YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 361 drug applications between 5 November 2025 and 11 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 49 drug names.

2025/11/05 – 2025/11/11

Period
2025/11/05 to 2025/11/11, 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
361
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
90

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

361filings, 66 of them generic

By application type

Application typeFilings
Supplement182
Generic66
New drug53
Import29
Import re-registration21
Unspecified10

By drug type

Drug typeFilings
Chemical drug214
TCM81
Therapeutic biologic58
Prophylactic biologic5
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

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cefditoren Pivoxil Granules4218
2Finerenone Tablets3269
3氟比洛芬凝胶贴膏 · No verified English name2216
4利伐沙班干混悬剂 · No verified English name212
5Carboplatin Injection2110
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

219 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized770
2Bracco Imaging S.P.A.610
3Bayer AG540
4Takeda Development Center Americas Inc.520
5Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized520
6Eisai Co. Ltd.510
7Novo Nordisk A/S510
8Sanofi-Aventis Recherche & Développement440
9Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized440
10Chongqing Ke Rui Nan Hai Pharmaceutical Co., Ltd. romanized440

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

101 this week

AcceptedDrugApplicants
2025/11/11Import · Class 1 注射用BAY 3547922 · No verified English nameJXSL2500220 Bayer AG; Bayer Healthcare Company Ltd.
2025/11/11Import · Class 1 BAY 3547926 注射液 · No verified English nameJXSL2500219 Bayer AG; Bayer Healthcare Company Ltd.
2025/11/11Import · Class 1 PF-08049820水合物片 · No verified English nameJXHL2500349 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2025/11/11Import · Class 1 PF-08049820水合物片 · No verified English nameJXHL2500348 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2025/11/11Import · Class 1 Zasocitinib (TAK-279) 片 · No verified English nameJXHL2500347 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2025/11/11Import · Class 1 Zasocitinib (TAK-279) 片 · No verified English nameJXHL2500346 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2025/11/11Import · Class 1 Zasocitinib(TAK-279)片 · No verified English nameJXHL2500345 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2025/11/11Generic · Class 3 Bifonazole SolutionCYHS2503921 Guo Ming Pharmaceutical (Hainan) Co., Ltd. romanized; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized
2025/11/11Generic · Class 3 复方电解质注射液(V) · No verified English nameCYHS2503918 Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/11/11Generic · Class 3 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2503916 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/11/11Generic · Class 3 青霉胺胶囊 · No verified English nameCYHS2503913 Shanghai Shang Yao Rui Er Medicines Co., Ltd. romanized; Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized
2025/11/11Generic · Class 3 Esflurbiprofen PatchesCYHL2500198 Sichuan Kelun Pharmaceutical Co., Ltd.
2025/11/11New drug · Class 2.3 天丹通络片 · No verified English nameCXZL2500109 Shandong Feng Huang Pharmaceutical Co., Ltd. romanized
2025/11/11New drug · Class 3.3 帕妥珠单抗注射液 · No verified English nameCXSS2500123 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/11/11New drug · Class 1 注射用DB-1317 · No verified English nameCXSL2500963 Ying En Bio Technology (Shanghai) Co., Ltd. romanized
2025/11/11New drug · Class 2.2 冻干水痘灭活疫苗 · No verified English nameCXSL2500962 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2025/11/11New drug · Class 1.2 带状疱疹mRNA疫苗 · No verified English nameCXSL2500961 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2025/11/11New drug · Class 1 注射用ZG005 · No verified English nameCXSL2500960 Name not romanized; Name not romanized
2025/11/11New drug · Class 1 注射用ZGGS18 · No verified English nameCXSL2500959 Name not romanized; Name not romanized
2025/11/11New drug · Class 1 SENL103自体T细胞注射液 · No verified English nameCXSL2500958 Hebei Sen Lang Bio Technology Co., Ltd. romanized
2025/11/11New drug · Class 2.2; 2.4 LT001 · No verified English nameCXHL2501235 Guangdong Li Tai Pharmaceutical Co., Ltd. romanized
2025/11/11New drug · Class 1 JYP0015片 · No verified English nameCXHL2501228 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2025/11/11New drug · Class 1 JYP0015片 · No verified English nameCXHL2501227 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2025/11/11New drug · Class 1 JYP0015片 · No verified English nameCXHL2501226 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2025/11/11New drug · Class 1 RA1115-B1滴眼液 · No verified English nameCXHL2501225 Suzhou Rui Ming Xin Yao Research and Development Co., Ltd. romanized
2025/11/11New drug · Class 1 RA1115-B1滴眼液 · No verified English nameCXHL2501224 Suzhou Rui Ming Xin Yao Research and Development Co., Ltd. romanized
2025/11/10New drug · Class 1 SPGL008注射液 · No verified English nameCXSL2500957 Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized
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.

71 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.