YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 427 drug applications between 27 February 2026 and 5 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 53 drug names.

2026/02/27 – 2026/03/05

Period
2026/02/27 to 2026/03/05, 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
427
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
118

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

427filings, 67 of them generic

By application type

Application typeFilings
Supplement215
New drug95
Generic67
Import36
Unspecified9
Import re-registration5

By drug type

Drug typeFilings
Chemical drug225
Therapeutic biologic100
TCM91
Prophylactic biologic6
Biologic4
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

53 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

252 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company950
2Amgen Inc.930
3Tianjin Hong Ren Tang Pharma Co., Ltd. romanized660
4Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized640
5Novartis Pharma AG620
6Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized550
7Shaanxi Pan Long Pharma Group Co., Ltd. romanized550
8Janssen Research & Development LLC530
9Changchun Jin Sai Pharma Co., Ltd. romanized530
10Novo Nordisk A/S510

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

154 this week

AcceptedDrugApplicants
2026/03/05Import · Class 1 Pasritamig注射液 · No verified English nameJXSL2600068 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/05Import · Class 1 Pasritamig注射液 · No verified English nameJXSL2600067 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/05Import · Class 1 JNJ-87189401 注射液 · No verified English nameJXSL2600066 Janssen Research & Development LLC; Johnson & Johnson (China)Investment Ltd.
2026/03/05Import · Class 1 JNJ-87189401 注射液 · No verified English nameJXSL2600065 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/05Generic · Class 3 Gabapentin Oral SolutionCYHS2600612 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Shanghai Zhong Hua Pharma Co., Ltd. romanized
2026/03/05New drug · Class 3.1 桃红四物汤颗粒 · No verified English nameCXZS2600016 Shanghai Kai Bao Pharma Co., Ltd. romanized
2026/03/05New drug · Class 3.4 人凝血因子Ⅸ · No verified English nameCXSL2600307 Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized
2026/03/05New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2600306 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/03/05New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600305 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/03/05New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2600304 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/03/05New drug · Class 1 HS-20117注射液 · No verified English nameCXSL2600303 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/03/05New drug · Class 2.4 甲磺酸阿美替尼片 · No verified English nameCXHS2600038 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2026/03/05New drug · Class 1 Alpha-0261片 · No verified English nameCXHL2600272 Shanghai A Er Fa Fen Zi Qi Ye Development Co., Ltd. romanized
2026/03/05New drug · Class 1 Alpha-0261片 · No verified English nameCXHL2600271 Shanghai A Er Fa Fen Zi Qi Ye Development Co., Ltd. romanized
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

124 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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