药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/10/24 – 2023/10/30
- New acceptances this week
- 337
- Drugs with new generic filings (by drug name, de-duplicated)
- 70
- 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
337filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 170 |
| Generic | 90 |
| New drug | 56 |
| Unspecified | 11 |
| Import | 5 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 236 |
| TCM | 57 |
| 治疗用生物制品 | 34 |
| Biologic | 7 |
| 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
70 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 乙酰半胱氨酸口服溶液 | 3 | 1 | 11 |
| 2 | 吡拉西坦注射液 | 3 | 1 | 9 |
| 3 | 盐酸尼卡地平注射液 | 3 | 1 | 12 |
| 4 | 丙戊酸钠缓释片（Ⅰ） | 2 | 2 | 4 |
| 5 | 倍他米松磷酸钠注射液 | 2 | 1 | 5 |
| 6 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 7 | 恩格列净二甲双胍缓释片 | 2 | 1 | 12 |
| 8 | 托伐普坦口崩片 | 2 | 1 | 5 |
| 9 | 托拉塞米注射液 | 2 | 1 | 1 |
| 10 | 拉考沙胺片 | 2 | 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
189 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山西双雁药业有限公司 | 28 | 9 | 0 |
| 2 | 江苏修正制药有限公司 | 18 | 17 | 0 |
| 3 | 河北御芝林药业有限公司 | 8 | 8 | 0 |
| 4 | 正大天晴药业集团股份有限公司 | 8 | 4 | 4 |
| 5 | 金诃藏药股份有限公司 | 7 | 6 | 0 |
| 6 | 哈尔滨瀚邦医疗科技有限公司 | 5 | 1 | 0 |
| 7 | 武汉滨湖双鹤药业有限责任公司 | 5 | 1 | 0 |
| 8 | 礼邦药业（上海）有限公司 | 5 | 1 | 0 |
| 9 | Takeda Manufacturing Austria AG | 4 | 1 | 0 |
| 10 | 中山康方生物医药有限公司 | 3 | 3 | 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
96 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/30New drug · Class 1 | TQB2928注射液CXSL2300742 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2023/10/30New drug · Class 1 | 注射用MK-2870CXSL2300741 | 默沙东研发（中国）有限公司 |
| 2023/10/30New drug · Class 1 | BT02单克隆抗体注射液CXSL2300740 | 上海柏全生物科技有限公司 |
| 2023/10/30New drug · Class 2.2 | HZ023口溶膜CXHL2301183 | 浙江和泽医药科技股份有限公司 |
| 2023/10/28Generic · Class 3 | 吡拉西坦注射液CYHS2302936 | 石家庄凯达生物工程有限公司 |
| 2023/10/28Generic · Class 3 | 吡拉西坦注射液CYHS2302935 | 石家庄凯达生物工程有限公司 |
| 2023/10/28Generic · Class 3 | 吡拉西坦注射液CYHS2302934 | 石家庄凯达生物工程有限公司 |
| 2023/10/28Generic · Class 3 | 盐酸左西替利嗪口服溶液CYHS2302933 | 浙江恒研医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/10/28Generic · Class 3 | 帕拉米韦注射液CYHS2302932 | 长春澜江医药科技有限公司; 山东新时代药业有限公司 |
| 2023/10/28Generic · Class 3 | 注射用盐酸兰地洛尔CYHS2302929 | 上海葆隆生物科技有限公司; 天津金耀药业有限公司 |
| 2023/10/28Generic · Class 3 | 倍他米松磷酸钠注射液CYHS2302928 | 江苏神龙药业有限公司; 新乡市常乐制药有限责任公司 |
| 2023/10/28Generic · Class 3 | 倍他米松磷酸钠注射液CYHS2302927 | 江苏神龙药业有限公司; 新乡市常乐制药有限责任公司 |
| 2023/10/28New drug · Class 1 | TJ033721注射液CXSL2300739 | 天境生物科技（上海）有限公司 |
| 2023/10/28New drug · Class 1 | ZT002注射液CXSL2300738 | 北京质肽生物医药科技有限公司 |
| 2023/10/28New drug · Class 1 | AK112注射液CXSL2300737 | 康方赛诺医药有限公司 |
| 2023/10/28New drug · Class 1 | AK130注射液CXSL2300736 | 中山康方生物医药有限公司 |
| 2023/10/28New drug · Class 1 | 注射用BGB-A3055CXSL2300735 | 广州百济神州生物制药有限公司 |
| 2023/10/28New drug · Class 1 | 注射用GRK-006CXHL2301182 | 慧安凯（厦门）医药科技有限公司; 苏州格兰科医药科技有限公司; 泉州海创医药科技有限公司 |
| 2023/10/28New drug · Class 1 | TQG3020片CXHL2301181 | 正大天晴药业集团股份有限公司 |
| 2023/10/28New drug · Class 1 | TQG3020片CXHL2301180 | 正大天晴药业集团股份有限公司 |
| 2023/10/28New drug · Class 1 | TQG3020片CXHL2301179 | 正大天晴药业集团股份有限公司 |
| 2023/10/28New drug · Class 1 | TQG3020片CXHL2301178 | 正大天晴药业集团股份有限公司 |
| 2023/10/28New drug · Class 1 | SIM0501片CXHL2301177 | 上海先祥医药科技有限公司 |
| 2023/10/28New drug · Class 1 | SIM0501片CXHL2301176 | 上海先祥医药科技有限公司 |
| 2023/10/28New drug · Class 1 | TQH3906胶囊CXHL2301175 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2023/10/28New drug · Class 1 | TQH3906胶囊CXHL2301174 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2023/10/27Import · Class 1 | DS-6000aJXSL2300189 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2023/10/27Generic · Class 3 | 盐酸拉贝洛尔氯化钠注射液CYHS2302925 | 北京柏雅联合药物研究所有限公司; 山东华鲁制药有限公司 |
| 2023/10/27Generic · Class 3 | 米力农注射液CYHS2302916 | 湖北亨迪药业股份有限公司; 湖北津药药业股份有限公司 |
| 2023/10/27Generic · Class 3 | 米力农注射液CYHS2302915 | 湖北亨迪药业股份有限公司; 湖北津药药业股份有限公司 |
66 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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