药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/11/28 – 2023/12/04
- New acceptances this week
- 322
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- 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
322filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 170 |
| Generic | 68 |
| New drug | 55 |
| Import | 24 |
| Import re-registration | 3 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 216 |
| 治疗用生物制品 | 52 |
| TCM | 47 |
| 预防用生物制品 | 5 |
| Biologic | 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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 他达拉非片 | 3 | 1 | 23 |
| 2 | 地氯雷他定口服溶液 | 3 | 1 | 26 |
| 3 | 乙酰半胱氨酸注射液 | 2 | 2 | 53 |
| 4 | 盐酸莫西沙星滴眼液 | 2 | 2 | 5 |
| 5 | 利培酮片 | 2 | 1 | 0 |
| 6 | 布洛芬混悬滴剂 | 2 | 1 | 0 |
| 7 | 枸橼酸西地那非片 | 2 | 1 | 12 |
| 8 | 氨磺必利注射液 | 2 | 1 | 1 |
| 9 | 硫辛酸片 | 2 | 1 | 4 |
| 10 | 罗沙司他胶囊 | 2 | 1 | 17 |
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
197 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山西振东制药股份有限公司 | 10 | 10 | 0 |
| 2 | medac Gesellschaft für klinische Spezialpr？parate mbH | 8 | 1 | 0 |
| 3 | CSL Behring GmbH | 7 | 1 | 0 |
| 4 | 海南盈达润泽药业有限公司 | 6 | 6 | 0 |
| 5 | 重庆希尔安药业有限公司 | 6 | 5 | 0 |
| 6 | 山西双雁药业有限公司 | 5 | 4 | 0 |
| 7 | AstraZeneca AB | 5 | 2 | 0 |
| 8 | 正大天晴药业集团股份有限公司 | 5 | 2 | 0 |
| 9 | 山东二叶制药有限公司 | 5 | 1 | 0 |
| 10 | 江苏恒瑞医药股份有限公司 | 4 | 2 | 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
100 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/04New drug · Class 2.4 | 盐酸安罗替尼胶囊CXHL2301334 | 正大天晴药业集团股份有限公司 |
| 2023/12/04New drug · Class 2.4 | 盐酸安罗替尼胶囊CXHL2301333 | 正大天晴药业集团股份有限公司 |
| 2023/12/04New drug · Class 2.4 | 盐酸安罗替尼胶囊CXHL2301332 | 正大天晴药业集团股份有限公司 |
| 2023/12/02Import · Class 2.2 | 帕博利珠单抗注射液JXSS2300085 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2023/12/02Import · Class 1 | AZD5305JXHL2300300 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/02Import · Class 1 | AZD5305JXHL2300299 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/02Import · Class 1 | AZD5305JXHL2300298 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/02Import · Class 1 | AZD5305JXHL2300297 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/02Generic · Class 3 | 富马酸酮替芬滴眼液CYHS2303334 | 石家庄四药有限公司 |
| 2023/12/02Generic · Class 3 | 注射用吲哚菁绿CYHS2303332 | 海南天盛保和生物科技有限公司; 海南合瑞制药股份有限公司 |
| 2023/12/02New drug · Class 2.2 | 派安普利单抗注射液CXSS2300089 | 正大天晴康方（上海）生物医药科技有限公司; 中山康方生物医药有限公司 |
| 2023/12/02New drug · Class 2.2 | 葡萄糖口服溶液CXHS2300109 | 国仁健康制药（北京）有限公司; 湖南嘉恒制药有限公司 |
| 2023/12/02New drug · Class 2.2 | SXF-103口溶膜CXHL2301331 | 上海欣峰制药有限公司 |
| 2023/12/01Import · Class 1 | 注射用ZetomipzomibJXHL2300296 | Kezar Life Sciences Inc.; Everest Medicines (China) Co. Ltd. |
| 2023/12/01Generic · Class 3 | 奥扎格雷钠注射液CYHS2303328 | 辽宁海神联盛制药有限公司; 山东华鲁制药有限公司 |
| 2023/12/01Generic · Class 3 | 吲哚布芬片CYHS2303321 | 山西德元堂药业有限公司 |
| 2023/12/01New drug · Class 1 | LAE102注射液CXSL2300836 | 来凯医药科技（上海）有限公司 |
| 2023/12/01New drug · Class 1 | 注射用DB-1303CXSL2300835 | 映恩生物制药（苏州）有限公司 |
| 2023/12/01New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2300834 | 上海盛迪医药有限公司 |
| 2023/12/01New drug · Class 1 | 注射用ZL-1310CXSL2300833 | 再鼎医药（上海）有限公司 |
| 2023/12/01New drug · Class 1 | 注射用BL-B01D1CXSL2300832 | 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司 |
| 2023/12/01New drug · Class 1 | 注射用SHR-A1921CXSL2300831 | 苏州盛迪亚生物医药有限公司 |
| 2023/12/01New drug · Class 1 | 注射用菲泽妥单抗CXSL2300830 | 天境生物科技（上海）有限公司 |
| 2023/12/01New drug · Class 3.3 | 司美格鲁肽注射液CXSL2300829 | 丽珠集团新北江制药股份有限公司 |
| 2023/12/01New drug · Class 3.3 | 司美格鲁肽注射液CXSL2300828 | 丽珠集团新北江制药股份有限公司 |
| 2023/12/01New drug · Class 2.2 | KEM2105缓释片CXHL2301330 | 长沙晶易医药科技股份有限公司 |
| 2023/12/01New drug · Class 1 | HRS2398片CXHL2301329 | 上海恒瑞医药有限公司 |
| 2023/12/01New drug · Class 1 | HRS2398片CXHL2301328 | 上海恒瑞医药有限公司 |
| 2023/12/01New drug · Class 1 | CPU-216片CXHL2301327 | 中国药科大学; 南京芩领医药科技有限公司 |
| 2023/12/01New drug · Class 1 | HRS-1167片CXHL2301326 | 江苏恒瑞医药股份有限公司 |
70 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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