药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/08/25 – 2026/08/31
- New acceptances this week
- 402
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- Accepted this week, now under review
- 314
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
402filings, 61 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 247 |
| Generic | 61 |
| New drug | 54 |
| Import | 31 |
| Import re-registration | 5 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 185 |
| TCM | 133 |
| 治疗用生物制品 | 77 |
| 预防用生物制品 | 7 |
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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 多替诺雷片 | 4 | 2 | 49 |
| 2 | 达格列净片 | 4 | 2 | 82 |
| 3 | 二硫化硒洗剂 | 3 | 2 | 14 |
| 4 | 普瑞巴林缓释片 | 3 | 1 | 12 |
| 5 | 依普利酮片 | 2 | 1 | 4 |
| 6 | 奥利司他胶囊 | 2 | 1 | 8 |
| 7 | 琥珀酸地文拉法辛缓释片 | 2 | 1 | 3 |
| 8 | 甘油灌肠剂 | 2 | 1 | 2 |
| 9 | 盐酸二甲双胍片 | 2 | 1 | 4 |
| 10 | 盐酸异丙嗪注射液 | 2 | 1 | 11 |
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
224 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林高邈药业股份有限公司 | 17 | 17 | 0 |
| 2 | F. Hoffmann-La Roche Ltd | 10 | 2 | 0 |
| 3 | Eli Lilly and Company | 9 | 3 | 0 |
| 4 | Novo Nordisk A/S | 9 | 2 | 0 |
| 5 | 明慧医药(上海)有限公司 | 7 | 4 | 0 |
| 6 | 洛阳伊龙药业有限公司 | 6 | 6 | 0 |
| 7 | 哈尔滨中药四厂有限公司 | 4 | 4 | 0 |
| 8 | 天方药业有限公司 | 4 | 4 | 0 |
| 9 | 湖北同德堂药业有限公司 | 4 | 4 | 0 |
| 10 | AbbVie Inc. | 4 | 3 | 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
106 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/31Import · Class 1 | 注射用MK-2750JXSL2600235 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/08/31Import · Class 1 | FUB523注射液JXSL2600234 | Novartis Pharma AG |
| 2026/08/31Import · Class 1 | RO7795068注射液JXHL2600378 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/31Import · Class 1 | RO7795068注射液JXHL2600377 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/31Import · Class 1 | RO7795068注射液JXHL2600376 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/31Import · Class 1 | RO7795068注射液JXHL2600375 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/31Import · Class 1 | RO7795068注射液JXHL2600374 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/31Import · Class 1 | RO7795068注射液JXHL2600373 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/31Import · Class 2.4 | 盐酸阿曲生坦片JXHL2600372 | Novartis Pharma AG |
| 2026/08/31Generic · Class 3 | 依巴斯汀口服溶液CYHS2602166 | 南昌立健药业有限公司 |
| 2026/08/31Generic · Class 3 | 二硫化硒洗剂CYHS2602163 | 景时(杭州)药业有限公司; 裕松源药业有限公司 |
| 2026/08/31Generic · Class 3 | 二硫化硒洗剂CYHS2602162 | 景时(杭州)药业有限公司; 裕松源药业有限公司 |
| 2026/08/31Generic · Class 3 | 依普利酮片CYHS2602158 | 北京诚济制药股份有限公司 |
| 2026/08/31Generic · Class 3 | 依普利酮片CYHS2602157 | 北京诚济制药股份有限公司 |
| 2026/08/31New drug · Class 1 | JUR-003注射液CXSL2600939 | 烁磊生物医药(上海)有限公司 |
| 2026/08/31New drug · Class 1 | JUR-003注射液CXSL2600938 | 烁磊生物医药(上海)有限公司 |
| 2026/08/31New drug · Class 1 | Cizutamig注射液(皮下注射)CXSL2600937 | 上海坦蒂生物医药科技有限公司 |
| 2026/08/31New drug · Class 1 | AZD7003CXSL2600936 | 阿斯利康投资(中国)有限公司 |
| 2026/08/31New drug · Class 1 | 沃拉德单抗注射液CXSL2600935 | 北京科信美德生物医药科技有限公司 |
| 2026/08/31New drug · Class 1 | 沃拉德单抗注射液CXSL2600934 | 北京科信美德生物医药科技有限公司 |
| 2026/08/31New drug · Class 3.3 | 冻干人用狂犬病疫苗(ZFB-3细胞)CXSL2600933 | 安徽智飞龙科马生物制药有限公司 |
| 2026/08/31New drug · Class 1 | 注射用BL-M08D1CXSL2600932 | 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 |
| 2026/08/31New drug · Class 1 | MWX205注射液CXHL2601057 | 上海民为生物技术有限公司 |
| 2026/08/28Import · Class 3.1 | 马塔西单抗注射液JXSL2600233 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/08/28Import · Class 1 | ABBV-901注射用粉末JXSL2600232 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/08/28Import · Class 1 | PFL-721片JXHL2600371 | PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd. |
| 2026/08/28Import · Class 1 | PFL-721片JXHL2600370 | PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd. |
| 2026/08/28Import · Class 2.4 | 贝组替凡片JXHL2600369 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2026/08/28Import · Class 1 | ATL-101鞘内注射液JXHL2600368 | Atalanta Therapeutics Inc.; Tenacia Biopharmaceuticals (Shanghai) Co. Ltd. |
| 2026/08/28Generic · Class 3 | 二硫化硒洗剂CYHS2602151 | 湖北午时药业股份有限公司 |
76 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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