药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/01/24 – 2023/01/30
- New acceptances this week
- 106
- Drugs with new generic filings (by drug name, de-duplicated)
- 29
- 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
106filings, 33 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 37 |
| Generic | 33 |
| New drug | 28 |
| Import re-registration | 6 |
| Import | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 86 |
| 治疗用生物制品 | 12 |
| TCM | 5 |
| 预防用生物制品 | 3 |
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
29 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥拉帕利片 | 2 | 1 | 0 |
| 2 | 左卡尼汀注射液 | 2 | 1 | 5 |
| 3 | 氨磺必利注射液 | 2 | 1 | 1 |
| 4 | 氯化钾颗粒 | 2 | 1 | 4 |
| 5 | 依帕司他片 | 1 | 1 | 1 |
| 6 | 双氯芬酸钠肠溶片 | 1 | 1 | 2 |
| 7 | 吉非替尼片 | 1 | 1 | 1 |
| 8 | 地氯雷他定口服溶液 | 1 | 1 | 26 |
| 9 | 多索茶碱注射液 | 1 | 1 | 5 |
| 10 | 奥美沙坦酯氢氯噻嗪片 | 1 | 1 | 3 |
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
79 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 正大天晴药业集团股份有限公司 | 5 | 2 | 0 |
| 2 | 科笛生物医药（无锡）有限公司 | 4 | 1 | 0 |
| 3 | 海思科医药集团股份有限公司 | 3 | 2 | 0 |
| 4 | 艾缇亚（上海）制药有限公司 | 3 | 1 | 0 |
| 5 | 海南葫芦娃药业集团股份有限公司 | 2 | 2 | 2 |
| 6 | 石药集团中奇制药技术（石家庄）有限公司 | 2 | 2 | 0 |
| 7 | A. Menarini GmbH | 2 | 1 | 0 |
| 8 | Kyowa Kirin Co. Ltd. | 2 | 1 | 0 |
| 9 | 南京恩泰医药科技有限公司 | 2 | 1 | 2 |
| 10 | 哈尔滨松鹤制药有限公司 | 2 | 1 | 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
45 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/30Import · Class 1 | 碘[131I]-IPA注射液JXHL2300014 | Telix International Pty Ltd; Grand Pharmaceutical (China) Co. Ltd. |
| 2023/01/30Generic · Class 3 | 羧甲司坦口服溶液CYHS2300247 | 健民药业集团股份有限公司 |
| 2023/01/30Generic · Class 3 | 恩替卡韦口服溶液CYHS2300245 | 海南全星制药有限公司 |
| 2023/01/30Generic · Class 3 | 地氯雷他定口服溶液CYHS2300240 | 亚宝药业四川制药有限公司 |
| 2023/01/30Generic · Class 3 | 氨磺必利注射液CYHL2300011 | 南京恩泰医药科技有限公司 |
| 2023/01/30Generic · Class 3 | 氨磺必利注射液CYHL2300010 | 南京恩泰医药科技有限公司 |
| 2023/01/30New drug · Class 2.2;2.4 | 孟鲁司特钠凝胶CXHL2300124 | 艾缇亚（上海）制药有限公司 |
| 2023/01/30New drug · Class 2.2 | 孟鲁司特钠凝胶CXHL2300123 | 艾缇亚（上海）制药有限公司 |
| 2023/01/30New drug · Class 2.2;2.4 | 孟鲁司特钠凝胶CXHL2300122 | 艾缇亚（上海）制药有限公司 |
| 2023/01/30New drug · Class 1 | P29注射液CXHL2300121 | 浙江和泽医药科技股份有限公司 |
| 2023/01/29Generic · Class 3 | 磷酸奥司他韦干糖浆CYHS2300236 | 湖南天济草堂制药股份有限公司 |
| 2023/01/29Generic · Class 3 | 布洛芬混悬滴剂CYHS2300235 | 海南万玮制药有限公司 |
| 2023/01/29Generic · Class 3 | 法莫替丁注射液CYHS2300234 | 重庆药谷制药有限公司; 太极集团四川太极制药有限公司 |
| 2023/01/29Generic · Class 3 | 缩宫素注射液CYHS2300230 | 山西威奇达光明制药有限公司 |
| 2023/01/29Generic · Class 3 | 氯化钾颗粒CYHS2300228 | 珠海市汇通达医药有限公司; 海南皇隆制药股份有限公司 |
| 2023/01/29Generic · Class 3 | 氯化钾颗粒CYHS2300227 | 珠海市汇通达医药有限公司; 海南皇隆制药股份有限公司 |
| 2023/01/29Generic · Class 3 | 注射用吲哚菁绿CYHS2300225 | 南京正大天晴制药有限公司 |
| 2023/01/29Generic · Class 3 | 依帕司他片CYHS2300224 | 成都倍特药业股份有限公司 |
| 2023/01/29Generic · Class 3 | 镥[177Lu]氧奥曲肽注射液CYHL2300009 | 原子高科股份有限公司 |
| 2023/01/29Generic · Class 3 | 氟比洛芬贴剂CYHL2300008 | 湖南九典制药股份有限公司 |
| 2023/01/29New drug · Class 3.3 | 雷珠单抗注射液CXSS2300004 | 齐鲁制药有限公司 |
| 2023/01/29New drug · Class 1 | 注射用RC118CXSL2300065 | 荣昌生物制药（烟台）股份有限公司 |
| 2023/01/29New drug · Class 1 | CM310重组人源化单克隆抗体注射液CXSL2300064 | 康诺亚生物医药科技（成都）有限公司 |
| 2023/01/29New drug · Class 3.3 | 吸附破伤风疫苗CXSL2300063 | 北京民海生物科技有限公司 |
| 2023/01/29New drug · Class 1 | 盐酸佐利替尼片CXHS2300020 | 江苏晨泰医药科技有限公司 |
| 2023/01/29New drug · Class 1 | 盐酸佐利替尼片CXHS2300019 | 江苏晨泰医药科技有限公司 |
| 2023/01/29New drug · Class 1 | HSK7653片CXHS2300018 | 海思科医药集团股份有限公司; 四川海思科制药有限公司 |
| 2023/01/29New drug · Class 1 | HSK7653片CXHS2300017 | 海思科医药集团股份有限公司; 四川海思科制药有限公司 |
| 2023/01/29New drug · Class 1 | SPH4336片CXHL2300120 | 上海医药集团股份有限公司 |
| 2023/01/29New drug · Class 1 | TQB3616胶囊CXHL2300119 | 正大天晴药业集团股份有限公司 |
15 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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