YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 309 drug applications between 31 December 2023 and 6 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 69 drug names.
2023/12/31 – 2024/01/06
- New acceptances this week
- 309
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- Accepted this week, now under review
- 3
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
309filings, 92 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 145 |
| Generic | 92 |
| New drug | 44 |
| Import | 16 |
| Unspecified | 6 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 233 |
| Therapeutic biologic | 37 |
| TCM | 36 |
| Prophylactic biologic | 3 |
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
69 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Minoxidil Liniment | 4 | 2 | 52 |
| 3 | Citicoline Injection | 3 | 1 | 0 |
| 4 | 氯化钙注射液 · No verified English name | 2 | 2 | 6 |
| 5 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 6 | 中/长链脂肪乳注射液(C6~24) · No verified English name | 2 | 1 | 0 |
| 7 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 8 | Lactulose Oral Solution | 2 | 1 | 34 |
| 9 | Divalproex Sodium Extended-Release Tablets | 2 | 1 | 0 |
| 10 | Ibuprofen Suspension | 2 | 1 | 14 |
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
188 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 6 | 5 | 4 |
| 4 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 3 | 3 |
| 6 | Bei Da Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd | 4 | 3 | 0 |
| 9 | Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 4 | 3 | 2 |
| 10 | AstraZeneca AB | 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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/01/06Import · Class 1 | Itepekimab注射液 · No verified English nameJXSL2400008 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/01/06Import · Class 1 | ABBV-383输注用溶液 · No verified English nameJXSL2400007 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/01/06Import · Class 1 | TAK-279胶囊 · No verified English nameJXHL2400004 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2024/01/06Import · Class 1 | TAK-279胶囊 · No verified English nameJXHL2400003 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2024/01/06Generic · Class 3 | Acetylcysteine InjectionCYHS2400081 | Hangzhou Yun Bai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/01/06Generic · Class 3 | Furosemide Oral SolutionCYHS2400080 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2024/01/06Generic · Class 3 | Pentoxifylline InjectionCYHS2400077 | Guangdong Mai Heng Pharmaceuticals Research and Development Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2024/01/06Generic · Class 3 | Tranexamic Acid and Sodium Chloride InjectionCYHS2400076 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/01/06Generic · Class 3 | Timolol Maleate Eye DropsCYHS2400075 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/01/06Generic · Class 3 | Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2400074 | Beijing Wan Hui Shuang He Pharma Co., Ltd. romanized; Hua Run Shuang He Pharma Co., Ltd. romanized |
| 2024/01/06Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2400071 | Hainan Qiu Shi Pharmaceuticals Technology Co., Ltd. romanized; Henan Run Hong Pharmaceutical Co., Ltd. romanized |
| 2024/01/06Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2400068 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2024/01/06Generic · Class 3 | Bismuth subcitrate potassium, Metronidazole and Tetracycline Hydrochloride CapsulesCYHL2400007 | Hubei Jing Jiang Yuan Pharmaceutical Co., Ltd. romanized |
| 2024/01/06New drug · Class 3.3 | QL2109注射液 · No verified English nameCXSL2400011 | Qilu Pharmaceutical Co., Ltd. |
| 2024/01/06New drug · Class 1 | 注射用VDJ010 · No verified English nameCXSL2400010 | Beijing Wei De Jie Bio Technology Co., Ltd. romanized |
| 2024/01/06New drug · Class 2.4; 2.2 | LY102片 · No verified English nameCXHL2400028 | Qingdao Hai Yang Biopharmaceuticals Research Institute romanized; Qingdao Hai Ji Biopharmaceuticals Co., Ltd. romanized; Zhongguo Hai Yang University romanized |
| 2024/01/06New drug · Class 2.4; 2.2 | LY102片 · No verified English nameCXHL2400027 | Qingdao Hai Yang Biopharmaceuticals Research Institute romanized; Qingdao Hai Ji Biopharmaceuticals Co., Ltd. romanized; Zhongguo Hai Yang University romanized |
| 2024/01/06New drug · Class 1 | LPM526000133富马酸盐胶囊 · No verified English nameCXHL2400026 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized |
| 2024/01/06New drug · Class 1 | LPM526000133富马酸盐胶囊 · No verified English nameCXHL2400025 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized |
| 2024/01/06New drug · Class 1 | LPM526000133富马酸盐胶囊 · No verified English nameCXHL2400024 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized |
| 2024/01/06New drug · Class 1 | LPM526000133富马酸盐胶囊 · No verified English nameCXHL2400023 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized |
| 2024/01/06New drug · Class 1 | LPM526000133富马酸盐胶囊 · No verified English nameCXHL2400022 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized |
| 2024/01/06New drug · Class 1 | LPM526000133富马酸盐胶囊 · No verified English nameCXHL2400021 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized |
| 2024/01/06New drug · Class 1 | AMX3009马来酸片 · No verified English nameCXHL2400020 | An Run Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2024/01/06New drug · Class 1 | AMX3009马来酸片 · No verified English nameCXHL2400019 | An Run Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2024/01/05Import · Class 1 | Tarlatamab · No verified English nameJXSL2400006 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2024/01/05Import · Class 1 | Tarlatamab · No verified English nameJXSL2400005 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2024/01/05Import · Class 1 | Tarlatamab · No verified English nameJXSL2400004 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2024/01/05Import · Class 2.2 | TAR-200 · No verified English nameJXHL2400002 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/01/05Generic · Class 3 | Diprophylline InjectionCYHS2400067 | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized |
65 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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