药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/05/05 – 2026/05/11
- New acceptances this week
- 429
- Drugs with new generic filings (by drug name, de-duplicated)
- 39
- Accepted this week, now under review
- 95
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
429filings, 50 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 249 |
| New drug | 70 |
| Generic | 50 |
| Import | 39 |
| Unspecified | 14 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 196 |
| TCM | 155 |
| 治疗用生物制品 | 66 |
| Biologic | 9 |
| 预防用生物制品 | 3 |
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
39 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 瑞维那新吸入溶液 | 2 | 2 | 53 |
| 2 | 西格列汀二甲双胍缓释片 | 2 | 2 | 14 |
| 3 | 利多卡因丁卡因乳膏 | 2 | 1 | 2 |
| 4 | 吡拉西坦注射液 | 2 | 1 | 9 |
| 5 | 多替诺雷片 | 2 | 1 | 49 |
| 6 | 注射用甲磺酸萘莫司他 | 2 | 1 | 38 |
| 7 | 盐酸曲唑酮缓释片 | 2 | 1 | 20 |
| 8 | 艾地骨化醇软胶囊 | 2 | 1 | 8 |
| 9 | 苯磺酸美洛加巴林片 | 2 | 1 | 58 |
| 10 | 达格列净片 | 2 | 1 | 82 |
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
250 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 21 | 3 | 0 |
| 2 | 昆明中药厂有限公司 | 12 | 8 | 0 |
| 3 | 太极集团重庆桐君阁药厂有限公司 | 10 | 9 | 0 |
| 4 | 齐鲁制药有限公司 | 9 | 4 | 1 |
| 5 | 百济神州(苏州)生物科技有限公司 | 6 | 2 | 0 |
| 6 | 宝光药业(成都)有限责任公司 | 5 | 5 | 0 |
| 7 | 青海帝玛尔藏药药业有限公司 | 5 | 5 | 0 |
| 8 | Pfizer Inc. | 5 | 4 | 0 |
| 9 | 吉林省中研药业有限公司 | 5 | 4 | 0 |
| 10 | 山东仙河药业有限公司 | 5 | 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/11Generic · Class 3 | 利多卡因丁卡因乳膏CYHL2600060 | 北京华素制药股份有限公司 |
| 2026/05/11Generic · Class 3 | 利多卡因丁卡因乳膏CYHL2600059 | 北京华素制药股份有限公司 |
| 2026/05/11New drug · Class 3.4 | 人纤维蛋白原CXSS2600082 | 广东丹霞生物制药有限公司 |
| 2026/05/11New drug · Class 2.2 | 纳基奥仑赛注射液CXSS2600081 | 合源生物科技股份有限公司 |
| 2026/05/11New drug · Class 1 | KBD102430片CXHL2600560 | 康百达(四川)生物医药科技有限公司 |
| 2026/05/11New drug · Class 1 | KBD102430片CXHL2600559 | 康百达(四川)生物医药科技有限公司 |
| 2026/05/11New drug · Class 1 | 比瑞替尼片CXHL2600558 | 迪哲(江苏)医药股份有限公司 |
| 2026/05/11New drug · Class 1 | GW5282片CXHL2600555 | 迪哲(江苏)医药股份有限公司; 格物生物技术(江苏)有限公司 |
| 2026/05/11New drug · Class 1 | GW5282片CXHL2600553 | 迪哲(江苏)医药股份有限公司; 格物生物技术(江苏)有限公司 |
| 2026/05/11New drug · Class 1 | GFH276片CXHL2600552 | 劲方医药科技(上海)股份有限公司 |
| 2026/05/11New drug · Class 2.4 | 索托克拉片CXHL2600551 | 百济神州(苏州)生物科技有限公司 |
| 2026/05/11New drug · Class 2.4 | 索托克拉片CXHL2600550 | 百济神州(苏州)生物科技有限公司 |
| 2026/05/11New drug · Class 2.4 | 索托克拉片CXHL2600549 | 百济神州(苏州)生物科技有限公司 |
| 2026/05/11New drug · Class 2.4 | 索托克拉片CXHL2600548 | 百济神州(苏州)生物科技有限公司 |
| 2026/05/10Generic · Class 3 | 奥美沙坦酯氨氯地平氢氯噻嗪片CYHL2600057 | 安徽佳和药业有限公司 |
| 2026/05/10New drug · Class 1.1 | 通降颗粒CXZS2600025 | 健民药业集团股份有限公司 |
| 2026/05/10New drug · Class 1 | Cizutamig注射液CXSL2600489 | 上海坦蒂生物医药科技有限公司 |
| 2026/05/10New drug · Class 1 | IG4001肠溶片CXHL2600547 | 苏州点石智药医药科技有限公司 |
| 2026/05/09Import · Class 2.2 | 帕博利珠单抗注射液JXSS2600041 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2026/05/09Import · Class 2.2 | 德莫奇单抗注射液JXSL2600114 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2026/05/09Import · Class 2.2 | 德莫奇单抗注射液JXSL2600113 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2026/05/09Import · Class 2.2 | 注射用替奈普酶JXSL2600112 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD2265JXHL2600162 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD9574JXHL2600161 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD9574JXHL2600160 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD9574JXHL2600159 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD9574JXHL2600158 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Generic · Class 3 | 乙酰半胱氨酸注射液CYHS2601066 | 江苏安必生制药有限公司 |
| 2026/05/09Generic · Class 3 | 注射用硫酸多黏菌素BCYHS2601064 | 湖州亚瑟制药有限公司 |
| 2026/05/09Generic · Class 3 | 盐酸溴己新口服溶液CYHS2601058 | 安徽环球药业股份有限公司 |
86 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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