药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/08/17 – 2021/08/23
- New acceptances this week
- 241
- Drugs with new generic filings (by drug name, de-duplicated)
- 31
- 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.
Drug and company names link to detail pages; sign in to view them.
New acceptances this week
By application type and drug type
241filings, 40 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 139 |
| Generic | 40 |
| New drug | 34 |
| Unspecified | 15 |
| Import | 13 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 156 |
| TCM | 43 |
| 治疗用生物制品 | 38 |
| Biologic | 3 |
| 预防用生物制品 | 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
31 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 吡仑帕奈片 | 4 | 1 | 2 |
| 2 | 伏格列波糖片 | 2 | 1 | 0 |
| 3 | 培哚普利叔丁胺片 | 2 | 1 | 5 |
| 4 | 奥硝唑注射液 | 2 | 1 | 0 |
| 5 | 琥珀酸曲格列汀片 | 2 | 1 | 1 |
| 6 | 碘帕醇注射液 | 2 | 1 | 0 |
| 7 | 舒更葡糖钠注射液 | 2 | 1 | 6 |
| 8 | 吸入用异丙托溴铵溶液 | 1 | 1 | 2 |
| 9 | 吸入用盐酸氨溴索溶液 | 1 | 1 | 10 |
| 10 | 塞来昔布胶囊 | 1 | 1 | 5 |
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
136 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山东润中药业有限公司 | 16 | 15 | 0 |
| 2 | Merck Sharp & Dohme Corp. | 6 | 1 | 0 |
| 3 | 湖北美思创药业有限公司 | 5 | 5 | 0 |
| 4 | 秦皇岛大恩药业有限公司 | 5 | 5 | 0 |
| 5 | 陕西宝灵康制药有限公司 | 5 | 4 | 0 |
| 6 | 哈尔滨瀚邦医疗科技有限公司 | 5 | 1 | 0 |
| 7 | 山东二叶制药有限公司 | 5 | 1 | 0 |
| 8 | 源合盛（吉林）药业有限公司 | 4 | 4 | 0 |
| 9 | 成都倍特得诺药业有限公司 | 4 | 2 | 1 |
| 10 | 江苏恒瑞医药股份有限公司 | 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
57 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/23Import · Class 3.1 | 雷莫西尤单抗注射液JXSS2101018 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2021/08/23Import · Class 3.1 | 雷莫西尤单抗注射液JXSS2101017 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2021/08/23Import · Class 1 | BI655130注射液JXSL2101098 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/08/23Import · Class 2.4 | ATG-010片JXHL2101168 | Karyopharm Therapeutics Inc.; Antengene Corporation Co. Ltd. |
| 2021/08/23New drug · Class 3.2 | 口服五价重配轮状病毒减毒活疫苗（Vero细胞）CXSL2101279 | 深圳康泰生物制品股份有限公司; 北京民海生物科技有限公司 |
| 2021/08/23New drug · Class 1 | SHR-1701注射液CXSL2101275 | 苏州盛迪亚生物医药有限公司 |
| 2021/08/23New drug · Class 1 | 重组抗PD-1人源化单克隆抗体注射液CXSL2101270 | 三生国健药业（上海）股份有限公司 |
| 2021/08/23New drug · Class 1 | ATG-008片CXHL2101427 | 上海德琪医药科技有限公司 |
| 2021/08/23New drug · Class 1 | ATG-008片CXHL2101426 | 上海德琪医药科技有限公司 |
| 2021/08/23New drug · Class 2.4 | 甲磺酸阿帕替尼片CXHL2101425 | 江苏恒瑞医药股份有限公司 |
| 2021/08/23New drug · Class 2.4 | 甲磺酸阿帕替尼片CXHL2101424 | 江苏恒瑞医药股份有限公司 |
| 2021/08/23New drug · Class 2.4 | 甲磺酸阿帕替尼片CXHL2101423 | 江苏恒瑞医药股份有限公司 |
| 2021/08/20Generic · Class 3 | 葡萄糖酸钙注射液CYHS2101610 | 浙江瑞邦药业股份有限公司; 山西诺成制药有限公司 |
| 2021/08/20Generic · Class 3 | 琥珀酸曲格列汀片CYHS2101572 | 石药集团欧意药业有限公司 |
| 2021/08/20New drug · Class 2.2 | 替雷利珠单抗注射液CXSS2101021 | 百济神州（上海）生物科技有限公司; 广州百济神州生物制药有限公司 |
| 2021/08/20New drug · Class 1 | TQB2450注射液CXSL2101276 | 正大天晴药业集团股份有限公司 |
| 2021/08/20New drug · Class 2.2 | 丁苯酞注射液CXHL2101422 | 奥信阳光（北京）药业科技有限公司 |
| 2021/08/20New drug · Class 1 | BEBT-209胶囊CXHL2101421 | 广州必贝特医药技术有限公司 |
| 2021/08/20New drug · Class 1 | BEBT-209胶囊CXHL2101420 | 广州必贝特医药技术有限公司 |
| 2021/08/19Import · Class 2.2 | 度伐利尤单抗注射液JXSL2101099 | MedImmune LLC; AstraZeneca Investment (China) Co. Limited |
| 2021/08/19Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHS2101604 | 海口天行健药物研究有限公司; 海南合瑞制药股份有限公司 |
| 2021/08/19New drug · Class 1 | AK112注射液CXSL2101274 | 中山康方生物医药有限公司 |
| 2021/08/19New drug · Class 1 | YH003注射液CXSL2101273 | 祐和医药科技（北京）有限公司 |
| 2021/08/19New drug · Class 2.2 | 克来夫定胶囊CXHL2101419 | 广西慧宝源医药科技有限公司 |
| 2021/08/19New drug · Class 2.2 | 克来夫定胶囊CXHL2101418 | 广西慧宝源医药科技有限公司 |
| 2021/08/19New drug · Class 1 | ENN0403 胶囊CXHL2101417 | 轶诺（浙江）药业有限公司 |
| 2021/08/19New drug · Class 1 | ENN0403 胶囊CXHL2101416 | 轶诺（浙江）药业有限公司 |
| 2021/08/19New drug · Class 1 | ENN0403 胶囊CXHL2101415 | 轶诺（浙江）药业有限公司 |
| 2021/08/19New drug · Class 1 | JAB-21822片CXHL2101414 | 北京加科思新药研发有限公司 |
| 2021/08/19New drug · Class 1 | JAB-21822片CXHL2101413 | 北京加科思新药研发有限公司 |
27 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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