药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/04/27 – 2021/05/03
- New acceptances this week
- 172
- Drugs with new generic filings (by drug name, de-duplicated)
- 17
- 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
172filings, 18 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 103 |
| New drug | 33 |
| Generic | 18 |
| Import | 10 |
| Import re-registration | 7 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 116 |
| TCM | 31 |
| 治疗用生物制品 | 24 |
| 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
17 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿法骨化醇片 | 2 | 1 | 1 |
| 2 | 利培酮口服溶液 | 1 | 1 | 6 |
| 3 | 双醋瑞因胶囊 | 1 | 1 | 3 |
| 4 | 孟鲁司特钠咀嚼片 | 1 | 1 | 4 |
| 5 | 富马酸丙酚替诺福韦片 | 1 | 1 | 0 |
| 6 | 拉考沙胺糖浆 | 1 | 1 | 0 |
| 7 | 注射用兰索拉唑 | 1 | 1 | 3 |
| 8 | 溴莫尼定噻吗洛尔滴眼液 | 1 | 1 | 2 |
| 9 | 玻璃酸钠滴眼液 | 1 | 1 | 29 |
| 10 | 甲磺酸仑伐替尼胶囊 | 1 | 1 | 4 |
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
103 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 内蒙古天奇中蒙制药股份有限公司 | 8 | 8 | 0 |
| 2 | 西安京西双鹤药业有限公司 | 6 | 1 | 0 |
| 3 | 天地恒一制药股份有限公司 | 5 | 5 | 1 |
| 4 | 四川科伦药业股份有限公司 | 5 | 2 | 0 |
| 5 | 河北天致药业有限公司 | 5 | 2 | 0 |
| 6 | Janssen-Cilag International NV | 4 | 2 | 0 |
| 7 | 江苏恒瑞医药股份有限公司 | 4 | 2 | 0 |
| 8 | 百济神州（苏州）生物科技有限公司 | 4 | 1 | 0 |
| 9 | 内蒙古孟和制药股份有限公司 | 3 | 3 | 0 |
| 10 | 成都青山利康药业有限公司 | 3 | 3 | 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
43 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/04/30Import · Class 1 | GSK3196165 注射液JXSL2101020 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2021/04/30Import · Class 1 | GSK3196165 注射液JXSL2101019 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2021/04/30Import · Class 1 | RRx-001注射液JXHL2101021 | EpicentRx Inc.; SciClone Pharmaceuticals (China) Co. Ltd. |
| 2021/04/30New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液CXSL2101051 | 山东新时代药业有限公司 |
| 2021/04/30New drug · Class 3.3 | 重组抗CD20人鼠嵌合单克隆抗体注射液CXSL2101050 | 山东新时代药业有限公司 |
| 2021/04/30New drug · Class 1 | IBI360CXSL2101044 | 信达生物制药（苏州）有限公司 |
| 2021/04/30New drug · Class 1 | 西奥罗尼胶囊CXHL2101098 | 深圳微芯生物科技股份有限公司 |
| 2021/04/30New drug · Class 1 | 西奥罗尼胶囊CXHL2101097 | 深圳微芯生物科技股份有限公司 |
| 2021/04/30New drug · Class 1 | BGB-11417薄膜包衣片CXHL2101096 | 百济神州（苏州）生物科技有限公司 |
| 2021/04/30New drug · Class 1 | BGB-11417薄膜包衣片CXHL2101095 | 百济神州（苏州）生物科技有限公司 |
| 2021/04/30New drug · Class 1 | BGB-11417薄膜包衣片CXHL2101094 | 百济神州（苏州）生物科技有限公司 |
| 2021/04/30New drug · Class 1 | BGB-11417薄膜包衣片CXHL2101093 | 百济神州（苏州）生物科技有限公司 |
| 2021/04/30New drug · Class 1 | ET0038片CXHL2101091 | 上海奕拓医药科技有限责任公司 |
| 2021/04/30New drug · Class 1 | ET0038片CXHL2101090 | 上海奕拓医药科技有限责任公司 |
| 2021/04/28Generic · Class 3 | 盐酸替罗非班注射液CYHS2101113 | 成都欣捷高新技术开发股份有限公司; 四川美大康佳乐药业有限公司 |
| 2021/04/28New drug · Class 2.2 | 替雷利珠单抗注射液CXSL2101048 | 百济神州（上海）生物科技有限公司 |
| 2021/04/28New drug · Class 2.2 | 替雷利珠单抗注射液CXSL2101047 | 百济神州（上海）生物科技有限公司 |
| 2021/04/28New drug · Class 2.2 | 西罗莫司滴眼液CXHL2101092 | 福州好吉医药科技发展有限公司 |
| 2021/04/27Import · Class 1 | CetrelimabJXSL2101017 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/04/27Import · Class 1 | 泽弗利单抗注射液JXSL2101015 | Agenus Inc.; Betta Pharmaceuticals Co. Ltd. |
| 2021/04/27Import · Class 2.2 | TAR-200JXHL2101020 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/04/27Import · Class 2.4 | Selpercatinib胶囊JXHL2101019 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/04/27Import · Class 2.4 | Selpercatinib胶囊JXHL2101018 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/04/27Generic · Class 3 | 注射用兰索拉唑CYHS2101110 | 山东新华鲁抗医药有限公司; 杭州澳亚生物技术股份有限公司 |
| 2021/04/27New drug · Class 1 | 重组人源化单克隆抗体MIL62注射液CXSL2101046 | 北京天广实生物技术股份有限公司 |
| 2021/04/27New drug · Class 1 | GNC-035四特异性抗体注射液CXSL2101045 | 四川百利药业有限责任公司 |
| 2021/04/27New drug · Class 1 | 重组抗IL-1β人源化单克隆抗体注射液CXSL2101043 | 三生国健药业（上海）股份有限公司 |
| 2021/04/27New drug · Class 1 | 重组抗IL-1β人源化单克隆抗体注射液CXSL2101042 | 三生国健药业（上海）股份有限公司 |
| 2021/04/27New drug · Class 1 | CAN106注射液CXSL2101041 | 诺爱药业（上海）有限公司 |
| 2021/04/27New drug · Class 1 | EX103注射液CXSL2101037 | 广州爱思迈生物医药科技有限公司 |
13 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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