药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/10/20 – 2026/10/26
- New acceptances this week
- 384
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- Accepted this week, now under review
- 384
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
384filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 228 |
| Generic | 60 |
| New drug | 51 |
| Import | 31 |
| Import re-registration | 9 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 187 |
| TCM | 121 |
| 治疗用生物制品 | 67 |
| Biologic | 6 |
| 预防用生物制品 | 2 |
| 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 玻璃酸钠滴眼液 | 3 | 2 | 29 |
| 2 | 磷酸芦可替尼片 | 3 | 1 | 27 |
| 3 | 苏沃雷生片 | 3 | 1 | 3 |
| 4 | 乙酰半胱氨酸口服溶液 | 2 | 1 | 11 |
| 5 | 多替诺雷片 | 2 | 1 | 49 |
| 6 | 环硅酸锆钠散 | 2 | 1 | 12 |
| 7 | 苯磺酸美洛加巴林口崩片 | 2 | 1 | 2 |
| 8 | 西诺氨酯片 | 2 | 1 | 21 |
| 9 | 达格列净片 | 2 | 1 | 82 |
| 10 | 达肝素钠注射液 | 2 | 1 | 2 |
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
258 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖南东健药业有限公司 | 8 | 8 | 0 |
| 2 | AbbVie Inc. | 6 | 4 | 0 |
| 3 | Merck Europe B.V. | 5 | 3 | 0 |
| 4 | Medice Arzneimittel Pütter GmbH & Co. KG | 5 | 1 | 0 |
| 5 | 广西万通制药有限公司 | 4 | 4 | 0 |
| 6 | 汕头市时代制药有限公司 | 4 | 4 | 0 |
| 7 | 津药达仁堂集团股份有限公司达仁堂制药厂 | 4 | 4 | 0 |
| 8 | Janssen-Cilag International NV | 4 | 3 | 0 |
| 9 | 信达生物制药(苏州)有限公司 | 4 | 3 | 0 |
| 10 | 天方药业有限公司 | 4 | 3 | 2 |
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
- Entered review this week
- 149
- Left review this week (approved or terminated, to be verified)
- 426
Data collected since 2026/10/22: this week counts snapshots from 2026/10/23 only.
Most filings leaving review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | F. Hoffmann-La Roche Ltd | 13 | 3 |
| 2 | Eli Lilly and Company | 12 | 3 |
| 3 | AstraZeneca AB | 11 | 5 |
| 4 | 江苏恒瑞医药股份有限公司 | 8 | 3 |
| 5 | 信达生物制药(苏州)有限公司 | 7 | 4 |
| 6 | Novo Nordisk A/S | 7 | 3 |
| 7 | 上海复星医药产业发展有限公司 | 6 | 2 |
| 8 | 宁康瑞珠生物制药(珠海)有限公司 | 6 | 2 |
| 9 | 山东绿叶制药有限公司 | 6 | 1 |
| 10 | Novartis Pharma AG | 5 | 4 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | 广西万通制药有限公司 | 4 | 4 |
| 2 | 津药达仁堂集团股份有限公司达仁堂制药厂 | 4 | 4 |
| 3 | Novo Nordisk A/S | 4 | 2 |
| 4 | 浙江尔婴药品有限公司 | 3 | 1 |
| 5 | 福安药业集团烟台只楚药业有限公司 | 3 | 1 |
| 6 | 佐今明制药股份有限公司 | 2 | 2 |
| 7 | 北京免疫方舟医药科技有限公司 | 2 | 2 |
| 8 | 华润双鹤湘中药业(湖南)有限公司 | 2 | 2 |
| 9 | 吉林吉春制药股份有限公司 | 2 | 2 |
| 10 | 哈尔滨珍宝制药有限公司 | 2 | 2 |
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
90 this week
60 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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