药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/09/20 – 2022/09/26
- New acceptances this week
- 280
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- 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
280filings, 49 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 135 |
| New drug | 51 |
| Generic | 49 |
| Import | 20 |
| Unspecified | 17 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 195 |
| 治疗用生物制品 | 38 |
| TCM | 32 |
| Biologic | 14 |
| 体外诊断试剂 | 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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 磷酸奥司他韦胶囊 | 3 | 1 | 42 |
| 2 | 别嘌醇片 | 2 | 1 | 4 |
| 3 | 盐酸多巴胺注射液 | 2 | 1 | 3 |
| 4 | 葡萄糖酸钙氯化钠注射液 | 2 | 1 | 5 |
| 5 | 阿糖胞苷注射液 | 2 | 1 | 0 |
| 6 | 非诺贝特酸胆碱缓释胶囊 | 2 | 1 | 1 |
| 7 | 乙酰半胱氨酸颗粒 | 1 | 1 | 4 |
| 8 | 他克莫司缓释胶囊 | 1 | 1 | 6 |
| 9 | 他氟前列素滴眼液 | 1 | 1 | 1 |
| 10 | 利多卡因凝胶贴膏 | 1 | 1 | 7 |
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
166 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北美林药业有限公司 | 22 | 16 | 0 |
| 2 | 上海延安药业有限公司 | 12 | 11 | 0 |
| 3 | 达嘉维康生物制药有限公司 | 8 | 8 | 0 |
| 4 | Vetter Pharma-Fertigung GmbH & Co. KG | 8 | 2 | 0 |
| 5 | 大连天山药业有限公司 | 6 | 6 | 0 |
| 6 | 江右制药（常德）有限公司 | 5 | 5 | 0 |
| 7 | 福州基石医药科技有限公司 | 4 | 4 | 0 |
| 8 | Takeda Development Center Americas Inc. | 4 | 2 | 0 |
| 9 | 北京浦润奥生物科技有限责任公司 | 4 | 1 | 0 |
| 10 | FUJIFILM Diosynth Biotechnologies UK Ltd | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/26Generic · Class 3 | 别嘌醇片CYHS2201610 | 成都倍特药业股份有限公司 |
| 2022/09/26Generic · Class 3 | 别嘌醇片CYHS2201609 | 成都倍特药业股份有限公司 |
| 2022/09/26New drug · Class 1 | 重组人源化单克隆抗体MIL93注射液CXSL2200483 | 北京天广实生物技术股份有限公司 |
| 2022/09/26New drug · Class 1 | 重组人IL12/15-PDL1B单纯疱疹Ⅰ型溶瘤病毒注射液（Vero细胞）CXSL2200482 | 中生复诺健生物科技（上海）有限公司 |
| 2022/09/25Generic · Class 3 | 盐酸多巴胺注射液CYHS2201608 | 成都欣捷高新技术开发股份有限公司; 峨眉山通惠制药有限公司 |
| 2022/09/25Generic · Class 3 | 盐酸多巴胺注射液CYHS2201607 | 成都欣捷高新技术开发股份有限公司; 峨眉山通惠制药有限公司 |
| 2022/09/24Import · Class 1 | ALXN1720注射液JXSL2200172 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/09/24Import · Class 1 | Futuximab/Modotuximab 注射液 (S95026)JXSL2200171 | Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development CO. LTD |
| 2022/09/24Import · Class 1 | Nemtabrutinib片JXHL2200294 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2022/09/24Import · Class 1 | Nemtabrutinib片JXHL2200293 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2022/09/24Generic · Class 3 | 重酒石酸卡巴拉汀口服溶液CYHS2201604 | 呋欧医药科技（湖州）有限公司; 浙江凯润药业股份有限公司 |
| 2022/09/24New drug · Class 2.3 | 养正消积胶囊CXZL2200043 | 石家庄以岭药业股份有限公司 |
| 2022/09/24New drug · Class 1 | 靶向HLA-A*02:01/NY-ESO-1的TCR-T细胞注射液CXSL2200481 | 深圳普瑞金生物药业股份有限公司 |
| 2022/09/24New drug · Class 1 | GC301腺相关病毒注射液CXSL2200480 | 北京锦篮基因科技有限公司 |
| 2022/09/24New drug · Class 1 | 注射用QLS31903CXSL2200479 | 齐鲁制药有限公司 |
| 2022/09/24New drug · Class 1 | 伯瑞替尼肠溶胶囊CXHS2200048 | 北京浦润奥生物科技有限责任公司; 凯莱英生命科学技术（天津）有限公司 |
| 2022/09/24New drug · Class 1 | 伯瑞替尼肠溶胶囊CXHS2200047 | 北京浦润奥生物科技有限责任公司; 凯莱英生命科学技术（天津）有限公司 |
| 2022/09/23Import · Class 1 | Mezagitamab 注射剂JXSL2200170 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2022/09/23Generic · Class 3 | 盐酸利多卡因凝胶CYHS2201594 | 南京汉欣医药科技有限公司; 美药星（南京）制药有限公司 |
| 2022/09/23Generic · Class 3 | 碳酸司维拉姆干混悬剂CYHS2201593 | 南京恒生制药有限公司 |
| 2022/09/23Generic · Class 3 | 盐酸丙卡特罗口服溶液CYHS2201592 | 南京恒道医药科技股份有限公司; 健民药业集团股份有限公司 |
| 2022/09/23New drug · Class 1 | C-13-60细胞制剂CXSL2200478 | 重庆精准生物技术有限公司 |
| 2022/09/23New drug · Class 1 | ILB-2101注射液CXSL2200477 | 英诺湖医药（杭州）有限公司 |
| 2022/09/23New drug · Class 1 | YH001注射液CXSL2200476 | 祐和医药科技（北京）有限公司 |
| 2022/09/23New drug · Class 1 | 1A46注射液CXSL2200475 | 成都恩沐生物科技有限公司; 海正生物制药有限公司; 浙江博锐生物制药有限公司 |
| 2022/09/23New drug · Class 2.2 | 司美格鲁肽注射液CXHL2200734 | 石药集团中奇制药技术（石家庄）有限公司 |
| 2022/09/23New drug · Class 1 | 伊匹乌肽滴眼液CXHL2200733 | 深圳益信康生物科技有限公司 |
| 2022/09/23New drug · Class 1 | GT919胶囊CXHL2200732 | 标新生物医药科技（上海）有限公司 |
| 2022/09/23New drug · Class 1 | GT919胶囊CXHL2200731 | 标新生物医药科技（上海）有限公司 |
| 2022/09/23New drug · Class 1 | GT919胶囊CXHL2200730 | 标新生物医药科技（上海）有限公司 |
55 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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