 4 | Yunnan Jin Bi Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Henan Xin Xiang Hua Xing Pharmaceutical Factory romanized | 6 | 2 | 0 |
| 6 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | AbbVie Inc. | 5 | 1 | 0 |
| 8 | Pharmathen International S.A. | 5 | 1 | 0 |
| 9 | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 4 | 4 | 2 |
| 10 | Janssen Research & Development LLC | 4 | 2 | 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 |
|---|---|---|
| 2025/07/30Import · Class 3.1 | 注射用塔拉妥单抗 · No verified English nameJXSS2500105 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2025/07/30Import · Class 3.1 | 注射用塔拉妥单抗 · No verified English nameJXSS2500104 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2025/07/30Import · Class 1 | Pasritamig注射液 · No verified English nameJXSL2500136 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/07/30Import · Class 1 | Pasritamig注射液 · No verified English nameJXSL2500135 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/07/30Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2500134 | Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd. |
| 2025/07/30Import · Class 2.2 | 纳武利尤单抗注射液 · No verified English nameJXSL2500133 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/30Import · Class 1 | BHV-8000缓释片 · No verified English nameJXHL2500205 | Biohaven Therapeutics Ltd.; Hangzhou Highlightll Pharmaceutical Co. Ltd |
| 2025/07/30Import · Class 1 | BHV-8000缓释片 · No verified English nameJXHL2500204 | Biohaven Therapeutics Ltd.; Hangzhou Highlightll Pharmaceutical Co. Ltd |
| 2025/07/30Import · Class 1 | PF-08049820水合物片 · No verified English nameJXHL2500203 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2025/07/30Import · Class 1 | PF-08049820水合物片 · No verified English nameJXHL2500202 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2025/07/30Import · Class 2.2 | 甲磺酸贝舒地尔口服混悬剂 · No verified English nameJXHL2500201 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/07/30Generic · Class 3 | 硝普钠氯化钠注射液 · No verified English nameCYHS2502752 | Nanjing Hai Chen Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/07/30Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2502745 | Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Zhejiang Kang Run Pharmaceutical Co., Ltd. romanized |
| 2025/07/30Generic · Class 3 | 多种微量元素注射液(I) · No verified English nameCYHS2502741 | Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized |
| 2025/07/30Generic · Class 3 | Bifonazole SolutionCYHS2502740 | Anhui Tai Du Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2025/07/30Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2502728 | Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized |
| 2025/07/30Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2502724 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.; Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2025/07/30Generic · Class 3 | Fosphenytoin Sodium InjectionCYHS2502721 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2025/07/30Generic · Class 3 | 铜[64Cu]氧奥曲肽注射液 · No verified English nameCYHL2500135 | Tong Rui Biopharmaceutical (Chengdu) Co., Ltd. romanized |
| 2025/07/30Generic · Class 3 | 甲苯磺酸卢美哌隆胶囊 · No verified English nameCYHL2500134 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2025/07/30Generic · Class 3 | 利非司特滴眼液 · No verified English nameCYHL2500133 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized |
| 2025/07/30New drug · Class 1 | 注射用BG-T187(皮下注射) · No verified English nameCXSL2500636 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2025/07/30New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2500634 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/07/30New drug · Class 1 | JL19001注射液 · No verified English nameCXSL2500633 | Jie Ku (Shanghai) Biopharmaceuticals Research Co., Ltd. romanized; Jie Ke (Tianjin) Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/30New drug · Class 1 | HSK47388片(I) · No verified English nameCXHL2500780 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/07/30New drug · Class 1 | BGB-58067片 · No verified English nameCXHL2500779 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/07/30New drug · Class 1 | BGB-58067片 · No verified English nameCXHL2500778 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/07/30New drug · Class 1 | BG-89894片 · No verified English nameCXHL2500777 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/07/30New drug · Class 1 | BG-89894片 · No verified English nameCXHL2500776 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/07/30New drug · Class 1 | TQB3201片 · No verified English nameCXHL2500775 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa 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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