药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/12/07 – 2021/12/13
- New acceptances this week
- 239
- Drugs with new generic filings (by drug name, de-duplicated)
- 30
- 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
239filings, 37 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 145 |
| Generic | 37 |
| New drug | 36 |
| Import | 11 |
| Import re-registration | 7 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 155 |
| TCM | 43 |
| 治疗用生物制品 | 39 |
| 预防用生物制品 | 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
30 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿普米司特片 | 3 | 1 | 3 |
| 2 | 枸橼酸托法替布片 | 2 | 2 | 1 |
| 3 | 坎地沙坦酯氢氯噻嗪片 | 2 | 1 | 0 |
| 4 | 缬沙坦片 | 2 | 1 | 0 |
| 5 | 羧甲司坦口服溶液 | 2 | 1 | 6 |
| 6 | 非布司他片 | 2 | 1 | 15 |
| 7 | 克霉唑阴道片 | 1 | 1 | 3 |
| 8 | 卡培他滨片 | 1 | 1 | 0 |
| 9 | 厄贝沙坦氢氯噻嗪片 | 1 | 1 | 5 |
| 10 | 头孢地尼胶囊 | 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
126 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 华润双鹤药业股份有限公司 | 16 | 15 | 0 |
| 2 | 大连金鼎昌医药科技有限公司 | 11 | 11 | 0 |
| 3 | 西安葛蓝新通制药有限公司 | 9 | 9 | 0 |
| 4 | medac Gesellschaft für klinische Spezialpr？parate mbH | 8 | 1 | 0 |
| 5 | 深圳信立泰药业股份有限公司 | 6 | 1 | 0 |
| 6 | 陕西长鸣制药有限公司 | 5 | 5 | 0 |
| 7 | 哈药集团中药二厂 | 5 | 4 | 0 |
| 8 | 宜昌人福药业有限责任公司 | 4 | 3 | 2 |
| 9 | 广东金城金素制药有限公司 | 4 | 2 | 1 |
| 10 | 深圳市瓴方生物医药科技有限公司 | 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
46 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/10Import · Class 3.1 | Tisotumab VedotinJXSL2101146 | Seagen Inc.; PRA Health Sciences China Inc. |
| 2021/12/10New drug · Class 2.2 | 注射用维迪西妥单抗CXSL2101475 | 荣昌生物制药（烟台）股份有限公司 |
| 2021/12/10New drug · Class 1 | THZ0106注射液CXSL2101473 | 天境生物科技（杭州）有限公司 |
| 2021/12/10New drug · Class 1 | 人源化抗人 IgE 单克隆抗体注射液CXSL2101472 | 天辰生物医药（苏州）有限公司 |
| 2021/12/10New drug · Class 1 | BC0306胶囊CXHL2101733 | 山东丹红制药有限公司 |
| 2021/12/10New drug · Class 1 | BC0306胶囊CXHL2101732 | 山东丹红制药有限公司 |
| 2021/12/10New drug · Class 1 | LF0397片CXHL2101716 | 深圳市瓴方生物医药科技有限公司 |
| 2021/12/10New drug · Class 1 | LF0397片CXHL2101715 | 深圳市瓴方生物医药科技有限公司 |
| 2021/12/09Import · Class 1 | 人同种异体骨髓来源的成骨细胞JXSL2101145 | Bone Therapeutics SA; SHENZHEN PREGENE BIOPHARMA CO. LTD |
| 2021/12/09Generic · Class 3 | 注射用兰索拉唑CYHS2102174 | 海南海灵化学制药有限公司 |
| 2021/12/09Generic · Class 3 | 羧甲司坦口服溶液CYHS2102169 | 北京亦嘉新创医疗器械技术研究院有限公司; 北京诚济制药股份有限公司 |
| 2021/12/09Generic · Class 3 | 羧甲司坦口服溶液CYHS2102168 | 北京亦嘉新创医疗器械技术研究院有限公司; 北京诚济制药股份有限公司 |
| 2021/12/09New drug · Class 1.1 | 全三七片CXZL2101039 | 云南白药集团股份有限公司 |
| 2021/12/09New drug · Class 1 | 注射用CU-20401CXSL2101474 | 科笛生物医药（无锡）有限公司 |
| 2021/12/09New drug · Class 1 | KF-0210片CXHL2101731 | 凯复（苏州）生物医药有限公司 |
| 2021/12/09New drug · Class 1 | KF-0210片CXHL2101730 | 凯复（苏州）生物医药有限公司 |
| 2021/12/08Generic · Class 3 | 普瑞巴林口服溶液CYHS2102160 | 秦皇岛爱晖药业有限公司; 保定爱晖药业有限公司 |
| 2021/12/08Generic · Class 3 | 坎地沙坦酯氢氯噻嗪片CYHS2102158 | 重庆圣华曦药业股份有限公司 |
| 2021/12/08Generic · Class 3 | 坎地沙坦酯氢氯噻嗪片CYHS2102157 | 重庆圣华曦药业股份有限公司 |
| 2021/12/08Generic · Class 3 | 注射用尼可地尔CYHS2102156 | 成都苑东生物制药股份有限公司; 山西普德药业有限公司 |
| 2021/12/08New drug · Class 1 | HB0028注射液CXSL2101471 | 华博生物医药技术（上海）有限公司; 上海华奥泰生物药业股份有限公司 |
| 2021/12/08New drug · Class 1 | KN060注射液CXSL2101468 | 苏州康宁杰瑞生物科技有限公司 |
| 2021/12/08New drug · Class 1 | LNF1904CXSL2101466 | 山东新时代药业有限公司 |
| 2021/12/08New drug · Class 1 | QY201片CXHL2101729 | 启元生物（杭州）有限公司 |
| 2021/12/08New drug · Class 1 | QY201片CXHL2101728 | 启元生物（杭州）有限公司 |
| 2021/12/08New drug · Class 1 | 盐酸BGB-23339薄膜包衣片CXHL2101727 | 百济神州（苏州）生物科技有限公司 |
| 2021/12/08New drug · Class 1 | 盐酸BGB-23339薄膜包衣片CXHL2101726 | 百济神州（苏州）生物科技有限公司 |
| 2021/12/08New drug · Class 1 | PRJ1-3024胶囊CXHL2101725 | 珠海宇繁生物科技有限责任公司 |
| 2021/12/08New drug · Class 1 | SAL0114片CXHL2101724 | 深圳信立泰药业股份有限公司 |
| 2021/12/08New drug · Class 1 | SAL0114片CXHL2101723 | 深圳信立泰药业股份有限公司 |
16 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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