YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 328 drug applications between 16 April 2025 and 22 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 67 drug names.
2025/04/16 – 2025/04/22
- New acceptances this week
- 328
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- Accepted this week, now under review
- 40
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
328filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 146 |
| Generic | 90 |
| New drug | 55 |
| Import | 18 |
| Import re-registration | 14 |
| Unspecified | 3 |
| Drug-device combination | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 226 |
| TCM | 52 |
| Therapeutic biologic | 49 |
| 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cefotaxime Sodium For Injection | 4 | 1 | 14 |
| 2 | 达普司他片 · No verified English name | 4 | 1 | 0 |
| 3 | 蒙脱石混悬液 · No verified English name | 3 | 3 | 31 |
| 4 | Riociguat Tablets | 3 | 1 | 4 |
| 5 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 6 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 7 | Tacrolimus Ointment | 2 | 1 | 6 |
| 8 | Deferasirox Granules | 2 | 1 | 2 |
| 9 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 22 |
| 10 | 复方聚乙二醇(3350)电解质散 · No verified English name | 2 | 1 | 3 |
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
206 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 9 | 3 | 0 |
| 2 | Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 3 | AstraZeneca AB | 5 | 4 | 0 |
| 4 | Bristol-Myers Squibb Company | 5 | 2 | 0 |
| 5 | Qilu Pharmaceutical (Hainan) Co., Ltd | 5 | 2 | 4 |
| 6 | Kowa Company Ltd. | 5 | 1 | 0 |
| 7 | Rong Kang Group Guangxi Kang Shi Yuan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 9 | Yunnan Bai Yao Group Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Guangdong Yue He Ze Drug Research Co., Ltd. romanized | 4 | 1 | 4 |
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
111 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/22Import · Class 1 | SAR442970注射液 · No verified English nameJXSL2500062 | Sanofi-Aventis Recherche & Développement; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2025/04/22Import · Class 2.1 | Tarlatamab · No verified English nameJXSL2500061 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2025/04/22Generic · Class 3 | Pregabalin Oral SolutionCYHS2501516 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2025/04/22Generic · Class 3 | 左卡尼汀咀嚼片 · No verified English nameCYHS2501515 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2025/04/22Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2501513 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/04/22Generic · Class 3 | 盐酸甲氧氯普胺口服溶液 · No verified English nameCYHS2501512 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized |
| 2025/04/22Generic · Class 3 | Potassium Chloride InjectionCYHS2501510 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/04/22Generic · Class 3 | Levofolinate Calcium for InjectionCYHS2501509 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2025/04/22Generic · Class 3 | Rifapentine TabletsCYHS2501508 | Zhuo He Pharma Group Co., Ltd. romanized; Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized |
| 2025/04/22Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2501506 | Hainan Nuo En Bio Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2025/04/22Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2501505 | Hainan Nuo En Bio Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2025/04/22Generic · Class 3 | 黄体酮注射液(Ⅱ) · No verified English nameCYHS2501504 | Shanxi Jin Xin Shuang He Pharma Co., Ltd. romanized |
| 2025/04/22New drug · Class 1.2 | 银杏总内酯滴丸 · No verified English nameCXZS2500018 | Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2025/04/22New drug · Class 1.2 | 银杏总内酯 · No verified English nameCXZS2500017 | Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2025/04/22New drug · Class 1.1 | 香芩解热颗粒 · No verified English nameCXZL2500024 | Yunnan Fang Sheng Rong He Pharma Co., Ltd. romanized; Yunnan Zhong Pharmaceuticals University romanized |
| 2025/04/22New drug · Class 1.2 | 重组三价脊髓灰质炎疫苗(Sf-RVN细胞) · No verified English nameCXSL2500324 | Kang Xi Nuo Bio Shareholding Company romanized; Kang Xi Nuo (Shanghai) Bio Technology Co., Ltd. romanized |
| 2025/04/22New drug · Class 1 | HCL001细胞注射液 · No verified English nameCXSL2500323 | Shanghai Hui Cun Medical Technology Co., Ltd. romanized |
| 2025/04/22New drug · Class 1 | 注射用XTL6001 · No verified English nameCXSL2500322 | Shanghai Xi Tai Li Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/22New drug · Class 1 | XW003注射液 · No verified English nameCXSL2500321 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized |
| 2025/04/22New drug · Class 1 | XW003注射液 · No verified English nameCXSL2500320 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized |
| 2025/04/22New drug · Class 1 | KYS2301凝胶 · No verified English nameCXHL2500407 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/04/22New drug · Class 1 | KYS2301凝胶 · No verified English nameCXHL2500406 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/04/22New drug · Class 1 | KYS2301凝胶 · No verified English nameCXHL2500405 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/04/22New drug · Class 1 | KC1086片 · No verified English nameCXHL2500404 | Beijing Kang Chen Pharma Co., Ltd. romanized |
| 2025/04/22New drug · Class 1 | KC1086片 · No verified English nameCXHL2500403 | Beijing Kang Chen Pharma Co., Ltd. romanized |
| 2025/04/19Import · Class 1 | SAR442970注射液 · No verified English nameJXSL2500059 | Sanofi-Aventis Recherche & Développement; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2025/04/19Import · Class 2.2 | 诺西那生钠注射液 · No verified English nameJXHS2500049 | Biogen Netherlands B.V.; Patheon Italia S.p.A. |
| 2025/04/19Import · Class 2.2 | 诺西那生钠注射液 · No verified English nameJXHS2500048 | Biogen Netherlands B.V.; Patheon Italia S.p.A. |
| 2025/04/19Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide Tablets(II)CYHS2501500 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2025/04/19Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2501488 | Henan Hua Luo Kang Run Pharma Co., Ltd. romanized |
81 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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