药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/05/10 – 2022/05/16
- New acceptances this week
- 185
- Drugs with new generic filings (by drug name, de-duplicated)
- 19
- 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
185filings, 25 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 104 |
| Generic | 25 |
| New drug | 24 |
| Import | 14 |
| Import re-registration | 12 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 153 |
| TCM | 15 |
| 治疗用生物制品 | 13 |
| 预防用生物制品 | 4 |
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
19 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 中/长链脂肪乳注射液（C6～24） | 2 | 1 | 0 |
| 2 | 盐酸左沙丁胺醇雾化吸入溶液 | 2 | 1 | 2 |
| 3 | 葡萄糖酸钙氯化钠注射液 | 2 | 1 | 5 |
| 4 | 达格列净片 | 2 | 1 | 82 |
| 5 | 马来酸噻吗洛尔滴眼液 | 2 | 1 | 4 |
| 6 | 马来酸阿塞那平舌下片 | 2 | 1 | 1 |
| 7 | 双醋瑞因胶囊 | 1 | 1 | 3 |
| 8 | 地奈德乳膏 | 1 | 1 | 0 |
| 9 | 塞来昔布胶囊 | 1 | 1 | 5 |
| 10 | 奥硝唑片 | 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
99 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 河南辅仁怀庆堂制药有限公司 | 19 | 17 | 0 |
| 2 | N.V. Organon | 8 | 1 | 0 |
| 3 | Pfizer Inc. | 4 | 3 | 0 |
| 4 | 哈药集团世一堂制药厂 | 4 | 3 | 0 |
| 5 | 山东齐都药业有限公司 | 4 | 3 | 0 |
| 6 | Meiji Seika Pharma Co. Ltd. | 4 | 1 | 0 |
| 7 | 凌科药业（杭州）有限公司 | 4 | 1 | 0 |
| 8 | 四川合信药业有限责任公司 | 4 | 1 | 0 |
| 9 | 浙江劲方药业有限公司 | 4 | 1 | 0 |
| 10 | 成都青山利康药业股份有限公司 | 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
48 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/05/13Import · Class 1 | Linzagolix片JXHL2200113 | Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd. |
| 2022/05/13Import · Class 1 | Linzagolix片JXHL2200112 | Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd. |
| 2022/05/13Generic · Class 3 | 重酒石酸去甲肾上腺素注射液CYHS2200733 | 成都硕德药业有限公司 |
| 2022/05/13New drug · Class 3.3 | ACYW135群脑膜炎球菌多糖结合疫苗CXSL2200213 | 辽宁成大生物股份有限公司; 北京成大天和生物科技有限公司; 成大生物（本溪）有限公司 |
| 2022/05/13New drug · Class 2.4 | 盐酸米托蒽醌脂质体注射液CXHL2200307 | 石药集团中诺药业（石家庄）有限公司 |
| 2022/05/12Import · Class 1 | PF-07104091片JXHL2200111 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/05/12Import · Class 1 | PF-07104091片JXHL2200110 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/05/12Import · Class 1 | Liafensine片JXHL2200109 | Denovo Biopharma LLC; Denovo Biopharma Co. Ltd. |
| 2022/05/12Generic · Class 3 | 氨溴特罗口服溶液CYHS2200731 | 呋欧医药科技（湖州）有限公司; 浙江凯润药业股份有限公司 |
| 2022/05/12New drug · Class 1 | CM310重组人源化单克隆抗体注射液CXSL2200212 | 康诺亚生物医药科技（成都）有限公司 |
| 2022/05/12New drug · Class 1 | GFH018 片CXHL2200306 | 浙江劲方药业有限公司 |
| 2022/05/12New drug · Class 1 | GFH018 片CXHL2200305 | 浙江劲方药业有限公司 |
| 2022/05/12New drug · Class 1 | GFH018 片CXHL2200304 | 浙江劲方药业有限公司 |
| 2022/05/12New drug · Class 1 | GFH018 片CXHL2200303 | 浙江劲方药业有限公司 |
| 2022/05/11Import · Class 1 | Cotadutide注射液JXHL2200108 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/05/11Import · Class 1 | Cotadutide注射液JXHL2200107 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/05/11Generic · Class 3 | 福多司坦口服溶液CYHS2200723 | 江苏正大丰海制药有限公司; 江苏欧歌制药有限公司 |
| 2022/05/11Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2200722 | 湖南华纳大药厂股份有限公司 |
| 2022/05/11Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2200721 | 湖南华纳大药厂股份有限公司 |
| 2022/05/11New drug · Class 1 | 注射用ZB001CXSL2200210 | 上海泽纳仕生物科技有限公司 |
| 2022/05/11New drug · Class 2.2 | 盐酸多奈哌齐口腔速溶膜CXHL2200300 | 四川百利药业有限责任公司 |
| 2022/05/11New drug · Class 2.2 | 盐酸多奈哌齐口腔速溶膜CXHL2200299 | 四川百利药业有限责任公司 |
| 2022/05/10Import · Class 2.2 | 度伐利尤单抗注射液JXSL2200057 | MedImmune LLC; AstraZeneca Investment (China) Co. Limited |
| 2022/05/10Import · Class 1 | Ponsegromab 注射液JXSL2200056 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/05/10Import · Class 1 | AB-729注射液JXHL2200106 | Arbutus Biopharma Corporation; QILU PHARMACEUTICAL CO. LTD. |
| 2022/05/10Import · Class 1 | AB-729注射液JXHL2200105 | Arbutus Biopharma Corporation; QILU PHARMACEUTICAL CO. LTD. |
| 2022/05/10Generic · Class 3 | 奥硝唑片CYHS2200719 | 石家庄四药有限公司 |
| 2022/05/10Generic · Class 3 | 地奈德乳膏CYHS2200717 | 重庆华邦胜凯制药有限公司; 重庆华邦制药有限公司 |
| 2022/05/10Generic · Class 3 | 葡萄糖酸钙氯化钠注射液CYHS2200716 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2022/05/10Generic · Class 3 | 葡萄糖酸钙氯化钠注射液CYHS2200715 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
18 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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