药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/06/28 – 2022/07/04
- New acceptances this week
- 315
- Drugs with new generic filings (by drug name, de-duplicated)
- 39
- Accepted this week, now under review
- 1
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
315filings, 55 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 130 |
| New drug | 69 |
| Generic | 55 |
| Import | 25 |
| Import re-registration | 23 |
| Unspecified | 13 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 243 |
| 治疗用生物制品 | 42 |
| TCM | 24 |
| 预防用生物制品 | 5 |
| 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
39 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸乌拉地尔注射液 | 4 | 2 | 5 |
| 2 | 磷酸特地唑胺片 | 3 | 3 | 1 |
| 3 | 左乙拉西坦缓释片 | 3 | 2 | 0 |
| 4 | 盐酸达泊西汀片 | 3 | 2 | 20 |
| 5 | 重酒石酸去甲肾上腺素注射液 | 2 | 2 | 9 |
| 6 | 左氧氟沙星注射液 | 2 | 1 | 1 |
| 7 | 帕利哌酮缓释片 | 2 | 1 | 4 |
| 8 | 恩格列净片 | 2 | 1 | 18 |
| 9 | 盐酸多奈哌齐口崩片 | 2 | 1 | 0 |
| 10 | 苯磺酸左氨氯地平片 | 2 | 1 | 47 |
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
192 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bayer AG | 6 | 6 | 0 |
| 2 | 河北武罗药业有限公司 | 6 | 6 | 0 |
| 3 | 湖北康为远药业有限公司 | 6 | 6 | 0 |
| 4 | 仁合益康集团有限公司 | 6 | 4 | 0 |
| 5 | MUNDIPHARMA GmbH | 6 | 1 | 0 |
| 6 | 杭州邦顺制药有限公司 | 6 | 1 | 0 |
| 7 | 正大天晴药业集团股份有限公司 | 4 | 2 | 0 |
| 8 | 苏州亚盛药业有限公司 | 4 | 2 | 0 |
| 9 | Novartis Pharma Schweiz AG | 4 | 1 | 0 |
| 10 | Pfizer Europe MA EEIG | 4 | 1 | 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
96 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/07/04Import · Class 1 | CetrelimabJXSL2200102 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/07/04Import · Class 1 | BN301JXSL2200101 | Sutro Biopharma Inc.; BioNova Pharmaceuticals (Shanghai) Limited |
| 2022/07/04Import · Class 1 | BN301JXSL2200100 | Sutro Biopharma Inc.; BioNova Pharmaceuticals (Shanghai) Limited |
| 2022/07/04Import · Class 2.4 | Upadacitinib片JXHL2200169 | AbbVie Inc. |
| 2022/07/04Generic · Class 3 | 左乙拉西坦缓释片CYHS2200993 | 华润赛科药业有限责任公司 |
| 2022/07/04Generic · Class 3 | 左乙拉西坦缓释片CYHS2200992 | 华润赛科药业有限责任公司 |
| 2022/07/04New drug · Class 1 | AC-003胶囊CXHL2200471 | 爱科诺生物医药(苏州)有限公司 |
| 2022/07/04New drug · Class 1 | AC-003胶囊CXHL2200470 | 爱科诺生物医药(苏州)有限公司 |
| 2022/07/04New drug · Class 1 | HE009片CXHL2200469 | 南昌弘益药业有限公司 |
| 2022/07/04New drug · Class 1 | HE009片CXHL2200468 | 南昌弘益药业有限公司 |
| 2022/07/04New drug · Class 1 | HE009片CXHL2200467 | 南昌弘益药业有限公司 |
| 2022/07/04New drug · Class 1 | BGB-15025片CXHL2200466 | 百济神州(苏州)生物科技有限公司 |
| 2022/07/02Import · Class 3.3 | 贝伐珠单抗注射液JXSL2200099 | Joint Stock Company“BIOCAD”,(JSC“BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd. |
| 2022/07/02Import · Class 3.3 | 贝伐珠单抗注射液JXSL2200098 | Joint Stock Company“BIOCAD”,(JSC“BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd. |
| 2022/07/02Import · Class 2.2 | Amivantamab注射液JXSL2200095 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/07/02New drug · Class 1 | BA1106注射液CXSL2200307 | 山东博安生物技术股份有限公司 |
| 2022/07/02New drug · Class 1 | LTC004CXSL2200306 | 北京志道生物科技有限公司 |
| 2022/07/02New drug · Class 1 | 注射用低分子量岩藻糖化糖胺聚糖钠CXSL2200305 | 牡丹江友搏药业有限责任公司 |
| 2022/07/02New drug · Class 1 | 靶向GPC3嵌合抗原受体自体T细胞注射液CXSL2200304 | 原启生物科技(上海)有限责任公司 |
| 2022/07/02New drug · Class 1 | AK119注射液CXSL2200296 | 中山康方生物医药有限公司 |
| 2022/07/02New drug · Class 1 | JBPOS0101胶囊CXHL2200463 | 浙江京新药业股份有限公司 |
| 2022/07/02New drug · Class 1 | JBPOS0101胶囊CXHL2200462 | 浙江京新药业股份有限公司 |
| 2022/07/02New drug · Class 1 | JBPOS0101胶囊CXHL2200461 | 浙江京新药业股份有限公司 |
| 2022/07/02New drug · Class 1 | GW201片CXHL2200460 | 北京广为医药科技有限公司 |
| 2022/07/02New drug · Class 1 | GW201片CXHL2200459 | 北京广为医药科技有限公司 |
| 2022/07/02New drug · Class 1 | GW201片CXHL2200458 | 北京广为医药科技有限公司 |
| 2022/07/02New drug · Class 1 | EVER001胶囊CXHL2200454 | 云顶新耀医药科技有限公司 |
| 2022/06/30Generic · Class 3 | 尼麦角林片CYHS2200980 | 福建海西新药创制股份有限公司; 浙江京新药业股份有限公司 |
| 2022/06/30Generic · Class 3 | 左氧氟沙星注射液CYHS2200978 | 长春海悦药业股份有限公司 |
| 2022/06/30Generic · Class 3 | 左氧氟沙星注射液CYHS2200977 | 长春海悦药业股份有限公司 |
66 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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