药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/10/26 – 2021/11/01
- New acceptances this week
- 314
- Drugs with new generic filings (by drug name, de-duplicated)
- 31
- 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
314filings, 39 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 165 |
| New drug | 56 |
| Generic | 39 |
| Import | 27 |
| Import re-registration | 22 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 224 |
| TCM | 42 |
| 治疗用生物制品 | 41 |
| 预防用生物制品 | 6 |
| Biologic | 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
31 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸莫西沙星氯化钠注射液 | 2 | 2 | 10 |
| 2 | 奥拉帕利片 | 2 | 1 | 0 |
| 3 | 左氧氟沙星滴眼液 | 2 | 1 | 16 |
| 4 | 托拉塞米注射液 | 2 | 1 | 1 |
| 5 | 普瑞巴林胶囊 | 2 | 1 | 12 |
| 6 | 甲磺酸仑伐替尼胶囊 | 2 | 1 | 4 |
| 7 | 缩宫素注射液 | 2 | 1 | 8 |
| 8 | 酒石酸伐尼克兰片 | 2 | 1 | 3 |
| 9 | 乙酰半胱氨酸颗粒 | 1 | 1 | 4 |
| 10 | 依帕司他片 | 1 | 1 | 1 |
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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林省益浦生物科技有限公司 | 9 | 9 | 0 |
| 2 | Novartis Pharma Schweiz AG | 6 | 3 | 0 |
| 3 | 东阿阿华医疗科技有限公司药业分公司 | 6 | 2 | 0 |
| 4 | 广东金城金素制药有限公司 | 6 | 1 | 0 |
| 5 | 陕西东科制药有限责任公司 | 5 | 5 | 0 |
| 6 | AstraZeneca AB | 5 | 3 | 0 |
| 7 | 江苏恒瑞医药股份有限公司 | 5 | 3 | 0 |
| 8 | 海南久常制药有限公司 | 5 | 3 | 0 |
| 9 | H. Lundbeck A/S | 5 | 2 | 0 |
| 10 | 石药集团中奇制药技术（石家庄）有限公司 | 5 | 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
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/01Import · Class 1 | DS-1062aJXSL2101122 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2021/11/01Import · Class 1 | MRTX849片JXHL2101227 | Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2021/11/01Import · Class 1 | MRTX849片JXHL2101226 | Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2021/11/01Generic · Class 3 | 盐酸替罗非班注射液CYHS2101951 | 广州曼翔医药有限公司; 广东星昊药业有限公司 |
| 2021/11/01New drug · Class 1.1 | 脑伤乐生颗粒CXZS2101005 | 深圳市沙松实业有限公司; 河南天方药业中药有限公司 |
| 2021/11/01New drug · Class 1 | AK104注射液CXSL2101405 | 康方药业有限公司 |
| 2021/11/01New drug · Class 1 | AK104注射液CXSL2101404 | 康方药业有限公司 |
| 2021/11/01New drug · Class 1 | AK112注射液CXSL2101403 | 中山康方生物医药有限公司 |
| 2021/11/01New drug · Class 1 | GR1501注射液CXSL2101401 | 重庆智翔金泰生物制药有限公司 |
| 2021/11/01New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液CXSL2101400 | 山东新时代药业有限公司 |
| 2021/11/01New drug · Class 1 | ASKG712注射液CXSL2101396 | 苏州奥赛康生物医药有限公司 |
| 2021/11/01New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液CXSL2101395 | 泰州翰中生物医药有限公司 |
| 2021/11/01New drug · Class 2.2 | 吸附无细胞百（组分）白破联合疫苗CXSL2101393 | 北京科兴中维生物技术有限公司 |
| 2021/11/01New drug · Class 1 | HLX35CXSL2101389 | 上海复宏汉霖生物技术股份有限公司 |
| 2021/11/01New drug · Class 1 | SHR3680片CXHS2101050 | 江苏恒瑞医药股份有限公司 |
| 2021/11/01New drug · Class 1 | CBP-307胶囊CXHL2101612 | 苏州康乃德生物医药有限公司 |
| 2021/11/01New drug · Class 1 | CBP-307胶囊CXHL2101611 | 苏州康乃德生物医药有限公司 |
| 2021/11/01New drug · Class 2.4 | 甲磺酸阿帕替尼片CXHL2101607 | 江苏恒瑞医药股份有限公司 |
| 2021/10/29Import · Class 3.1 | 纳武利尤单抗注射液JXSS2101028 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb （China）Investment Co. Ltd |
| 2021/10/29Import · Class 3.1 | 纳武利尤单抗注射液JXSS2101027 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb （China）Investment Co. Ltd |
| 2021/10/29Generic · Class 3 | 叶酸片CYHS2101949 | 浙江佰奥医药科技有限公司; 浙江北生药业汉生制药有限公司 |
| 2021/10/29Generic · Class 3 | 氨溴特罗口服溶液CYHS2101947 | 河北创健药业有限公司; 河北仁合益康药业有限公司 |
| 2021/10/29Generic · Class 3 | 依帕司他片CYHS2101945 | 西安万隆制药股份有限公司 |
| 2021/10/29Generic · Class 3 | 盐酸可乐定缓释片CYHL2101033 | 山东达因海洋生物制药股份有限公司 |
| 2021/10/29New drug · Class 1 | PD-1基因定制活化T细胞注射液CXSL2101398 | 安徽柯顿生物科技有限公司 |
| 2021/10/29New drug · Class 1 | 注射用MRG003CXSL2101397 | 上海美雅珂生物技术有限责任公司 |
| 2021/10/29New drug · Class 2.1;2.2 | 注射用RF16001CXHL2101621 | 北京辉粒科技有限公司; 宜昌人福药业有限责任公司 |
| 2021/10/29New drug · Class 1 | JMKX001899片CXHL2101620 | 上海济煜医药科技有限公司 |
| 2021/10/29New drug · Class 1 | JMKX001899片CXHL2101619 | 上海济煜医药科技有限公司 |
| 2021/10/29New drug · Class 2.4 | 盐酸米托蒽醌脂质体注射液CXHL2101618 | 石药集团中诺药业（石家庄）有限公司 |
59 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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