YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 236 drug applications between 13 May 2021 and 19 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 25 drug names.
2021/05/13 – 2021/05/19
- New acceptances this week
- 236
- Drugs with new generic filings (by drug name, de-duplicated)
- 25
- Accepted this week, now under review
- 0
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
236filings, 38 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 107 |
| New drug | 58 |
| Generic | 38 |
| Import | 23 |
| Unspecified | 7 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 177 |
| Therapeutic biologic | 40 |
| TCM | 12 |
| Prophylactic biologic | 4 |
| In vitro diagnostic reagent | 2 |
| Biologic | 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
25 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 4 | 3 | 23 |
| 2 | Propofol Medium And Long Chain Fat Emulsion Injection | 3 | 1 | 3 |
| 3 | Clindamycin Injection | 3 | 1 | 4 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | 阿普斯特片 · No verified English name | 3 | 1 | 0 |
| 6 | Ambroxol Hydrochloride Injection | 2 | 2 | 9 |
| 7 | 硫酸特布他林雾化吸入用溶液 · No verified English name | 2 | 1 | 1 |
| 8 | Sodium Valproate Concentrated Solution for Injection | 1 | 1 | 0 |
| 9 | Linagliptin Tablets | 1 | 1 | 2 |
| 10 | 地氯雷他定口服溶液 · No verified English name | 1 | 1 | 26 |
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
150 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 15 | 10 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 6 | 3 | 1 |
| 3 | Takeda Development Center Americas Inc. | 5 | 2 | 0 |
| 4 | Xian Li Bang Pharmaceutical Co., Ltd. romanized | 5 | 2 | 3 |
| 5 | Shandong Luo Xin Pharma Group Co., Ltd. romanized | 4 | 2 | 0 |
| 6 | Wei Shi Pharma (Ru Gao) Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Pfizer Europe MA EEIG | 3 | 2 | 0 |
| 9 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Tianjin Tian Shi Li (Liaoning) Pharmaceutical Co., Ltd. romanized | 3 | 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
92 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/05/19Import · Class 1 | BR55 · No verified English nameJXHL2101044 | Bracco International B.V.; Bracco Imaging Medical Technologies(Shanghai) Co. Ltd. |
| 2021/05/19Import · Class 2.4 | 注射用依拉环素 · No verified English nameJXHL2101043 | Everest Medicines (US) Limited; EverID Medicines (Beijing) Limited |
| 2021/05/19Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2101179 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2021/05/19Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2101178 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/05/19Generic · Class 3 | Leflunomide TabletsCYHS2101172 | Mei Luo Pharma Co., Ltd. romanized |
| 2021/05/19Generic · Class 3 | 聚普瑞锌颗粒? · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2101166 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2021/05/19New drug · Class 1 | PA3-17注射液 · No verified English nameCXSL2101087 | Bo Sheng Ji Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2021/05/19New drug · Class 1 | SI-B001双特异性抗体注射液 · No verified English nameCXSL2101086 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/05/19New drug · Class 1 | SI-B001双特异性抗体注射液 · No verified English nameCXSL2101083 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/05/19New drug · Class 2.4 | 注射用培尿酸酶 · No verified English nameCXSL2101071 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2021/05/19New drug · Class 1 | 全人源抗CD19和CD22自体T细胞注射液 · No verified English nameCXSL2101070 | Nanjing Xun Lu Medical Technology Co., Ltd. romanized |
| 2021/05/19New drug · Class 1 | ASC40片 · No verified English nameCXHL2101139 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2021/05/19New drug · Class 1 | ASC40片 · No verified English nameCXHL2101138 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2021/05/19New drug · Class 1 | ASC40片 · No verified English nameCXHL2101137 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2021/05/19New drug · Class 1 | 注射用聚乙二醇伊立替康 · No verified English nameCXHL2101136 | Tianjin Jian Kai Technology Co., Ltd. romanized |
| 2021/05/19New drug · Class 1 | XG005片 · No verified English nameCXHL2101135 | Chang Yu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/05/19New drug · Class 1 | 盐酸伊非尼酮片 · No verified English nameCXHL2101134 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2021/05/19New drug · Class 1 | 盐酸伊非尼酮片 · No verified English nameCXHL2101133 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2021/05/18Import · Class 3.1 | 注射用戈沙妥组单抗 · No verified English nameJXSS2101007 | Immunomedics Inc.; BSP Pharmaceuticals S.p.A.; Everest Medicines (Suzhou) Inc. |
| 2021/05/18Import · Class 1 | MK-1026片 · No verified English nameJXHL2101041 | Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/05/18Import · Class 1 | MK-1026片 · No verified English nameJXHL2101040 | Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/05/18Generic · Class 3 | Succinylcholine Chloride InjectionCYHS2101170 | Nanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanized |
| 2021/05/18Generic · Class 3 | 奥美拉唑碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCYHS2101169 | Ji Ning Hua Neng Pharmaceutical Factory Co., Ltd. romanized |
| 2021/05/18Generic · Class 3 | Chlorphenamine Maleate InjectionCYHS2101157 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2021/05/18Generic · Class 3 | 阿普斯特片 · No verified English nameCYHS2101156 | Hua Run Shuang He Pharma Co., Ltd. romanized; Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2021/05/18Generic · Class 3 | 阿普斯特片 · No verified English nameCYHS2101155 | Hua Run Shuang He Pharma Co., Ltd. romanized; Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2021/05/18Generic · Class 3 | 阿普斯特片 · No verified English nameCYHS2101154 | Hua Run Shuang He Pharma Co., Ltd. romanized; Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2021/05/18New drug · Class 1.1 | 理中消痞颗粒 · No verified English nameCXZL2101008 | Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized |
| 2021/05/18New drug | 人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法) · No verified English nameCXSS2101002 | Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized |
| 2021/05/18New drug · Class 1 | SI-B001双特异性抗体注射液 · No verified English nameCXSL2101084 | Sichuan Bai Li Pharma Co., Ltd. romanized |
62 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.