药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/05/26 – 2026/06/01

Period
2026/05/26 to 2026/06/01, 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
360
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
91

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

360filings, 56 of them generic

By application type

Application typeFilings
Supplement229
Generic56
New drug42
Import19
Unspecified9
Import re-registration5

By drug type

Drug typeFilings
Chemical drug173
TCM131
治疗用生物制品46
Biologic5
预防用生物制品5

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

38 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

235 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

91 this week

AcceptedDrugApplicants
2026/06/01Import · Class 2.2 尼卡利单抗注射液JXSS2600045 Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.
2026/06/01Import · Class 2.2 尼卡利单抗注射液JXSS2600044 Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.
2026/06/01Import · Class 1 ABBV-1758注射液JXSL2600125 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/06/01Import · Class 2.2 伊奈利珠单抗注射液JXSL2600124 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/06/01Import · Class 1 LY4257496注射液JXHL2600193 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/06/01Generic · Class 3 盐酸异丙嗪注射液CYHS2601244 亚宝药业集团股份有限公司
2026/06/01Generic · Class 3 盐酸异丙嗪注射液CYHS2601243 亚宝药业集团股份有限公司
2026/06/01Generic · Class 3 注射用西维来司他钠CYHS2601242 山东豪瑞恩制药有限公司
2026/06/01Generic · Class 3 聚卡波非钙片CYHS2601241 浙江佐力药业股份有限公司
2026/06/01Generic · Class 3 盐酸氯普鲁卡因注射液CYHS2601237 成都瑞尔医药科技有限公司; 成都百裕制药股份有限公司
2026/06/01Generic · Class 3 注射用盐酸兰地洛尔CYHS2601236 宜昌人福药业有限责任公司
2026/06/01Generic · Class 3 葡萄糖酸氯己定含漱液CYHS2601233 北京远方通达医药技术有限公司; 南京集萃剂鼎医药有限公司
2026/06/01Generic · Class 3 复合磷酸氢钾注射液CYHS2601232 仁合益康汇泽药业河北有限公司
2026/06/01Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%)CYHS2601230 广东科泓药业有限公司
2026/06/01Generic · Class 3 普罗布考片CYHS2601226 宁夏康亚药业股份有限公司
2026/06/01Generic · Class 3 盐酸氯普鲁卡因注射液CYHS2601220 北京紫萌医药科技有限公司; 酒泉大得利制药股份有限公司
2026/06/01Generic · Class 3 盐酸氯普鲁卡因注射液CYHS2601219 北京紫萌医药科技有限公司; 酒泉大得利制药股份有限公司
2026/06/01Generic · Class 3 右酮洛芬氨丁三醇注射液CYHS2601218 中润药业有限公司; 山西普德药业有限公司
2026/06/01New drug · Class 2.3 灵莲花颗粒CXZL2600050 浙江佐力药业股份有限公司
2026/06/01New drug · Class 1 GR2302注射液(皮下注射)CXSL2600589 智翔(上海)医药科技有限公司; 重庆智翔金泰生物制药股份有限公司
2026/06/01New drug · Class 1 GR2302注射液(皮下注射)CXSL2600588 智翔(上海)医药科技有限公司; 重庆智翔金泰生物制药股份有限公司
2026/06/01New drug · Class 1 GR2302注射液CXSL2600587 智翔(上海)医药科技有限公司; 重庆智翔金泰生物制药股份有限公司
2026/06/01New drug · Class 1 SHR-1179注射液CXSL2600586 广东恒瑞医药有限公司
2026/06/01New drug · Class 1 伊匹乌肽散剂CXHL2600642 温州益承睛湛生物科技有限公司
2026/06/01New drug · Class 1 注射用APG-1252CXHL2600641 苏州亚盛药业有限公司
2026/06/01New drug · Class 1 TRI-611片CXHL2600640 诺为泰医药科技(上海)有限公司
2026/06/01New drug · Class 1 TRI-611片CXHL2600639 诺为泰医药科技(上海)有限公司
2026/05/29Import · Class 2.2 阿替利珠单抗注射液JXSS2600043 Roche Registration GmbH; Roche Diagnostics GmbH; F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2026/05/29Import · Class 1 INCA33890注射液JXSL2600123 Incyte Corporation; Incyte Biosciences (Shanghai) Co. Ltd.
2026/05/29Import · Class 1 Ponsegromab注射液JXSL2600122 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.

61 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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