YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 62 drug applications between 31 January 2025 and 6 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 25, covering 22 drug names.
2025/01/31 – 2025/02/06
- New acceptances this week
- 62
- Drugs with new generic filings (by drug name, de-duplicated)
- 22
- Accepted this week, now under review
- 4
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
62filings, 25 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 25 |
| Supplement | 20 |
| New drug | 10 |
| Import re-registration | 4 |
| Import | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 50 |
| TCM | 8 |
| Therapeutic biologic | 3 |
| 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
22 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Voglibose Tablets | 2 | 1 | 0 |
| 2 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 3 | Imatinib Mesylate Tablets | 2 | 1 | 5 |
| 4 | Sodium Valproate Oral Solution | 1 | 1 | 1 |
| 5 | Acetylcysteine Injection | 1 | 1 | 53 |
| 6 | Dienogest Tablets | 1 | 1 | 2 |
| 7 | Candesartan Cilexetil and Hydrochlorothiazide Tablets | 1 | 1 | 2 |
| 8 | 复方聚乙二醇(3350)电解质散 · No verified English name | 1 | 1 | 3 |
| 9 | Olanzapine Tablets | 1 | 1 | 4 |
| 10 | Nimodipine Tablets | 1 | 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
50 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Wuhan Jiu An Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 2 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 3 | 1 | 0 |
| 3 | DAIICHI SANKYO CO. LTD. | 2 | 2 | 0 |
| 4 | Boehringer Ingelheim International GmbH | 2 | 1 | 0 |
| 5 | Shanghai Shyndec Pharmaceutical Co., Ltd. | 2 | 1 | 2 |
| 6 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized | 2 | 1 | 0 |
| 7 | Shandong Lukang Pharmaceutical Co.,Ltd. | 2 | 1 | 2 |
| 8 | Guangzhou Kang Chen Pharma Co., Ltd. romanized | 2 | 1 | 0 |
| 9 | Hainan Sai Li Ke Pharma Co., Ltd. romanized | 2 | 1 | 0 |
| 10 | Shaanxi Tian Yu Pharmaceutical Co., Ltd. romanized | 2 | 1 | 2 |
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
20 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/06Import · Class 1 | [225Ac]Ac-PSMA-617注射液 · No verified English nameJXHL2500015 | Novartis Pharma AG |
| 2025/02/06Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2500579 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/02/06Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2500578 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2025/02/06Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2500576 | Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2025/02/06Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2500569 | Henan Fu Sen Pharma Co., Ltd. romanized |
| 2025/02/06Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2500568 | Fujian Da Pu Biopharmaceuticals Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/02/06Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2500567 | Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2025/02/06New drug · Class 1.1 | 黄苓凝胶 · No verified English nameCXZL2500006 | Shandong Han Fang Pharmaceutical Co., Ltd. romanized |
| 2025/02/06New drug · Class 1.2 | AFN1213注射液 · No verified English nameCXSL2500101 | Hefei A Fa Na Bio Technology Co., Ltd. romanized |
| 2025/02/06New drug · Class 1 | HS-20118片 · No verified English nameCXHL2500153 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/06New drug · Class 1 | HS-20118片 · No verified English nameCXHL2500152 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/06New drug · Class 1 | HS-20118片 · No verified English nameCXHL2500151 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/06New drug · Class 1 | SK-09片 · No verified English nameCXHL2500150 | Guangzhou Kang Chen Pharma Co., Ltd. romanized |
| 2025/02/06New drug · Class 1 | SK-09片 · No verified English nameCXHL2500149 | Guangzhou Kang Chen Pharma Co., Ltd. romanized |
| 2025/02/05Generic · Class 3 | 磷/碳酸氢钠血滤置换液(4mmol/L钾、1.25mmol/L钙) · No verified English nameCYHS2500563 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/02/05Generic · Class 3 | Bumetanide InjectionCYHS2500562 | Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2025/02/05Generic · Class 3 | Acetylcysteine InjectionCYHS2500560 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/02/05New drug · Class 1 | AK139注射液 · No verified English nameCXSL2500100 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2025/02/05New drug · Class 1 | AK139注射液 · No verified English nameCXSL2500099 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2025/02/05New drug · Class 2.2 | DM2065贴 · No verified English nameCXHL2500148 | Beijing De Mo Gao Ke Pharmaceuticals Technology Co., Ltd. romanized |
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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