药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/04/02 – 2024/04/08
- New acceptances this week
- 211
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- Accepted this week, now under review
- 4
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
211filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 100 |
| Generic | 48 |
| New drug | 36 |
| Import | 18 |
| Unspecified | 5 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 131 |
| TCM | 40 |
| 治疗用生物制品 | 39 |
| Biologic | 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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 布美他尼注射液 | 2 | 2 | 16 |
| 2 | 腺苷钴胺胶囊 | 2 | 2 | 8 |
| 3 | 哌柏西利胶囊 | 2 | 1 | 0 |
| 4 | 地拉罗司片 | 2 | 1 | 3 |
| 5 | 奥美沙坦酯口崩片 | 2 | 1 | 0 |
| 6 | 醋酸阿托西班注射液 | 2 | 1 | 2 |
| 7 | 非布司他片 | 2 | 1 | 15 |
| 8 | 乳酸钠林格注射液 | 1 | 1 | 6 |
| 9 | 二甲双胍恩格列净片(Ⅰ) | 1 | 1 | 7 |
| 10 | 依托咪酯中/长链脂肪乳注射液 | 1 | 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
139 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 宸寰医药集团有限公司 | 5 | 5 | 0 |
| 2 | 通化正源药业有限责任公司 | 5 | 3 | 0 |
| 3 | 华夏生生药业(北京)有限公司 | 4 | 4 | 4 |
| 4 | 河南省百泉制药有限公司 | 4 | 4 | 0 |
| 5 | Eli Lilly and Company | 4 | 2 | 0 |
| 6 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. | 4 | 1 | 0 |
| 7 | 上海君实生物医药科技股份有限公司 | 4 | 1 | 0 |
| 8 | 凯思凯迪(上海)医药科技有限公司 | 4 | 1 | 0 |
| 9 | 山东二叶制药有限公司 | 4 | 1 | 0 |
| 10 | 杭州九源基因生物医药股份有限公司 | 4 | 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
73 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/04/08Import · Class 1 | BAY 3018250JXSL2400068 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2024/04/08Import · Class 2.4 | Capivasertib片JXHL2400087 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2024/04/08Import · Class 2.4 | Capivasertib片JXHL2400086 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2024/04/08Generic · Class 3 | 盐酸肾上腺素注射液CYHS2401032 | 湖南海誓生物医药有限公司; 康普药业股份有限公司 |
| 2024/04/08Generic · Class 3 | 腺苷钴胺胶囊CYHS2401029 | 杭州沐源生物医药科技有限公司; 广东安诺药业股份有限公司 |
| 2024/04/08Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2401025 | 广州市联瑞制药有限公司 |
| 2024/04/08Generic · Class 3 | 注射用奥氮平CYHS2401024 | 齐鲁制药有限公司 |
| 2024/04/08Generic · Class 3 | 腺苷钴胺胶囊CYHS2401022 | 华北制药股份有限公司 |
| 2024/04/08Generic · Class 3 | 阿仑膦酸钠口服溶液CYHS2401018 | 山东朗诺制药有限公司 |
| 2024/04/08Generic · Class 3 | 复合磷酸氢钾注射液CYHS2401015 | 华夏生生药业(北京)有限公司 |
| 2024/04/08New drug · Class 2.2 | 信迪利单抗注射液CXSS2400038 | 信达生物制药(苏州)有限公司 |
| 2024/04/08New drug · Class 1 | 注射用人脐带间充质干细胞CXSL2400212 | 艾尔普再生医学科技(深圳)有限公司 |
| 2024/04/08New drug · Class 2.2 | 水合氯醛糖浆CXHS2400025 | 成都倍特得诺药业有限公司 |
| 2024/04/08New drug · Class 1 | RS-C1001片CXHL2400340 | 青岛睿森生物科技有限公司 |
| 2024/04/08New drug · Class 1 | RS-C1001片CXHL2400339 | 青岛睿森生物科技有限公司 |
| 2024/04/08New drug · Class 1 | KY386注射用浓溶液CXHL2400338 | 深圳开悦生命科技有限公司 |
| 2024/04/07New drug · Class 1.1 | 益气消瘤颗粒CXZL2400019 | 广东方盛融大药业有限公司 |
| 2024/04/04Import · Class 3.1 | 帕博利珠单抗注射液JXSS2400034 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2024/04/04Import · Class 2.2 | 司美格鲁肽注射液JXHL2400085 | Dr. Reddy's Laboratories Limited; Dr. Reddy's (Beijing) Pharmaceutical Co. Ltd. |
| 2024/04/04Import · Class 1 | Golcadomide胶囊JXHL2400084 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2024/04/04Import · Class 1 | Golcadomide胶囊JXHL2400083 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2024/04/04Import · Class 1 | Golcadomide胶囊JXHL2400082 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2024/04/04Import · Class 1 | BAY 2862789口服溶液JXHL2400081 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2024/04/04Generic · Class 3 | 地拉罗司片CYHS2401014 | 上海复星医药产业发展有限公司; 苏州二叶制药有限公司 |
| 2024/04/04Generic · Class 3 | 地拉罗司片CYHS2401013 | 上海复星医药产业发展有限公司; 苏州二叶制药有限公司 |
| 2024/04/04Generic · Class 3 | 钠钾镁钙注射用浓溶液CYHS2401011 | 华夏生生药业(北京)有限公司 |
| 2024/04/04Generic · Class 3 | 布美他尼注射液CYHS2401010 | 北京六环药业有限公司; 华夏生生药业(北京)有限公司 |
| 2024/04/04New drug · Class 1.1 | 龙七胶囊CXZS2400011 | 江苏康缘药业股份有限公司 |
| 2024/04/04New drug · Class 2.3 | 丹红化瘀口服液CXZL2400018 | 广州白云山和记黄埔中药有限公司 |
| 2024/04/04New drug · Class 1 | 注射用RAB001CXHL2400337 | 中山莱博瑞辰生物医药有限公司 |
43 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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