YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 307 drug applications between 30 December 2023 and 5 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 58 drug names.
2023/12/30 – 2024/01/05
- New acceptances this week
- 307
- Drugs with new generic filings (by drug name, de-duplicated)
- 58
- Accepted this week, now under review
- 2
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
307filings, 81 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 153 |
| Generic | 81 |
| New drug | 50 |
| Import | 14 |
| Unspecified | 6 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 229 |
| TCM | 40 |
| Therapeutic biologic | 36 |
| Prophylactic 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
58 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 | Levofloxacin Tablets | 2 | 2 | 7 |
| 5 | 氯化钙注射液 · No verified English name | 2 | 2 | 6 |
| 6 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 7 | 中/长链脂肪乳注射液(C6~24) · No verified English name | 2 | 1 | 0 |
| 8 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 9 | Lactulose Oral Solution | 2 | 1 | 34 |
| 10 | Divalproex Sodium Extended-Release 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
193 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 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 3 | 3 |
| 4 | Bei Da Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 5 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd | 4 | 3 | 0 |
| 7 | Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 4 | 3 | 2 |
| 8 | Eli Lilly and Company | 4 | 2 | 0 |
| 9 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 2 | 0 |
| 10 | Xizang Bang Chen Pharma Group 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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2024/01/05Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2400066 | Henan Shang Heng Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/01/05Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2400065 | Henan Shang Heng Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/01/05Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2400064 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2024/01/05Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2400063 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2024/01/05Generic · Class 3 | Acetate And Glucose Electrolytes InjectionCYHS2400054 | Shandong Ke Lun Pharma Co., Ltd. romanized |
| 2024/01/05Generic · Class 3 | Acetate And Glucose Electrolytes InjectionCYHS2400053 | Shandong Ke Lun Pharma Co., Ltd. romanized |
| 2024/01/05Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2400051 | Zhong Run Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2024/01/05Generic · Class 3 | Divalproex Sodium Extended-Release TabletsCYHL2400004 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/01/05Generic · Class 3 | Divalproex Sodium Extended-Release TabletsCYHL2400003 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/01/05New drug · Class 3.1 | 温经汤颗粒 · No verified English nameCXZS2400001 | Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized |
| 2024/01/05New drug · Class 2.2 | 卡度尼利单抗注射液 · No verified English nameCXSS2400003 | Kang Fang Pharma Co., Ltd. romanized; Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2024/01/05New drug · Class 1 | SKG0106眼内注射溶液 · No verified English nameCXSL2400009 | Lan Yue Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2024/01/05New drug · Class 2.4 | 索凡替尼胶囊 · No verified English nameCXHL2400018 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2024/01/05New drug · Class 1 | TQB3006片 · No verified English nameCXHL2400017 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/01/05New drug · Class 2.4 | 注射用磷丙泊酚二钠 · No verified English nameCXHL2400016 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/01/05New drug · Class 2.4 | 注射用磷丙泊酚二钠 · No verified English nameCXHL2400015 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/01/05New drug · Class 1 | BPI-221351片 · No verified English nameCXHL2400014 | Bei Da Pharma Co., Ltd. romanized |
| 2024/01/05New drug · Class 1 | BPI-221351片 · No verified English nameCXHL2400013 | Bei Da Pharma Co., Ltd. romanized |
| 2024/01/05New drug · Class 1 | BPI-520105片 · No verified English nameCXHL2400012 | Bei Da Pharma Co., Ltd. romanized |
| 2024/01/05New drug · Class 1 | BPI-520105片 · No verified English nameCXHL2400011 | Bei Da Pharma Co., Ltd. romanized |
| 2024/01/05New drug · Class 1 | BPI-520105片 · No verified English nameCXHL2400010 | Bei Da Pharma Co., Ltd. romanized |
| 2024/01/04Import · Class 2.2 | 注射用罗特西普 · No verified English nameJXSL2400003 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2024/01/04Import · Class 2.2 | 注射用罗特西普 · No verified English nameJXSL2400002 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2024/01/04Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2400050 | Fujian Sheng Yi Long Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Wan Run Pharma Co., Ltd. romanized |
| 2024/01/04Generic · Class 3 | Minoxidil LinimentCYHS2400046 | Hefei Hua Wei 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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