药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/06/15 – 2021/06/21
- New acceptances this week
- 221
- Drugs with new generic filings (by drug name, de-duplicated)
- 24
- 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
221filings, 32 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 124 |
| New drug | 36 |
| Generic | 32 |
| Import | 18 |
| Unspecified | 9 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 166 |
| 治疗用生物制品 | 39 |
| TCM | 15 |
| 预防用生物制品 | 1 |
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
24 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 塞来昔布胶囊 | 4 | 1 | 5 |
| 2 | 左乙拉西坦口服溶液 | 2 | 2 | 3 |
| 3 | 头孢克肟胶囊 | 2 | 1 | 2 |
| 4 | 注射用头孢曲松钠/氯化钠注射液 | 2 | 1 | 3 |
| 5 | 硫酸镁注射液 | 2 | 1 | 7 |
| 6 | 缬沙坦片 | 2 | 1 | 0 |
| 7 | 丙泊酚中/长链脂肪乳注射液 | 1 | 1 | 3 |
| 8 | 吸入用七氟烷 | 1 | 1 | 0 |
| 9 | 吸入用异丙托溴铵溶液 | 1 | 1 | 2 |
| 10 | 吸入用盐酸氨溴索溶液 | 1 | 1 | 10 |
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
130 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | The Wellcome Foundation Limited | 7 | 2 | 0 |
| 2 | 武汉福星生物药业有限公司 | 6 | 1 | 0 |
| 3 | 东北制药集团沈阳第一制药有限公司 | 5 | 4 | 0 |
| 4 | 石药集团欧意药业有限公司 | 5 | 2 | 0 |
| 5 | Bayer AG | 5 | 1 | 0 |
| 6 | IPSEN PHARMA | 5 | 1 | 0 |
| 7 | Lian Cardiovascular Limited | 5 | 1 | 0 |
| 8 | 哈尔滨瀚邦医疗科技有限公司 | 5 | 1 | 0 |
| 9 | 杭州森泽医药科技有限公司 | 4 | 4 | 0 |
| 10 | 齐鲁制药有限公司 | 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
63 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/06/21Import · Class 1 | Palovarotene胶囊JXHL2101099 | IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD. |
| 2021/06/21Import · Class 1 | Palovarotene胶囊JXHL2101098 | IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD. |
| 2021/06/21Import · Class 1 | Palovarotene胶囊JXHL2101097 | IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD. |
| 2021/06/21Import · Class 1 | Palovarotene胶囊JXHL2101096 | IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD. |
| 2021/06/21Import · Class 1 | Palovarotene胶囊JXHL2101095 | IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD. |
| 2021/06/21Import · Class 1 | Afuresertib片JXHL2101094 | Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd. |
| 2021/06/21Import · Class 1 | Afuresertib片JXHL2101093 | Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd. |
| 2021/06/21Import · Class 1 | Etrasimod片JXHL2101082 | Arena Pharmaceuticals Inc.; Everest Medicines (China) Co. Ltd |
| 2021/06/21Import · Class 1 | Etrasimod片JXHL2101081 | Arena Pharmaceuticals Inc.; Everest Medicines (China) Co. Ltd |
| 2021/06/21Generic · Class 3 | 奥硝唑注射液CYHS2101322 | 山东华铂凯盛生物科技有限公司; 通化金马药业集团股份有限公司 |
| 2021/06/21New drug · Class 1 | QX004N注射液CXSL2101142 | 江苏荃信生物医药有限公司 |
| 2021/06/21New drug · Class 1 | BDB-001注射液CXSL2101141 | 舒泰神(北京)生物制药股份有限公司; 北京德丰瑞生物技术有限公司 |
| 2021/06/21New drug · Class 2.4 | 环泊酚注射液CXHS2101025 | 辽宁海思科制药有限公司 |
| 2021/06/21New drug · Class 1 | OB756片CXHL2101216 | 杭州邦顺制药有限公司 |
| 2021/06/21New drug · Class 1 | EN002凝胶CXHL2101215 | 恩康药业科技(广州)有限公司 |
| 2021/06/21New drug · Class 1 | EN002凝胶CXHL2101214 | 恩康药业科技(广州)有限公司 |
| 2021/06/18Generic · Class 3 | 硝苯地平缓释片CYHS2101305 | 南京易亨制药有限公司 |
| 2021/06/18New drug · Class 1 | EX101注射液CXSL2101140 | 广州爱思迈生物医药科技有限公司 |
| 2021/06/18New drug · Class 1 | 重组人源化抗表皮生长因子受体单克隆抗体注射液CXSL2101139 | 上海津曼特生物科技有限公司 |
| 2021/06/18New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液CXSL2101138 | 石药集团中奇制药技术(石家庄)有限公司 |
| 2021/06/18New drug · Class 1 | 注射用IMM01CXSL2101109 | 宜明昂科生物医药技术(上海)有限公司 |
| 2021/06/18New drug · Class 1 | SYHX1901片CXHL2101206 | 石药集团欧意药业有限公司 |
| 2021/06/18New drug · Class 1 | SYHX1901片CXHL2101205 | 石药集团欧意药业有限公司 |
| 2021/06/18New drug · Class 2.4 | 注射用苏拉明钠CXHL2101187 | 广东康大制药有限公司 |
| 2021/06/17Import · Class 1 | 注射用STP705JXHL2101092 | Sirnaomics Inc.; Sirnaomics Biopharmaceuticals (Suzhou) Co. Ltd. |
| 2021/06/17Generic · Class 3 | 头孢克肟胶囊CYHS2101301 | 山东裕欣药业有限公司; 山东罗欣药业集团股份有限公司 |
| 2021/06/17Generic · Class 3 | 头孢克肟胶囊CYHS2101300 | 山东裕欣药业有限公司; 山东罗欣药业集团股份有限公司 |
| 2021/06/17Generic · Class 3 | 硫酸镁注射液CYHS2101298 | 石家庄杏泽医药科技有限公司; 山东华鲁制药有限公司 |
| 2021/06/17Generic · Class 3 | 硫酸镁注射液CYHS2101297 | 石家庄杏泽医药科技有限公司; 山东华鲁制药有限公司 |
| 2021/06/17Generic · Class 3 | 曲前列尼尔注射液CYHS2101273 | 江苏众强药业有限公司; 广东星昊药业有限公司 |
33 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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