药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/10/15 – 2024/10/21

Period
2024/10/15 to 2024/10/21, 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
360
Drugs with new generic filings (by drug name, de-duplicated)
77
Accepted this week, now under review
3

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, 100 of them generic

By application type

Application typeFilings
Supplement139
Generic100
New drug81
Import25
Unspecified10
Import re-registration5

By drug type

Drug typeFilings
Chemical drug226
TCM64
治疗用生物制品56
Biologic7
预防用生物制品7

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

77 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

234 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

145 this week

AcceptedDrugApplicants
2024/10/21New drug · Class 1 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液CXSL2400714 上海邦耀生物科技有限公司
2024/10/21New drug · Class 1 SYH2059片CXHL2401117 上海翊石医药科技有限公司
2024/10/21New drug · Class 1 SYH2059片CXHL2401116 上海翊石医药科技有限公司
2024/10/20Generic · Class 3 氯化钾口服溶液CYHS2403542 浙江易泽达医药科技有限公司; 浙江杭康药业有限公司
2024/10/19New drug · Class 1 注射用ZG005CXSL2400713 苏州泽璟生物制药股份有限公司; 上海泽璟医药技术有限公司
2024/10/19New drug · Class 1 WJB001胶囊CXHL2401115 微境生物医药科技(上海)有限公司
2024/10/19New drug · Class 1 WJB001胶囊CXHL2401114 微境生物医药科技(上海)有限公司
2024/10/19New drug · Class 1 ART101注射液CXHL2401113 苏州昂拓生物医药有限公司
2024/10/19New drug · Class 1 AK-1286片CXHL2401112 上海璎黎药业有限公司
2024/10/19New drug · Class 1 AK-1286片CXHL2401111 上海璎黎药业有限公司
2024/10/19New drug · Class 1 LKR202注射液CXHL2401110 上海利康瑞生物工程有限公司; 上海昊海生物科技股份有限公司
2024/10/19New drug · Class 1 盐酸吉卡昔替尼片CXHL2401109 苏州泽璟生物制药股份有限公司; 上海泽璟医药技术有限公司
2024/10/18Import · Class 3.1 Tremelimumab注射液JXSS2400099 AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd.
2024/10/18Import · Class 3.1 度伐利尤单抗注射液JXSS2400098 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2024/10/18Import · Class 3.1 Tremelimumab注射液JXSS2400097 AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd.
2024/10/18Import · Class 3.1 度伐利尤单抗注射液JXSS2400096 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2024/10/18Import · Class 2.2 Dostarlimab注射液JXSL2400197 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2024/10/18Import · Class 1 Belrestotug注射液JXSL2400196 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2024/10/18Import · Class 1 Orforglipron胶囊JXHL2400254 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/18Import · Class 1 Orforglipron胶囊JXHL2400253 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/18Import · Class 1 Orforglipron胶囊JXHL2400252 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/18Import · Class 1 Orforglipron胶囊JXHL2400251 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/18Import · Class 1 Orforglipron胶囊JXHL2400250 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/18Import · Class 1 Orforglipron胶囊JXHL2400249 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/18Generic · Class 3 中长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液CYHS2403541 辽宁海思科制药有限公司
2024/10/18Generic · Class 3 注射用硫酸多黏菌素BCYHS2403540 广州艾奇西新药研究有限公司; 广东星昊药业有限公司
2024/10/18Generic · Class 3 碳酸氢钠林格注射液(Ⅰ)CYHS2403539 海南爱科制药有限公司
2024/10/18Generic · Class 3 匹伐他汀钙口崩片CYHS2403538 广东万泰元科创药业有限公司; 深圳信立泰药业股份有限公司
2024/10/18Generic · Class 3 匹伐他汀钙口崩片CYHS2403537 广东万泰元科创药业有限公司; 深圳信立泰药业股份有限公司
2024/10/18Generic · Class 3 匹伐他汀钙口崩片CYHS2403536 广东万泰元科创药业有限公司; 深圳信立泰药业股份有限公司

115 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.