YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 370 drug applications between 31 October 2024 and 6 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 70 drug names.
2024/10/31 – 2024/11/06
- New acceptances this week
- 370
- Drugs with new generic filings (by drug name, de-duplicated)
- 70
- Accepted this week, now under review
- 1
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
370filings, 99 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 175 |
| Generic | 99 |
| New drug | 61 |
| Import | 20 |
| Import re-registration | 9 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 266 |
| TCM | 73 |
| Therapeutic biologic | 24 |
| Prophylactic biologic | 4 |
| Biologic | 2 |
| 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
70 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 | Methotrexate Injection | 3 | 2 | 11 |
| 4 | Oseltamivir Phosphate For Oral Suspension | 3 | 2 | 2 |
| 5 | Mivacurium Chloride Injection | 3 | 2 | 3 |
| 6 | Ampicillin Sodium and Sulbactam Sodium for Injection | 3 | 1 | 13 |
| 7 | Repaglinide Tablets | 3 | 1 | 6 |
| 8 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
| 9 | Pentoxifylline Modified Release Tablets | 2 | 2 | 6 |
| 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
220 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangdong Sunho Pharmaceutical Co., Ltd. | 19 | 13 | 0 |
| 2 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | GE Healthcare AS | 6 | 1 | 0 |
| 5 | Teva Neuroscience Inc. | 6 | 1 | 0 |
| 6 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Ya Bao Pharma Group Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Amgen Inc. | 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
121 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/06Import · Class 3.1 | 艾可瑞妥单抗注射用浓溶液 · No verified English nameJXSS2400100 | AbbVie Deutschland GmbH & Co. KG; Vetter Pharma-Fertigung GmbH & Co. KG; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/11/06Import · Class 1 | Baxdrostat片 · No verified English nameJXHL2400264 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/11/06Import · Class 1 | Baxdrostat片 · No verified English nameJXHL2400263 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/11/06Generic · Class 3 | Carbocisteine Oral SolutionCYHS2403779 | Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized |
| 2024/11/06Generic · Class 3 | Cimetidine InjectionCYHS2403778 | Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized |
| 2024/11/06Generic · Class 3 | 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2403776 | Hainan Mei Kang Da Pharma Co., Ltd. romanized; Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2024/11/06Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2403774 | Yunnan Xian Shi Pharma Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2024/11/06Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2403772 | HAINAN HUALON PHARMACEUTICAL CO.,LTD |
| 2024/11/06New drug · Class 1 | 注射用SIBP-A18 · No verified English nameCXSL2400751 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2024/11/06New drug · Class 1 | IBR900细胞注射液 · No verified English nameCXSL2400750 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2024/11/06New drug · Class 1 | CYH001肠溶胶囊 · No verified English nameCXHL2401193 | Beijing Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/06New drug · Class 1 | CYH001肠溶胶囊 · No verified English nameCXHL2401192 | Beijing Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/06New drug · Class 1 | CVI-2742胶囊 · No verified English nameCXHL2401191 | Xi Wei Ai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/11/06New drug · Class 1 | CVI-2742胶囊 · No verified English nameCXHL2401190 | Xi Wei Ai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/11/06New drug · Class 2.4 | 胶原酶软膏 · No verified English nameCXHL2401189 | Yuan Da Sheng Ming Ke Xue (An Shan) Co., Ltd. romanized |
| 2024/11/06New drug · Class 2.4 | 注射用紫杉醇阳离子脂质体 · No verified English nameCXHL2401188 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2024/11/06New drug · Class 1 | 注射用培泰菁绿 · No verified English nameCXHL2401187 | Nanjing Nuo Yuan Medical Devices Co., Ltd. romanized |
| 2024/11/06New drug · Class 1 | DF-003胶囊 · No verified English nameCXHL2401186 | Shanghai Yao Yuan Bio Technology Co., Ltd. romanized |
| 2024/11/06New drug · Class 1 | DF-003胶囊 · No verified English nameCXHL2401185 | Shanghai Yao Yuan Bio Technology Co., Ltd. romanized |
| 2024/11/06New drug · Class 1 | DF-003胶囊 · No verified English nameCXHL2401184 | Shanghai Yao Yuan Bio Technology Co., Ltd. romanized |
| 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 |
91 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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