YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 515 drug applications between 9 October 2025 and 15 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 82 drug names.
2025/10/09 – 2025/10/15
- New acceptances this week
- 515
- Drugs with new generic filings (by drug name, de-duplicated)
- 82
- Accepted this week, now under review
- 123
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
515filings, 103 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 243 |
| New drug | 112 |
| Generic | 103 |
| Unspecified | 24 |
| Import | 24 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 305 |
| TCM | 109 |
| Therapeutic biologic | 74 |
| Biologic | 18 |
| Prophylactic biologic | 6 |
| 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
82 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 | 达普司他片 · No verified English name | 3 | 1 | 0 |
| 5 | Pemafibrate Tablets | 2 | 2 | 23 |
| 6 | Furosemide Injection | 2 | 2 | 6 |
| 7 | Vortioxetine Hydrobromide Tablets | 2 | 2 | 10 |
| 8 | 磷酸奥司他韦颗粒 · No verified English name | 2 | 2 | 12 |
| 9 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 22 |
| 10 | Dotinurad Tablets | 2 | 1 | 55 |
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
285 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 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 10 | 2 | 0 |
| 3 | AstraZeneca AB | 9 | 4 | 0 |
| 4 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized | 8 | 4 | 0 |
| 5 | Bristol-Myers Squibb Company | 8 | 2 | 0 |
| 6 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 7 | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | 6 | 6 | 0 |
| 8 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 9 | Ai Min Pharma Group Co., Ltd. romanized | 6 | 6 | 0 |
| 10 | Shaanxi Sun Si Miao Gao Xin 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
174 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/15Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2500200 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/10/15Import · Class 1 | AZD0486 · No verified English nameJXSL2500199 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/10/15Import · Class 1 | AZD0486 · No verified English nameJXSL2500198 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/10/15Generic · Class 3 | Olopatadine Hydrochloride GranulesCYHS2503688 | Zhuhai Tong Yuan Pharma Co., Ltd. romanized |
| 2025/10/15Generic · Class 3 | 比拉斯汀口崩片 · No verified English nameCYHS2503686 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/10/15Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2503683 | Hebei Shan Mu Shi Pharma Co., Ltd. romanized |
| 2025/10/15Generic · Class 3 | Dequalinium Chloride Buccal TabletsCYHS2503682 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2025/10/15Generic · Class 3 | 注射用氨曲南/氯化钠注射液 · No verified English nameCYHS2503681 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/10/15Generic · Class 3 | 注射用氨曲南/氯化钠注射液 · No verified English nameCYHS2503680 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/10/15Generic · Class 3 | 碳酸氢钠血滤置换液(钾4mmol/L) · No verified English nameCYHS2503679 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/10/15Generic · Class 3 | 碳酸氢钠血滤置换液(无钾) · No verified English nameCYHS2503677 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/10/15Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2503675 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/10/15Generic · Class 3 | 达普司他片 · No verified English nameCYHL2500186 | NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2025/10/15Generic · Class 3 | 达普司他片 · No verified English nameCYHL2500185 | NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2025/10/15Generic · Class 3 | 达普司他片 · No verified English nameCYHL2500184 | NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2025/10/15New drug · Class 1.2 | LC提取物 · No verified English nameCXZL2500100 | Zhongguo Ke College Hangzhou Yi Xue Research Institute romanized |
| 2025/10/15New drug · Class 1.2 | LC肠溶胶囊 · No verified English nameCXZL2500099 | Zhongguo Ke College Hangzhou Yi Xue Research Institute romanized |
| 2025/10/15New drug · Class 1.1 | 连冰喷雾剂 · No verified English nameCXZL2500098 | Zhuo He Pharma Group Co., Ltd. romanized |
| 2025/10/15New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSS2500114 | Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized |
| 2025/10/15New drug · Class 2.2 | 贝伐珠单抗眼内注射溶液 · No verified English nameCXSS2500113 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2025/10/15New drug · Class 3.3 | 13价肺炎球菌多糖结合疫苗 · No verified English nameCXSS2500107 | Lanzhou Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2025/10/15New drug · Class 1 | CM512注射液 · No verified English nameCXSL2500889 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2025/10/15New drug · Class 1 | CM512注射液 · No verified English nameCXSL2500888 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2025/10/15New drug · Class 1 | 人脐带源间充质干细胞注射液 · No verified English nameCXSL2500887 | Pu Hua Sai Er Bio Medical Technology Co., Ltd. romanized |
| 2025/10/15New drug · Class 1 | YX3D-01 人脐带间充质干细胞注射液 · No verified English nameCXSL2500886 | Yi Xing Pharmaceuticals Research and Development (Qin Huang Dao Bei Dai He Qu) Co., Ltd. romanized |
| 2025/10/15New drug · Class 1 | 注射用HX111 · No verified English nameCXSL2500885 | Han Si Ai Tai Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized |
| 2025/10/15New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2500884 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2025/10/15New drug · Class 1 | SIG001注射液 · No verified English nameCXSL2500883 | Guangzhou Ai Sai Ji Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/15New drug · Class 1 | XS411细胞注射液 · No verified English nameCXSL2500882 | Shi Ze Biopharmaceuticals (Suzhou) Co., Ltd. romanized; Shi Ze Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/10/15New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2500881 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
144 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.