YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 344 drug applications between 16 January 2025 and 22 January 2025 (data as of 14 November 2026 06:00). Of these, generic applications numbered 111, covering 79 drug names.
2025/01/16 – 2025/01/22
- New acceptances this week
- 344
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- Accepted this week, now under review
- 13
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
344filings, 111 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 150 |
| Generic | 111 |
| New drug | 57 |
| Import | 22 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 254 |
| TCM | 44 |
| Therapeutic biologic | 42 |
| Prophylactic biologic | 4 |
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
79 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 7 | 3 | 27 |
| 2 | Mivacurium Chloride Injection | 4 | 2 | 3 |
| 3 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 4 | Ethyl Iosapentate Capsules | 2 | 2 | 25 |
| 5 | Piracetam Injection | 2 | 2 | 9 |
| 6 | Candesartan Cilexetil and Hydrochlorothiazide Tablets | 2 | 2 | 2 |
| 7 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 8 | Tedizolid Phosphate For Injection | 2 | 2 | 3 |
| 9 | Sodium Thiosulfate Injection | 2 | 2 | 2 |
| 10 | 聚乙二醇钠钾散 · No verified English name | 2 | 2 | 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
219 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 13 | 9 | 0 |
| 2 | Anhui Shuang He Pharma Co., Ltd. romanized | 8 | 2 | 0 |
| 3 | Yunnan Yi Zhi Hao Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 4 | Anhui Jin Ma Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | AstraZeneca AB | 5 | 4 | 0 |
| 6 | Fresenius Kabi AB | 5 | 1 | 0 |
| 7 | Bristol-Myers Squibb Company | 4 | 4 | 0 |
| 8 | Guizhou Heng He Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 4 | 1 | 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
121 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/22Import · Class 3.1 | 瑞玛奈珠单抗注射液 · No verified English nameJXSS2500003 | TEVA GmbH; Vetter Pharma-Fertigung GmbH & Co. KG; Teva Pharmaceutical Information Consulting (Shanghai) Co. Ltd. |
| 2025/01/22Generic · Class 3 | Vigabatrin Powder for Oral SolutionCYHS2500416 | Shanghai Ao Ke Yuan Pharmaceutical Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | Raltitrexed for InjectionCYHS2500415 | Sichuan Bai Li Pharma Co., Ltd. romanized; Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2500414 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/01/22Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2500413 | Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | Tobramycin Sulfate InjectionCYHS2500412 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2500410 | Gan Zheng (Hainan) Bio Pharma Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | 吡格列酮二甲双胍片(15mg/500mg) · No verified English nameCYHS2500407 | Ningbo Mei Shu Pharma Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. |
| 2025/01/22Generic · Class 3 | Piracetam InjectionCYHS2500406 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | Sulpiride InjectionCYHS2500405 | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | Sulpiride InjectionCYHS2500404 | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2500403 | Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2500402 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2500401 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2500399 | Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2500398 | Suzhou Te Rui Pharma Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | 头孢地尼干混悬剂 · No verified English nameCYHS2500396 | Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | 头孢地尼干混悬剂 · No verified English nameCYHS2500395 | Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized |
| 2025/01/22Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2500394 | Gui Lin Nan Yao Co., Ltd. romanized; Suzhou Erye Pharmaceutical Co., Ltd |
| 2025/01/22Generic · Class 3 | 阿瑞匹坦注射液 · No verified English nameCYHL2500021 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2025/01/22New drug · Class 3.3 | 注射用曲妥珠单抗 · No verified English nameCXSS2500007 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2025/01/22New drug · Class 1 | 依苏帕格鲁肽α注射液 · No verified English nameCXSL2500070 | Guangzhou Yin Nuo Pharmaceuticals Group Co., Ltd. romanized |
| 2025/01/22New drug · Class 1 | 依苏帕格鲁肽α注射液 · No verified English nameCXSL2500069 | Guangzhou Yin Nuo Pharmaceuticals Group Co., Ltd. romanized |
| 2025/01/22New drug · Class 1 | 依苏帕格鲁肽α注射液 · No verified English nameCXSL2500068 | Guangzhou Yin Nuo Pharmaceuticals Group Co., Ltd. romanized |
| 2025/01/22New drug · Class 1 | SHR-4658注射液 · No verified English nameCXSL2500067 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/01/22New drug · Class 1 | XS411细胞注射液 · No verified English nameCXSL2500066 | Shi Ze Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/01/22New drug · Class 1 | IBR854细胞注射液 · No verified English nameCXSL2500065 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2025/01/22New drug · Class 1 | IBR854细胞注射液 · No verified English nameCXSL2500064 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2025/01/22New drug · Class 1 | 异体人再生胰岛注射液(E-islet 01) · No verified English nameCXSL2500063 | Zhi Xin Hao Zheng (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/22New drug · Class 1 | 注射用TQB2922 · No verified English nameCXSL2500062 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
91 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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