药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/05/18 – 2021/05/24
- New acceptances this week
- 233
- Drugs with new generic filings (by drug name, de-duplicated)
- 26
- 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
233filings, 36 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 123 |
| New drug | 37 |
| Generic | 36 |
| Import | 25 |
| Unspecified | 8 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 176 |
| 治疗用生物制品 | 40 |
| TCM | 13 |
| 预防用生物制品 | 2 |
| 体外诊断试剂 | 1 |
| 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
26 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿普斯特片 | 4 | 2 | 0 |
| 2 | 丙泊酚中/长链脂肪乳注射液 | 3 | 1 | 3 |
| 3 | 草酸艾司西酞普兰片 | 3 | 1 | 6 |
| 4 | 孟鲁司特钠咀嚼片 | 2 | 2 | 4 |
| 5 | 舒更葡糖钠注射液 | 2 | 1 | 6 |
| 6 | 阿托伐他汀钙片 | 2 | 1 | 24 |
| 7 | 丙戊酸钠注射用浓溶液 | 1 | 1 | 0 |
| 8 | 利格列汀片 | 1 | 1 | 2 |
| 9 | 厄贝沙坦片 | 1 | 1 | 4 |
| 10 | 吡美莫司乳膏 | 1 | 1 | 6 |
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
145 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Merck Sharp & Dohme B.V. | 8 | 2 | 0 |
| 2 | AstraZeneca AB | 6 | 4 | 0 |
| 3 | 江苏豪森药业集团有限公司 | 6 | 3 | 0 |
| 4 | 安徽安科生物工程（集团）股份有限公司 | 6 | 1 | 0 |
| 5 | 浙江普洛康裕制药有限公司 | 5 | 5 | 0 |
| 6 | 西安力邦制药有限公司 | 5 | 2 | 3 |
| 7 | 浙江优胜美特中药有限公司 | 4 | 3 | 0 |
| 8 | 山东罗欣药业集团股份有限公司 | 4 | 2 | 0 |
| 9 | N.V.Organon | 4 | 1 | 0 |
| 10 | 四川百利药业有限责任公司 | 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
65 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/05/24Import · Class 3.1 | Fremanezumab注射液JXSL2101031 | TEVA GmbH; Teva Pharmaceutical Information Consulting (Shanghai) Co. Ltd. |
| 2021/05/24Generic · Class 3 | 盐酸氨溴索口服溶液CYHS2101195 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2021/05/24New drug · Class 1 | AK104注射液CXSL2101092 | 康方药业有限公司 |
| 2021/05/24New drug · Class 1 | BGB-15025胶囊CXHL2101152 | 百济神州（苏州）生物科技有限公司 |
| 2021/05/24New drug · Class 1 | BGB-15025胶囊CXHL2101151 | 百济神州（苏州）生物科技有限公司 |
| 2021/05/24New drug · Class 1 | BGB-15025胶囊CXHL2101150 | 百济神州（苏州）生物科技有限公司 |
| 2021/05/24New drug · Class 2.1;2.2;2.4 | 右美托咪定透皮贴剂CXHL2101149 | 宜昌人福药业有限责任公司 |
| 2021/05/24New drug · Class 1 | HS-20094注射液CXHL2101148 | 江苏豪森药业集团有限公司 |
| 2021/05/24New drug · Class 1 | HS-20094注射液CXHL2101147 | 江苏豪森药业集团有限公司 |
| 2021/05/24New drug · Class 1 | HS-20094注射液CXHL2101146 | 江苏豪森药业集团有限公司 |
| 2021/05/21Import · Class 2.2 | 帕博利珠单抗注射液JXSL2101029 | Merck Sharp & Dohme Corp.; MSD R&D（China）Co. Ltd. |
| 2021/05/21Import · Class 1 | PB2452注射液JXSL2101028 | SFJ Pharmaceuticals Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2021/05/21Generic · Class 3 | 阿普斯特片CYHS2101190 | 桂林南药股份有限公司 |
| 2021/05/21New drug · Class 1 | 注射用DN015089CXHL2101140 | 上海迪诺医药科技有限公司 |
| 2021/05/20Import · Class 1 | 泽弗利单抗注射液JXSL2101030 | Agenus Inc.; Betta Pharmaceuticals Co. Ltd. |
| 2021/05/20Import · Class 1 | CapivasertibJXHL2101051 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/05/20Import · Class 1 | CapivasertibJXHL2101050 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/05/20Import · Class 2.4 | Selumetinib胶囊JXHL2101049 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2021/05/20Import · Class 2.4 | Selumetinib胶囊JXHL2101048 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2021/05/20Import · Class 2.4 | 达罗他胺片JXHL2101047 | Bayer HealthCare Pharmaceuticals Inc.; Bayer Healthcare Company Ltd. |
| 2021/05/20Import · Class 2.4 | Tucatinib片JXHL2101046 | Seagen Inc.; MSD R&D (China) Co. Ltd. |
| 2021/05/20Import · Class 2.4 | Tucatinib片JXHL2101045 | Seagen Inc.; MSD R&D (China) Co. Ltd. |
| 2021/05/20New drug · Class 1.1 | 参远片CXZL2101010 | 中国医学科学院药用植物研究所 |
| 2021/05/20New drug · Class 1 | HR17031注射液CXSL2101090 | 江苏恒瑞医药股份有限公司 |
| 2021/05/20New drug · Class 1 | 全人源抗CD19和CD22自体T细胞注射液CXSL2101089 | 南京驯鹿医疗技术有限公司 |
| 2021/05/20New drug · Class 1 | 全人源抗CD19和CD22自体T细胞注射液CXSL2101088 | 南京驯鹿医疗技术有限公司 |
| 2021/05/20New drug · Class 1 | SI-B001双特异性抗体注射液CXSL2101085 | 四川百利药业有限责任公司 |
| 2021/05/20New drug · Class 2.4 | 甲磺酸阿美替尼片CXHS2101017 | 江苏豪森药业集团有限公司 |
| 2021/05/20New drug · Class 1 | 复方ACC007片CXHS2101016 | 江苏艾迪药业股份有限公司 |
| 2021/05/20New drug · Class 1 | LDS片CXHL2101144 | 上海璃道医药科技有限公司 |
35 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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