药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/06/07 – 2022/06/13

Period
2022/06/07 to 2022/06/13, 7 days inclusive
Data as of
2026/11/08 06:00
Cached records
94,440 acceptance records, 11,586 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
324
Drugs with new generic filings (by drug name, de-duplicated)
23
Accepted this week, now under review
0

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

324filings, 40 of them generic

By application type

Application typeFilings
Supplement198
New drug41
Generic40
Import27
Unspecified9
Import re-registration9

By drug type

Drug typeFilings
Chemical drug197
治疗用生物制品72
TCM45
Biologic6
预防用生物制品4

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

23 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

158 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

74 this week

AcceptedDrugApplicants
2022/06/13Import · Class 3.1 地舒单抗注射液JXSS2200019 Amgen Europe B.V.; Amgen Manufacturing Limited; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/06/13Import · Class 2.2 贝伐珠单抗注射液JXSL2200084 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/06/13Import · Class 3.3 雷珠单抗注射液JXSL2200083 Samsung Bioepis NL B.V.; Shanghai Affamed Therapeutics Co. Limited
2022/06/13Import · Class 1 RO7435846片JXHL2200143 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2022/06/13Import · Class 1 RO7435846片JXHL2200142 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2022/06/13Import · Class 1 RO7435846片JXHL2200141 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2022/06/13Generic · Class 3 盐酸文拉法辛缓释片CYHS2200865 海南慧谷药业有限公司
2022/06/13Generic · Class 3 盐酸多巴胺注射液CYHS2200864 成都苑东生物制药股份有限公司
2022/06/13Generic · Class 3 盐酸多巴胺注射液CYHS2200863 成都苑东生物制药股份有限公司
2022/06/13Generic · Class 3 米诺地尔外用溶液CYHS2200862 江苏万高药业股份有限公司
2022/06/13Generic · Class 3 米诺地尔外用溶液CYHS2200861 江苏万高药业股份有限公司
2022/06/13Generic · Class 3 乌司他丁注射液CYHL2200049 江苏艾迪药业股份有限公司
2022/06/13New drug · Class 1 托莱西单抗注射液CXSS2200059 信达生物制药(苏州)有限公司
2022/06/13New drug · Class 1 TG103注射液CXSL2200262 石药集团百克(山东)生物制药股份有限公司
2022/06/13New drug · Class 2.2 注射用多西他赛聚合物胶束CXHL2200375 山西康宝生物制品股份有限公司
2022/06/10Import · Class 1 CagriSema注射液JXSL2200082 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 1 CagriSema注射液JXSL2200081 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 1 CagriSema注射液JXSL2200080 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 1 CagriSema注射液JXSL2200079 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 1 CagriSema注射液JXSL2200078 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 2.2 帕博利珠单抗注射液JXSL2200077 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2022/06/10Import · Class 1 MK-4830注射液JXSL2200076 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2022/06/10Import · Class 1 BI 907828片JXHL2200139 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/10Import · Class 1 BI 907828片JXHL2200138 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/10Import · Class 1 BI 907828片JXHL2200137 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/10Generic · Class 3 磷酸奥司他韦干混悬剂CYHS2200858 杨凌科森生物制药有限责任公司
2022/06/10Generic · Class 3 磷酸奥司他韦干混悬剂CYHS2200857 杨凌科森生物制药有限责任公司
2022/06/10New drug · Class 1.1 小儿香薷颗粒CXZL2200026 一力制药股份有限公司
2022/06/10New drug · Class 1 ZS801注射液CXSL2200261 四川至善唯新生物科技有限公司
2022/06/10New drug · Class 1 HB0036注射液CXSL2200260 华博生物医药技术(上海)有限公司; 上海华奥泰生物药业股份有限公司

44 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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