药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/02/03 – 2026/02/09
- New acceptances this week
- 518
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 122
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
518filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 332 |
| Generic | 78 |
| New drug | 73 |
| Unspecified | 13 |
| Import re-registration | 12 |
| Import | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 236 |
| TCM | 219 |
| 治疗用生物制品 | 55 |
| Biologic | 6 |
| 预防用生物制品 | 2 |
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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥美沙坦酯氨氯地平氢氯噻嗪片 | 5 | 1 | 5 |
| 2 | 左氧氟沙星氯化钠注射液 | 3 | 1 | 14 |
| 3 | 环磷酰胺注射液 | 3 | 1 | 6 |
| 4 | 甲苯磺酸艾多沙班片 | 3 | 1 | 9 |
| 5 | 布洛芬混悬液 | 2 | 2 | 14 |
| 6 | 氧 | 2 | 2 | 15 |
| 7 | 琥珀酸亚铁片 | 2 | 2 | 21 |
| 8 | 丙酸氟替卡松乳膏 | 2 | 1 | 12 |
| 9 | 头孢托仑匹酯颗粒 | 2 | 1 | 18 |
| 10 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
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
211 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 重庆康刻尔制药股份有限公司 | 123 | 95 | 0 |
| 2 | 哈药集团生物工程有限公司 | 34 | 17 | 0 |
| 3 | 江西普丽尔药业有限公司 | 21 | 20 | 0 |
| 4 | 修正药业集团（湖南）药业有限公司 | 10 | 8 | 0 |
| 5 | 江苏豪森药业集团有限公司 | 9 | 2 | 0 |
| 6 | AstraZeneca AB | 7 | 4 | 0 |
| 7 | 达嘉维康生物制药有限公司 | 6 | 6 | 0 |
| 8 | 爱民药业集团股份有限公司 | 5 | 5 | 0 |
| 9 | 江苏恒瑞医药股份有限公司 | 5 | 3 | 0 |
| 10 | PHARMATHEN INVESTMENTS GROUP LIMITED | 5 | 1 | 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
111 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/02/09New drug · Class 1 | 注射用BG-T187（皮下注射）CXSL2600197 | 广州百济神州生物制药有限公司 |
| 2026/02/09New drug · Class 1 | LY-M003注射液CXSL2600187 | 凌意（杭州）生物科技有限公司 |
| 2026/02/09New drug · Class 1 | IBI115CXSL2600186 | 信达生物制药（苏州）有限公司 |
| 2026/02/09New drug · Class 1 | QLS7320注射液CXHL2600167 | 齐鲁制药有限公司 |
| 2026/02/09New drug · Class 1 | QLS7320注射液CXHL2600166 | 齐鲁制药有限公司 |
| 2026/02/09New drug · Class 1 | QLS7320注射液CXHL2600165 | 齐鲁制药有限公司 |
| 2026/02/09New drug · Class 1 | 注射用华卟啉钠CXHL2600161 | 上海光声制药股份有限公司 |
| 2026/02/09New drug · Class 1 | JY54注射液CXHL2600160 | 杭州九源基因生物医药股份有限公司 |
| 2026/02/09New drug · Class 2.4 | 安奈拉唑钠肠溶片CXHL2600159 | 轩竹（北京）医药科技有限公司 |
| 2026/02/09New drug · Class 1 | HS-10522片CXHL2600158 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2026/02/09New drug · Class 1 | HS-10522片CXHL2600157 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2026/02/09New drug · Class 1 | HS-10522片CXHL2600156 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2026/02/09New drug · Class 1 | WS-0101溶液CXHL2600155 | 北京厚燊维康科技有限责任公司 |
| 2026/02/08Import · Class 3.1 | 重组呼吸道合胞病毒疫苗（CHO细胞，AS01E佐剂系统）JXSS2600008 | GlaxoSmithKline Biologicals SA; GlaxoSmithKline Biologicals; GlaxoSmithKline (China) Investment Company Limited |
| 2026/02/07Import · Class 1 | AZD3470薄膜衣片JXHL2600035 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/02/07Import · Class 1 | AZD3470薄膜衣片JXHL2600034 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/02/07Import · Class 2.4 | 依普隆特生钠注射液JXHL2600033 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/02/07Generic · Class 3 | 琥珀酸亚铁片CYHS2600404 | 北京仁众药业有限公司 |
| 2026/02/07Generic · Class 3 | 己酮可可碱缓释片CYHS2600403 | 国药集团容生制药有限公司; 江苏永安制药有限公司 |
| 2026/02/07New drug · Class 2.3 | 西帕依麦孜彼子口服液CXZL2600022 | 新奇康药业股份有限公司; 新疆奇沐医药研究院（有限公司）; 奇沐（广东横琴）医药科技有限公司 |
| 2026/02/07New drug · Class 3.4 | 人凝血因子ⅧCXSS2600016 | 远大蜀阳生命科学（成都）有限公司 |
| 2026/02/07New drug · Class 1 | ALXN2220注射液CXSL2600185 | 阿斯利康全球研发（中国）有限公司 |
| 2026/02/07New drug · Class 1 | ZHB117舌下片CXSL2600184 | 江苏众红生物工程创药研究院有限公司 |
| 2026/02/07New drug · Class 1 | ZHB117舌下片CXSL2600183 | 江苏众红生物工程创药研究院有限公司 |
| 2026/02/07New drug · Class 1 | 注射用GLR1059CXSL2600182 | 甘李药业股份有限公司 |
| 2026/02/06Import · Class 1 | 伊利尤单抗注射液JXSS2600007 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2026/02/06Import · Class 1 | 伊利尤单抗注射液JXSS2600006 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2026/02/06Import · Class 2.4 | 宗艾替尼片JXHL2600032 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/02/06Generic · Class 3 | 硫酸阿米卡星注射液CYHS2600409 | 山东安信制药有限公司; 齐鲁制药有限公司 |
| 2026/02/06Generic · Class 3 | 二硫化硒洗剂CYHS2600398 | 海南药谷云生物科技有限公司; 杭州万邦天诚药业有限公司 |
81 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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