药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/09/07 – 2021/09/13
- New acceptances this week
- 242
- Drugs with new generic filings (by drug name, de-duplicated)
- 23
- 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
242filings, 35 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 35 |
| New drug | 33 |
| Import | 11 |
| Unspecified | 10 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 158 |
| TCM | 38 |
| 治疗用生物制品 | 36 |
| 预防用生物制品 | 7 |
| Biologic | 3 |
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
23 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 吸入用盐酸氨溴索溶液 | 3 | 2 | 10 |
| 2 | 注射用卡非佐米 | 3 | 1 | 0 |
| 3 | 烟酸缓释片 | 3 | 1 | 0 |
| 4 | 阿普米司特片 | 3 | 1 | 3 |
| 5 | 匹伐他汀钙片 | 2 | 1 | 0 |
| 6 | 氨磺必利片 | 2 | 1 | 0 |
| 7 | 盐酸林可霉素注射液 | 2 | 1 | 1 |
| 8 | 米力农注射液 | 2 | 1 | 0 |
| 9 | 克霉唑阴道片 | 1 | 1 | 3 |
| 10 | 利伐沙班片 | 1 | 1 | 3 |
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
134 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 平光制药股份有限公司 | 22 | 21 | 0 |
| 2 | 湖北叶真堂药业有限公司 | 14 | 14 | 0 |
| 3 | 贵州苗仁堂生物医药科技有限责任公司 | 7 | 7 | 0 |
| 4 | Eli Lilly Nederland B.V. | 6 | 3 | 0 |
| 5 | Bristol-Myers Squibb Pharma EEIG | 5 | 1 | 0 |
| 6 | 宜昌人福药业有限责任公司 | 4 | 2 | 4 |
| 7 | 石药集团欧意药业有限公司 | 4 | 2 | 3 |
| 8 | 百济神州（苏州）生物科技有限公司 | 4 | 1 | 0 |
| 9 | Novo Nordisk A/S | 3 | 3 | 0 |
| 10 | 济川药业集团有限公司 | 3 | 3 | 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
53 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/09/13Import · Class 1 | IcoSema 注射液JXSL2101108 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2021/09/13Import · Class 1 | TPX-0022胶囊JXHL2101174 | Turning Point Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2021/09/13Import · Class 2.4 | ATG-010片JXHL2101172 | Karyopharm Therapeutics Inc.; Antengene Corporation Co. Ltd. |
| 2021/09/13Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHS2101715 | 海南全星制药有限公司 |
| 2021/09/13Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHS2101714 | 海南全星制药有限公司 |
| 2021/09/13Generic · Class 3 | 阿奇霉素颗粒（Ⅱ）CYHS2101710 | 江西亿友药业有限公司 |
| 2021/09/13Generic · Class 3 | 米力农注射液CYHS2101702 | 四川汇宇制药股份有限公司 |
| 2021/09/13Generic · Class 3 | 米力农注射液CYHS2101701 | 四川汇宇制药股份有限公司 |
| 2021/09/13Generic · Class 3 | 胞磷胆碱钠注射液CYHS2101682 | 山东玉满坤生物科技有限公司; 瑞阳制药股份有限公司 |
| 2021/09/13New drug · Class 1 | JS012注射液CXSL2101324 | 上海君实生物医药科技股份有限公司 |
| 2021/09/13New drug · Class 3.2 | ACYW135群脑膜炎球菌多糖结合疫苗CXSL2101323 | 艾美卫信生物药业（浙江）有限公司 |
| 2021/09/13New drug · Class 1 | BGB-A445注射液CXSL2101322 | 广州百济神州生物制药有限公司 |
| 2021/09/13New drug · Class 2.2 | 注射用卡瑞利珠单抗CXSL2101321 | 苏州盛迪亚生物医药有限公司 |
| 2021/09/13New drug · Class 1 | SHR-1909注射液CXSL2101320 | 上海恒瑞医药有限公司 |
| 2021/09/13New drug · Class 1 | HH-101注射液CXSL2101319 | 华辉安健（北京）生物科技有限公司 |
| 2021/09/13New drug · Class 3.3 | 司美格鲁肽注射液CXSL2101318 | 丽珠集团新北江制药股份有限公司 |
| 2021/09/13New drug · Class 1 | CM336注射液CXSL2101317 | 康诺亚生物医药科技（成都）有限公司 |
| 2021/09/13New drug · Class 1 | BJ-001 注射液CXSL2101316 | 博际生物医药科技（杭州）有限公司 |
| 2021/09/13New 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CXSL2101311 | 江苏康宁杰瑞生物制药有限公司 |
| 2021/09/13New 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CXSL2101310 | 江苏康宁杰瑞生物制药有限公司 |
| 2021/09/13New drug · Class 1 | 普乐登赛CXSL2101309 | 上海惠盾生物技术有限公司 |
| 2021/09/13New drug · Class 2.4 | 盐酸米托蒽醌脂质体注射液CXHL2101471 | 石药集团中诺药业（石家庄）有限公司 |
| 2021/09/13New drug · Class 1 | 苹果酸法米替尼胶囊CXHL2101470 | 江苏恒瑞医药股份有限公司 |
| 2021/09/13New drug · Class 1 | 苹果酸法米替尼胶囊CXHL2101469 | 江苏恒瑞医药股份有限公司 |
| 2021/09/13New drug · Class 2.2 | 制霉菌素凝胶CXHL2101468 | 山东达因海洋生物制药股份有限公司 |
| 2021/09/13New drug · Class 1 | AND019胶囊CXHL2101467 | 杭州安道药业有限公司 |
| 2021/09/13New drug · Class 1 | AND019胶囊CXHL2101466 | 杭州安道药业有限公司 |
| 2021/09/13New drug · Class 2.2 | 西罗莫司滴眼液CXHL2101465 | 福州好吉医药科技发展有限公司 |
| 2021/09/13New drug · Class 1 | MT2004胶囊CXHL2101464 | 西安奥立泰医药科技有限公司 |
| 2021/09/13New drug · Class 1 | MT2004胶囊CXHL2101463 | 西安奥立泰医药科技有限公司 |
23 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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