药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/03/08 – 2022/03/14
- New acceptances this week
- 222
- Drugs with new generic filings (by drug name, de-duplicated)
- 24
- 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
222filings, 33 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 119 |
| Generic | 33 |
| New drug | 31 |
| Import | 15 |
| Import re-registration | 15 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 146 |
| TCM | 40 |
| 治疗用生物制品 | 32 |
| Biologic | 3 |
| 预防用生物制品 | 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
24 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 棕榈酸帕利哌酮注射液 | 3 | 1 | 8 |
| 2 | 赛洛多辛胶囊 | 2 | 2 | 1 |
| 3 | 孟鲁司特钠咀嚼片 | 2 | 1 | 4 |
| 4 | 氨磺必利注射液 | 2 | 1 | 1 |
| 5 | 氯巴占片 | 2 | 1 | 2 |
| 6 | 盐酸右美托咪定注射液 | 2 | 1 | 0 |
| 7 | 苯甲酸阿格列汀片 | 2 | 1 | 1 |
| 8 | 非布司他片 | 2 | 1 | 15 |
| 9 | 利托那韦片 | 1 | 1 | 0 |
| 10 | 右佐匹克隆片 | 1 | 1 | 0 |
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
113 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山东泽宇生物有限公司 | 12 | 11 | 0 |
| 2 | 黑龙江珍宝岛药业股份有限公司 | 10 | 10 | 0 |
| 3 | 百济神州（苏州）生物科技有限公司 | 8 | 1 | 0 |
| 4 | 乐泰药业有限公司 | 6 | 6 | 0 |
| 5 | 海南煦沃药业有限公司 | 6 | 5 | 0 |
| 6 | 齐鲁制药有限公司 | 6 | 3 | 3 |
| 7 | 信达生物制药（苏州）有限公司 | 6 | 1 | 0 |
| 8 | 江右制药（常德）有限公司 | 5 | 5 | 0 |
| 9 | Merck Sharp & Dohme Corp. | 5 | 2 | 0 |
| 10 | 北京柏雅联合药物研究所有限公司 | 4 | 4 | 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
52 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/03/14Import · Class 1 | LY3209590注射液JXSL2200027 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/03/14Import · Class 1 | AZD2936JXSL2200026 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/03/14New drug · Class 2.2 | 贝那鲁肽注射液CXSS2200027 | 上海仁会生物制药股份有限公司 |
| 2022/03/14New drug · Class 2.2 | 贝那鲁肽注射液CXSS2200026 | 上海仁会生物制药股份有限公司 |
| 2022/03/14New drug · Class 1 | QX008N注射液CXSL2200127 | 江苏荃信生物医药股份有限公司 |
| 2022/03/14New drug · Class 1 | QX008N注射液CXSL2200126 | 江苏荃信生物医药股份有限公司 |
| 2022/03/14New drug · Class 1 | 重组人GM-CSF 溶瘤II型单纯疱疹病毒（OH2）注射液（Vero 细胞）CXSL2200125 | 武汉滨会生物科技股份有限公司生物创新园分公司 |
| 2022/03/14New drug · Class 2.4 | 奥布替尼片CXHS2200016 | 北京诺诚健华医药科技有限公司; 无锡合全药业有限公司 |
| 2022/03/14New drug · Class 1 | XZB-0004胶囊CXHL2200161 | 轩竹生物科技股份有限公司 |
| 2022/03/14New drug · Class 1 | XZB-0004胶囊CXHL2200160 | 轩竹生物科技股份有限公司 |
| 2022/03/14New drug · Class 1 | XZB-0004胶囊CXHL2200159 | 轩竹生物科技股份有限公司 |
| 2022/03/14New drug · Class 1 | XZB-0004胶囊CXHL2200158 | 轩竹生物科技股份有限公司 |
| 2022/03/14New drug · Class 1 | QLH11906片CXHL2200156 | 齐鲁制药有限公司 |
| 2022/03/14New drug · Class 1 | QLH11906片CXHL2200155 | 齐鲁制药有限公司 |
| 2022/03/14New drug · Class 2.4 | 多聚糖超顺磁氧化铁注射液CXHL2200154 | 正大天晴药业集团股份有限公司 |
| 2022/03/11Import · Class 3.1 | 注射用维布妥昔单抗JXSL2200028 | Takeda Pharma A/S; Takeda(China) International Trading Co. Ltd |
| 2022/03/11Import · Class 1 | NNC0194-0499注射液JXSL2200025 | Novo Nordisk A/S; Novo Nordisk（China）Pharmaceuticals Co. Ltd. |
| 2022/03/11Import · Class 1 | CB-5339 胶囊JXHL2200056 | Cleave Therapeutics Inc.; CASI Pharmaceuticals (China) Co. Ltd. |
| 2022/03/11Import · Class 1 | CB-5339 胶囊JXHL2200055 | Cleave Therapeutics Inc.; CASI Pharmaceuticals (China) Co. Ltd. |
| 2022/03/11Generic · Class 3 | 阿立哌唑口崩片CYHS2200439 | 瑞阳制药股份有限公司 |
| 2022/03/11Generic · Class 3 | 氯巴占片CYHS2200436 | 宜昌人福药业有限责任公司 |
| 2022/03/11Generic · Class 3 | 氯巴占片CYHS2200435 | 宜昌人福药业有限责任公司 |
| 2022/03/11Generic · Class 3 | 洛索洛芬钠口服溶液CYHS2200434 | 湖南普道医药技术有限公司; 湖南九典制药股份有限公司 |
| 2022/03/11Generic · Class 3 | 盐酸右美托咪定注射液CYHS2200422 | 遂成药业股份有限公司 |
| 2022/03/11Generic · Class 3 | 盐酸右美托咪定注射液CYHS2200421 | 遂成药业股份有限公司 |
| 2022/03/11New drug · Class 2.1 | 黄氏响声儿童喷雾剂CXZL2200014 | 无锡济煜山禾医药科技有限公司; 无锡济煜山禾药业股份有限公司 |
| 2022/03/11New drug · Class 1.4 | 四价流感病毒亚单位疫苗CXSS2200023 | 江苏中慧元通生物科技股份有限公司 |
| 2022/03/11New drug · Class 1 | QL1706注射液CXSL2200124 | 齐鲁制药有限公司 |
| 2022/03/10Generic · Class 3 | 右佐匹克隆片CYHS2200427 | 常州四药制药有限公司 |
| 2022/03/10New drug · Class 2.2 | 丁苯酞注射液CXHL2200153 | 仁合益康集团有限公司 |
22 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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