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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 507 drug applications between 2 July 2026 and 8 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 52 drug names.

2026/07/02 – 2026/07/08

Period
2026/07/02 to 2026/07/08, 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
507
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
126

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

507filings, 77 of them generic

By application type

Application typeFilings
Supplement293
New drug84
Generic77
Import33
Unspecified12
Import re-registration8

By drug type

Drug typeFilings
Chemical drug235
TCM203
Therapeutic biologic61
Biologic5
Prophylactic biologic3

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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nafamostat Mesilate for Injection6438
2司美格鲁肽注射液 · No verified English name5192
3Dotinurad Tablets4255
4泊马度胺胶囊 · No verified English name414
5Levothyroxine Sodium Oral Solution314
6Sodium Hyaluronate Eye Drops2230
7Ambroxol Hydrochloride Oral Solution2246
8Glucosamine Sulfate Capsules2251
9依折麦布阿托伐他汀钙片(Ⅰ)、(Ⅱ) · No verified English name212
10Cefditoren Pivoxil Granules2118

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

282 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized24180
2AstraZeneca AB1320
3Lan Yun Zhi He Bio Technology Co., Ltd. romanized880
4Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized870
5Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized810
6Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized660
7Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized640
8Liquidia Technologies Inc.610
9Hubei Tai Zi Pharma Co., Ltd. romanized550
10Gui Lin San Jin Pharma Co., Ltd. romanized540

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

152 this week

AcceptedDrugApplicants
2026/07/08Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600155 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/07/08Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600154 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/07/08Import · Class 1 DS-1103a · No verified English nameJXSL2600153 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2026/07/08Import · Class 1 DS-3939a · No verified English nameJXSL2600152 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2026/07/08Import · Class 2.2 L606 (曲前列尼尔脂质体吸入混悬液) · No verified English nameJXHL2600265 Liquidia Technologies Inc.; Shanghai Harvest Medical Technology Co. Ltd.
2026/07/08Import · Class 2.2 L606 (曲前列尼尔脂质体吸入混悬液) · No verified English nameJXHL2600264 Liquidia Technologies Inc.; Shanghai Harvest Medical Technology Co. Ltd.
2026/07/08Import · Class 2.2 L606 (曲前列尼尔脂质体吸入混悬液) · No verified English nameJXHL2600263 Liquidia Technologies Inc.; Shanghai Harvest Medical Technology Co. Ltd.
2026/07/08Import · Class 2.2 L606 (曲前列尼尔脂质体吸入混悬液) · No verified English nameJXHL2600262 Liquidia Technologies Inc.; Shanghai Harvest Medical Technology Co. Ltd.
2026/07/08Import · Class 2.2 L606 (曲前列尼尔脂质体吸入混悬液) · No verified English nameJXHL2600261 Liquidia Technologies Inc.; Shanghai Harvest Medical Technology Co. Ltd.
2026/07/08Import · Class 2.2 L606 (曲前列尼尔脂质体吸入混悬液) · No verified English nameJXHL2600260 Liquidia Technologies Inc.; Shanghai Harvest Medical Technology Co. Ltd.
2026/07/08Generic · Class 3 眼用丝裂霉素溶液用粉末 · No verified English nameCYHS2601638 Han Hui Pharmaceutical Co., Ltd. romanized; Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2026/07/08Generic · Class 3 琥珀酸地文拉法辛缓释片 · No verified English nameCYHS2601636 Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized; Hefei Si Pu Rui Pharma Co., Ltd. romanized
2026/07/08Generic · Class 3 Dexketoprofen Trometamol InjectionCYHS2601635 Shandong Qidu Pharmaceutical Co., Ltd.
2026/07/08Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2601634 Shenyang Da Shan Pharmaceuticals Technology Co., Ltd. romanized; Liaoning Da Xiong Pharmaceutical Co., Ltd. romanized
2026/07/08New drug · Class 1.2 注射用和厚朴酚脂质体冻干粉 · No verified English nameCXZL2600059 Beijing Jin Rui Ji Ye Pharmaceuticals Technology Co., Ltd. romanized
2026/07/08New drug · Class 1 LBL-034注射液 · No verified English nameCXSL2600716 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2026/07/08New drug · Class 1 SYS6043 · No verified English nameCXSL2600715 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/07/08New drug · Class 1 AZD7003 · No verified English nameCXSL2600714 A Si Li Kang Investment (Zhongguo) Co., Ltd. romanized
2026/07/08New drug · Class 3.2 ACYW135群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2600713 Fu Xing An Te Jin (Chengdu) Biopharmaceutical Co., Ltd. romanized
2026/07/08New drug · Class 1 BA1203注射液 · No verified English nameCXSL2600712 Shandong Bo An Bio Technology Co., Ltd. romanized
2026/07/08New drug · Class 1 艾普美妥司他片 · No verified English nameCXHS2600099 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2026/07/08New drug · Class 1 艾普美妥司他片 · No verified English nameCXHS2600098 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2026/07/08New drug · Class 1 CMS-D001片 · No verified English nameCXHL2600829 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2026/07/08New drug · Class 1 CMS-D001片 · No verified English nameCXHL2600828 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2026/07/08New drug · Class 1 HRS-1596片 · No verified English nameCXHL2600827 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/08New drug · Class 1 HRS-1596片 · No verified English nameCXHL2600826 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/08New drug · Class 1 HRS-1596片 · No verified English nameCXHL2600825 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/08New drug · Class 1 HRS-1596片 · No verified English nameCXHL2600824 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/08New drug · Class 1 LJR003胶囊 · No verified English nameCXHL2600823 Lang Jie Rui (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized; Lang Jie Rui (Suzhou) Bio Technology Co., Ltd. romanized
2026/07/08New drug · Class 1 ZX-8177片 · No verified English nameCXHL2600822 Zheng Xiang Pharmaceuticals (Nanjing) Group Co., Ltd. romanized

122 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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