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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 362 drug applications between 3 November 2025 and 9 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 46 drug names.

2025/11/03 – 2025/11/09

Period
2025/11/03 to 2025/11/09, 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
362
Drugs with new generic filings (by drug name, de-duplicated)
46
Accepted this week, now under review
85

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

362filings, 61 of them generic

By application type

Application typeFilings
Supplement193
Generic61
New drug49
Import23
Import re-registration19
Unspecified17

By drug type

Drug typeFilings
Chemical drug198
TCM88
Therapeutic biologic62
Biologic11
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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Finerenone Tablets3269
2氟比洛芬凝胶贴膏 · No verified English name2216
3利伐沙班干混悬剂 · No verified English name212
4Carboplatin Injection2110
5Cefditoren Pivoxil Granules2118
6Vonoprazan Fumarate Tablets2160
7Lamotrigine Dispersible Tablets212
8氯化钾氯化钠注射液 · No verified English name214
9注射用头孢曲松钠/氯化钠注射液 · No verified English name213
10Dapoxetine Hydrochloride Tablets2120

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

220 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S820
2Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized770
3Jiangsu Hao Sen Pharma Group Co., Ltd. romanized620
4Bao Long Pharma Co., Ltd. romanized550
5Chongqing Ke Rui Nan Hai Pharmaceutical Co., Ltd. romanized550
6Eisai Co. Ltd.510
7Sanofi-Aventis Recherche & Développement440
8Merck Sharp & Dohme LLC420
9Sanofi Winthrop Industrie420
10Shanghai He Huang Pharma Co., Ltd. romanized420

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

90 this week

AcceptedDrugApplicants
2025/11/08Import · Class 1 ABBV-706注射用冻干粉 · No verified English nameJXSL2500213 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/11/08Import · Class 1 CID-103注射液 · No verified English nameJXSL2500212 CASI Pharmaceuticals Inc.; CASI Pharmaceuticals (China) Co. Ltd.
2025/11/08Import · Class 1 Frexalimab注射液 · No verified English nameJXSL2500211 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/11/08Generic · Class 3 Mesalazine Sustained-release GranulesCYHS2503907 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2025/11/08Generic · Class 3 Mesalazine Sustained-release GranulesCYHS2503906 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2025/11/08New drug · Class 1 SHR-1049注射液 · No verified English nameCXSL2500956 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/11/08New drug · Class 3.3 度普利尤单抗注射液 · No verified English nameCXSL2500955 Jiangsu Jing Xing Pharmaceuticals Technology Co., Ltd. romanized
2025/11/08New drug · Class 1 IBI343 · No verified English nameCXSL2500954 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/11/08New drug · Class 3.3 KH816注射液 · No verified English nameCXSL2500953 Chengdu Kang Hong Bio Technology Co., Ltd. romanized
2025/11/08New drug · Class 1 OB756片 · No verified English nameCXHL2501223 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2025/11/07Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500218 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/11/07Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500217 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/11/07Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500216 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/11/07Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500215 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/11/07Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500214 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/11/07Import · Class 2.4 左炔诺孕酮宫内释放系统 · No verified English nameJXHL2500344 Bayer Yakuhin Ltd.
2025/11/07Generic · Class 3 盐酸昂丹司琼口服溶液 · No verified English nameCYHS2503895 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized
2025/11/07Generic · Class 3 Delafloxacin for InjectionCYHL2500197 Chengdu Ming De Zhi Yuan Pharmaceuticals Technology Co., Ltd. romanized
2025/11/07New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500122 Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized
2025/11/07New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500121 Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized
2025/11/07New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500120 Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized
2025/11/07New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500119 Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized
2025/11/07New drug · Class 1 注射用重组酰化胰高血糖素样肽2类似物 · No verified English nameCXSL2500952 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2025/11/07New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500951 Hangzhou Yi Wen Sai Bio Technology Co., Ltd. romanized
2025/11/07New drug · Class 1 注射用YKYY031 · No verified English nameCXSL2500950 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized
2025/11/07New drug · Class 1 IPG11406片 · No verified English nameCXHL2501222 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/07New drug · Class 1 IPG11406片 · No verified English nameCXHL2501221 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/07New drug · Class 1 IPG11406片 · No verified English nameCXHL2501220 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/07New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2501219 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Chengdu Wei Xin Pharma Co., Ltd. romanized
2025/11/07New drug · Class 1 镥[177Lu]JH040182注射液 · No verified English nameCXHL2501218 Jing He Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized

60 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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