药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/05/03 – 2022/05/09
- New acceptances this week
- 138
- Drugs with new generic filings (by drug name, de-duplicated)
- 14
- 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
138filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 60 |
| New drug | 37 |
| Generic | 20 |
| Import | 17 |
| Unspecified | 2 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 88 |
| 治疗用生物制品 | 28 |
| TCM | 18 |
| 预防用生物制品 | 4 |
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
14 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥氮平盐酸氟西汀胶囊 | 5 | 1 | 0 |
| 2 | 氨磺必利注射液 | 2 | 1 | 1 |
| 3 | 盐酸莫西沙星滴眼液 | 2 | 1 | 5 |
| 4 | 复方聚乙二醇电解质散（Ⅲ） | 1 | 1 | 1 |
| 5 | 替硝唑片 | 1 | 1 | 0 |
| 6 | 氧（液态） | 1 | 1 | 14 |
| 7 | 注射用伏立康唑 | 1 | 1 | 4 |
| 8 | 注射用右雷佐生 | 1 | 1 | 1 |
| 9 | 注射用盐酸罗沙替丁醋酸酯 | 1 | 1 | 5 |
| 10 | 盐酸托莫西汀口服溶液 | 1 | 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
78 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | UNION therapeutics A/S | 6 | 2 | 0 |
| 2 | 成都弘基生物科技有限公司 | 6 | 1 | 0 |
| 3 | 江苏恒瑞医药股份有限公司 | 5 | 3 | 0 |
| 4 | 江苏长泰药业股份有限公司 | 5 | 1 | 5 |
| 5 | 吉林真元制药有限公司 | 4 | 4 | 0 |
| 6 | 北京科兴生物制品有限公司 | 4 | 2 | 0 |
| 7 | N.V. Organon | 4 | 1 | 0 |
| 8 | 长春金赛药业有限责任公司 | 4 | 1 | 0 |
| 9 | 山东汉方制药有限公司 | 3 | 3 | 0 |
| 10 | Pfizer Inc. | 3 | 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
62 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/05/07Import · Class 2.2 | 纳武利尤单抗注射液JXSL2200055 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊CYHS2200710 | 江苏长泰药业股份有限公司 |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊CYHS2200709 | 江苏长泰药业股份有限公司 |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊CYHS2200708 | 江苏长泰药业股份有限公司 |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊CYHS2200707 | 江苏长泰药业股份有限公司 |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊CYHS2200706 | 江苏长泰药业股份有限公司 |
| 2022/05/07New drug · Class 1 | 注射用SKB264CXSL2200208 | 四川科伦博泰生物医药股份有限公司 |
| 2022/05/07New drug · Class 1 | 注射用重组人源化抗CD47单克隆抗体CXSL2200207 | 乐普生物科技股份有限公司 |
| 2022/05/07New drug · Class 1 | KH631眼用注射液CXSL2200206 | 成都弘基生物科技有限公司 |
| 2022/05/07New drug · Class 1 | KH631眼用注射液CXSL2200205 | 成都弘基生物科技有限公司 |
| 2022/05/07New drug · Class 1 | KH631眼用注射液CXSL2200204 | 成都弘基生物科技有限公司 |
| 2022/05/07New drug · Class 1 | KH631眼用注射液CXSL2200203 | 成都弘基生物科技有限公司 |
| 2022/05/07New drug · Class 1 | KH631眼用注射液CXSL2200202 | 成都弘基生物科技有限公司 |
| 2022/05/07New drug · Class 1 | KH631眼用注射液CXSL2200201 | 成都弘基生物科技有限公司 |
| 2022/05/07New drug · Class 1 | 注射用SHR-1802CXSL2200200 | 上海恒瑞医药有限公司 |
| 2022/05/07New drug · Class 1 | 阿得贝利单抗注射液CXSL2200199 | 上海盛迪医药有限公司 |
| 2022/05/07New drug · Class 1 | 阿得贝利单抗注射液CXSL2200198 | 上海盛迪医药有限公司 |
| 2022/05/07New drug · Class 1 | 注射用SHR-A1811CXSL2200197 | 苏州盛迪亚生物医药有限公司 |
| 2022/05/07New drug · Class 1 | PM8001注射液CXSL2200195 | 普米斯生物技术（珠海）有限公司 |
| 2022/05/07New drug · Class 1 | EG017软膏CXHL2200286 | 长春金赛药业有限责任公司 |
| 2022/05/07New drug · Class 1 | EG017软膏CXHL2200285 | 长春金赛药业有限责任公司 |
| 2022/05/07New drug · Class 1 | EG017软膏CXHL2200284 | 长春金赛药业有限责任公司 |
| 2022/05/07New drug · Class 1 | EG017软膏CXHL2200283 | 长春金赛药业有限责任公司 |
| 2022/05/07New drug · Class 1 | HRS-7085片CXHL2200282 | 山东盛迪医药有限公司 |
| 2022/05/07New drug · Class 1 | HRS-7085片CXHL2200281 | 山东盛迪医药有限公司 |
| 2022/05/07New drug · Class 1 | SPN0103-009注射液CXHL2200280 | 杭州澳赛诺生物科技有限公司 |
| 2022/05/07New drug · Class 2.4 | 马来酸吡咯替尼片CXHL2200279 | 江苏恒瑞医药股份有限公司 |
| 2022/05/07New drug · Class 2.4 | 马来酸吡咯替尼片CXHL2200278 | 江苏恒瑞医药股份有限公司 |
| 2022/05/07New drug · Class 1 | HRS-1167片CXHL2200277 | 江苏恒瑞医药股份有限公司 |
| 2022/05/07New drug · Class 1 | HRS-1167片CXHL2200276 | 江苏恒瑞医药股份有限公司 |
32 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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