药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/09/03 – 2024/09/09

Period
2024/09/03 to 2024/09/09, 7 days inclusive
Data as of
2026/11/05 06:00
Cached records
94,245 acceptance records, 11,689 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
293
Drugs with new generic filings (by drug name, de-duplicated)
67
Accepted this week, now under review
2

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

293filings, 89 of them generic

By application type

Application typeFilings
Supplement123
Generic89
New drug51
Import19
Import re-registration9
Unspecified2

By drug type

Drug typeFilings
Chemical drug188
TCM62
治疗用生物制品38
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

67 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

181 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 whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

99 this week

AcceptedDrugApplicants
2024/09/09Generic · Class 3 维生素K1注射液CYHS2402966 石家庄四药有限公司
2024/09/09Generic · Class 3 地氯雷他定口服溶液CYHS2402965 哈尔滨市康隆药业有限责任公司
2024/09/09Generic · Class 3 琥珀酸曲格列汀片CYHS2402964 苏州东瑞制药有限公司
2024/09/09Generic · Class 3 琥珀酸曲格列汀片CYHS2402963 苏州东瑞制药有限公司
2024/09/07Generic · Class 3 注射用乳糖酸红霉素CYHS2402962 海南广升誉制药有限公司; 海南灵康制药有限公司
2024/09/07Generic · Class 3 注射用乳糖酸红霉素CYHS2402961 海南广升誉制药有限公司; 海南灵康制药有限公司
2024/09/07Generic · Class 3 注射用乳糖酸红霉素CYHS2402960 海南广升誉制药有限公司; 海南灵康制药有限公司
2024/09/07Generic · Class 3 维生素B12注射液CYHS2402959 华夏生生药业(北京)有限公司
2024/09/07Generic · Class 3 复合磷酸氢钾注射液CYHS2402957 江西泰吉立生物医药科技有限公司; 浙江赛默制药有限公司
2024/09/07Generic · Class 3 布瑞哌唑口崩片CYHS2402954 成都康弘药业集团股份有限公司
2024/09/07Generic · Class 3 维生素B?注射液CYHS2402953 江西泰吉立生物医药科技有限公司; 成都市海通药业有限公司
2024/09/07Generic · Class 3 布瑞哌唑口崩片CYHS2402952 成都康弘药业集团股份有限公司
2024/09/07Generic · Class 3 布瑞哌唑口崩片CYHS2402951 成都康弘药业集团股份有限公司
2024/09/07Generic · Class 3 奥美沙坦酯口崩片CYHS2402944 江西施美药业股份有限公司
2024/09/07New drug · Class 1 LP-003 注射液CXSL2400599 天辰生物医药(苏州)有限公司
2024/09/07New drug · Class 1 SHR-3045注射液CXSL2400598 广东恒瑞医药有限公司; 上海恒瑞医药有限公司
2024/09/07New drug · Class 1 聚乙二醇化重组门冬酰胺酶注射液CXSL2400597 重庆派金生物科技有限公司
2024/09/07New drug · Class 2.2 ZC2211CXHL2400927 杭州志呈科技有限公司
2024/09/07New drug · Class 2.2 ZC2211CXHL2400926 杭州志呈科技有限公司
2024/09/07New drug · Class 1 JMKX003676片CXHL2400925 浙江杭煜制药有限公司
2024/09/07New drug · Class 1 JMKX003676片CXHL2400924 浙江杭煜制药有限公司
2024/09/07New drug · Class 1 KPC000154片CXHL2400923 昆药集团股份有限公司; 昆药集团(珠海横琴)科技有限公司
2024/09/07New drug · Class 1 KPC000154片CXHL2400922 昆药集团股份有限公司; 昆药集团(珠海横琴)科技有限公司
2024/09/07New drug · Class 1 JMKX003676片CXHL2400921 浙江杭煜制药有限公司
2024/09/07New drug · Class 2.2 司美格鲁肽注射液CXHL2400920 华润双鹤药业股份有限公司
2024/09/07New drug · Class 2.2 司美格鲁肽注射液CXHL2400919 华润双鹤药业股份有限公司
2024/09/07New drug · Class 2.2 司美格鲁肽注射液CXHL2400918 华润双鹤药业股份有限公司
2024/09/07New drug · Class 2.2 司美格鲁肽注射液CXHL2400917 华润双鹤药业股份有限公司
2024/09/07New drug · Class 2.2 司美格鲁肽注射液CXHL2400916 华润双鹤药业股份有限公司
2024/09/06Generic · Class 3 吸入用盐酸丙卡特罗溶液CYHS2402939 江苏大红鹰恒顺药业有限公司

69 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.