药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/10/22 – 2024/10/28
- New acceptances this week
- 367
- Drugs with new generic filings (by drug name, de-duplicated)
- 80
- Accepted this week, now under review
- 1
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
367filings, 116 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 176 |
| Generic | 116 |
| New drug | 48 |
| Import | 15 |
| Unspecified | 10 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 236 |
| TCM | 74 |
| 治疗用生物制品 | 41 |
| Biologic | 9 |
| 预防用生物制品 | 7 |
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
80 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 富马酸伏诺拉生片 | 6 | 3 | 58 |
| 2 | 甲氨蝶呤注射液 | 6 | 1 | 12 |
| 3 | 维生素B6注射液 | 4 | 4 | 13 |
| 4 | 克立硼罗软膏 | 2 | 2 | 28 |
| 5 | 比拉斯汀口服溶液 | 2 | 2 | 7 |
| 6 | 氯化钙注射液 | 2 | 2 | 6 |
| 7 | 法莫替丁注射液 | 2 | 2 | 8 |
| 8 | 注射用盐酸兰地洛尔 | 2 | 2 | 19 |
| 9 | 乳果糖口服溶液 | 2 | 1 | 40 |
| 10 | 乳酸钠林格注射液 | 2 | 1 | 6 |
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
219 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广东星昊药业有限公司 | 24 | 17 | 0 |
| 2 | 吉林省尚城药业有限公司 | 9 | 8 | 0 |
| 3 | 沈阳东新药业有限公司 | 9 | 8 | 0 |
| 4 | 哈尔滨誉衡制药有限公司 | 6 | 1 | 6 |
| 5 | 福州海王金象中药制药有限公司 | 5 | 5 | 0 |
| 6 | Novo Nordisk A/S | 5 | 1 | 0 |
| 7 | Sanofi-Aventis Recherche & Développement | 4 | 4 | 0 |
| 8 | 华川制药有限公司 | 4 | 4 | 0 |
| 9 | 北京百邑无忧科技发展有限公司 | 4 | 3 | 0 |
| 10 | 成都诺和晟鸿生物制药有限公司 | 4 | 3 | 4 |
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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/28Generic · Class 3 | 乳酸钠林格冲洗液CYHS2403652 | 石家庄四药有限公司 |
| 2024/10/28Generic · Class 3 | 己酮可可碱注射液CYHS2403651 | 国药集团容生制药有限公司 |
| 2024/10/28New drug · Class 3.3 | 帕妥珠单抗注射液CXSS2400116 | 杭州博之锐生物制药有限公司 |
| 2024/10/28New drug · Class 1 | SYS6045CXSL2400733 | 石药集团巨石生物制药有限公司 |
| 2024/10/28New drug · Class 1 | 1D228片CXHL2401138 | 广州中科莱恩药物研究有限公司; 广东莱恩医药研究院有限公司 |
| 2024/10/28New drug · Class 2.3 | SMF-213CXHL2401137 | 江西施美药业股份有限公司 |
| 2024/10/28New drug · Class 1 | 伊匹乌肽雾化吸入溶液CXHL2401136 | 益承康泰(厦门)生物科技有限公司 |
| 2024/10/28New drug · Class 1 | SYH2051片CXHL2401135 | 石药集团中奇制药技术(石家庄)有限公司 |
| 2024/10/28New drug · Class 1 | SYH2051片CXHL2401134 | 石药集团中奇制药技术(石家庄)有限公司 |
| 2024/10/26Import · Class 1 | Remternetug注射液JXSL2400205 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/26Generic · Class 3 | 布比卡因脂质体注射液CYHS2403649 | 浙江圣兆药物科技股份有限公司; 杭州澳亚生物技术股份有限公司 |
| 2024/10/26Generic · Class 3 | 布比卡因脂质体注射液CYHS2403648 | 浙江圣兆药物科技股份有限公司; 杭州澳亚生物技术股份有限公司 |
| 2024/10/26Generic · Class 3 | 咪达唑仑口服溶液CYHS2403647 | 成都苑东生物制药股份有限公司 |
| 2024/10/26Generic · Class 3 | 辅酶Q10片CYHS2403644 | 成都倍特药业股份有限公司 |
| 2024/10/26Generic · Class 3 | 氯化钙注射液CYHS2403638 | 绪必迪药业(沧州)有限公司; 河北凯威制药有限责任公司 |
| 2024/10/26Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2403635 | 江西科为制药有限公司; 浙江赛默制药有限公司 |
| 2024/10/26New drug · Class 2.2 | 注射用泰它西普CXSS2400115 | 荣昌生物制药(烟台)股份有限公司 |
| 2024/10/26New drug · Class 1 | HB0028注射液CXSL2400732 | 上海华奥泰生物药业股份有限公司; 华博生物医药技术(上海)有限公司 |
| 2024/10/26New drug · Class 1 | HB002.1T注射液CXSL2400731 | 浙江华海生物科技有限公司 |
| 2024/10/26New drug · Class 1 | SHR-4375注射液CXSL2400730 | 苏州盛迪亚生物医药有限公司 |
| 2024/10/26New drug · Class 1 | MAX-10181片CXHL2401133 | 北京再极医药科技有限公司 |
| 2024/10/26New drug · Class 1 | MAX-10181片CXHL2401132 | 北京再极医药科技有限公司 |
| 2024/10/26New drug · Class 1 | MAX-10181片CXHL2401131 | 北京再极医药科技有限公司 |
| 2024/10/25Import · Class 1 | S095029JXSL2400204 | Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development Co. LTD |
| 2024/10/25Import · Class 2.4 | 甲磺酸奥希替尼片JXHL2400258 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2024/10/25Import · Class 2.4 | 甲磺酸奥希替尼片JXHL2400257 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2024/10/25Generic · Class 3 | 维生素B6注射液CYHS2403632 | 山东齐都药业有限公司 |
| 2024/10/25Generic · Class 3 | 维生素B6注射液CYHS2403631 | 山东济坤生物制药有限公司; 烟台鲁银药业有限公司 |
| 2024/10/25Generic · Class 3 | 倍他米松磷酸钠注射液CYHS2403629 | 四川美大康华康药业有限公司 |
| 2024/10/25Generic · Class 3 | 维生素B6注射液CYHS2403625 | 西安安健药业有限公司 |
84 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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