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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 353 drug applications between 31 October 2025 and 6 November 2025 (data as of 14 November 2026 06:00). Of these, generic applications numbered 61, covering 52 drug names.

2025/10/31 – 2025/11/06

Period
2025/10/31 to 2025/11/06, 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
353
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
87

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

353filings, 61 of them generic

By application type

Application typeFilings
Supplement200
Generic61
New drug42
Import re-registration18
Import17
Unspecified15

By drug type

Drug typeFilings
Chemical drug210
TCM94
Therapeutic biologic35
Biologic10
Prophylactic biologic4

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
1Cefditoren Pivoxil Granules2118
2Vonoprazan Fumarate Tablets2158
3氯化钾氯化钠注射液 · No verified English name214
4注射用头孢曲松钠/氯化钠注射液 · No verified English name213
5Dapoxetine Hydrochloride Tablets2120
6Minoxidil Liniment2152
7苯磺酸氨氯地平口崩片 · No verified English name212
8Sitagliptin and Metformin Hydrochloride Extended-release Tablets2112
9Dapagliflozin Tablets2184
10Scopolamine Butylbromide Injection117

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

225 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Hao Sen Pharma Group Co., Ltd. romanized620
2Bao Long Pharma Co., Ltd. romanized550
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized550
4Bayer Vital GmbH520
5Eisai Co. Ltd.510
6Chongqing Ke Rui Nan Hai Pharmaceutical Co., Ltd. romanized440
7Sanofi Winthrop Industrie420
8Shanghai He Huang Pharma Co., Ltd. romanized420
9Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized420
10Biogen Netherlands B.V.410

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

81 this week

AcceptedDrugApplicants
2025/11/06Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2500138 Merck Sharp & Dohme LLC; 1. MSD Ireland (Carlow); 2. Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/11/06Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2500137 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd.
2025/11/06Import · Class 1 AZD5492 · No verified English nameJXSL2500210 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/11/06Import · Class 1 SAR445399 · No verified English nameJXSL2500209 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/11/06Generic · Class 3 Indobufen TabletsCYHS2503889 Hunan Zheng Qing Pharmaceutical Group Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized
2025/11/06Generic · Class 3 辅酶Q10片 · No verified English nameCYHS2503886 Anhui Tai Du Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/11/06Generic · Class 3 苯磺酸氨氯地平口崩片 · No verified English nameCYHS2503884 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/11/06Generic · Class 3 苯磺酸氨氯地平口崩片 · No verified English nameCYHS2503883 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/11/06Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2503876 Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2025/11/06Generic · Class 3 Ketoprofen PatchesCYHL2500196 Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized
2025/11/06New drug · Class 1.1 车前子片 · No verified English nameCXZL2500108 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized
2025/11/06New drug · Class 1 注射用QL2401 · No verified English nameCXSL2500949 Qilu Pharmaceutical Co., Ltd.
2025/11/06New drug · Class 1 注射用YL205 · No verified English nameCXSL2500948 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2025/11/06New drug · Class 1 SYS6055注射液 · No verified English nameCXSL2500947 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized
2025/11/06New drug · Class 1.2 冻干鼻喷流感减毒活疫苗 · No verified English nameCXSL2500946 Di Fu Run Si (Hefei) Bio Technology Co., Ltd. romanized; Zhejiang Di Fu Run Si Bio Technology Co., Ltd. romanized
2025/11/06New drug · Class 1 RGB-5088胰岛细胞注射液 · No verified English nameCXSL2500945 Hangzhou Rui Pu Chen Chuang Technology Co., Ltd. romanized
2025/11/06New drug · Class 1 HRS-7535片 · No verified English nameCXHL2501216 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/11/06New drug · Class 1 HRS-7535片 · No verified English nameCXHL2501215 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/11/06New drug · Class 1 HRS-7535片 · No verified English nameCXHL2501214 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/11/06New drug · Class 1 HS-10383-B片 · No verified English nameCXHL2501213 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/06New drug · Class 1 HS-10383-B片 · No verified English nameCXHL2501212 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/06New drug · Class 1 HS-10383-B片 · No verified English nameCXHL2501211 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/05Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSS2500136 Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2025/11/05Import · Class 1 BIIB115注射液 · No verified English nameJXHL2500343 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2025/11/05Import · Class 1 E2086 · No verified English nameJXHL2500342 Eisai Co. Ltd.; Eisai China Inc.
2025/11/05Import · Class 1 E2086 · No verified English nameJXHL2500341 Eisai Co. Ltd.; Eisai China Inc.
2025/11/05Import · Class 1 E2086 · No verified English nameJXHL2500340 Eisai Co. Ltd.; Eisai China Inc.
2025/11/05Import · Class 1 E2086 · No verified English nameJXHL2500339 Eisai Co. Ltd.; Eisai China Inc.
2025/11/05Import · Class 1 E2086 · No verified English nameJXHL2500338 Eisai Co. Ltd.; Eisai China Inc.
2025/11/05Import · Class 1 SAR443122 硬胶囊 · No verified English nameJXHL2500337 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.

51 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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