YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 286 drug applications between 13 February 2025 and 19 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 91, covering 64 drug names.
2025/02/13 – 2025/02/19
- New acceptances this week
- 286
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 18
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
286filings, 91 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 134 |
| Generic | 91 |
| New drug | 46 |
| Import | 9 |
| Unspecified | 5 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 193 |
| Therapeutic biologic | 46 |
| TCM | 42 |
| Prophylactic biologic | 3 |
| 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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 5 | 3 | 27 |
| 2 | Esomeprazole Magnesium for Delayed-release Oral Suspension | 4 | 2 | 4 |
| 3 | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules | 4 | 1 | 2 |
| 4 | Potassium Phosphates Injection | 2 | 2 | 2 |
| 5 | Polymyxin B sulfate for Injection | 2 | 2 | 6 |
| 6 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 7 | Multiple Electrolytes and Sodium Acetate Injection | 2 | 1 | 4 |
| 8 | Oxcarbazepine Tablets | 2 | 1 | 4 |
| 9 | Brexpiprazole Tablets | 2 | 1 | 31 |
| 10 | Topiroxostat Tablets | 2 | 1 | 0 |
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
180 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Janssen-Cilag International NV | 12 | 4 | 0 |
| 2 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Henan Ying Feng Pharmaceuticals Co., Ltd. romanized | 8 | 4 | 0 |
| 4 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | Hua Chuan Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 6 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 5 | 2 | 3 |
| 7 | Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized | 4 | 3 | 2 |
| 8 | Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized | 4 | 1 | 4 |
| 9 | Xian Li Bang Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized | 3 | 3 | 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
98 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/19Generic · Class 3 | Multiple Electrolytes and Sodium Acetate InjectionCYHS2500795 | Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized |
| 2025/02/19Generic · Class 3 | Multiple Electrolytes and Sodium Acetate InjectionCYHS2500794 | Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized |
| 2025/02/19Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2500792 | Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized |
| 2025/02/19Generic · Class 3 | Butorphanol Tartrate InjectionCYHS2500791 | Xi Nan Pharma Co., Ltd. romanized |
| 2025/02/19Generic · Class 3 | Butorphanol Tartrate InjectionCYHS2500790 | Xi Nan Pharma Co., Ltd. romanized |
| 2025/02/19Generic · Class 3 | 维生素B12注射液 · No verified English nameCYHS2500788 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2025/02/19Generic · Class 3 | 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2500787 | Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized |
| 2025/02/19Generic · Class 3 | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2500046 | Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2025/02/19Generic · Class 3 | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2500045 | Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2025/02/19Generic · Class 3 | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2500044 | Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2025/02/19Generic · Class 3 | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2500043 | Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2025/02/19New drug · Class 3.3 | 冻干A群C群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSS2500029 | Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized |
| 2025/02/19New drug · Class 3.2 | 静注人免疫球蛋白 · No verified English nameCXSL2500165 | Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized |
| 2025/02/19New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2500164 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/02/19New drug · Class 1 | 伏欣奇拜单抗注射液 · No verified English nameCXSL2500163 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/02/19New drug · Class 1 | BBM-P002注射液 · No verified English nameCXSL2500162 | Xin Zhong Pharmaceuticals Technology (Beijing) Co., Ltd. romanized; Shanghai Xin Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Mian Yi Bio Technology Co., Ltd. romanized |
| 2025/02/18Generic · Class 3 | Lansoprazole For InjectionCYHS2500783 | Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized |
| 2025/02/18Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2500780 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2025/02/18Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2500776 | Anhui Chang Jiang Pharma Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized |
| 2025/02/18Generic · Class 3 | 聚乙二醇4000散 · No verified English nameCYHS2500775 | Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Hangzhou Qian Yuan Bao Ling Pharma Co., Ltd. romanized |
| 2025/02/18Generic · Class 3 | 盐酸非索非那定干混悬剂 · No verified English nameCYHS2500774 | Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized; Tianjin Drug Research Institute Pharma Co., Ltd. romanized |
| 2025/02/18Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2500767 | Beijing Ren Zhong Pharma Co., Ltd. romanized; Anhui Fu Bang Pharma Co., Ltd. romanized |
| 2025/02/18Generic · Class 3 | Potassium Phosphates InjectionCYHS2500765 | Hua Ren Pharma (Ri Zhao) Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2025/02/18Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2500764 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/02/18Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2500763 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/02/18Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2500762 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/02/18Generic · Class 3 | Relugolix TabletsCYHL2500042 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2025/02/18New drug · Class 1.1 | 活血消异颗粒 · No verified English nameCXZL2500013 | Zhu Zhou Qian Jin Pharma Co., Ltd. romanized |
| 2025/02/18New drug · Class 1.2 | 美蠊复新液 · No verified English nameCXZL2500012 | Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized |
| 2025/02/18New drug · Class 1.2 | 美蠊复新液 · No verified English nameCXZL2500011 | Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized |
68 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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