YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 361 drug applications between 12 January 2025 and 18 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 98, covering 70 drug names.
2025/01/12 – 2025/01/18
- New acceptances this week
- 361
- Drugs with new generic filings (by drug name, de-duplicated)
- 70
- Accepted this week, now under review
- 9
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
361filings, 98 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 174 |
| Generic | 98 |
| New drug | 61 |
| Import | 21 |
| Import re-registration | 4 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 274 |
| TCM | 52 |
| Therapeutic biologic | 31 |
| 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
70 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Mivacurium Chloride Injection | 4 | 2 | 3 |
| 2 | Ethyl Iosapentate Capsules | 2 | 2 | 27 |
| 3 | Pentoxifylline Modified Release Tablets | 2 | 2 | 6 |
| 4 | Sildenafil Citrate Oral Disintegrating Tablets | 2 | 2 | 8 |
| 5 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 6 | Tedizolid Phosphate For Injection | 2 | 2 | 3 |
| 7 | 聚乙二醇钠钾散 · No verified English name | 2 | 2 | 3 |
| 8 | Benzbromarone Tablets | 2 | 2 | 4 |
| 9 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 2 | 2 | 12 |
| 10 | ω-3 Fish Oil Medium and Long Chain Fat Emulsion Injection | 2 | 1 | 2 |
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
213 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 18 | 13 | 0 |
| 2 | Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 12 | 12 | 0 |
| 3 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 8 | 5 | 0 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 3 | 0 |
| 5 | Anhui Shuang He Pharma Co., Ltd. romanized | 8 | 2 | 0 |
| 6 | Lang Li Biopharmaceuticals (Wuhan) Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Yunnan Yi Zhi Hao Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 8 | Fresenius Kabi AB | 5 | 1 | 0 |
| 9 | Hebei Guang Xiang Pharmaceuticals Technology Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Chengdu Rong Sheng Pharma 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
109 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/18Import · Class 3.1 | 艾加莫德α注射液 · No verified English nameJXSL2500011 | argenx BV; ICON Clinical Research (Beijing No. 2) Co. Ltd. |
| 2025/01/18Import · Class 1 | HCB301注射液 · No verified English nameJXSL2500010 | FBD Biologics Limited; Shanghai Hanchor Biotech Inc. |
| 2025/01/18Import · Class 1 | 艾曲帕米鼻喷雾剂 · No verified English nameJXHS2500007 | Milestone Pharmaceuticals Inc.; Catalent Pharma Solutions LLC; Corxel Pharmaceuticals (Shanghai) Co. Ltd |
| 2025/01/18Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2500353 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/01/18Generic · Class 3 | Metronidazole Vaginal GelCYHS2500352 | Hangzhou Shang He Health Technology Co., Ltd. romanized; Zhejiang Ding Tai Pharma Co., Ltd. romanized |
| 2025/01/18Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2500350 | Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized |
| 2025/01/18Generic · Class 3 | Brivaracetam Oral SolutionCYHL2500019 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2025/01/18New drug · Class 2.2 | 注射用重组人TNK组织型纤溶酶原激活剂 · No verified English nameCXSL2500054 | Shi Yao Group Ming Fu Le Pharma (Guangzhou) Co., Ltd. romanized |
| 2025/01/18New drug · Class 1 | 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2500053 | Shanghai Bang Yao Bio Technology Co., Ltd. romanized |
| 2025/01/18New drug · Class 2.2 | MIRSRT缓释片 · No verified English nameCXHL2500098 | Jilin Tian Heng Pharma Co., Ltd. romanized |
| 2025/01/18New drug · Class 2.2 | MIRSRT缓释片 · No verified English nameCXHL2500097 | Jilin Tian Heng Pharma Co., Ltd. romanized |
| 2025/01/18New drug · Class 2.2 | MIRSRT缓释片 · No verified English nameCXHL2500096 | Jilin Tian Heng Pharma Co., Ltd. romanized |
| 2025/01/18New drug · Class 1 | DNV001注射液 · No verified English nameCXHL2500095 | Hangzhou Ding Le Xin Wei Bio Technology Co., Ltd. romanized |
| 2025/01/18New drug · Class 1 | HRS-6719片 · No verified English nameCXHL2500094 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/01/18New drug · Class 1 | 奥格特韦钠胶囊 · No verified English nameCXHL2500093 | Zhejiang Ai Sen Pharma Co., Ltd. romanized |
| 2025/01/18New drug · Class 1 | HRS-6719片 · No verified English nameCXHL2500092 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/01/18New drug · Class 1 | SYH2046片 · No verified English nameCXHL2500091 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/18New drug · Class 1 | SYH2046片 · No verified English nameCXHL2500090 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/17Import · Class 1 | Zasocitinib (TAK-279) 片 · No verified English nameJXHL2500012 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2025/01/17Import · Class 1 | Zasocitinib (TAK-279) 片 · No verified English nameJXHL2500011 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2025/01/17Generic · Class 3 | Folic Acid TabletsCYHS2500342 | Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
| 2025/01/17Generic · Class 3 | Sulfasalazine Oral SuspensionCYHS2500341 | Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized |
| 2025/01/17Generic · Class 3 | Memantine Hydrochloride Oral SolutionCYHS2500337 | Changzhou Si Yao Pharmaceutical Co., Ltd. romanized |
| 2025/01/17Generic · Class 3 | Piracetam InjectionCYHS2500336 | Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized |
| 2025/01/17Generic · Class 3 | Bumetanide InjectionCYHS2500331 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/01/17Generic · Class 3 | Bumetanide InjectionCYHS2500330 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/01/17Generic · Class 3 | 富马酸酮替芬滴眼液 · No verified English nameCYHS2500329 | Shijiazhuang Gree Pharmaceutical Co., Ltd |
| 2025/01/17Generic · Class 3 | 富马酸酮替芬滴眼液 · No verified English nameCYHS2500328 | Shijiazhuang Gree Pharmaceutical Co., Ltd |
| 2025/01/17Generic · Class 3 | 醋酸地非法林注射液 · No verified English nameCYHL2500018 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/01/17New drug · Class 1 | 注射用ZL-1310 · No verified English nameCXSL2500052 | Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized |
79 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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