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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 465 drug applications between 8 January 2026 and 14 January 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 121, covering 78 drug names.

2026/01/08 – 2026/01/14

Period
2026/01/08 to 2026/01/14, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
465
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
146

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

465filings, 121 of them generic

By application type

Application typeFilings
Supplement188
Generic121
New drug121
Import21
Unspecified7
Import re-registration7

By drug type

Drug typeFilings
Chemical drug272
TCM94
Therapeutic biologic89
Prophylactic biologic9
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

78 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

249 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized34340
2Eli Lilly Nederland B.V.1210
3Shenzhen Xin Li Tai Pharma Co., Ltd. romanized1210
4Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized1210
5Bayer Vital GmbH840
6Gan Li Pharma Shandong Co., Ltd. romanized810
7Name not romanized610
8Hunan Ke Lun Pharmaceutical Co., Ltd. romanized542
9Boehringer Ingelheim International GmbH530
10ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.525

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

177 this week

AcceptedDrugApplicants
2026/01/14Import · Class 2.2 依柯胰岛素司美格鲁肽注射液 · No verified English nameJXSS2600004 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/01/14Import · Class 2.2 依柯胰岛素司美格鲁肽注射液 · No verified English nameJXSS2600003 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/01/14Import · Class 2.2 依柯胰岛素司美格鲁肽注射液 · No verified English nameJXSS2600002 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/01/14Import · Class 2.2 可伐利单抗注射液 · No verified English nameJXSL2600003 F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd
2026/01/14Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2600174 Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
2026/01/14Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2600173 Beijing Hua Su Pharmaceutical Co., Ltd. romanized
2026/01/14Generic · Class 3 6-[18F]Fluoro-L-DOPA InjectionCYHL2600010 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2026/01/14New drug · Class 2.2 双苓止泻颗粒 · No verified English nameCXZL2600005 Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized
2026/01/14New drug · Class 1 注射用HDM2024 · No verified English nameCXSL2600084 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2026/01/14New drug · Class 3.3 IBI3027 · No verified English nameCXSL2600083 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/01/14New drug · Class 3.3 IBI3027 · No verified English nameCXSL2600082 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/01/14New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2600081 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/01/14New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2600080 Beijing Ji Nuo Wei Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Lang Fang Lin Kong Zi Mao Qu) Bio Zhi Pin Co., Ltd. romanized; Ji Nuo Wei (Hebei) Bio Technology Co., Ltd. romanized; Changchun Hai Ji Ya Bio Technology Co., Ltd. romanized
2026/01/14New drug · Class 1 FKC289注射液 · No verified English nameCXSL2600079 Fu Xing Kai Rui (Shanghai) Bio Technology Co., Ltd. romanized
2026/01/14New drug · Class 1.2 RG004注射液 · No verified English nameCXSL2600078 Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized
2026/01/14New drug · Class 1 注射用KHN922 · No verified English nameCXSL2600077 Chengdu Kang Hong Bio Technology Co., Ltd. romanized
2026/01/14New drug · Class 1 SCTB41注射液 · No verified English nameCXSL2600076 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/01/14New drug · Class 1 注射用LY4170156 · No verified English nameCXSL2600075 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/01/14New drug · Class 2.2; 2.4 烟酰胺腺嘌呤二核苷酸片 · No verified English nameCXHL2600070 Kang Nuo Biopharmaceutical Co., Ltd. romanized
2026/01/13Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2600163 Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2026/01/13Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2600162 Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2026/01/13Generic · Class 3 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2600155 Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2026/01/13Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2600153 Henan Shuang He Hua Li Pharma Co., Ltd. romanized
2026/01/13Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2600152 Henan Shuang He Hua Li Pharma Co., Ltd. romanized
2026/01/13Generic · Class 3 Acetylcysteine TabletsCYHS2600151 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized
2026/01/13Generic · Class 3 Brivaracetam TabletsCYHS2600146 Chengdu Ao Bang Pharma Co., Ltd. romanized
2026/01/13Generic · Class 3 Brivaracetam TabletsCYHS2600145 Chengdu Ao Bang Pharma Co., Ltd. romanized
2026/01/13Generic · Class 3 Brimonidine Tartrate Eye DropsCYHL2600009 Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized
2026/01/13Generic · Class 3 Brimonidine Tartrate Eye DropsCYHL2600008 Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized
2026/01/13Generic · Class 3 Ulipristal Acetate TabletsCYHL2600007 Hangzhou Tian Cheng Tai Feng Pharma Co., Ltd. romanized

147 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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