药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/09/03 – 2024/09/09
- New acceptances this week
- 293
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- Accepted this week, now under review
- 2
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
293filings, 89 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 123 |
| Generic | 89 |
| New drug | 51 |
| Import | 19 |
| Import re-registration | 9 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 188 |
| TCM | 62 |
| 治疗用生物制品 | 38 |
| 预防用生物制品 | 5 |
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 | 玻璃酸钠滴眼液 | 3 | 2 | 29 |
| 2 | 布瑞哌唑口崩片 | 3 | 1 | 10 |
| 3 | 注射用乳糖酸红霉素 | 3 | 1 | 15 |
| 4 | 左卡尼汀注射液 | 2 | 2 | 5 |
| 5 | 氯化钙注射液 | 2 | 2 | 6 |
| 6 | 盐酸尼卡地平注射液 | 2 | 2 | 12 |
| 7 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 8 | 维生素B?注射液 | 2 | 2 | 3 |
| 9 | 他达拉非片 | 2 | 1 | 23 |
| 10 | 依伏卡塞片 | 2 | 1 | 9 |
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
181 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 四川依科制药有限公司 | 11 | 11 | 0 |
| 2 | 锦州福寿堂医药科技有限公司 | 9 | 9 | 0 |
| 3 | AstraZeneca AB | 5 | 2 | 0 |
| 4 | 华润双鹤药业股份有限公司 | 5 | 1 | 0 |
| 5 | 安徽省先锋制药有限公司 | 4 | 3 | 3 |
| 6 | Janssen-Cilag International NV | 4 | 2 | 0 |
| 7 | Novartis Pharma Schweiz AG | 4 | 2 | 0 |
| 8 | 仁合益康集团有限公司 | 4 | 2 | 2 |
| 9 | 石家庄凯达生物工程有限公司 | 4 | 2 | 4 |
| 10 | ASPEN PHARMA TRADING LIMITED | 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
99 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/09Generic · Class 3 | 维生素K1注射液CYHS2402966 | 石家庄四药有限公司 |
| 2024/09/09Generic · Class 3 | 地氯雷他定口服溶液CYHS2402965 | 哈尔滨市康隆药业有限责任公司 |
| 2024/09/09Generic · Class 3 | 琥珀酸曲格列汀片CYHS2402964 | 苏州东瑞制药有限公司 |
| 2024/09/09Generic · Class 3 | 琥珀酸曲格列汀片CYHS2402963 | 苏州东瑞制药有限公司 |
| 2024/09/07Generic · Class 3 | 注射用乳糖酸红霉素CYHS2402962 | 海南广升誉制药有限公司; 海南灵康制药有限公司 |
| 2024/09/07Generic · Class 3 | 注射用乳糖酸红霉素CYHS2402961 | 海南广升誉制药有限公司; 海南灵康制药有限公司 |
| 2024/09/07Generic · Class 3 | 注射用乳糖酸红霉素CYHS2402960 | 海南广升誉制药有限公司; 海南灵康制药有限公司 |
| 2024/09/07Generic · Class 3 | 维生素B12注射液CYHS2402959 | 华夏生生药业(北京)有限公司 |
| 2024/09/07Generic · Class 3 | 复合磷酸氢钾注射液CYHS2402957 | 江西泰吉立生物医药科技有限公司; 浙江赛默制药有限公司 |
| 2024/09/07Generic · Class 3 | 布瑞哌唑口崩片CYHS2402954 | 成都康弘药业集团股份有限公司 |
| 2024/09/07Generic · Class 3 | 维生素B?注射液CYHS2402953 | 江西泰吉立生物医药科技有限公司; 成都市海通药业有限公司 |
| 2024/09/07Generic · Class 3 | 布瑞哌唑口崩片CYHS2402952 | 成都康弘药业集团股份有限公司 |
| 2024/09/07Generic · Class 3 | 布瑞哌唑口崩片CYHS2402951 | 成都康弘药业集团股份有限公司 |
| 2024/09/07Generic · Class 3 | 奥美沙坦酯口崩片CYHS2402944 | 江西施美药业股份有限公司 |
| 2024/09/07New drug · Class 1 | LP-003 注射液CXSL2400599 | 天辰生物医药(苏州)有限公司 |
| 2024/09/07New drug · Class 1 | SHR-3045注射液CXSL2400598 | 广东恒瑞医药有限公司; 上海恒瑞医药有限公司 |
| 2024/09/07New drug · Class 1 | 聚乙二醇化重组门冬酰胺酶注射液CXSL2400597 | 重庆派金生物科技有限公司 |
| 2024/09/07New drug · Class 2.2 | ZC2211CXHL2400927 | 杭州志呈科技有限公司 |
| 2024/09/07New drug · Class 2.2 | ZC2211CXHL2400926 | 杭州志呈科技有限公司 |
| 2024/09/07New drug · Class 1 | JMKX003676片CXHL2400925 | 浙江杭煜制药有限公司 |
| 2024/09/07New drug · Class 1 | JMKX003676片CXHL2400924 | 浙江杭煜制药有限公司 |
| 2024/09/07New drug · Class 1 | KPC000154片CXHL2400923 | 昆药集团股份有限公司; 昆药集团(珠海横琴)科技有限公司 |
| 2024/09/07New drug · Class 1 | KPC000154片CXHL2400922 | 昆药集团股份有限公司; 昆药集团(珠海横琴)科技有限公司 |
| 2024/09/07New drug · Class 1 | JMKX003676片CXHL2400921 | 浙江杭煜制药有限公司 |
| 2024/09/07New drug · Class 2.2 | 司美格鲁肽注射液CXHL2400920 | 华润双鹤药业股份有限公司 |
| 2024/09/07New drug · Class 2.2 | 司美格鲁肽注射液CXHL2400919 | 华润双鹤药业股份有限公司 |
| 2024/09/07New drug · Class 2.2 | 司美格鲁肽注射液CXHL2400918 | 华润双鹤药业股份有限公司 |
| 2024/09/07New drug · Class 2.2 | 司美格鲁肽注射液CXHL2400917 | 华润双鹤药业股份有限公司 |
| 2024/09/07New drug · Class 2.2 | 司美格鲁肽注射液CXHL2400916 | 华润双鹤药业股份有限公司 |
| 2024/09/06Generic · Class 3 | 吸入用盐酸丙卡特罗溶液CYHS2402939 | 江苏大红鹰恒顺药业有限公司 |
69 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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