药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/11/07 – 2023/11/13
- New acceptances this week
- 378
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- 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
378filings, 104 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 188 |
| Generic | 104 |
| New drug | 54 |
| Import | 14 |
| Unspecified | 11 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 265 |
| TCM | 84 |
| 治疗用生物制品 | 27 |
| Biologic | 2 |
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 | 重酒石酸去甲肾上腺素注射液 | 6 | 3 | 9 |
| 2 | 富马酸伏诺拉生片 | 4 | 2 | 58 |
| 3 | 氯化钾颗粒 | 4 | 2 | 4 |
| 4 | 布洛芬注射液 | 3 | 2 | 4 |
| 5 | 氯化钾口服溶液 | 3 | 2 | 12 |
| 6 | 中/长链脂肪乳注射液(C6~24) | 3 | 1 | 0 |
| 7 | 吡拉西坦注射液 | 3 | 1 | 9 |
| 8 | 甲硫酸新斯的明注射液 | 3 | 1 | 4 |
| 9 | 法莫替丁注射液 | 2 | 2 | 8 |
| 10 | 磷酸奥司他韦干混悬剂 | 2 | 2 | 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
214 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山西双雁药业有限公司 | 14 | 14 | 0 |
| 2 | 江西人可医药科技有限公司 | 11 | 4 | 0 |
| 3 | 江西南昌济生制药有限责任公司 | 10 | 10 | 0 |
| 4 | 江苏豪森药业集团有限公司 | 10 | 3 | 0 |
| 5 | Sanofi Winthrop Industrie | 7 | 3 | 0 |
| 6 | 石家庄四药有限公司 | 7 | 2 | 1 |
| 7 | 浙江华海药业股份有限公司 | 5 | 4 | 5 |
| 8 | Merck Sharp & Dohme LLC | 5 | 2 | 0 |
| 9 | 吉林省神鹿制药有限公司 | 4 | 4 | 0 |
| 10 | 广西鸿济药业集团有限公司 | 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
118 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/13Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2303109 | 杭州民生药业股份有限公司 |
| 2023/11/13Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2303108 | 杭州民生药业股份有限公司 |
| 2023/11/13Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2303107 | 杭州民生药业股份有限公司 |
| 2023/11/13Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2303106 | 山东京卫制药有限公司 |
| 2023/11/13Generic · Class 3 | 盐酸苯海拉明片CYHS2303105 | 长春海悦药业股份有限公司 |
| 2023/11/11Import · Class 2.2 | 帕博利珠单抗注射液JXSL2300192 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2023/11/11Generic · Class 3 | 氯化钾颗粒CYHS2303100 | 山西皇城相府药业股份有限公司 |
| 2023/11/11Generic · Class 3 | 氯化钾颗粒CYHS2303099 | 山西皇城相府药业股份有限公司 |
| 2023/11/11New drug · Class 1 | ZS805注射液CXSL2300775 | 四川至善唯新生物科技有限公司 |
| 2023/11/11New drug · Class 1 | 注射用MK-2870CXSL2300774 | 默沙东研发(中国)有限公司 |
| 2023/11/11New drug · Class 2.4;2.2 | 硫酸阿托品滴眼液CXHL2301262 | 乐普药业股份有限公司 |
| 2023/11/11New drug · Class 2.4;2.2 | 硫酸阿托品滴眼液CXHL2301261 | 乐普药业股份有限公司 |
| 2023/11/11New drug · Class 2.4 | 盐酸氨酮戊酸颗粒剂CXHL2301260 | 上海复旦张江生物医药股份有限公司 |
| 2023/11/11New drug · Class 1 | FCN-338片CXHL2301259 | 上海复星医药产业发展有限公司 |
| 2023/11/11New drug · Class 1 | FCN-338片CXHL2301258 | 上海复星医药产业发展有限公司 |
| 2023/11/11New drug · Class 2.4 | 硫酸阿托品滴眼液CXHL2301257 | 苏州欧康维视生物科技有限公司 |
| 2023/11/11New drug · Class 2.4 | 硫酸阿托品滴眼液CXHL2301256 | 苏州欧康维视生物科技有限公司 |
| 2023/11/10Import · Class 2.3 | 马昔腾坦他达拉非片JXHL2300281 | Actelion Pharmaceuticals Ltd; Johnson & Johnson (China) Investment Ltd. |
| 2023/11/10Import · Class 1 | LNP023胶囊JXHL2300280 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/11/10Generic · Class 3 | 氯化钾口服溶液CYHS2303094 | 山东朗诺制药有限公司 |
| 2023/11/10Generic · Class 3 | 醋酸钠林格注射液CYHS2303093 | 浙江康吉尔药业有限公司 |
| 2023/11/10Generic · Class 3 | 对乙酰氨基酚布洛芬片CYHS2303092 | 长春澜江医药科技有限公司; 植恩生物技术股份有限公司 |
| 2023/11/10Generic · Class 3 | 维生素K1注射液CYHS2303088 | 海南倍特药业有限公司 |
| 2023/11/10Generic · Class 3 | 维生素K1注射液CYHS2303087 | 海南倍特药业有限公司 |
| 2023/11/10Generic · Class 3 | 吡格列酮二甲双胍片CYHS2303085 | 江苏安必生制药有限公司 |
| 2023/11/10Generic · Class 3 | 布洛芬注射液CYHL2300136 | 山东新华制药股份有限公司 |
| 2023/11/10New drug · Class 3.4 | 人凝血酶原复合物CXSS2300087 | 国药集团兰州生物制药有限公司 |
| 2023/11/10New drug · Class 1 | 重组抗IL-1β人源化单克隆抗体注射液CXSL2300773 | 三生国健药业(上海)股份有限公司 |
| 2023/11/10New drug · Class 1 | BR115注射液CXSL2300772 | 浙江博锐生物制药有限公司; 海正生物制药有限公司; 成都恩沐生物科技有限公司 |
| 2023/11/10New drug · Class 1 | 注射用AMT-116CXSL2300771 | 普众发现医药科技(上海)有限公司 |
88 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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