药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/07/11 – 2023/07/17
- New acceptances this week
- 428
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- 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
428filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 228 |
| Generic | 77 |
| New drug | 58 |
| Import | 32 |
| Import re-registration | 25 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 327 |
| 治疗用生物制品 | 49 |
| TCM | 43 |
| 预防用生物制品 | 8 |
| 体外诊断试剂 | 1 |
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 | 氢溴酸伏硫西汀片 | 4 | 2 | 8 |
| 2 | 注射用头孢唑肟钠 | 4 | 2 | 4 |
| 3 | 氯化钾口服溶液 | 3 | 2 | 12 |
| 4 | 玻璃酸钠滴眼液 | 3 | 2 | 29 |
| 5 | 利丙双卡因乳膏 | 2 | 2 | 25 |
| 6 | 乙酰半胱氨酸颗粒 | 2 | 1 | 4 |
| 7 | 二十碳五烯酸乙酯软胶囊 | 2 | 1 | 25 |
| 8 | 卡络磺钠注射液 | 2 | 1 | 1 |
| 9 | 吸入用盐酸丙卡特罗溶液 | 2 | 1 | 2 |
| 10 | 奥卡西平片 | 2 | 1 | 4 |
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
228 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 修正药业集团天汉药业有限公司 | 32 | 23 | 0 |
| 2 | 海南倍特药业有限公司 | 15 | 3 | 0 |
| 3 | AstraZeneca AB | 13 | 5 | 0 |
| 4 | 上海皇象铁力蓝天制药有限公司 | 6 | 6 | 0 |
| 5 | Boehringer Ingelheim International GmbH | 6 | 4 | 0 |
| 6 | Upjohn Manufacturing Ireland Unlimited Company | 6 | 1 | 0 |
| 7 | 博瑞新创生物医药科技(无锡)有限公司 | 6 | 1 | 0 |
| 8 | 江右制药(常德)有限公司 | 5 | 5 | 0 |
| 9 | 成都天之翼尚品医药科技有限公司 | 5 | 3 | 2 |
| 10 | 北大医药股份有限公司 | 5 | 2 | 3 |
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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/07/17Import · Class 1 | AZD9833片JXHL2300166 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2023/07/17Import · Class 1 | AZD5305JXHL2300165 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/07/17Import · Class 1 | AZD5305JXHL2300164 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/07/17Import · Class 1 | AZD5305JXHL2300163 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/07/17Import · Class 1 | AZD5305JXHL2300162 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/07/17Generic · Class 3 | 吸入用盐酸丙卡特罗溶液CYHS2301922 | 云南先施药业有限公司; 浙江赛默制药有限公司 |
| 2023/07/17Generic · Class 3 | 吸入用盐酸丙卡特罗溶液CYHS2301921 | 云南先施药业有限公司; 浙江赛默制药有限公司 |
| 2023/07/17New drug · Class 1 | 盐酸佐利替尼片CXHL2300789 | 江苏晨泰医药科技有限公司 |
| 2023/07/17New drug · Class 1 | 盐酸佐利替尼片CXHL2300788 | 江苏晨泰医药科技有限公司 |
| 2023/07/17New drug · Class 1 | PG-011凝胶(Ⅱ)CXHL2300787 | 北京普祺医药科技股份有限公司 |
| 2023/07/17New drug · Class 1 | PG-011凝胶(Ⅱ)CXHL2300786 | 北京普祺医药科技股份有限公司 |
| 2023/07/15New drug · Class 2.1 | 泰它西普注射液CXSL2300485 | 荣昌生物制药(烟台)股份有限公司 |
| 2023/07/15New drug · Class 1 | MC-1-50细胞制剂CXSL2300484 | 重庆精准生物技术有限公司 |
| 2023/07/15New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液CXSL2300482 | 石药集团中奇制药技术(石家庄)有限公司 |
| 2023/07/15New drug · Class 1 | LQ3片CXHL2300785 | 四川易阿索医药科技有限公司 |
| 2023/07/15New drug · Class 1 | LQ3片CXHL2300784 | 四川易阿索医药科技有限公司 |
| 2023/07/15New drug · Class 1 | LQ3片CXHL2300783 | 四川易阿索医药科技有限公司 |
| 2023/07/14Import · Class 2.2 | 法瑞西单抗注射液JXSS2300058 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG |
| 2023/07/14Import · Class 1 | IMG-020注射液JXSL2300129 | INMAGENE PTE. LTD.; Inmagene Biopharmaceuticals (Hangzhou) Co. Ltd. |
| 2023/07/14Import · Class 1 | RO7435846片JXHL2300161 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/07/14Import · Class 1 | RO7435846片JXHL2300160 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/07/14Import · Class 1 | RO7435846片JXHL2300159 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/07/14Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2301904 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2023/07/14Generic · Class 3 | 盐酸右美托咪定注射液CYHS2301902 | 江西赣南海欣药业股份有限公司 |
| 2023/07/14Generic · Class 3 | 盐酸右美托咪定注射液CYHS2301901 | 江西赣南海欣药业股份有限公司 |
| 2023/07/14Generic · Class 3 | 地奈德乳膏CYHS2301899 | 江苏知原药业股份有限公司 |
| 2023/07/14Generic · Class 3 | 腺苷钴胺胶囊CYHS2301894 | 圣嘉(滨海)生物医药科技有限公司; 中孚药业股份有限公司 |
| 2023/07/14New drug · Class 1 | 注射用ASKG315CXSL2300481 | 江苏奥赛康生物医药有限公司 |
| 2023/07/14New drug · Class 1.2 | 自复制RNA带状疱疹疫苗(JCXH-105注射液)CXSL2300480 | 嘉晨西海(杭州)生物技术有限公司 |
| 2023/07/14New drug · Class 1 | 重组人源抗狂犬病病毒单克隆抗体注射液CXSL2300479 | 兰州生物制品研究所有限责任公司 |
78 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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