药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2021/11/23 – 2021/11/29

Period
2021/11/23 to 2021/11/29, 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
241
Drugs with new generic filings (by drug name, de-duplicated)
27
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

241filings, 38 of them generic

By application type

Application typeFilings
Supplement125
Generic38
New drug35
Import28
Unspecified12
Import re-registration3

By drug type

Drug typeFilings
Chemical drug167
治疗用生物制品38
TCM31
预防用生物制品3
Biologic2

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

27 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

130 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

70 this week

AcceptedDrugApplicants
2021/11/29Import · Class 1 BAY 2586116鼻喷雾剂JXHL2101259 Bayer AG; Bayer Healthcare Company Ltd.
2021/11/29Import · Class 1 BAY 2586116鼻喷雾剂JXHL2101258 Bayer AG; Bayer Healthcare Company Ltd.
2021/11/29Import · Class 1 BAY 2586116鼻喷雾剂JXHL2101257 Bayer AG; Bayer Healthcare Company Ltd.
2021/11/29Generic · Class 3 吸入用盐酸丙卡特罗溶液CYHS2102099 南京华盖制药有限公司
2021/11/29Generic · Class 3 注射用盐酸罗沙替丁醋酸酯CYHS2102095 扬子江药业集团南京海陵药业有限公司; 扬子江药业集团江苏紫龙药业有限公司
2021/11/29Generic · Class 3 艾司奥美拉唑镁肠溶干混悬剂CYHS2102094 成都苑东生物制药股份有限公司
2021/11/29Generic · Class 3 艾司奥美拉唑镁肠溶干混悬剂CYHS2102093 成都苑东生物制药股份有限公司
2021/11/29New drug · Class 3.2 注射用重组人甲状旁腺素(1-84)CXSL2101455 四川泸州步长生物制药有限公司
2021/11/29New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液CXSL2101454 江苏康宁杰瑞生物制药有限公司
2021/11/29New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液CXSL2101453 江苏康宁杰瑞生物制药有限公司
2021/11/29New drug · Class 1 CAB-ROR2-ADC注射剂CXSL2101439 凯博斯(上海)生物医药有限公司
2021/11/29New drug · Class 1 HSK31858片CXHL2101696 海思科医药集团股份有限公司
2021/11/29New drug · Class 1 HSK31858片CXHL2101695 海思科医药集团股份有限公司
2021/11/29New drug · Class 1 JMKX000189注射液CXHL2101694 上海济煜医药科技有限公司; 浙江杭煜制药有限公司
2021/11/29New drug · Class 1 注射用PMS-001CXHL2101693 青岛普美圣医药科技有限公司
2021/11/29New drug · Class 1 TLL-018片CXHL2101692 杭州高光制药有限公司
2021/11/29New drug · Class 1 BGT-002片CXHL2101691 博骥源(上海)生物医药有限公司
2021/11/29New drug · Class 1 BGT-002片CXHL2101690 博骥源(上海)生物医药有限公司
2021/11/26Import · Class 2.2 帕博利珠单抗注射液JXSS2101033 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2021/11/26Import · Class 1 HBM9161(HL161BKN)注射液JXSL2101139 Harbour BioMed Therapeutics Limited; 和铂医药(苏州)有限公司
2021/11/26Import · Class 2.4 甲磺酸奥希替尼片JXHL2101261 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/11/26Import · Class 2.4 甲磺酸奥希替尼片JXHL2101260 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/11/26New drug · Class 1.2 丹酚酸ACXZL2101035 江西青峰药业有限公司
2021/11/26New drug · Class 1 SI-B003双特异性抗体注射液CXSL2101452 四川百利药业有限责任公司; 成都百利多特生物药业有限责任公司
2021/11/26New drug · Class 1 SI-B003双特异性抗体注射液CXSL2101451 四川百利药业有限责任公司; 成都百利多特生物药业有限责任公司
2021/11/26New drug · Class 1 KN052注射液CXSL2101450 江苏康宁杰瑞生物制药有限公司
2021/11/26New drug · Class 1 PM1022 注射液CXSL2101447 普米斯生物技术(珠海)有限公司
2021/11/26New drug · Class 1 重组抗IL-4Rα单域抗体雾化液(毕赤酵母)CXSL2101446 上海洛启生物医药技术有限公司
2021/11/26New drug · Class 1 ES002023注射液CXSL2101445 科望(苏州)生物医药科技有限公司
2021/11/26New drug · Class 1 硝酮嗪肠溶片CXHL2101688 广州喜鹊医药有限公司

40 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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