药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/11/21 – 2023/11/27
- New acceptances this week
- 331
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- Accepted this week, now under review
- 1
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
331filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 153 |
| Generic | 95 |
| New drug | 46 |
| Import | 19 |
| Unspecified | 12 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 235 |
| TCM | 51 |
| 治疗用生物制品 | 36 |
| Biologic | 6 |
| 预防用生物制品 | 3 |
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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氯化钾颗粒 | 4 | 2 | 4 |
| 2 | 布立西坦片 | 4 | 1 | 16 |
| 3 | 注射用拉氧头孢钠 | 3 | 1 | 4 |
| 4 | 碘海醇注射液 | 3 | 1 | 2 |
| 5 | 他氟前列素滴眼液 | 2 | 2 | 1 |
| 6 | 法莫替丁注射液 | 2 | 2 | 8 |
| 7 | 盐酸艾司洛尔注射液 | 2 | 2 | 3 |
| 8 | 他克莫司缓释胶囊 | 2 | 1 | 6 |
| 9 | 托拉塞米注射液 | 2 | 1 | 1 |
| 10 | 氟马西尼注射液 | 2 | 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
216 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 四川金信康达医药科技有限公司 | 10 | 9 | 0 |
| 2 | 江苏豪森药业集团有限公司 | 7 | 2 | 0 |
| 3 | 黑龙江宋慈制药有限责任公司 | 5 | 5 | 0 |
| 4 | Eli Lilly and Company | 5 | 1 | 0 |
| 5 | GUERBET | 5 | 1 | 0 |
| 6 | Merck Sharp & Dohme LLC | 5 | 1 | 0 |
| 7 | Novo Nordisk A/S | 5 | 1 | 0 |
| 8 | 河北万邦复临药业有限公司 | 4 | 4 | 0 |
| 9 | 山东晶辉生物技术有限公司 | 4 | 2 | 4 |
| 10 | Fresenius Kabi Austria GmbH | 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/27Import · Class 1 | MK-6194 注射液JXSL2300207 | Merck Sharp & Dohme LLC; 不适用 |
| 2023/11/27Import · Class 1 | MK-6194 注射液JXSL2300206 | Merck Sharp & Dohme LLC; 不适用 |
| 2023/11/27Import · Class 1 | MK-6194 注射液JXSL2300205 | Merck Sharp & Dohme LLC; 不适用 |
| 2023/11/27Import · Class 1 | MK-6194 注射液JXSL2300204 | Merck Sharp & Dohme LLC; 不适用 |
| 2023/11/27Import · Class 1 | MK-6194 注射液JXSL2300203 | Merck Sharp & Dohme LLC; 不适用 |
| 2023/11/27New drug · Class 1 | ADG126注射液CXSL2300810 | 天演药业(苏州)有限公司 |
| 2023/11/25Generic · Class 3 | 盐酸昂丹司琼片CYHS2303264 | 杭州沐源生物医药科技有限公司; 宁波美诺华天康药业有限公司 |
| 2023/11/25Generic · Class 3 | 盐酸昂丹司琼片CYHS2303263 | 杭州沐源生物医药科技有限公司; 宁波美诺华天康药业有限公司 |
| 2023/11/25Generic · Class 3 | 托拉塞米注射液CYHS2303262 | 湖南赛隆药业(长沙)有限公司; 湖南赛隆药业有限公司 |
| 2023/11/25Generic · Class 3 | 托拉塞米注射液CYHS2303261 | 湖南赛隆药业(长沙)有限公司; 湖南赛隆药业有限公司 |
| 2023/11/25Generic · Class 3 | 盐酸左西替利嗪口服溶液CYHS2303260 | 山东致泰医药技术有限公司; 华益泰康药业股份有限公司 |
| 2023/11/25Generic · Class 3 | 盐酸左西替利嗪口服溶液CYHS2303259 | 山东致泰医药技术有限公司; 华益泰康药业股份有限公司 |
| 2023/11/25Generic · Class 3 | 注射用硫酸多黏菌素BCYHS2303257 | 江苏利泰尔药业有限公司 |
| 2023/11/25Generic · Class 3 | 法莫替丁注射液CYHS2303256 | 国仁健康制药(北京)有限公司; 内蒙古白医制药股份有限公司 |
| 2023/11/25New drug · Class 1 | WG1025CXSL2300809 | 北京唯源立康生物科技股份有限公司 |
| 2023/11/25New drug · Class 1 | aT19注射液CXSL2300808 | 北京永泰瑞科生物科技有限公司 |
| 2023/11/25New drug · Class 1 | GP681片CXHS2300106 | 江西青峰药业有限公司; 江西科睿药业有限公司 |
| 2023/11/24Generic · Class 3 | 福多司坦口服溶液CYHS2303253 | 江苏开元药业有限公司; 南京海纳制药有限公司 |
| 2023/11/24Generic · Class 3 | 氯化钾注射液CYHS2303251 | 北京布霖生物科技有限公司; 华夏生生药业(北京)有限公司 |
| 2023/11/24Generic · Class 3 | 腺苷钴胺胶囊CYHS2303246 | 河北东圣科宇医药科技有限公司; 石家庄市华新药业有限责任公司 |
| 2023/11/24Generic · Class 3 | 氯化钾颗粒CYHS2303245 | 贵州瑞和制药有限公司; 天津汉瑞药业有限公司 |
| 2023/11/24Generic · Class 3 | 氯化钾颗粒CYHS2303244 | 贵州瑞和制药有限公司; 天津汉瑞药业有限公司 |
| 2023/11/24Generic · Class 3 | 复方匹可硫酸钠颗粒CYHS2303242 | 北京柏雅联合药物研究所有限公司; 石家庄宇惠制药有限公司 |
| 2023/11/24Generic · Class 3 | 氟马西尼注射液CYHS2303241 | 上海旭东海普药业有限公司 |
| 2023/11/24Generic · Class 3 | 氟马西尼注射液CYHS2303240 | 上海旭东海普药业有限公司 |
| 2023/11/24Generic · Class 3 | 聚乙二醇3350散CYHS2303239 | 舒泰神(北京)生物制药股份有限公司 |
| 2023/11/24New drug · Class 1.1 | 辛芪通鼻片CXZS2300024 | 北京以岭药业有限公司; 石家庄以岭药业股份有限公司 |
| 2023/11/24New drug · Class 1 | B013注射液CXSL2300807 | 上海上药交联医药科技有限公司 |
| 2023/11/24New drug · Class 1 | GR2102注射液CXSL2300806 | 智翔(上海)医药科技有限公司; 重庆智翔金泰生物制药股份有限公司 |
| 2023/11/24New drug · Class 1 | GR1802注射液CXSL2300805 | 重庆智翔金泰生物制药股份有限公司 |
72 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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