药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/07/28 – 2026/08/03
- New acceptances this week
- 461
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- Accepted this week, now under review
- 224
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
461filings, 87 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 241 |
| Generic | 87 |
| New drug | 78 |
| Import | 32 |
| Unspecified | 15 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 243 |
| TCM | 143 |
| 治疗用生物制品 | 71 |
| Biologic | 4 |
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
61 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 地氯雷他定口服溶液 | 4 | 2 | 26 |
| 2 | 达格列净片 | 4 | 2 | 82 |
| 3 | 枸橼酸伊沙佐米胶囊 | 3 | 1 | 7 |
| 4 | 注射用泼尼松龙琥珀酸钠 | 3 | 1 | 3 |
| 5 | 磷酸奥司他韦胶囊 | 3 | 1 | 42 |
| 6 | 盐酸氮？斯汀鼻喷雾剂 | 2 | 2 | 7 |
| 7 | 吸入用异丙托溴铵溶液 | 2 | 1 | 2 |
| 8 | 多替诺雷片 | 2 | 1 | 49 |
| 9 | 氨溴特罗口服溶液 | 2 | 1 | 23 |
| 10 | 注射用托伐普坦磷酸钠 | 2 | 1 | 15 |
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
275 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AbbVie Inc. | 13 | 7 | 0 |
| 2 | Eli Lilly and Company | 7 | 2 | 0 |
| 3 | 辽宁民康制药有限公司 | 6 | 2 | 0 |
| 4 | 上海朗昇生物科技有限公司 | 6 | 1 | 0 |
| 5 | 上海凯宝新谊（新乡）药业有限公司 | 5 | 5 | 0 |
| 6 | AstraZeneca AB | 5 | 4 | 0 |
| 7 | 正大天晴药业集团股份有限公司 | 5 | 2 | 3 |
| 8 | Novo Nordisk A/S | 5 | 1 | 0 |
| 9 | Takeda Development Center Americas Inc. | 5 | 1 | 0 |
| 10 | 恒拓集团广西圣康制药有限公司 | 4 | 4 | 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. Companies are counted by first applicant.
Class 3 and new-drug acceptances
132 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/03Import · Class 2.2 | Risankizumab注射液JXSL2600185 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/08/03Import · Class 2.2 | Risankizumab注射液JXSL2600184 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/08/03Import · Class 1 | ABBV-382注射液JXSL2600183 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/08/03Import · Class 1 | MAR002JXSL2600182 | Marea Therapeutics Inc.; Beijing MEDPACE Ltd. |
| 2026/08/03Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末JXSL2600181 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/08/03Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末JXSL2600180 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/08/03Import · Class 1 | Eloralintide注射液JXHL2600313 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/03Import · Class 1 | Eloralintide注射液JXHL2600312 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/03Import · Class 1 | Eloralintide注射液JXHL2600311 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/03Import · Class 1 | Eloralintide注射液JXHL2600310 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/03Generic · Class 3 | 盐酸昂丹司琼片CYHS2601877 | 南京海鲸药业股份有限公司 |
| 2026/08/03Generic · Class 3 | 盐酸昂丹司琼片CYHS2601876 | 南京海鲸药业股份有限公司 |
| 2026/08/03Generic · Class 3 | 氨溴特罗口服溶液CYHS2601868 | 白云山汤阴东泰药业有限责任公司 |
| 2026/08/03Generic · Class 3 | 氨溴特罗口服溶液CYHS2601866 | 白云山汤阴东泰药业有限责任公司 |
| 2026/08/03Generic · Class 3 | 注射用盐酸兰地洛尔CYHS2601863 | 广东隆赋药业股份有限公司 |
| 2026/08/03Generic · Class 3 | 注射用乳糖酸红霉素CYHS2601857 | 广东大翔制药有限公司; 海南通用三洋药业有限公司 |
| 2026/08/03Generic · Class 3 | 地氯雷他定口服溶液CYHS2601855 | 吉林华康药业股份有限公司 |
| 2026/08/03Generic · Class 3 | 地氯雷他定口服溶液CYHS2601854 | 吉林华康药业股份有限公司 |
| 2026/08/03Generic · Class 3 | 醋酸钠林格葡萄糖注射液（Ⅰ）CYHS2601853 | 广东科泓药业有限公司 |
| 2026/08/03New drug · Class 1.1 | 1301-07颗粒CXZL2600069 | 中国药科大学 |
| 2026/08/03New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2600811 | 上海盛迪医药有限公司 |
| 2026/08/03New drug · Class 2.2 | 注射用瑞康曲妥珠单抗CXSL2600810 | 苏州盛迪亚生物医药有限公司 |
| 2026/08/03New drug · Class 1 | ABBV-701注射液CXSL2600809 | 艾伯维医药贸易（上海）有限公司 |
| 2026/08/03New drug · Class 1 | QLS2401注射液CXSL2600808 | 上海齐鲁制药研究中心有限公司 |
| 2026/08/03New drug · Class 1 | 艾托莫德片CXHL2600952 | 渐宽（苏州）生物科技有限公司 |
| 2026/07/31Generic · Class 3 | 硫酸阿托品滴眼液CYHS2601848 | 江苏安必生制药有限公司 |
| 2026/07/31New drug · Class 1.1 | 复方野菊花颗粒CXZL2600068 | 浙江中医药大学 |
| 2026/07/31New drug · Class 1.1 | 藿连消滞颗粒CXZL2600067 | 和光中药科技（天津）有限公司 |
| 2026/07/31New drug · Class 2.4 | 注射用重组A型肉毒毒素（Sf9细胞，150 kD天然氨基酸序列）CXSL2600807 | 苏州若弋生物科技有限公司 |
| 2026/07/31New drug · Class 1 | 注射用3SN001CXSL2600806 | 沈阳三生制药有限责任公司 |
102 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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