药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2020/12/29 – 2021/01/04
The daily national snapshot started on 2026/10/22; the earlier days of this week have no complete acceptance-list snapshot yet, so this week's counts may be lower than the national total.
- New acceptances this week
- 115
- Drugs with new generic filings (by drug name, de-duplicated)
- 9
- 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
115filings, 10 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 70 |
| Unspecified | 19 |
| New drug | 13 |
| Generic | 10 |
| Import | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 90 |
| 治疗用生物制品 | 19 |
| 预防用生物制品 | 3 |
| TCM | 2 |
| 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
9 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸罗哌卡因注射液 | 2 | 1 | 5 |
| 2 | 恩曲他滨替诺福韦片 | 1 | 1 | 0 |
| 3 | 托拉塞米注射液 | 1 | 1 | 1 |
| 4 | 玻璃酸钠滴眼液 | 1 | 1 | 29 |
| 5 | 盐酸氨溴索注射液 | 1 | 1 | 9 |
| 6 | 盐酸莫西沙星氯化钠注射液 | 1 | 1 | 10 |
| 7 | 罗库溴铵注射液 | 1 | 1 | 1 |
| 8 | 舒更葡糖钠注射液 | 1 | 1 | 6 |
| 9 | 阿哌沙班片 | 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
66 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bard Pharmaceuticals Ltd. | 11 | 8 | 0 |
| 2 | F. Hoffmann-La Roche Ltd | 8 | 1 | 0 |
| 3 | Novartis Pharma Schweiz AG | 6 | 2 | 0 |
| 4 | Merck Sharp & Dohme Limited | 4 | 2 | 0 |
| 5 | Bristol-Myers Squibb Pharma EEIG | 4 | 1 | 0 |
| 6 | 江苏淮安双鹤药业有限责任公司 | 4 | 1 | 0 |
| 7 | 山东新华制药股份有限公司 | 3 | 3 | 0 |
| 8 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. | 3 | 2 | 0 |
| 9 | Patheon Inc. | 3 | 1 | 0 |
| 10 | Pfizer Inc. | 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
16 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/01/01Import · Class 1 | PM1016注射液JXSL2000238 | TILT Biotherapeutics Ltd. |
| 2021/01/01Import · Class 2.2 | DS-8201aJXSL2000237 | Daiichi Sankyo Inc. |
| 2021/01/01Generic · Class 3 | 托拉塞米注射液CYHS2000959 | 扬子江药业集团南京海陵药业有限公司; 扬子江药业集团有限公司 |
| 2021/01/01New drug · Class 1.1 | 坤怡宁颗粒CXZS2000010 | 天士力医药集团股份有限公司 |
| 2021/01/01New drug · Class 1.1 | 安心颗粒CXZL2000025 | 苏州玉森新药开发有限公司 |
| 2021/01/01New drug · Class 1 | SGN1CXSL2000388 | 广州华津医药科技有限公司 |
| 2021/01/01New drug · Class 1 | BC006单抗注射液CXSL2000387 | 宝船生物医药科技（上海）有限公司 |
| 2021/01/01New drug · Class 1 | CM326注射液CXSL2000384 | 康诺亚生物医药科技（成都）有限公司 |
| 2021/01/01New drug · Class 1 | 重组人源化抗表皮生长因子受体单克隆抗体注射液CXSL2000379 | 上海津曼特生物科技有限公司 |
| 2021/01/01New drug · Class 1 | SYHX1901片CXHL2000679 | 石药集团欧意药业有限公司 |
| 2021/01/01New drug · Class 1 | SYHX1901片CXHL2000678 | 石药集团欧意药业有限公司 |
| 2021/01/01New drug · Class 1 | LM-061片CXHL2000677 | 上海礼新医药研发有限公司 |
| 2021/01/01New drug · Class 1 | LM-061片CXHL2000676 | 上海礼新医药研发有限公司 |
| 2021/01/01New drug · Class 1 | 注射用CX13-608CXHL2000675 | 宁波圣健生物医药科技有限公司 |
| 2021/01/01New drug · Class 2.2;2.4 | 醋酸阿比特龙片（I）CXHL2000674 | 江苏恒瑞医药股份有限公司 |
| 2021/01/01New drug · Class 2.4 | 氟唑帕利胶囊CXHL2000673 | 江苏恒瑞医药股份有限公司 |
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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