YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 184 drug applications between 3 March 2021 and 9 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 21, covering 15 drug names.
2021/03/03 – 2021/03/09
- New acceptances this week
- 184
- Drugs with new generic filings (by drug name, de-duplicated)
- 15
- 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
184filings, 21 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 96 |
| New drug | 33 |
| Import | 22 |
| Generic | 21 |
| Unspecified | 9 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 134 |
| Therapeutic biologic | 25 |
| TCM | 21 |
| Biologic | 2 |
| In vitro diagnostic reagent | 1 |
| 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
15 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Apremilast Tablets | 3 | 1 | 0 |
| 2 | Levofloxacin Injection | 2 | 1 | 1 |
| 3 | Atomoxetine Hydrochloride Capsules | 2 | 1 | 6 |
| 4 | Memantine Hydrochloride Tablets | 2 | 1 | 2 |
| 5 | Esomeprazole Magnesium Enteric-Coated Capsules | 2 | 1 | 4 |
| 6 | Tadalafil Tablets | 1 | 1 | 23 |
| 7 | Cefdinir Capsules | 1 | 1 | 0 |
| 8 | Tofacitinib Citrate Tablets | 1 | 1 | 1 |
| 9 | 注射用奥美拉唑钠(静脉滴注) · No verified English name | 1 | 1 | 0 |
| 10 | Parecoxib Sodium for Injection | 1 | 1 | 2 |
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
103 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized | 10 | 2 | 0 |
| 2 | Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized | 8 | 5 | 0 |
| 3 | Fresenius Kabi Austria GmbH | 7 | 2 | 0 |
| 4 | Gansu Qi Zheng Zang Yao Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Da Lian Tian Shan Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | CISEN PHARMACEUTICAL CO., LTD. | 4 | 3 | 1 |
| 8 | Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Jilin Si Huan Ao Kang Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Karyopharm Therapeutics Inc. | 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
59 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/03/09Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2100264 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2021/03/09Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2100263 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2021/03/09New drug · Class 2.2 | 重组抗EGFR人鼠嵌合单克隆抗体注射液 · No verified English nameCXSL2100086 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/03/09New drug · Class 3.3 | 水痘减毒活疫苗 · No verified English nameCXSL2100085 | Ke Xing (Da Lian) Yi Miao Technology Co., Ltd. romanized |
| 2021/03/09New drug · Class 1 | GW117口崩片 · No verified English nameCXHL2100158 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/09New drug · Class 1 | GW117口崩片 · No verified English nameCXHL2100157 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/09New drug · Class 1 | BR790片 · No verified English nameCXHL2100156 | Jiangxi Qing Feng Pharma Co., Ltd. romanized |
| 2021/03/09New drug · Class 1 | BR790片 · No verified English nameCXHL2100155 | Jiangxi Qing Feng Pharma Co., Ltd. romanized |
| 2021/03/08Generic · Class 3 | Levofloxacin InjectionCYHS2101016 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2021/03/08Generic · Class 3 | Levofloxacin InjectionCYHS2101015 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2021/03/06New drug · Class 1 | YH003注射液 · No verified English nameCXSL2101002 | Name not romanized |
| 2021/03/05Import · Class 1 | Tanezumab注射液 · No verified English nameJXSL2100037 | Pfizer Inc. |
| 2021/03/05Import · Class 2.2 | 注射用Luspatercept · No verified English nameJXSL2100036 | Celgene Corporation |
| 2021/03/05Import · Class 2.2 | 注射用Luspatercept · No verified English nameJXSL2100035 | Celgene Corporation |
| 2021/03/05Import · Class 1 | ATG-016片 · No verified English nameJXHL2100082 | Karyopharm Therapeutics Inc. |
| 2021/03/05Import · Class 1 | ATG-016片 · No verified English nameJXHL2100081 | Karyopharm Therapeutics Inc. |
| 2021/03/05Import · Class 1 | 注射用EC-DG · No verified English nameJXHL2100080 | Name not romanized |
| 2021/03/05New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSS2100030 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized |
| 2021/03/05New drug · Class 1 | JS103注射液 · No verified English nameCXSL2100083 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/05New drug · Class 2.2 | 盐酸罗哌卡因脂质体混悬注射液 · No verified English nameCXHL2100170 | Nanjing Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2021/03/04Import · Class 1 | CG0070注射液 · No verified English nameJXSL2100029 | CG Oncology Inc. |
| 2021/03/04Import · Class 1 | MB-102注射液 · No verified English nameJXHL2100079 | MediBeacon Inc. |
| 2021/03/04Import · Class 1 | ALG-010133注射液 · No verified English nameJXHL2100075 | Aligos Therapeutics Inc. |
| 2021/03/04Import · Class 1 | JNJ-67856633 硬胶囊 · No verified English nameJXHL2100074 | Janssen Research & Development LLC |
| 2021/03/04Import · Class 1 | JNJ-67856633 硬胶囊 · No verified English nameJXHL2100073 | Janssen Research & Development LLC |
| 2021/03/04Import · Class 2.4 | ATG-010片 · No verified English nameJXHL2100072 | Karyopharm Therapeutics Inc. |
| 2021/03/04Import · Class 1 | ZN-c3片 · No verified English nameJXHL2100071 | Zentera Therapeutics HK Limited |
| 2021/03/04Import · Class 1 | ZN-c3片 · No verified English nameJXHL2100070 | Zentera Therapeutics HK Limited |
| 2021/03/04Import · Class 1 | 注射用LY3437943 · No verified English nameJXHL2100069 | Eli Lilly and Company |
| 2021/03/04Generic · Class 3 | Carbocisteine Oral SolutionCYHS2100254 | Guangdong Pin Cheng Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
29 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.