药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/10/04 – 2022/10/10
- New acceptances this week
- 134
- Drugs with new generic filings (by drug name, de-duplicated)
- 21
- 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
134filings, 28 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 63 |
| New drug | 34 |
| Generic | 28 |
| Import re-registration | 6 |
| Import | 2 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 99 |
| TCM | 20 |
| 治疗用生物制品 | 15 |
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
21 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 地夸磷索钠滴眼液 | 3 | 2 | 5 |
| 2 | 丙戊酸钠注射用浓溶液 | 2 | 1 | 0 |
| 3 | 复方醋酸钠林格注射液 | 2 | 1 | 2 |
| 4 | 孟鲁司特钠咀嚼片 | 2 | 1 | 4 |
| 5 | 托拉塞米注射液 | 2 | 1 | 1 |
| 6 | 盐酸昂丹司琼注射液 | 2 | 1 | 5 |
| 7 | 乙酰半胱氨酸泡腾片 | 1 | 1 | 3 |
| 8 | 吸入用复方异丙托溴铵溶液 | 1 | 1 | 4 |
| 9 | 地氯雷他定片 | 1 | 1 | 0 |
| 10 | 头孢泊肟酯片 | 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
88 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 哈尔滨君安堂医药有限公司 | 7 | 7 | 0 |
| 2 | 江苏恒瑞医药股份有限公司 | 4 | 2 | 0 |
| 3 | 南京正大天晴制药有限公司 | 4 | 1 | 0 |
| 4 | 广西凌云县制药有限责任公司 | 3 | 3 | 0 |
| 5 | 中山万汉制药有限公司 | 3 | 2 | 3 |
| 6 | Bracco Imaging Italia s.r.l. | 3 | 1 | 0 |
| 7 | 江苏晨牌邦德药业有限公司 | 3 | 1 | 0 |
| 8 | 河南利欣制药股份有限公司 | 3 | 1 | 0 |
| 9 | 华佗国药股份有限公司 | 2 | 2 | 0 |
| 10 | 原子高科股份有限公司 | 2 | 2 | 2 |
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
49 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/10/10Import · Class 3.4 | 注射用A型肉毒毒素JXSL2200179 | JETEMA Co. Ltd. |
| 2022/10/10Generic · Class 3 | 托拉塞米注射液CYHS2201686 | 浙江华海药业股份有限公司; 成都市海通药业有限公司 |
| 2022/10/10Generic · Class 3 | 托拉塞米注射液CYHS2201685 | 浙江华海药业股份有限公司; 成都市海通药业有限公司 |
| 2022/10/10Generic · Class 3 | 聚乙二醇4000散（儿童型）CYHS2201684 | 浙江远力健药业有限责任公司 |
| 2022/10/10Generic · Class 3 | 美洛昔康纳米晶注射液CYHL2200085 | 扬子江药业集团有限公司 |
| 2022/10/10Generic · Class 3 | 注射用硫化胶体CYHL2200084 | 原子高科股份有限公司 |
| 2022/10/10Generic · Class 3 | 锝[99mTc]硫化胶体注射液CYHL2200083 | 原子高科股份有限公司 |
| 2022/10/10New drug · Class 1.1 | 拈痛祛风颗粒CXZS2200013 | 成都华西天然药物有限公司; 成都永康制药有限公司 |
| 2022/10/10New drug · Class 1.1 | 风叶咳喘平口服液CXZS2200012 | 卓和药业集团股份有限公司; 亚宝药业四川制药有限公司 |
| 2022/10/10New drug · Class 1 | 注射用SIM0237CXSL2200508 | 江苏先声药业有限公司 |
| 2022/10/10New drug · Class 1 | EMB-09注射液CXSL2200507 | 上海岸迈生物科技有限公司 |
| 2022/10/10New drug · Class 1 | SIM0348注射液CXSL2200506 | 江苏先声药业有限公司 |
| 2022/10/10New drug · Class 1 | CG-BM1异体人骨髓间充质干细胞注射液CXSL2200505 | 广州赛隽生物科技有限公司 |
| 2022/10/10New drug · Class 1 | AK2017注射液CXSL2200504 | 安徽安科生物工程（集团）股份有限公司 |
| 2022/10/10New drug · Class 1 | NTQ2494片CXHL2200773 | 南京正大天晴制药有限公司 |
| 2022/10/10New drug · Class 1 | NTQ2494片CXHL2200772 | 南京正大天晴制药有限公司 |
| 2022/10/10New drug · Class 1 | NTQ2494片CXHL2200771 | 南京正大天晴制药有限公司 |
| 2022/10/10New drug · Class 1 | NTQ2494片CXHL2200770 | 南京正大天晴制药有限公司 |
| 2022/10/10New drug · Class 1 | VG081821AC片CXHL2200769 | 浙江春禾医药科技有限公司 |
| 2022/10/10New drug · Class 1 | VG081821AC片CXHL2200768 | 浙江春禾医药科技有限公司 |
| 2022/10/10New drug · Class 1 | RP902片CXHL2200767 | 润佳（苏州）医药科技有限公司 |
| 2022/10/10New drug · Class 1 | RP902片CXHL2200766 | 润佳（苏州）医药科技有限公司 |
| 2022/10/10New drug · Class 1 | TQB3616胶囊CXHL2200765 | 正大天晴药业集团股份有限公司 |
| 2022/10/10New drug · Class 1 | TQB3616胶囊CXHL2200764 | 正大天晴药业集团股份有限公司 |
| 2022/10/09Import · Class 1 | Ritlecitinib胶囊JXHL2200297 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/10/09Generic · Class 3 | 普瑞巴林口崩片CYHS2201675 | 广州帝奇医药技术有限公司; 重庆华邦制药有限公司 |
| 2022/10/09Generic · Class 3 | 复方醋酸钠林格注射液CYHS2201674 | 广东大翔制药有限公司 |
| 2022/10/09Generic · Class 3 | 复方醋酸钠林格注射液CYHS2201673 | 广东大翔制药有限公司 |
| 2022/10/09Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2201670 | 华润双鹤利民药业（济南）有限公司 |
| 2022/10/09Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2201669 | 华润双鹤利民药业（济南）有限公司 |
19 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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