药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/07/07 – 2026/07/13

Period
2026/07/07 to 2026/07/13, 7 days inclusive
Data as of
2026/11/03 06:00
Cached records
94,050 acceptance records, 11,694 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
460
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
150

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

460filings, 65 of them generic

By application type

Application typeFilings
Supplement253
New drug85
Generic65
Import31
Unspecified17
Import re-registration9

By drug type

Drug typeFilings
Chemical drug232
TCM134
治疗用生物制品81
Biologic7
预防用生物制品6

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

54 drugs with new generic filings; top 10 listed

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

292 companies with new acceptances; top 10 listed

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

141 this week

AcceptedDrugApplicants
2026/07/13Import · Class 3.1 帕博利珠单抗注射液JXSS2600062 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd.
2026/07/13Import · Class 1 AMG 133JXSL2600162 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/07/13Import · Class 1 AMG 133JXSL2600161 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/07/13Import · Class 1 AMG 133JXSL2600160 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/07/13Import · Class 1 AMG 133JXSL2600159 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/07/13Import · Class 1 AMG 133JXSL2600158 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/07/13Import · Class 1 AMG 133JXSL2600157 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/07/13Import · Class 1 PF-08653944注射液JXHL2600272 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/13Import · Class 1 PF-08653944注射液JXHL2600271 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/13Import · Class 1 PF-08653944注射液JXHL2600270 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/13Import · Class 1 PF-08653944注射液JXHL2600269 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/13Generic · Class 3 盐酸奥洛他定口崩片CYHS2601670 海南科进生物制药有限公司
2026/07/13Generic · Class 3 富马酸氯马斯汀注射液CYHS2601666 江苏润恒制药有限公司
2026/07/13Generic · Class 3 盐酸溴己新口服溶液CYHS2601664 河北山姆士药业有限公司
2026/07/13Generic · Class 3 盐酸溴己新口服溶液CYHS2601663 河北山姆士药业有限公司
2026/07/13Generic · Class 3 唑尼沙胺胶囊CYHS2601662 湖南尚众合生物医药有限公司; 天地恒一制药股份有限公司
2026/07/13Generic · Class 3 吡非尼酮片CYHS2601659 山东朗诺制药有限公司
2026/07/13New drug · Class 3.1 当归饮子颗粒CXZS2600036 海南斯达制药有限公司; 安徽宏信药业发展有限公司
2026/07/13New drug · Class 1.1 糖宁通络乳膏CXZL2600060 百灵毓秀(珠海)医药有限公司
2026/07/13New drug · Class 1 Sac002注射液CXSL2600735 中美赛尔生物科技(广东)有限公司
2026/07/13New drug · Class 1 HS-20117-2注射液CXSL2600734 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司
2026/07/13New drug · Class 1 注射用AK158D1CXSL2600733 中山康方生物医药有限公司
2026/07/13New drug · Class 1 BNT317注射液CXSL2600732 百欧恩泰(上海)医药有限公司
2026/07/13New drug · Class 1 Cizutamig注射液(皮下注射)CXSL2600731 上海坦蒂生物医药科技有限公司
2026/07/13New drug · Class 2.4 苯磺酸克利加巴林胶囊CXHS2600102 海思科医药集团股份有限公司; 四川海思科制药有限公司
2026/07/13New drug · Class 2.4 镥[177Lu]氧奥曲肽注射液CXHL2600846 北京先通国际医药科技股份有限公司
2026/07/13New drug · Class 1 ABP-745缓释片ACXHL2600845 杭州新元素药业股份有限公司
2026/07/13New drug · Class 1 ABP-745缓释片BCXHL2600844 杭州新元素药业股份有限公司
2026/07/13New drug · Class 2.3 EP-0229TCXHL2600843 成都硕德药业有限公司
2026/07/13New drug · Class 1 BCR-0008片CXHL2600842 杭州百新生物医药科技有限公司

111 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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