药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/06/13 – 2023/06/19
- New acceptances this week
- 264
- Drugs with new generic filings (by drug name, de-duplicated)
- 43
- Accepted this week, now under review
- 2
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
264filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 133 |
| Generic | 57 |
| New drug | 42 |
| Import | 19 |
| Unspecified | 9 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 183 |
| TCM | 47 |
| 治疗用生物制品 | 30 |
| Biologic | 2 |
| 预防用生物制品 | 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
43 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿卡波糖片 | 3 | 2 | 3 |
| 2 | 二十碳五烯酸乙酯软胶囊 | 2 | 2 | 25 |
| 3 | 恩格列净片 | 2 | 2 | 18 |
| 4 | 美索巴莫注射液 | 2 | 2 | 3 |
| 5 | ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 | 2 | 1 | 0 |
| 6 | 伊布替尼片 | 2 | 1 | 0 |
| 7 | 呋塞米注射液 | 2 | 1 | 6 |
| 8 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 9 | 左卡尼汀注射液 | 2 | 1 | 5 |
| 10 | 盐酸丙卡特罗口服溶液 | 2 | 1 | 12 |
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
174 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 长沙爱贝高药业有限公司 | 6 | 6 | 0 |
| 2 | Janssen Research & Development LLC | 5 | 5 | 0 |
| 3 | 上海皇象铁力蓝天制药有限公司 | 5 | 5 | 0 |
| 4 | 安国亚东生物制药有限公司 | 5 | 5 | 0 |
| 5 | 黄石燕舞药业有限公司 | 4 | 4 | 0 |
| 6 | Novartis Pharma Schweiz AG | 4 | 3 | 0 |
| 7 | 四川科伦药业股份有限公司 | 4 | 3 | 4 |
| 8 | 杭州剂泰医药科技有限责任公司 | 4 | 1 | 0 |
| 9 | 浙江亚太药业股份有限公司 | 4 | 1 | 0 |
| 10 | 石药集团中奇制药技术(石家庄)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
78 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/19Generic · Class 3 | 伊布替尼片CYHS2301654 | 齐鲁制药(海南)有限公司 |
| 2023/06/19Generic · Class 3 | 伊布替尼片CYHS2301653 | 齐鲁制药(海南)有限公司 |
| 2023/06/19New drug · Class 1 | 人肝细胞血浆灌流器CXSL2300421 | 苏州瑞徕生物科技有限公司 |
| 2023/06/19New drug · Class 2.2 | IBI310CXSL2300420 | 信达生物制药(苏州)有限公司 |
| 2023/06/19New drug · Class 1 | HSK21542片CXHL2300665 | 西藏海思科制药有限公司 |
| 2023/06/19New drug · Class 1 | HSK21542片CXHL2300664 | 西藏海思科制药有限公司 |
| 2023/06/19New drug · Class 1 | TCIC-002颗粒CXHL2300663 | 唐传生物科技(厦门)有限公司 |
| 2023/06/19New drug · Class 1 | TCIC-002颗粒CXHL2300662 | 唐传生物科技(厦门)有限公司 |
| 2023/06/17Generic · Class 3 | 盐酸丙美卡因滴眼液CYHS2301650 | 合肥立方制药股份有限公司; 浙江莎普爱思药业股份有限公司 |
| 2023/06/17Generic · Class 3 | 注射用苯唑西林钠CYHS2301647 | 江苏江丰医药科技有限公司; 山东睿鹰制药集团有限公司 |
| 2023/06/17New drug · Class 1 | SPH3127片CXHS2300055 | 上海上药信谊药厂有限公司 |
| 2023/06/17New drug · Class 1 | RAB001注射液CXHL2300661 | 中山莱博瑞辰生物医药有限公司 |
| 2023/06/17New drug · Class 1 | 泰普格雷片CXHL2300660 | 天津药物研究院有限公司 |
| 2023/06/17New drug · Class 1 | 泰普格雷片CXHL2300659 | 天津药物研究院有限公司 |
| 2023/06/17New drug · Class 1 | 泰普格雷片CXHL2300658 | 天津药物研究院有限公司 |
| 2023/06/16Import · Class 1 | MEDI5752JXSL2300110 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/06/16Import · Class 2.2 | 古塞奇尤单抗注射液JXSL2300109 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/06/16Import · Class 2.3 | Guselkumab/Golimumab(JNJ-78934804)注射液JXSL2300108 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/06/16Import · Class 2.2 | 戈利木单抗注射液JXSL2300107 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/06/16Import · Class 1 | LOXO-783片JXHL2300143 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/06/16Import · Class 1 | LOXO-783片JXHL2300142 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/06/16Import · Class 1 | RO7435846片JXHL2300141 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/06/16Import · Class 1 | RO7435846片JXHL2300140 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/06/16Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2301644 | 湖南银泽华浩生物科技有限公司; 双鹤药业(海南)有限责任公司 |
| 2023/06/16Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2301643 | 湖南银泽华浩生物科技有限公司; 双鹤药业(海南)有限责任公司 |
| 2023/06/16Generic · Class 3 | 二羟丙茶碱注射液CYHS2301642 | 江苏瑜兴医药科技有限公司; 亚邦医药股份有限公司 |
| 2023/06/16Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2301639 | 山西振东泰盛制药有限公司 |
| 2023/06/16Generic · Class 3 | 呋塞米口服溶液CYHS2301638 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2023/06/16Generic · Class 3 | 盐酸丙卡特罗口服溶液CYHS2301636 | 广东稳健药业有限公司; 山西同达药业有限公司 |
| 2023/06/16Generic · Class 3 | 盐酸丙卡特罗口服溶液CYHS2301635 | 广东稳健药业有限公司; 山西同达药业有限公司 |
48 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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