药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/04/16 – 2024/04/22
- New acceptances this week
- 309
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- 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
309filings, 89 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 128 |
| Generic | 89 |
| New drug | 62 |
| Import | 18 |
| Unspecified | 9 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 191 |
| TCM | 61 |
| 治疗用生物制品 | 49 |
| 预防用生物制品 | 5 |
| Biologic | 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
69 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 二甲硅油乳剂 | 3 | 1 | 14 |
| 2 | 哌柏西利胶囊 | 3 | 1 | 0 |
| 3 | 帕米膦酸二钠注射液 | 3 | 1 | 2 |
| 4 | 棕榈酸帕利哌酮注射液 | 3 | 1 | 8 |
| 5 | 阿立哌唑口服溶液 | 3 | 1 | 5 |
| 6 | 普拉洛芬滴眼液 | 2 | 2 | 7 |
| 7 | 盐酸甲氧氯普胺注射液 | 2 | 2 | 6 |
| 8 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 9 | 地氯雷他定口服溶液 | 2 | 1 | 26 |
| 10 | 复方聚乙二醇电解质散（II） | 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
204 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北炎黄本草药业有限公司 | 8 | 8 | 0 |
| 2 | 宸寰医药集团有限公司 | 6 | 6 | 0 |
| 3 | 华津（重庆）药业有限公司 | 6 | 1 | 0 |
| 4 | 黑龙江宋慈制药有限责任公司 | 5 | 4 | 0 |
| 5 | 山东新时代药业有限公司 | 5 | 2 | 5 |
| 6 | 青海久美藏药药业有限公司 | 4 | 4 | 0 |
| 7 | 南京海纳制药有限公司 | 4 | 3 | 4 |
| 8 | Bristol-Myers Squibb Pharma EEIG | 4 | 2 | 0 |
| 9 | 北京亚东生物制药有限公司 | 4 | 2 | 0 |
| 10 | 长春金赛药业有限责任公司 | 4 | 2 | 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
109 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/04/22Generic · Class 3 | 盐酸布比卡因注射液CYHS2401201 | 广东鼎信医药科技有限公司; 广东星昊药业有限公司 |
| 2024/04/22Generic · Class 3 | 地氯雷他定口服溶液CYHS2401200 | 石家庄凯达生物工程有限公司; 乐声药业石家庄有限公司 |
| 2024/04/22Generic · Class 3 | 地氯雷他定口服溶液CYHS2401199 | 石家庄凯达生物工程有限公司; 乐声药业石家庄有限公司 |
| 2024/04/22Generic · Class 3 | 贝那普利氢氯噻嗪片CYHS2401197 | 维生原（厦门）生物科技有限公司; 石家庄市华新药业有限责任公司 |
| 2024/04/22Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHS2401191 | 北京韩美药品有限公司 |
| 2024/04/22New drug · Class 2.2 | TRD303溶液CXHL2400407 | 北京泰德制药股份有限公司 |
| 2024/04/20Import · Class 2.2 | Anifrolumab注射液JXSL2400078 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2024/04/20Generic · Class 3 | 倍他米松磷酸钠注射液CYHS2401190 | 漯河市汇创医药有限公司; 裕松源药业有限公司 |
| 2024/04/20New drug · Class 1.1 | 珍珠滴丸CXZS2400012 | 贵州民族药业股份有限公司 |
| 2024/04/20New drug · Class 1 | KY-0118注射剂CXSL2400254 | 科弈（浙江）药业科技有限公司 |
| 2024/04/20New drug · Class 1 | 注射用BGB-B2033CXSL2400253 | 广州百济神州生物制药有限公司 |
| 2024/04/20New drug · Class 1 | EX101注射液CXSL2400252 | 广州爱思迈生物医药科技有限公司 |
| 2024/04/20New drug · Class 2.2 | 信迪利单抗注射液CXSL2400251 | 信达生物制药（苏州）有限公司 |
| 2024/04/20New drug · Class 1 | WSD0922-FU片CXHL2400406 | 威尚（上海）生物医药有限公司 |
| 2024/04/20New drug · Class 1 | WSD0922-FU片CXHL2400405 | 威尚（上海）生物医药有限公司 |
| 2024/04/20New drug · Class 1 | WSD0922-FU片CXHL2400404 | 威尚（上海）生物医药有限公司 |
| 2024/04/19Import · Class 1 | Axatilimab注射液JXSL2400077 | Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd. |
| 2024/04/19Generic · Class 3 | 依巴斯汀口服溶液CYHS2401178 | 南京海纳制药有限公司 |
| 2024/04/19Generic · Class 3 | 氯硝西泮注射液CYHS2401176 | 国药集团国瑞药业有限公司 |
| 2024/04/19Generic · Class 3 | 二羟丙茶碱注射液CYHS2401173 | 四川天杏汇医药科技有限公司; 成都百裕制药股份有限公司 |
| 2024/04/19Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2401171 | 山东如至生物医药科技有限公司; 山东威智百科药业有限公司 |
| 2024/04/19Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2401169 | 北京柏雅联合药物研究所有限公司; 广东星昊药业有限公司 |
| 2024/04/19New drug · Class 1 | VPD/FC01008 注射液CXSL2400250 | 微能生命科技集团有限公司 |
| 2024/04/19New drug · Class 1 | 重组人源抗破伤风毒素单克隆抗体注射液CXSL2400249 | 兰州生物制品研究所有限责任公司 |
| 2024/04/19New drug · Class 3.3 | 流感病毒裂解疫苗CXSL2400248 | 武汉生物制品研究所有限责任公司 |
| 2024/04/19New drug · Class 3.3 | 流感病毒裂解疫苗CXSL2400247 | 武汉生物制品研究所有限责任公司 |
| 2024/04/19New drug · Class 2.2 | 盐酸普萘洛尔滴剂CXHS2400029 | 四川奥邦古得药业有限公司; 成都利尔药业有限公司 |
| 2024/04/19New drug · Class 1 | FH-2001胶囊CXHL2400403 | 江苏星盛新辉医药有限公司 |
| 2024/04/19New drug · Class 2.4 | 林普利塞片CXHL2400402 | 上海璎黎药业有限公司 |
| 2024/04/19New drug · Class 1 | HRS-1358片CXHL2400401 | 山东盛迪医药有限公司 |
79 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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