YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 129 drug applications between 16 July 2021 and 22 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 21, covering 18 drug names.
2021/07/16 – 2021/07/22
- New acceptances this week
- 129
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- 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
129filings, 21 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 68 |
| New drug | 23 |
| Generic | 21 |
| Import | 7 |
| Unspecified | 6 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 98 |
| Therapeutic biologic | 15 |
| TCM | 11 |
| Biologic | 4 |
| Prophylactic 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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ropivacaine hydrochloride injection | 2 | 1 | 5 |
| 2 | Iodixanol Injection | 2 | 1 | 0 |
| 3 | Eldecalcitol Soft Capsules | 2 | 1 | 8 |
| 4 | Sodium Valproate Oral Solution | 1 | 1 | 1 |
| 5 | Paracetamol Tablets | 1 | 1 | 6 |
| 6 | 异丙托溴铵吸入气雾剂 · No verified English name | 1 | 1 | 2 |
| 7 | Tranexamic Acid Injection | 1 | 1 | 11 |
| 8 | Voriconazole for Injection | 1 | 1 | 5 |
| 9 | 注射用奥美拉唑钠(静脉滴注) · No verified English name | 1 | 1 | 0 |
| 10 | Azithromycin For Injection | 1 | 1 | 11 |
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
84 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Xian Tang Chen Pharmaceutical Co., Ltd. romanized | 7 | 6 | 0 |
| 3 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 4 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 3 | 3 | 0 |
| 5 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 3 | 2 | 3 |
| 6 | Loxo Oncology Inc. | 3 | 1 | 0 |
| 7 | Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 3 | 1 | 0 |
| 8 | SANOFI PASTEUR | 2 | 2 | 0 |
| 9 | Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | 2 | 2 | 0 |
| 10 | Hu Lun Bei Er Song Lu Pharmaceutical Co., Ltd. romanized | 2 | 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
34 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/07/21Generic · Class 3 | Paracetamol TabletsCYHS2101461 | Beijing Yi Ling Pharmaceuticals Technology Development Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2021/07/21Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2101460 | Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
| 2021/07/21New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101208 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2021/07/21New drug · Class 1 | FTL001单抗注射液 · No verified English nameCXSL2101204 | Fei Tong (Chengdu) Bio Technology Co., Ltd. romanized |
| 2021/07/20Import · Class 2.2 | 阿替利珠单抗注射液 · No verified English nameJXSL2101067 | F.Hoffmann-La Roche Ltd.; Roche(China)Holding Ltd. |
| 2021/07/20Generic · Class 3 | Citicoline Sodium InjectionCYHS2101456 | Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2021/07/20New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2101206 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/07/20New drug · Class 2.1 | HR011408注射液 · No verified English nameCXSL2101205 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/07/20New drug · Class 1 | ZXBT-1158胶囊 · No verified English nameCXHL2101308 | Dong Guan Shi Zhen Xing Bei Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/20New drug · Class 1 | ZXBT-1158胶囊 · No verified English nameCXHL2101307 | Dong Guan Shi Zhen Xing Bei Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/20New drug · Class 1 | ZX-7101A片 · No verified English nameCXHL2101306 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2021/07/20New drug · Class 1 | ZX-7101A片 · No verified English nameCXHL2101305 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2021/07/20New drug · Class 2.2 | 盐酸伊立替康脂质体注射液 · No verified English nameCXHL2101304 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/07/20New drug · Class 2.4 | 氟唑帕利胶囊 · No verified English nameCXHL2101303 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/07/20New drug · Class 2.2 | 丁苯酞注射液 · No verified English nameCXHL2101298 | Jilin Sheng Qi Jian Bio Technology Co., Ltd. romanized |
| 2021/07/19Generic · Class 3 | Levobupivacaine Hydrochloride InjectionCYHS2101449 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2021/07/19New drug · Class 2.3 | 滋肾育胎丸 · No verified English nameCXZL2101019 | Guangzhou Bai Yun Shan Zhong Yi Pharma Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | 重组抗VEGFR2全人源单克隆抗体注射液 · No verified English nameCXSL2101203 | Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101191 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | 注射用RC118 · No verified English nameCXSL2101189 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2021/07/19New drug · Class 2.2 | 依达拉奉舌下片 · No verified English nameCXHS2101030 | Nanjing Bai Xin Yu Pharmaceuticals Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | LPM3770164缓释片 · No verified English nameCXHL2101302 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | LPM3770164缓释片 · No verified English nameCXHL2101301 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | LPM3770164缓释片 · No verified English nameCXHL2101300 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | LPM3770164缓释片 · No verified English nameCXHL2101299 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2021/07/16Import · Class 1 | LOXO-305片 · No verified English nameJXHL2101139 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/07/16Import · Class 1 | LOXO-305片 · No verified English nameJXHL2101138 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/07/16Import · Class 1 | LOXO-305片 · No verified English nameJXHL2101137 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/07/16Import · Class 1 | Finerenone TabletsJXHL2101136 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/07/16Import · Class 1 | Finerenone TabletsJXHL2101135 | Bayer AG; Bayer Healthcare Company Ltd. |
4 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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