药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/02/16 – 2021/02/22
- New acceptances this week
- 120
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- 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
120filings, 23 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 70 |
| Generic | 23 |
| New drug | 17 |
| Import | 9 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 92 |
| 治疗用生物制品 | 18 |
| TCM | 8 |
| 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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 哌柏西利胶囊 | 3 | 1 | 0 |
| 2 | 注射用培美曲塞二钠 | 2 | 1 | 2 |
| 3 | 注射用阿奇霉素 | 2 | 1 | 11 |
| 4 | 盐酸帕洛诺司琼注射液 | 2 | 1 | 1 |
| 5 | 依托考昔片 | 1 | 1 | 8 |
| 6 | 吸入用七氟烷 | 1 | 1 | 0 |
| 7 | 布立西坦注射液 | 1 | 1 | 0 |
| 8 | 戊酸雌二醇片 | 1 | 1 | 7 |
| 9 | 拉考沙胺糖浆 | 1 | 1 | 0 |
| 10 | 来那度胺胶囊 | 1 | 1 | 3 |
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
74 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 西安京西双鹤药业有限公司 | 6 | 2 | 0 |
| 2 | 河北天成药业股份有限公司 | 4 | 4 | 0 |
| 3 | 海南海灵化学制药有限公司 | 4 | 2 | 0 |
| 4 | 苏州君境生物医药科技有限公司 | 4 | 2 | 0 |
| 5 | Pfizer Europe MA EEIG | 4 | 1 | 0 |
| 6 | 江苏恒瑞医药股份有限公司 | 3 | 2 | 1 |
| 7 | 湖北梦阳药业股份有限公司 | 3 | 2 | 0 |
| 8 | H. Lundbeck A/S | 3 | 1 | 0 |
| 9 | Novo Nordisk A/S | 3 | 1 | 0 |
| 10 | Pfizer Australia Pty Ltd | 3 | 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
25 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/02/22New drug · Class 2.2 | 替雷利珠单抗注射液CXSL2100061 | 百济神州（上海）生物科技有限公司 |
| 2021/02/22New drug · Class 1 | AP-L1898胶囊CXHL2100123 | 苏州君境生物医药科技有限公司 |
| 2021/02/22New drug · Class 1 | AP-L1898胶囊CXHL2100122 | 苏州君境生物医药科技有限公司 |
| 2021/02/21Generic · Class 3 | 盐酸多塞平片CYHS2100214 | 沈阳华泰药物研究有限公司; 沈阳福宁药业有限公司 |
| 2021/02/21Generic · Class 3 | 布立西坦注射液CYHS2100213 | 扬子江药业集团四川海蓉药业有限公司 |
| 2021/02/21New drug · Class 1 | JMKX000189片CXHL2100120 | 上海济煜医药科技有限公司 |
| 2021/02/21New drug · Class 1 | JMKX000189片CXHL2100119 | 上海济煜医药科技有限公司 |
| 2021/02/21New drug · Class 1 | JMKX000189片CXHL2100118 | 上海济煜医药科技有限公司 |
| 2021/02/21New drug · Class 1 | FM888胶囊CXHL2100117 | 青岛永展医药科技有限公司 |
| 2021/02/21New drug · Class 1 | FM888胶囊CXHL2100116 | 青岛永展医药科技有限公司 |
| 2021/02/20Import · Class 1 | Belzutifan片JXHL2100053 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. |
| 2021/02/20New drug · Class 1 | 9MW1911注射液CXSL2100060 | 迈威（上海）生物科技股份有限公司 |
| 2021/02/20New drug · Class 1 | QL1779注射液CXSL2100059 | 齐鲁制药有限公司 |
| 2021/02/20New drug · Class 1 | 9MW1911注射液CXSL2100058 | 迈威（上海）生物科技股份有限公司 |
| 2021/02/20New drug · Class 2.4 | 甲磺酸仑伐替尼胶囊CXHL2100115 | 先声药业有限公司 |
| 2021/02/20New drug · Class 1 | 注射用BXOS110CXHL2100113 | 拜西欧斯（北京）生物技术有限公司 |
| 2021/02/19Import · Class 3.1 | 达雷妥尤单抗注射液JXSS2100016 | Janssen-Cilag International NV; Cilag AG |
| 2021/02/19Import · Class 3.1 | 达雷妥尤单抗注射液JXSS2100015 | Janssen-Cilag International NV; Cilag AG |
| 2021/02/19Import · Class 2.2 | Semaglutide片JXSL2100028 | Novo Nordisk A/S |
| 2021/02/19Import · Class 2.2 | Semaglutide片JXSL2100027 | Novo Nordisk A/S |
| 2021/02/19Import · Class 2.2 | Semaglutide片JXSL2100026 | Novo Nordisk A/S |
| 2021/02/19New drug · Class 1 | 9MW1911注射液CXSL2100057 | 迈威（上海）生物科技股份有限公司 |
| 2021/02/19New drug · Class 2.2 | 磷酸奥司他韦缓释片CXHL2100114 | 广东东阳光药业有限公司 |
| 2021/02/19New drug · Class 1 | WJ01024片CXHL2100108 | 苏州君境生物医药科技有限公司 |
| 2021/02/19New drug · Class 1 | WJ01024片CXHL2100107 | 苏州君境生物医药科技有限公司 |
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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