药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/05/05 – 2026/05/11

Period
2026/05/05 to 2026/05/11, 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
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 typeFilings
Supplement249
New drug70
Generic50
Import39
Unspecified14
Import re-registration7

By drug type

Drug typeFilings
Chemical drug196
TCM155
治疗用生物制品66
Biologic9
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

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

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

AcceptedDrugApplicants
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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