YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 375 drug applications between 18 January 2025 and 24 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 134, covering 95 drug names.
2025/01/18 – 2025/01/24
- New acceptances this week
- 375
- Drugs with new generic filings (by drug name, de-duplicated)
- 95
- 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
375filings, 134 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 145 |
| Generic | 134 |
| New drug | 70 |
| Import | 23 |
| Unspecified | 2 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 268 |
| Therapeutic biologic | 50 |
| TCM | 48 |
| Prophylactic biologic | 9 |
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
95 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 | Levofloxacin Injection | 4 | 2 | 1 |
| 3 | Mivacurium Chloride Injection | 4 | 2 | 3 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | Gadoteric Acid Meglumine Salt Injection | 3 | 1 | 1 |
| 6 | Lactulose Oral Solution | 2 | 2 | 34 |
| 7 | Candesartan Cilexetil and Hydrochlorothiazide Tablets | 2 | 2 | 2 |
| 8 | 盐酸纳美芬注射液 · No verified English name | 2 | 2 | 1 |
| 9 | Sodium Thiosulfate Injection | 2 | 2 | 3 |
| 10 | Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ) | 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
249 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 7 | 5 | 0 |
| 2 | Anhui Jin Ma Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 3 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 5 | 3 | 1 |
| 4 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 5 | Bristol-Myers Squibb Company | 4 | 4 | 0 |
| 6 | Guizhou Heng He Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized | 4 | 3 | 2 |
| 8 | Jiangxi Ke Rui Pharma Co., Ltd. romanized | 4 | 3 | 2 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 1 |
| 10 | Jilin Sheng Xi Dian Pharma Technology Development 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
145 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/24Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSL2500018 | MedImmune LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2025/01/24Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSL2500017 | MedImmune LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2025/01/24Import · Class 2.4 | Finerenone TabletsJXHS2500017 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2025/01/24Import · Class 2.4 | Finerenone TabletsJXHS2500016 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2025/01/24Import · Class 2.4 | Finerenone TabletsJXHS2500015 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2025/01/24Generic · Class 3 | Risedronate Sodium TabletsCYHS2500475 | Beijing Foyou Pharma CO.,LTD |
| 2025/01/24Generic · Class 3 | 头孢克肟胶囊 · No verified English nameCYHS2500468 | Nanjing Rui Jie Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ya Bang Qiang Sheng Pharma Co., Ltd. romanized |
| 2025/01/24Generic · Class 3 | Pentoxifylline InjectionCYHS2500467 | Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2025/01/24Generic · Class 3 | Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2500461 | Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized |
| 2025/01/24Generic · Class 3 | Potassium Chloride GranulesCYHS2500460 | Nanjing Huang Long Bio Technology Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized |
| 2025/01/24Generic · Class 3 | Levofloxacin InjectionCYHS2500459 | Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized |
| 2025/01/24Generic · Class 3 | Levofloxacin InjectionCYHS2500458 | Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized |
| 2025/01/24Generic · Class 3 | Potassium Chloride GranulesCYHS2500457 | Nanjing Huang Long Bio Technology Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized |
| 2025/01/24Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2500451 | Zhengzhou Wei Xian Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2025/01/24Generic · Class 3 | Labetalol Hydrochloride InjectionCYHS2500448 | Shanghai Zhao Hui Pharma Co., Ltd. romanized |
| 2025/01/24Generic · Class 3 | Labetalol Hydrochloride InjectionCYHS2500447 | Shanghai Zhao Hui Pharma Co., Ltd. romanized |
| 2025/01/24Generic · Class 3 | Ketoprofen PatchesCYHL2500023 | Hebei Yi Pin Pharmaceutical Co., Ltd. romanized |
| 2025/01/24New drug · Class 3.1 | 苓桂术甘颗粒 · No verified English nameCXZS2500003 | Hunan Yi Neng Biopharmaceuticals Co., Ltd. romanized; Hunan Kang Shou Pharmaceutical Co., Ltd. romanized |
| 2025/01/24New drug · Class 1.1 | 吾斯提库都斯颗粒 · No verified English nameCXZL2500004 | He Tian Wei Wu Er Pharma Co., Ltd. romanized |
| 2025/01/24New drug · Class 3.2 | 长效重组人促卵泡激素注射液 · No verified English nameCXSS2500014 | Beijing SL Pharmaceutical Co., Ltd. |
| 2025/01/24New drug · Class 3.2 | 长效重组人促卵泡激素注射液 · No verified English nameCXSS2500013 | Beijing SL Pharmaceutical Co., Ltd. |
| 2025/01/24New drug · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameCXSS2500012 | Cheng Da Bio (Ben Xi) Co., Ltd. romanized |
| 2025/01/24New drug · Class 1 | 舒地胰岛素注射液 · No verified English nameCXSS2500011 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/01/24New drug · Class 1 | 舒地胰岛素注射液 · No verified English nameCXSS2500010 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/01/24New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2500009 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized |
| 2025/01/24New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2500008 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized |
| 2025/01/24New drug · Class 1 | FT-017注射液 · No verified English nameCXSL2500078 | Fang Tuo Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/01/24New drug · Class 1 | HiCM388注射液 · No verified English nameCXSL2500077 | Ai Er Pu Zai Sheng Yi Xue Technology (Shenzhen) Co., Ltd. romanized |
| 2025/01/24New drug · Class 2.2 | 纳基奥仑赛注射液 · No verified English nameCXSL2500076 | Guangdong He Yuan Biopharmaceuticals Co., Ltd. romanized; He Yuan Bio Technology (Tianjin) Co., Ltd. romanized |
| 2025/01/24New drug · Class 1 | UTAA09注射液 · No verified English nameCXSL2500075 | Bo Sheng Ji Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized; Bo Sheng Ji An Ke Xi Bao Technology Co., Ltd. romanized |
115 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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