药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/06/10 – 2025/06/16

Period
2025/06/10 to 2025/06/16, 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
433
Drugs with new generic filings (by drug name, de-duplicated)
77
Accepted this week, now under review
68

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

433filings, 119 of them generic

By application type

Application typeFilings
Supplement184
Generic119
New drug66
Import43
Unspecified11
Import re-registration9
医疗器械(联合审评)1

By drug type

Drug typeFilings
Chemical drug281
治疗用生物制品71
TCM69
Biologic7
预防用生物制品3
体外诊断试剂1
Unspecified1

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

264 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

140 this week

AcceptedDrugApplicants
2025/06/14Import · Class 1 注射用MK-2400JXSL2500089 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/06/14Import · Class 1 注射用MK-5909JXSL2500088 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/06/14Import · Class 2.4 甲苯磺酸利特昔替尼胶囊JXHL2500144 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd
2025/06/14Import · Class 2.4 甲苯磺酸利特昔替尼胶囊JXHL2500143 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd
2025/06/14Import · Class 1 AZD6793JXHL2500142 AstraZeneca AB
2025/06/14Import · Class 1 AZD6793JXHL2500141 AstraZeneca AB
2025/06/14Import · Class 1 AZD6793JXHL2500140 AstraZeneca AB
2025/06/14Generic · Class 3 酮咯酸氨丁三醇片CYHS2502133 南京海融制药有限公司
2025/06/14Generic · Class 3 盐酸溴己新口服溶液CYHS2502131 岳阳新华达制药有限公司
2025/06/14Generic · Class 3 乙酰半胱氨酸口服溶液CYHS2502130 合肥国药诺和药业有限公司; 合肥诚志生物制药有限公司
2025/06/14Generic · Class 3 乙酰半胱氨酸口服溶液CYHS2502129 合肥国药诺和药业有限公司; 合肥诚志生物制药有限公司
2025/06/14Generic · Class 3 氯化钙注射液CYHS2502125 成都青山利康药业股份有限公司; 广东星昊药业有限公司
2025/06/14Generic · Class 3 腺苷钴胺胶囊CYHS2502123 江苏诚康药业有限公司
2025/06/14Generic · Class 3 醋酸锌颗粒CYHS2502120 仁合益康集团有限公司; 河北仁合益康药业有限公司
2025/06/14Generic · Class 3 醋酸锌颗粒CYHS2502119 仁合益康集团有限公司; 河北仁合益康药业有限公司
2025/06/14Generic · Class 3 贝美前列素涂剂CYHL2500113 浙江孚诺医药股份有限公司
2025/06/14New drug · Class 1 IBI343CXSL2500487 信达生物制药(苏州)有限公司
2025/06/14New drug · Class 1 注射用ZG005CXSL2500486 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
2025/06/14New drug · Class 1 洛奈利单抗注射液CXSL2500485 山东新时代药业有限公司
2025/06/14New drug · Class 2.2 兰索拉唑碳酸氢钠干混悬剂CXHS2500067 南京海纳制药有限公司
2025/06/14New drug · Class 1 HP-001胶囊CXHL2500580 上海超阳药业有限公司
2025/06/14New drug · Class 1 HP-001胶囊CXHL2500579 上海超阳药业有限公司
2025/06/14New drug · Class 1 HP-001胶囊CXHL2500578 上海超阳药业有限公司
2025/06/14New drug · Class 2.4 盐酸吉卡昔替尼片CXHL2500577 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
2025/06/14New drug · Class 1 注射用FZ-P001钠CXHL2500576 上海复旦张江生物医药股份有限公司
2025/06/14New drug · Class 2.2 JSS-222CXHL2500575 江西施美药业股份有限公司
2025/06/14New drug · Class 2.2 司美格鲁肽注射液CXHL2500574 福建基诺厚普生物科技有限公司
2025/06/14New drug · Class 2.2 司美格鲁肽注射液CXHL2500573 福建基诺厚普生物科技有限公司
2025/06/14New drug · Class 2.2 司美格鲁肽注射液CXHL2500572 福建基诺厚普生物科技有限公司
2025/06/14New drug · Class 2.2 司美格鲁肽注射液CXHL2500571 福建基诺厚普生物科技有限公司

110 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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