药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/03/23 – 2021/03/29
- New acceptances this week
- 201
- Drugs with new generic filings (by drug name, de-duplicated)
- 8
- 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
201filings, 10 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 110 |
| New drug | 42 |
| Import | 21 |
| Unspecified | 12 |
| Generic | 10 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 144 |
| 治疗用生物制品 | 33 |
| TCM | 15 |
| 预防用生物制品 | 8 |
| 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
8 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 塞来昔布胶囊 | 2 | 1 | 5 |
| 2 | 酒石酸伐尼克兰片 | 2 | 1 | 3 |
| 3 | 头孢地尼颗粒 | 1 | 1 | 3 |
| 4 | 氟比洛芬酯注射液 | 1 | 1 | 0 |
| 5 | 特利加压素注射液 | 1 | 1 | 0 |
| 6 | 盐酸文拉法辛缓释胶囊 | 1 | 1 | 0 |
| 7 | 碳酸镧咀嚼片 | 1 | 1 | 2 |
| 8 | 磷酸西格列汀片 | 1 | 1 | 2 |
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
109 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 四川科伦药业股份有限公司 | 12 | 5 | 0 |
| 2 | 海南赛立克药业有限公司 | 11 | 11 | 0 |
| 3 | Kyowa Kirin Co. Ltd. | 6 | 1 | 0 |
| 4 | 华北制药金坦生物技术股份有限公司 | 5 | 1 | 0 |
| 5 | Aurobindo Pharma Limited | 4 | 1 | 0 |
| 6 | Merck Europe B.V. | 4 | 1 | 0 |
| 7 | Sunovion Pharmaceuticals Inc. | 4 | 1 | 0 |
| 8 | 深圳明赛瑞霖药业有限公司 | 4 | 1 | 0 |
| 9 | Bard Pharmaceuticals Limited | 3 | 2 | 0 |
| 10 | Merck Sharp & Dohme Corp. | 3 | 2 | 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
58 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/03/29Import · Class 2.4 | BYL719JXHL2101001 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/03/29Import · Class 2.4 | BYL719JXHL2101000 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/03/29New drug · Class 1 | SH3765片CXHL2101015 | 南京汇诚制药有限公司 |
| 2021/03/29New drug · Class 1 | SH3765片CXHL2101014 | 南京汇诚制药有限公司 |
| 2021/03/29New drug · Class 2.2 | 吡非尼酮双释片CXHL2101012 | 越洋医药开发（广州）有限公司 |
| 2021/03/27New drug · Class 2.4 | ZHB111注射液CXSL2100107 | 江苏众红生物工程创药研究院有限公司 |
| 2021/03/27New drug · Class 2.2 | 注射用西罗莫司（白蛋白结合型）CXHL2101013 | 石药集团中奇制药技术（石家庄）有限公司 |
| 2021/03/27New drug · Class 1 | 聚乙二醇化艾塞那肽注射液CXHL2100209 | 派格生物医药（苏州）股份有限公司 |
| 2021/03/26Generic · Class 3 | 氟比洛芬酯注射液CYHS2100294 | 重庆药友制药有限责任公司 |
| 2021/03/26New drug · Class 2.2 | 注射用卡瑞利珠单抗CXSS2100032 | 苏州盛迪亚生物医药有限公司 |
| 2021/03/26New drug · Class 2.2 | 注射用卡瑞利珠单抗CXSS2100031 | 苏州盛迪亚生物医药有限公司 |
| 2021/03/26New drug · Class 1 | Ociperlimab注射液CXSL2100106 | 百济神州（广州）生物科技有限公司 |
| 2021/03/26New drug · Class 1 | GH35片CXHL2101011 | 勤浩医药（苏州）有限公司 |
| 2021/03/26New drug · Class 1 | GH35片CXHL2101010 | 勤浩医药（苏州）有限公司 |
| 2021/03/26New drug · Class 2.3 | 磷酸盐血滤置换液CXHL2100208 | 成都青山利康药业有限公司 |
| 2021/03/26New drug · Class 2.3 | 磷酸盐血滤置换液（无钙）CXHL2100207 | 成都青山利康药业有限公司 |
| 2021/03/26New drug · Class 1 | XZP-5955 片CXHL2100206 | 轩竹生物科技有限公司 |
| 2021/03/26New drug · Class 1 | XZP-5955 片CXHL2100205 | 轩竹生物科技有限公司 |
| 2021/03/26New drug · Class 1 | XZP-5955 片CXHL2100204 | 轩竹生物科技有限公司 |
| 2021/03/25Import · Class 1 | Tiragolumab注射液JXSL2100042 | F.Hoffmann-La Roche Ltd |
| 2021/03/25Import · Class 1 | SEP-363856片JXHL2100108 | Sunovion Pharmaceuticals Inc. |
| 2021/03/25Import · Class 1 | SEP-363856片JXHL2100107 | Sunovion Pharmaceuticals Inc. |
| 2021/03/25Import · Class 1 | SEP-363856片JXHL2100106 | Sunovion Pharmaceuticals Inc. |
| 2021/03/25Import · Class 1 | SEP-363856片JXHL2100105 | Sunovion Pharmaceuticals Inc. |
| 2021/03/25Generic · Class 3 | 特利加压素注射液CYHS2100290 | 深圳市健翔生物制药有限公司 |
| 2021/03/25New drug · Class 3.3 | 贝伐珠单抗注射液CXSL2100105 | 百奥泰生物制药股份有限公司 |
| 2021/03/25New drug · Class 3.3 | 贝伐珠单抗注射液CXSL2100104 | 百奥泰生物制药股份有限公司 |
| 2021/03/25New drug · Class 1 | AK117注射液CXSL2100103 | 中山康方生物医药有限公司 |
| 2021/03/25New drug · Class 1 | 二甲苯磺酸萘普替尼片CXHL2100203 | 深圳海王医药科技研究院有限公司 |
| 2021/03/24Import · Class 1 | 巴替利单抗注射液JXSL2100044 | Agenus Inc. |
28 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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