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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 494 drug applications between 26 February 2026 and 4 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 89, covering 65 drug names.

2026/02/26 – 2026/03/04

Period
2026/02/26 to 2026/03/04, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
494
Drugs with new generic filings (by drug name, de-duplicated)
65
Accepted this week, now under review
150

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.

Names with a public page are linked.

New acceptances this week

By application type and drug type

494filings, 89 of them generic

By application type

Application typeFilings
Supplement232
New drug120
Generic89
Import34
Unspecified12
Import re-registration7

By drug type

Drug typeFilings
Chemical drug285
Therapeutic biologic108
TCM91
Prophylactic biologic6
Biologic3
In vitro diagnostic reagent1

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

65 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3223
2Finerenone Tablets3269
3Cariprazine hydrochloride Capsules313
4注射用甲苯磺酸奥马环素 · No verified English name229
5盐酸氮?斯汀滴眼液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.226
6Iguratimod Tablets2223
7Eplerenone Tablets214
8Diclofenac Sodium Sustained Release Tablets2110
9Nimodipine Oral Solution214
10Bumetanide Injection2113

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

275 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Amgen Inc.930
2Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized750
3Eli Lilly and Company740
4Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized740
5The Wellcome Foundation Limited720
6Tianjin Hong Ren Tang Pharma Co., Ltd. romanized660
7Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized640
8Qilu Pharmaceutical Co., Ltd.640
9Novartis Pharma AG620
10Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized620

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

185 this week

AcceptedDrugApplicants
2026/03/04Import · Class 2.2 Mirikizumab注射液 · No verified English nameJXSL2600064 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/04Import · Class 2.2 Mirikizumab注射液 · No verified English nameJXSL2600063 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/04Import · Class 2.2 Mirikizumab注射液 · No verified English nameJXSL2600062 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/04Import · Class 1 LY4395089片 · No verified English nameJXHL2600079 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/04Import · Class 1 LY4395089片 · No verified English nameJXHL2600078 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/04Import · Class 1 BMS-986458片 · No verified English nameJXHL2600077 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/03/04Import · Class 1 BMS-986458片 · No verified English nameJXHL2600076 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/03/04Import · Class 1 SNV1521片 · No verified English nameJXHL2600075 Synnovation Therapeutics Inc.; Clinical Service Center Co. Ltd.
2026/03/04Import · Class 1 SNV1521片 · No verified English nameJXHL2600074 Synnovation Therapeutics Inc.; Clinical Service Center Co. Ltd.
2026/03/04Import · Class 1 SNV1521片 · No verified English nameJXHL2600073 Synnovation Therapeutics Inc.; Clinical Service Center Co. Ltd.
2026/03/04Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600072 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/03/04Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2600611 Hebei Shan Mu Shi Pharma Co., Ltd. romanized
2026/03/04New drug · Class 1.1 灵草舒筋酊 · No verified English nameCXZL2600025 Shanghai Shou Zheng Zhong Pharmaceuticals Research Co., Ltd. romanized
2026/03/04New drug · Class 3.2 静注人免疫球蛋白 · No verified English nameCXSL2600302 Guizhou Tai Bang Bio Zhi Pin Co., Ltd. romanized
2026/03/04New drug · Class 1 注射用AMT-116 · No verified English nameCXSL2600301 Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/03/04New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2600300 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/03/04New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2600297 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/03/04New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600296 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/03/04New drug · Class 1 QR055453D片 · No verified English nameCXHL2600270 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2026/03/04New drug · Class 1 QR055453D片 · No verified English nameCXHL2600269 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2026/03/04New drug · Class 1 QR055453D片 · No verified English nameCXHL2600268 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2026/03/04New drug · Class 2.1; 2.4 盐酸R-氯胺酮注射液 · No verified English nameCXHL2600267 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/03/04New drug · Class 1 注射用LY103 · No verified English nameCXHL2600266 Qingdao Hai Yang Biopharmaceuticals Research Institute Co., Ltd. romanized; Zhongguo Hai Yang University romanized; Qingdao Hai Ji Biopharmaceuticals Co., Ltd. romanized
2026/03/04New drug · Class 1 注射用LY103 · No verified English nameCXHL2600265 Qingdao Hai Yang Biopharmaceuticals Research Institute Co., Ltd. romanized; Zhongguo Hai Yang University romanized; Qingdao Hai Ji Biopharmaceuticals Co., Ltd. romanized
2026/03/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2600019 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2026/03/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2600018 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2026/03/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2600017 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2026/03/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2600016 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2026/03/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2600015 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2026/03/03Import · Class 3.1 来瑞奇珠单抗注射液 · No verified English nameJXSS2600014 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.

155 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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