药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/02/28 – 2023/03/06
- New acceptances this week
- 232
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
232filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 124 |
| Generic | 48 |
| New drug | 28 |
| Import | 11 |
| Import re-registration | 11 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 158 |
| TCM | 40 |
| 治疗用生物制品 | 24 |
| 预防用生物制品 | 6 |
| Biologic | 3 |
| 体外诊断试剂 | 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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 乳果糖口服溶液 | 4 | 2 | 36 |
| 2 | 达格列净片 | 4 | 2 | 82 |
| 3 | 盐酸去氧肾上腺素注射液 | 3 | 2 | 5 |
| 4 | 利丙双卡因乳膏 | 2 | 2 | 25 |
| 5 | 卡络磺钠注射液 | 2 | 1 | 1 |
| 6 | 托拉塞米注射液 | 2 | 1 | 1 |
| 7 | 氨茶碱注射液 | 2 | 1 | 3 |
| 8 | 玻璃酸钠滴眼液 | 2 | 1 | 29 |
| 9 | 盐酸氨溴索口服溶液 | 2 | 1 | 45 |
| 10 | 米诺地尔外用溶液 | 2 | 1 | 0 |
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
153 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 黑龙江亿达鸿药业有限公司 | 15 | 14 | 0 |
| 2 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 3 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 4 | N.V. Organon | 4 | 2 | 0 |
| 5 | 内蒙古亿利制药有限公司 | 3 | 3 | 0 |
| 6 | 威海华洋药业有限公司 | 3 | 2 | 0 |
| 7 | 成都瑞尔医药科技有限公司 | 3 | 2 | 3 |
| 8 | 江苏康宁杰瑞生物制药有限公司 | 3 | 2 | 0 |
| 9 | 苏州二叶制药有限公司 | 3 | 2 | 0 |
| 10 | 黑龙江中桂制药有限公司 | 3 | 2 | 2 |
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
63 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/03/06New drug · Class 2.2;2.4 | 注射用辅酶ICXHL2300269 | 合肥康诺生物制药有限公司 |
| 2023/03/04Import · Class 2.2 | Upadacitinib口服溶液JXHL2300042 | AbbVie Inc. |
| 2023/03/04Generic · Class 3 | 对乙酰氨基酚甘露醇注射液CYHS2300699 | 吉林康乃尔药业有限公司 |
| 2023/03/04Generic · Class 3 | 富马酸酮替芬鼻喷雾剂CYHS2300696 | 山东泰合医药科技有限公司; 山东京卫制药有限公司 |
| 2023/03/04Generic · Class 3 | 氨茶碱注射液CYHS2300685 | 北京百美特生物制药有限公司 |
| 2023/03/04Generic · Class 3 | 氨茶碱注射液CYHS2300684 | 北京百美特生物制药有限公司 |
| 2023/03/04New drug · Class 1.1 | 健脾益肾丸CXZL2300016 | 深圳市中医院 |
| 2023/03/04New drug · Class 1 | BSI-060T注射液CXSL2300171 | 博奥信生物技术(南京)有限公司 |
| 2023/03/04New drug · Class 1 | XH101注射液CXSL2300170 | 深圳市新合生物医疗科技有限公司 |
| 2023/03/04New drug · Class 1 | 靶向BCMA-CD19的安全型嵌合抗原受体T细胞注射液CXSL2300169 | 湖南思为康医药有限公司 |
| 2023/03/04New drug · Class 1 | 9MW3911注射液CXSL2300168 | 南京诺艾新生物技术有限公司 |
| 2023/03/03Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母)JXSS2300020 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd. |
| 2023/03/03Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母)JXSS2300019 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd. |
| 2023/03/03Import · Class 1 | Milvexian片JXHL2300041 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/03/03Generic · Class 3 | 盐酸去氧肾上腺素注射液CYHS2300680 | 广州维奥康药业科技有限公司; 广东星昊药业有限公司 |
| 2023/03/03Generic · Class 3 | 米诺地尔外用溶液CYHS2300679 | 济南中海医药科技有限公司; 烟台鲁银药业有限公司 |
| 2023/03/03Generic · Class 3 | 米诺地尔外用溶液CYHS2300678 | 济南中海医药科技有限公司; 烟台鲁银药业有限公司 |
| 2023/03/03Generic · Class 3 | 琥珀酸美托洛尔缓释胶囊CYHS2300677 | 福建省宝诺医药研发有限公司; 浙江京新药业股份有限公司 |
| 2023/03/03Generic · Class 3 | 盐酸去氧肾上腺素注射液CYHS2300675 | 成都瑞尔医药科技有限公司; 四川美大康佳乐药业有限公司 |
| 2023/03/03Generic · Class 3 | 盐酸去氧肾上腺素注射液CYHS2300674 | 成都瑞尔医药科技有限公司; 四川美大康佳乐药业有限公司 |
| 2023/03/03Generic · Class 3 | 托拉塞米注射液CYHS2300673 | 北京元延医药科技股份有限公司; 西安汉丰药业有限责任公司 |
| 2023/03/03Generic · Class 3 | 托拉塞米注射液CYHS2300672 | 北京元延医药科技股份有限公司; 西安汉丰药业有限责任公司 |
| 2023/03/03New drug · Class 1 | 重组人源化抗HER2双特异性抗体注射液CXSL2300166 | 上海津曼特生物科技有限公司 |
| 2023/03/03New drug · Class 1 | BRL-186616片CXHL2300268 | 厦门市博瑞来医药科技有限公司 |
| 2023/03/03New drug · Class 1 | BRL-186616片CXHL2300267 | 厦门市博瑞来医药科技有限公司 |
| 2023/03/03New drug · Class 2.2 | 注射用阿立哌唑缓释微球CXHL2300266 | 辉粒药业(苏州)有限公司 |
| 2023/03/03New drug · Class 2.4 | 注射用多西他赛(白蛋白结合型)CXHL2300265 | 石药集团中奇制药技术(石家庄)有限公司 |
| 2023/03/03New drug · Class 1 | WXSH0102片CXHL2300264 | 辰欣药业股份有限公司 |
| 2023/03/03New drug · Class 1 | WXSH0102片CXHL2300263 | 辰欣药业股份有限公司 |
| 2023/03/03New drug · Class 2.4 | 奥布替尼片CXHL2300262 | 北京诺诚健华医药科技有限公司 |
33 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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