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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 455 drug applications between 5 November 2026 and 11 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 53 drug names.

2026/11/05 – 2026/11/11

Period
2026/11/05 to 2026/11/11, 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
455
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
455

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

455filings, 83 of them generic

By application type

Application typeFilings
Supplement245
Generic83
New drug73
Import47
Import re-registration6
Unspecified1

By drug type

Drug typeFilings
Chemical drug258
TCM104
Therapeutic biologic90
Prophylactic biologic2
Biologic1

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Dotinurad Tablets4255
2Ibuprofen Injection428
3Mirogabalin Besilate Tablets4261
4Ertugliflozin Tablets3313
5Brivaracetam Tablets3119
6Piperacillin Sodium for Injection3116
7Fosfomycin Sodium For Injection3116
8Edaravone and Dexborneol Concentrated Solution for Injection2234
9Ethyl Iosapentate Capsules2127
10Oxaliplatin Injection214

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

280 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1F. Hoffmann-La Roche Ltd820
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized730
3Amgen Inc.720
4Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized650
5Pfizer Inc.630
6Shenzhen Xin Li Tai Pharma Co., Ltd. romanized610
7AstraZeneca AB530
8Chengdu Shuo De Pharma Co., Ltd. romanized531
9Yi Chang Ren Fu Pharma Co., Ltd. romanized523
10MyoKardia Inc.510

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

Entered review this week
477
Left the under-review list this week
494

Of these, NMPA published approval-document delivery for 238 (including 224 supplemental applications, not counted as new marketing approvals) and notification delivery for 8; the outcome of the other 248 is to be checked.

Most filings leaving review, by company

Most filings leaving review, by company
#Company (first applicant)FilingsDrugs
1Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized112
2AstraZeneca AB64
3Sichuan Pharmaceutical Formulations Co., Ltd. romanized63
4Liaoning Min Kang Pharmaceutical Co., Ltd. romanized62
5Novo Nordisk A/S51
6Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized44
7Sichuan Tai Le Pharmaceutical Co., Ltd. romanized44
8Hubei Dong Xin Pharma Co., Ltd. romanized44
9Merck Sharp & Dohme LLC43
10Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized43

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Amgen Inc.123
2Novo Nordisk A/S101
3Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized65
4Pfizer Inc.63
5F. Hoffmann-La Roche Ltd61
6Shenzhen Xin Li Tai Pharma Co., Ltd. romanized61
7AstraZeneca AB53
8Chengdu Shuo De Pharma Co., Ltd. romanized53
9Yi Chang Ren Fu Pharma Co., Ltd. romanized52
10MyoKardia Inc.51

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

144 this week

AcceptedDrugApplicants
2026/11/11Import · Class 1 RO7497372 注射液 · No verified English nameJXSL2600313 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/11/11Import · Class 1 RO7497372 注射液 · No verified English nameJXSL2600312 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/11/11Import · Class 1 Verve-102注射液 · No verified English nameJXSL2600311 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/11/11Import · Class 1 PF-08653945注射液 · No verified English nameJXHL2600506 Pfizer Inc.; Pfizer(Beijing)Research and Development Co. Ltd.
2026/11/11Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2602780 Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2026/11/11Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2602779 Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2026/11/11Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2602778 Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2026/11/11Generic · Class 3 Ibuprofen InjectionCYHS2602772 Zhengzhou Zhuo Feng Pharmaceutical Co., Ltd. romanized
2026/11/11Generic · Class 3 Ibuprofen InjectionCYHS2602771 Zhengzhou Zhuo Feng Pharmaceutical Co., Ltd. romanized
2026/11/11Generic · Class 3 右美托咪定舌下膜 · No verified English nameCYHL2600129 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2026/11/11Generic · Class 3 Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2600128 Zhejiang Hao Ge Pharma Co., Ltd. romanized
2026/11/11New drug · Class 1.1 轻身调脂消渴片 · No verified English nameCXZL2600115 Jiangsu Jiu Xu Pharma Co., Ltd. romanized; Zhongguo Zhong Yi Ke College Guang An Men Hospital romanized
2026/11/11New drug · Class 1 LYW2402-NS-HK人源基质细胞注射液(三维工艺制备) · No verified English nameCXSL2601253 Liaoning Yi Xue Zhen Liao Technology Research and Development Center Co., Ltd. romanized
2026/11/11New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2601252 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/11/11New drug · Class 2.3 比索洛尔左氨氯地平片 · No verified English nameCXHS2600153 Jiangxi Shimei Pharmaceutical Co., Ltd
2026/11/11New drug · Class 1 HRS-7172片 · No verified English nameCXHL2601409 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/11/11New drug · Class 1 HRS-7172片 · No verified English nameCXHL2601408 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/11/11New drug · Class 1 HRS-7172片 · No verified English nameCXHL2601407 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/11/11New drug · Class 1 LW402片 · No verified English nameCXHL2601406 Shanghai Zhang Sen Pharma Co., Ltd. romanized
2026/11/11New drug · Class 1 LW402片 · No verified English nameCXHL2601405 Shanghai Zhang Sen Pharma Co., Ltd. romanized
2026/11/11New drug · Class 1 IG001119片 · No verified English nameCXHL2601404 Yang Guang An Jin (Nanjing) Biopharmaceuticals Technology Co., Ltd. romanized
2026/11/11New drug · Class 1 IG001119片 · No verified English nameCXHL2601403 Yang Guang An Jin (Nanjing) Biopharmaceuticals Technology Co., Ltd. romanized
2026/11/11New drug · Class 1 HRS-4642注射液 · No verified English nameCXHL2601402 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/11/11New drug · Class 1 JMKX003948片 · No verified English nameCXHL2601401 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2026/11/11New drug · Class 1 JMKX003948片 · No verified English nameCXHL2601400 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2026/11/11New drug · Class 1 JMKX003948片 · No verified English nameCXHL2601399 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2026/11/11New drug · Class 1 HRS-2329片 · No verified English nameCXHL2601398 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/11/11New drug · Class 1 HRS-2329片 · No verified English nameCXHL2601397 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/11/11New drug · Class 1 HRS-6093片 · No verified English nameCXHL2601396 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/11/11New drug · Class 1 HRS-6093片 · No verified English nameCXHL2601395 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

114 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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