药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/08/24 – 2021/08/30
- New acceptances this week
- 255
- Drugs with new generic filings (by drug name, de-duplicated)
- 25
- Accepted this week, now under review
- 3
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.
Drug and company names link to detail pages; sign in to view them.
New acceptances this week
By application type and drug type
255filings, 37 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 167 |
| Generic | 37 |
| New drug | 27 |
| Import | 13 |
| Import re-registration | 8 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 150 |
| TCM | 65 |
| 治疗用生物制品 | 31 |
| 预防用生物制品 | 7 |
| Biologic | 2 |
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 | 沙美特罗替卡松吸入粉雾剂 | 3 | 1 | 12 |
| 2 | 甲苯磺酸艾多沙班片 | 3 | 1 | 9 |
| 3 | 替莫唑胺胶囊 | 2 | 2 | 0 |
| 4 | 乙酰半胱氨酸颗粒 | 2 | 1 | 4 |
| 5 | 吸入用七氟烷 | 2 | 1 | 0 |
| 6 | 替格瑞洛片 | 2 | 1 | 10 |
| 7 | 枸橼酸西地那非片 | 2 | 1 | 12 |
| 8 | 琥珀酸去甲文拉法辛缓释片 | 2 | 1 | 0 |
| 9 | 米力农注射液 | 2 | 1 | 0 |
| 10 | 聚多卡醇注射液 | 2 | 1 | 23 |
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
123 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北叶真堂药业有限公司 | 20 | 20 | 0 |
| 2 | 上海皇象铁力蓝天制药有限公司 | 16 | 15 | 0 |
| 3 | GUERBET | 13 | 1 | 0 |
| 4 | 广西葛洪堂方略制药有限公司 | 7 | 7 | 0 |
| 5 | 大同五洲通制药有限责任公司 | 7 | 3 | 0 |
| 6 | 秦皇岛大恩药业有限公司 | 6 | 6 | 0 |
| 7 | Merck Sharp & Dohme B.V. | 6 | 1 | 0 |
| 8 | Upjohn Manufacturing Ireland Unlimited | 6 | 1 | 0 |
| 9 | 南京正大天晴制药有限公司 | 5 | 2 | 5 |
| 10 | 四川依科制药有限公司 | 4 | 4 | 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
43 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/30Import · Class 1 | CG0070注射液JXSL2101105 | CG Oncology Inc.; Lepu Biopharma Co. Ltd. |
| 2021/08/30Generic · Class 3 | 米力农注射液CYHS2101658 | 华润三九（雅安）药业有限公司 |
| 2021/08/30Generic · Class 3 | 米力农注射液CYHS2101657 | 华润三九（雅安）药业有限公司 |
| 2021/08/30Generic · Class 3 | 盐酸普拉格雷片CYHS2101653 | 重庆医药（集团）股份有限公司; 重庆科瑞制药（集团）有限公司 |
| 2021/08/30Generic · Class 3 | 普瑞巴林口服溶液CYHS2101642 | 成都慧德医药科技有限公司; 成都迪康药业股份有限公司 |
| 2021/08/30New drug · Class 3.3 | 地舒单抗注射液CXSS2101023 | 齐鲁制药有限公司 |
| 2021/08/30New drug · Class 3.3 | 四价流感病毒裂解疫苗CXSL2101293 | 江苏康润生物科技有限公司 |
| 2021/08/30New drug · Class 3.2 | 四价流感病毒裂解疫苗CXSL2101292 | 江苏康润生物科技有限公司 |
| 2021/08/30New drug · Class 1 | 注射用CN202CXSL2101291 | 同润生物医药（上海）有限公司 |
| 2021/08/30New drug · Class 1 | PZ-1片CXHL2101440 | 重庆文理学院 |
| 2021/08/30New drug · Class 1 | PZ-1片CXHL2101439 | 重庆文理学院 |
| 2021/08/27Import · Class 1 | Rozanolixizumab注射液JXSL2101103 | UCB Pharma SA; UCB Trading (Shanghai) Co. Ltd |
| 2021/08/27Import · Class 1 | HBM9161(HL161BKN)注射液JXSL2101102 | Harbour BioMed Therapeutics Limited; 和铂医药（苏州）有限公司 |
| 2021/08/27Generic · Class 3 | 琥珀酸去甲文拉法辛缓释片CYHS2101652 | 浙江尖峰药业有限公司 |
| 2021/08/27Generic · Class 3 | 琥珀酸去甲文拉法辛缓释片CYHS2101651 | 浙江尖峰药业有限公司 |
| 2021/08/27Generic · Class 3 | 法维拉韦片CYHS2101646 | 北京四环制药有限公司 |
| 2021/08/27New drug · Class 1.1 | 乳藤胶囊CXZL2101023 | 中南民族大学 |
| 2021/08/27New drug · Class 1 | UBP1213sc注射液CXSL2101290 | 上海君实生物医药科技股份有限公司 |
| 2021/08/27New drug · Class 3.3 | 阿柏西普眼内注射溶液CXSL2101289 | 四川三叶草生物制药有限公司 |
| 2021/08/27New drug · Class 1 | YH001注射液CXSL2101288 | 祐和医药科技（北京）有限公司 |
| 2021/08/27New drug · Class 1 | LBL-007注射液CXSL2101286 | 南京维立志博生物科技有限公司 |
| 2021/08/27New drug · Class 3.3 | 长效重组人胰高血糖素样肽-1注射液CXSL2101283 | 北京双鹭药业股份有限公司 |
| 2021/08/27New drug · Class 3.3 | 长效重组人胰高血糖素样肽-1注射液CXSL2101282 | 北京双鹭药业股份有限公司 |
| 2021/08/27New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液CXSL2101280 | 石药集团中奇制药技术（石家庄）有限公司 |
| 2021/08/27New drug · Class 1 | GH21胶囊CXHL2101438 | 勤浩医药（苏州）有限公司 |
| 2021/08/27New drug · Class 1 | GH21胶囊CXHL2101437 | 勤浩医药（苏州）有限公司 |
| 2021/08/27New drug · Class 1 | GH21胶囊CXHL2101436 | 勤浩医药（苏州）有限公司 |
| 2021/08/26Import · Class 1 | M7824 (MSB0011359C)JXSL2101104 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2021/08/26Import · Class 3.3 | 乌司奴单抗注射液JXSL2101100 | Alvotech Swiss AG; Alvotech & CCHT Biopharmaceutical Co. Ltd. |
| 2021/08/26Generic · Class 3 | 盐酸多柔比星脂质体注射液CYHS2101637 | 浙江智达药业有限公司 |
13 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.