YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 345 drug applications between 3 February 2025 and 9 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 132, covering 91 drug names.
2025/02/03 – 2025/02/09
- New acceptances this week
- 345
- Drugs with new generic filings (by drug name, de-duplicated)
- 91
- Accepted this week, now under review
- 15
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
345filings, 132 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 132 |
| Supplement | 106 |
| New drug | 76 |
| Import | 15 |
| Import re-registration | 11 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 257 |
| Therapeutic biologic | 53 |
| TCM | 29 |
| Prophylactic biologic | 4 |
| 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
91 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 11 | 7 | 60 |
| 2 | Brexpiprazole Tablets | 6 | 2 | 31 |
| 3 | Tacrolimus Capsules | 4 | 2 | 2 |
| 4 | 盐酸纳美芬注射液 · No verified English name | 3 | 2 | 1 |
| 5 | Polidocanol Injection | 3 | 1 | 23 |
| 6 | Tofacitinib Citrate Extended Release tablets | 2 | 2 | 2 |
| 7 | Sacubitril Valsartan Sodium Tablets | 2 | 2 | 70 |
| 8 | Cetrorelix Acetate for Injection | 2 | 2 | 4 |
| 9 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 2 | 2 | 9 |
| 10 | 盐酸舍曲林口服浓缩液 · 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
214 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 11 | 3 | 0 |
| 2 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized | 9 | 3 | 0 |
| 3 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 5 | 4 | 5 |
| 5 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 3 | 2 |
| 6 | Beijing Hua Shen Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 4 | 2 | 4 |
| 9 | Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 10 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized | 4 | 2 | 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
124 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/09Import · Class 1 | Bleximenib片 · No verified English nameJXHL2500023 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/02/09Import · Class 1 | Bleximenib片 · No verified English nameJXHL2500022 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/02/09Import · Class 1 | Bleximenib片 · No verified English nameJXHL2500021 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/02/09Import · Class 2.4 | 放射性药物镓[68Ga]oxodotreotide注射液配制用药盒 · No verified English nameJXHL2500020 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/02/09Import · Class 2.4 | 镥[177Lu]oxodotreotide注射液 · No verified English nameJXHL2500019 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/02/09Generic · Class 3 | 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2500685 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/02/09Generic · Class 3 | 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2500677 | Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized |
| 2025/02/09Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2500675 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2025/02/09Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2500673 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2025/02/09Generic · Class 3 | 山梨醇甘露醇冲洗剂 · No verified English nameCYHS2500672 | Qingdao Ao Rui Sen Medical Technology Co., Ltd. romanized; Qingdao Rui Nai Medical Technology Co., Ltd. romanized |
| 2025/02/09Generic · Class 3 | 美沙拉秦肠溶缓释胶囊 · No verified English nameCYHS2500660 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2025/02/09Generic · Class 3 | 贝派度酸依折麦布片 · No verified English nameCYHL2500034 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/02/09Generic · Class 3 | Mannitol-S InjectionCYHL2500033 | Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2025/02/09New drug · Class 3.1 | 芍药甘草颗粒 · No verified English nameCXZS2500004 | Shandong Run Zhong Pharma Co., Ltd. romanized |
| 2025/02/09New drug · Class 1.1 | 七福饮颗粒 · No verified English nameCXZL2500007 | Henan Fu Di Bio Technology Co., Ltd. romanized |
| 2025/02/09New drug · Class 1.2 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSS2500027 | Lv Zhu Biopharmaceutical (Zhuhai Shi) Co., Ltd. romanized |
| 2025/02/09New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSS2500026 | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2025/02/09New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSS2500025 | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2025/02/09New drug · Class 1.2 | YKYY025注射液 · No verified English nameCXSL2500130 | Hangzhou Tian Long Pharma Co., Ltd. romanized |
| 2025/02/09New drug · Class 1 | 人牙囊间充质干细胞注射液 · No verified English nameCXSL2500129 | Chengdu Shi Lian Kang Jian Bio Technology Co., Ltd. romanized |
| 2025/02/09New drug · Class 1 | 注射用KJ103 · No verified English nameCXSL2500128 | Shanghai Bao Ji Pharma Co., Ltd. romanized |
| 2025/02/09New drug · Class 3.3 | 地舒单抗注射液 · No verified English nameCXSL2500127 | Hua Lan Ji Yin Gong Cheng (Henan) Co., Ltd. romanized; Hua Lan Ji Yin Gong Cheng Co., Ltd. romanized |
| 2025/02/09New drug · Class 1 | NCR201注射液 · No verified English nameCXSL2500126 | Zhong Sheng Su Yuan (Guangzhou) Bio Technology Co., Ltd. romanized; Anhui Zhong Sheng Su Yuan Bio Technology Co., Ltd. romanized |
| 2025/02/09New drug · Class 1 | HWS116注射液 · No verified English nameCXSL2500125 | Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized |
| 2025/02/09New drug · Class 1 | DNTH103注射液 · No verified English nameCXSL2500124 | Yuan Yi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/02/09New drug · Class 1 | IBI3020 · No verified English nameCXSL2500123 | Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2025/02/09New drug · Class 1 | HS-10529片 · No verified English nameCXHL2500182 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/09New drug · Class 1 | HS-10529片 · No verified English nameCXHL2500181 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/09New drug · Class 1 | TJ0113胶囊 · No verified English nameCXHL2500180 | Hangzhou Tian Ji Ji Shi Bio Technology Co., Ltd. romanized |
| 2025/02/09New drug · Class 1 | HIF-117胶囊 · No verified English nameCXHL2500179 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
94 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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