YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 401 drug applications between 8 October 2025 and 14 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 68 drug names.
2025/10/08 – 2025/10/14
- New acceptances this week
- 401
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 96
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
401filings, 85 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 206 |
| Generic | 85 |
| New drug | 70 |
| Import | 19 |
| Unspecified | 13 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 229 |
| TCM | 99 |
| Therapeutic biologic | 56 |
| Biologic | 10 |
| Prophylactic biologic | 4 |
| Unspecified | 2 |
| 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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride Oral Solution | 3 | 2 | 46 |
| 2 | 甘油灌肠剂 · No verified English name | 3 | 1 | 2 |
| 3 | 甲苯磺酸卢美哌隆胶囊 · No verified English name | 3 | 1 | 2 |
| 4 | Pemafibrate Tablets | 2 | 2 | 23 |
| 5 | Furosemide Injection | 2 | 2 | 6 |
| 6 | Vortioxetine Hydrobromide Tablets | 2 | 2 | 10 |
| 7 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 22 |
| 8 | Dotinurad Tablets | 2 | 1 | 55 |
| 9 | Paracetamol Tablets | 2 | 1 | 6 |
| 10 | 枸橼酸西地那非口溶膜 · No verified English name | 2 | 1 | 8 |
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
232 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 21 | 15 | 0 |
| 2 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized | 8 | 4 | 0 |
| 3 | Bristol-Myers Squibb Company | 8 | 2 | 0 |
| 4 | AstraZeneca AB | 7 | 3 | 0 |
| 5 | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | 6 | 6 | 0 |
| 6 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Ai Min Pharma Group Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 5 | 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
117 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/14Import · Class 1 | AZD2936 · No verified English nameJXSL2500197 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/10/14Import · Class 1 | Brivekimig注射液 · No verified English nameJXSL2500196 | Sanofi-aventis recherche & développement; Sanofi (China) Investment Co. Ltd. |
| 2025/10/14Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2500315 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/10/14Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2500314 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/10/14Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2500313 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/10/14Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2500312 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/10/14Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2503670 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/10/14Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2503669 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/10/14Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2503666 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/10/14Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2503664 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2025/10/14Generic · Class 3 | 甘油灌肠剂 · No verified English nameCYHS2503662 | Hebei Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized |
| 2025/10/14Generic · Class 3 | 甘油灌肠剂 · No verified English nameCYHS2503661 | Hebei Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized |
| 2025/10/14Generic · Class 3 | 甘油灌肠剂 · No verified English nameCYHS2503660 | Hebei Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized |
| 2025/10/14Generic · Class 3 | 碳酸氢钠林格注射液(Ⅰ) · No verified English nameCYHS2503656 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/10/14Generic · Class 3 | 环孢素口服溶液 · No verified English nameCYHS2503654 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/10/14Generic · Class 3 | Temozolomide For InjectionCYHS2503653 | Beijing SL Pharmaceutical Co., Ltd. |
| 2025/10/14Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2503650 | Shandong Pu Rui Man Pharma Co., Ltd. romanized |
| 2025/10/14Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2503646 | Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2025/10/14Generic · Class 3 | 甲苯磺酸卢美哌隆胶囊 · No verified English nameCYHL2500183 | Qilu Pharmaceutical Co., Ltd. |
| 2025/10/14Generic · Class 3 | 甲苯磺酸卢美哌隆胶囊 · No verified English nameCYHL2500182 | Qilu Pharmaceutical Co., Ltd. |
| 2025/10/14Generic · Class 3 | 甲苯磺酸卢美哌隆胶囊 · No verified English nameCYHL2500181 | Qilu Pharmaceutical Co., Ltd. |
| 2025/10/14Generic · Class 3 | Colistimethate Sodium for InjectionCYHL2500180 | Chengdu Tong De Pharma Co., Ltd. romanized |
| 2025/10/14New drug · Class 1.1 | 七味防己黄芪颗粒 · No verified English nameCXZL2500097 | Zheng Da Qing Chun Bao Pharma Co., Ltd. romanized |
| 2025/10/14New drug · Class 1.2 | 百蕊提取物颗粒 · No verified English nameCXZL2500096 | Yue Kang Pharma Group Co., Ltd. romanized |
| 2025/10/14New drug · Class 1.2 | 百蕊提取物 · No verified English nameCXZL2500095 | Yue Kang Pharma Group Co., Ltd. romanized |
| 2025/10/14New drug · Class 2.1; 2.2 | 泰它西普注射液 · No verified English nameCXSS2500112 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/10/14New drug · Class 1 | 依达格鲁肽α注射液 · No verified English nameCXSS2500111 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized |
| 2025/10/14New drug · Class 1 | 依达格鲁肽α注射液 · No verified English nameCXSS2500110 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized |
| 2025/10/14New drug · Class 1 | 依达格鲁肽α注射液 · No verified English nameCXSS2500109 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized |
| 2025/10/14New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSS2500108 | Yi Dao Bio Technology (Suzhou) Co., Ltd. romanized |
87 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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