YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 671 drug applications between 11 October 2025 and 17 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 116, covering 89 drug names.
2025/10/11 – 2025/10/17
- New acceptances this week
- 671
- Drugs with new generic filings (by drug name, de-duplicated)
- 89
- Accepted this week, now under review
- 143
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
671filings, 116 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 357 |
| New drug | 134 |
| Generic | 116 |
| Unspecified | 30 |
| Import | 26 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 407 |
| TCM | 143 |
| Therapeutic biologic | 89 |
| Biologic | 21 |
| Prophylactic biologic | 8 |
| Unspecified | 3 |
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
89 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Glucosamine Sulfate Capsules | 4 | 4 | 51 |
| 2 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 3 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 4 | Ambroxol Hydrochloride Oral Solution | 3 | 2 | 46 |
| 5 | 甘油灌肠剂 · No verified English name | 3 | 1 | 2 |
| 6 | 甲苯磺酸卢美哌隆胶囊 · No verified English name | 3 | 1 | 2 |
| 7 | LevomilnacipranHydrochloride Extended-release Capsules | 3 | 1 | 6 |
| 8 | 达普司他片 · No verified English name | 3 | 1 | 0 |
| 9 | Pemafibrate Tablets | 2 | 2 | 23 |
| 10 | 磷酸奥司他韦颗粒 · No verified English name | 2 | 2 | 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
342 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 66 | 49 | 0 |
| 2 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 10 | 2 | 0 |
| 3 | AstraZeneca AB | 8 | 4 | 0 |
| 4 | Qilu Pharmaceutical Co., Ltd. | 8 | 4 | 3 |
| 5 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 6 | Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 7 | Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 8 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 7 | 3 | 2 |
| 9 | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | 6 | 6 | 0 |
| 10 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 6 | 6 | 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
202 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/17Import · Class 1 | Duvakitug注射液 · No verified English nameJXSL2500202 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/10/17Generic · Class 3 | Digoxin InjectionCYHS2503725 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/10/17Generic · Class 3 | Digoxin InjectionCYHS2503724 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/10/17Generic · Class 3 | 多种微量元素注射液(Ι) · No verified English nameCYHS2503721 | Wei Sheng Yuan (Xiamen) Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/10/17Generic · Class 3 | 醋酸锌颗粒 · No verified English nameCYHS2503719 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2025/10/17Generic · Class 3 | 醋酸锌颗粒 · No verified English nameCYHS2503718 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2025/10/17New drug · Class 2.1 | TFA003片 · No verified English nameCXZL2500101 | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | 注射用BG-C9074 · No verified English nameCXSL2500904 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | IM19嵌合抗原受体T细胞注射液(IM19 CAR-T细胞注射液) · No verified English nameCXSL2500903 | Shandong Jin Sai Bio Technology Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | INS19嵌合抗原受体T细胞注射液(INS19 CAR-T细胞注射液) · No verified English nameCXSL2500902 | Shandong Jin Sai Bio Technology Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | INS19嵌合抗原受体T细胞注射液(INS19 CAR-T细胞注射液) · No verified English nameCXSL2500901 | Shandong Jin Sai Bio Technology Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | MIL116注射液 · No verified English nameCXSL2500900 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2025/10/17New drug · Class 3.3 | 艾美赛珠单抗注射液 · No verified English nameCXSL2500899 | Wuhan You Zhi You Biopharmaceutical Co., Ltd. romanized |
| 2025/10/17New drug · Class 1.2 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2500898 | Jiangsu Li Wei Si De Bio Technology Co., Ltd. romanized; Li Wei Si De Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/10/17New drug · Class 3.3 | 艾美赛珠单抗注射液 · No verified English nameCXSL2500897 | Wuhan You Zhi You Biopharmaceutical Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | SHR-7787 注射液 · No verified English nameCXSL2500896 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/10/17New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500895 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2500894 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | AGA2115注射液 · No verified English nameCXSL2500893 | An Ji Sheng Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | BG-75202片 · No verified English nameCXHL2501141 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | BG-75202片 · No verified English nameCXHL2501140 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | BG-75202片 · No verified English nameCXHL2501139 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | EP-0226片 · No verified English nameCXHL2501137 | Chengdu Easton Biopharmaceuticals Co.,Ltd.; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Zhong Shan Drug Innovation Research Institute romanized |
| 2025/10/17New drug · Class 1 | EP-0226片 · No verified English nameCXHL2501136 | Chengdu Easton Biopharmaceuticals Co.,Ltd.; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Zhong Shan Drug Innovation Research Institute romanized |
| 2025/10/17New drug · Class 2.2 | 特立帕肽注射液 · No verified English nameCXHL2501135 | Yunnan Xian Shi Pharma Co., Ltd. romanized |
| 2025/10/17New drug · Class 1 | 注射用BH1621 · No verified English nameCXHL2501134 | Zhuhai Bei Hai Bio Technology Co., Ltd. romanized |
| 2025/10/16Import · Class 3.1 | 瑞利珠单抗注射液 · No verified English nameJXSS2500133 | Alexion Europe SAS; Alexion Pharma International Operations Limited; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/10/16Import · Class 3.1 | 瑞利珠单抗注射液 · No verified English nameJXSS2500132 | Alexion Europe SAS; Alexion Pharma International Operations Limited; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/10/16Import · Class 2.2 | 度普利尤单抗注射液 · No verified English nameJXSL2500201 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/10/16Import · Class 2.4 | KarXT胶囊 · No verified English nameJXHL2500320 | Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd. |
172 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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