药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/06/13 – 2023/06/19

Period
2023/06/13 to 2023/06/19, 7 days inclusive
Data as of
2026/11/07 06:00
Cached records
94,440 acceptance records, 11,686 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
264
Drugs with new generic filings (by drug name, de-duplicated)
43
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

264filings, 57 of them generic

By application type

Application typeFilings
Supplement133
Generic57
New drug42
Import19
Unspecified9
Import re-registration4

By drug type

Drug typeFilings
Chemical drug183
TCM47
治疗用生物制品30
Biologic2
预防用生物制品2

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

43 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

174 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

78 this week

AcceptedDrugApplicants
2023/06/19Generic · Class 3 伊布替尼片CYHS2301654 齐鲁制药(海南)有限公司
2023/06/19Generic · Class 3 伊布替尼片CYHS2301653 齐鲁制药(海南)有限公司
2023/06/19New drug · Class 1 人肝细胞血浆灌流器CXSL2300421 苏州瑞徕生物科技有限公司
2023/06/19New drug · Class 2.2 IBI310CXSL2300420 信达生物制药(苏州)有限公司
2023/06/19New drug · Class 1 HSK21542片CXHL2300665 西藏海思科制药有限公司
2023/06/19New drug · Class 1 HSK21542片CXHL2300664 西藏海思科制药有限公司
2023/06/19New drug · Class 1 TCIC-002颗粒CXHL2300663 唐传生物科技(厦门)有限公司
2023/06/19New drug · Class 1 TCIC-002颗粒CXHL2300662 唐传生物科技(厦门)有限公司
2023/06/17Generic · Class 3 盐酸丙美卡因滴眼液CYHS2301650 合肥立方制药股份有限公司; 浙江莎普爱思药业股份有限公司
2023/06/17Generic · Class 3 注射用苯唑西林钠CYHS2301647 江苏江丰医药科技有限公司; 山东睿鹰制药集团有限公司
2023/06/17New drug · Class 1 SPH3127片CXHS2300055 上海上药信谊药厂有限公司
2023/06/17New drug · Class 1 RAB001注射液CXHL2300661 中山莱博瑞辰生物医药有限公司
2023/06/17New drug · Class 1 泰普格雷片CXHL2300660 天津药物研究院有限公司
2023/06/17New drug · Class 1 泰普格雷片CXHL2300659 天津药物研究院有限公司
2023/06/17New drug · Class 1 泰普格雷片CXHL2300658 天津药物研究院有限公司
2023/06/16Import · Class 1 MEDI5752JXSL2300110 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/06/16Import · Class 2.2 古塞奇尤单抗注射液JXSL2300109 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/06/16Import · Class 2.3 Guselkumab/Golimumab(JNJ-78934804)注射液JXSL2300108 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/06/16Import · Class 2.2 戈利木单抗注射液JXSL2300107 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/06/16Import · Class 1 LOXO-783片JXHL2300143 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/06/16Import · Class 1 LOXO-783片JXHL2300142 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/06/16Import · Class 1 RO7435846片JXHL2300141 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/06/16Import · Class 1 RO7435846片JXHL2300140 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/06/16Generic · Class 3 艾司奥美拉唑镁肠溶胶囊CYHS2301644 湖南银泽华浩生物科技有限公司; 双鹤药业(海南)有限责任公司
2023/06/16Generic · Class 3 艾司奥美拉唑镁肠溶胶囊CYHS2301643 湖南银泽华浩生物科技有限公司; 双鹤药业(海南)有限责任公司
2023/06/16Generic · Class 3 二羟丙茶碱注射液CYHS2301642 江苏瑜兴医药科技有限公司; 亚邦医药股份有限公司
2023/06/16Generic · Class 3 甲硫酸新斯的明注射液CYHS2301639 山西振东泰盛制药有限公司
2023/06/16Generic · Class 3 呋塞米口服溶液CYHS2301638 仁合益康集团有限公司; 河北仁合益康药业有限公司
2023/06/16Generic · Class 3 盐酸丙卡特罗口服溶液CYHS2301636 广东稳健药业有限公司; 山西同达药业有限公司
2023/06/16Generic · Class 3 盐酸丙卡特罗口服溶液CYHS2301635 广东稳健药业有限公司; 山西同达药业有限公司

48 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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