YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 462 drug applications between 3 April 2025 and 9 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 135, covering 97 drug names.
2025/04/03 – 2025/04/09
- New acceptances this week
- 462
- Drugs with new generic filings (by drug name, de-duplicated)
- 97
- Accepted this week, now under review
- 35
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
462filings, 135 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 230 |
| Generic | 135 |
| New drug | 51 |
| Import | 30 |
| Unspecified | 9 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 281 |
| TCM | 116 |
| Therapeutic biologic | 63 |
| Prophylactic biologic | 2 |
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
97 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 5 | 2 | 23 |
| 2 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 3 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 4 | Oxacillin Sodium for Injection | 3 | 1 | 13 |
| 5 | Letermovir Injection | 2 | 2 | 6 |
| 6 | 氯化钙注射液 · No verified English name | 2 | 2 | 6 |
| 7 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 2 | 2 | 5 |
| 8 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 9 | Iguratimod Tablets | 2 | 2 | 23 |
| 10 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 2 | 2 | 5 |
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
260 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 13 | 11 | 0 |
| 2 | Ningbo Tian Yi Pharma Technology Co., Ltd. romanized | 12 | 6 | 12 |
| 3 | Guo Yao Group Beijing Hua Miao Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 4 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 8 | 6 | 0 |
| 5 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 7 | 5 | 0 |
| 6 | Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | AstraZeneca AB | 6 | 3 | 0 |
| 8 | Bayer Inc. | 6 | 1 | 0 |
| 9 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Shandong Er Ye Pharmaceutical 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
122 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/09Import · Class 3.1 | 注射用阿帕达酶α · No verified English nameJXSS2500044 | Takeda Pharmaceuticals U.S.A. Inc.; Takeda Manufacturing Austria AG |
| 2025/04/09Import · Class 3.1 | 注射用阿帕达酶α · No verified English nameJXSS2500043 | Takeda Pharmaceuticals U.S.A. Inc.; Takeda Manufacturing Austria AG |
| 2025/04/09Import · Class 1 | VAY736注射液 · No verified English nameJXSL2500057 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/04/09Import · Class 1 | MEDI5752 · No verified English nameJXSL2500056 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/04/09Import · Class 1 | ABBV-324注射用粉末 · No verified English nameJXSL2500055 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/04/09Import · Class 1 | Casdatifan 片 · No verified English nameJXHL2500076 | Arcus Biosciences Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd. |
| 2025/04/09Import · Class 1 | BI1815368 片 · No verified English nameJXHL2500075 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (Cnina) Investment Co. Ltd. |
| 2025/04/09Import · Class 1 | BI1815368 片 · No verified English nameJXHL2500074 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (Cnina) Investment Co. Ltd. |
| 2025/04/09Import · Class 1 | BI 690517片 · No verified English nameJXHL2500073 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2025/04/09Import · Class 1 | BI 690517片 · No verified English nameJXHL2500072 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2025/04/09Generic · Class 3 | 黄体酮注射液(Ⅱ) · No verified English nameCYHS2501363 | Guangzhou Bai Yun Shan Ming Xing Pharmaceutical Co., Ltd. romanized |
| 2025/04/09Generic · Class 3 | Luliconazole CreamCYHS2501361 | Guangdong Hua Run Shun Feng Pharma Co., Ltd. romanized |
| 2025/04/09Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2501357 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/04/09Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2501356 | Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/04/09Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2501355 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/04/09Generic · Class 3 | 碳酸氢钠血滤置换液(无钾、无钙、0.6mmol/L镁) · No verified English nameCYHS2501352 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/04/09Generic · Class 3 | 碳酸氢钠血滤置换液(钾4mmol/L无钙) · No verified English nameCYHS2501351 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/04/09Generic · Class 3 | 碳酸氢钠血滤置换液(钾2mmol/L 无钙) · No verified English nameCYHS2501350 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/04/09Generic · Class 3 | 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2501342 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2025/04/09Generic · Class 3 | 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2501341 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2025/04/09Generic · Class 3 | 酮洛芬凝胶贴膏 · No verified English nameCYHL2500078 | Hunan Pai Ge Lan Pharma Co., Ltd. romanized |
| 2025/04/09Generic · Class 3 | 镥[177Lu]氧奥曲肽注射液 · No verified English nameCYHL2500076 | Mai De Nuo Medical Technology Group Co., Ltd. romanized |
| 2025/04/09New drug · Class 1.1 | 三贝苎鼾胶囊 · No verified English nameCXZS2500016 | Zhejiang Bao Ren Tang Pharma Co., Ltd. romanized; Beijing Ya Dong Biopharmaceutical Co., Ltd. romanized |
| 2025/04/09New drug · Class 1 | 舒欣瑞纳注射液 · No verified English nameCXSL2500280 | Jiangsu Gui Qiong Pharma Co., Ltd. romanized; Jiangsu He Tai Bio Co., Ltd. romanized |
| 2025/04/09New drug · Class 1 | XLH01片 · No verified English nameCXHL2500367 | Shandong Run Zhong Pharma Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized |
| 2025/04/09New drug · Class 1 | XLH01片 · No verified English nameCXHL2500366 | Shandong Run Zhong Pharma Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized |
| 2025/04/09New drug · Class 1 | WEYZ-1乳膏 · No verified English nameCXHL2500365 | Nanjing Wei Er You Zhong Pharmaceuticals Co., Ltd. romanized |
| 2025/04/09New drug · Class 1 | DAT-1604片 · No verified English nameCXHL2500364 | Beijing Dan Qing Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/09New drug · Class 1 | DAT-1604片 · No verified English nameCXHL2500363 | Beijing Dan Qing Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/09New drug · Class 2.2 | BCM957 · No verified English nameCXHL2500362 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
92 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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