YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 419 drug applications between 30 October 2024 and 5 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 106, covering 76 drug names.
2024/10/30 – 2024/11/05
- New acceptances this week
- 419
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- 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
419filings, 106 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 205 |
| Generic | 106 |
| New drug | 64 |
| Import | 23 |
| Unspecified | 11 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 280 |
| TCM | 85 |
| Therapeutic biologic | 40 |
| Prophylactic biologic | 7 |
| Biologic | 6 |
| In vitro diagnostic reagent | 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
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Doxofylline Tablets | 4 | 2 | 2 |
| 2 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 3 | Oseltamivir Phosphate For Oral Suspension | 3 | 2 | 2 |
| 4 | Mivacurium Chloride Injection | 3 | 2 | 3 |
| 5 | Ampicillin Sodium and Sulbactam Sodium for Injection | 3 | 1 | 13 |
| 6 | Repaglinide Tablets | 3 | 1 | 6 |
| 7 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
| 8 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 9 | Potassium Phosphates Injection | 2 | 2 | 2 |
| 10 | 盐酸纳美芬注射液 · No verified English name | 2 | 2 | 1 |
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
237 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangdong Sunho Pharmaceutical Co., Ltd. | 22 | 16 | 0 |
| 2 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 16 | 12 | 0 |
| 3 | Novo Nordisk A/S | 11 | 3 | 0 |
| 4 | Amgen Inc. | 7 | 2 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | GE Healthcare AS | 6 | 1 | 0 |
| 7 | Teva Neuroscience Inc. | 6 | 1 | 0 |
| 8 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Ya Bao Pharma Group Co., Ltd. romanized | 4 | 3 | 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
126 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/05Import · Class 1 | PF-07868489 · No verified English nameJXSL2400216 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2024/11/05Import · Class 2.2 | Tarlatamab · No verified English nameJXSL2400215 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2024/11/05Import · Class 2.2 | Tarlatamab · No verified English nameJXSL2400214 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2024/11/05Import · Class 2.2 | Tarlatamab · No verified English nameJXSL2400213 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2024/11/05Import · Class 3.1 | Teprotumumab · No verified English nameJXSL2400212 | Horizon Therapeutics Ireland DAC; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/11/05Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2403771 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2024/11/05Generic · Class 3 | Ursodeoxycholic Acid TabletsCYHS2403770 | Mei Xiang Bio Technology (Hainan) Co., Ltd. romanized; Su Zhou Yi Fan Pharma Co., Ltd. romanized |
| 2024/11/05Generic · Class 3 | Thioctic Acid TabletsCYHS2403769 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2024/11/05Generic · Class 3 | Thioctic Acid TabletsCYHS2403768 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2024/11/05Generic · Class 3 | Potassium Phosphates InjectionCYHS2403766 | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized |
| 2024/11/05Generic · Class 3 | Diprophylline InjectionCYHS2403765 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2024/11/05Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2403764 | Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/11/05Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2403763 | Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/11/05Generic · Class 3 | Torsemide InjectionCYHS2403762 | Jiangsu Heng Xin Pharma Co., Ltd. romanized |
| 2024/11/05Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2403761 | Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2024/11/05Generic · Class 3 | 甲苯磺酸艾多沙班口崩片 · No verified English nameCYHS2403760 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2024/11/05Generic · Class 3 | 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2403756 | Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/11/05Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2403750 | Chengdu Giantech Hi-technology Development Co., Ltd.; Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/11/05New drug · Class 3.1 | 五味消毒颗粒 · No verified English nameCXZS2400034 | Nanjing Zhong Shan Pharmaceutical Co., Ltd. romanized |
| 2024/11/05New drug · Class 1 | HB0017注射液 · No verified English nameCXSL2400749 | Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized |
| 2024/11/05New drug · Class 1 | 注射用YL201 · No verified English nameCXSL2400748 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2024/11/05New drug · Class 1 | HSK39004吸入粉雾剂 · No verified English nameCXHL2401183 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2024/11/05New drug · Class 1 | HSK39004吸入粉雾剂 · No verified English nameCXHL2401182 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2024/11/05New drug · Class 1 | HSK39004吸入粉雾剂 · No verified English nameCXHL2401181 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2024/11/05New drug · Class 1 | TM471-1胶囊 · No verified English nameCXHL2401180 | Zhi Wei Biopharmaceuticals (Xin Xiang) Co., Ltd. romanized; Henan Shi Fan University romanized |
| 2024/11/05New drug · Class 1 | TM471-1胶囊 · No verified English nameCXHL2401179 | Zhi Wei Biopharmaceuticals (Xin Xiang) Co., Ltd. romanized; Henan Shi Fan University romanized |
| 2024/11/05New drug · Class 1 | BGB-21447片 · No verified English nameCXHL2401178 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/11/05New drug · Class 1 | BGB-21447片 · No verified English nameCXHL2401177 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/11/05New drug · Class 2.4 | 注射用艾博韦泰 · No verified English nameCXHL2401176 | Qian Yan Bio Pharma (Nanjing) Co., Ltd. romanized |
| 2024/11/05New drug · Class 1 | JKN2306片 · No verified English nameCXHL2401175 | Health Yuan Pharma Group Co., Ltd. romanized |
96 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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