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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 301 drug applications between 20 October 2025 and 26 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 45 drug names.

2025/10/20 – 2025/10/26

Period
2025/10/20 to 2025/10/26, 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
301
Drugs with new generic filings (by drug name, de-duplicated)
45
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

301filings, 58 of them generic

By application type

Application typeFilings
Supplement170
Generic58
New drug51
Import11
Import re-registration8
Unspecified3

By drug type

Drug typeFilings
Chemical drug206
TCM59
Therapeutic biologic33
Prophylactic biologic2
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

45 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapagliflozin Tablets3284
2Glucosamine Sulfate Capsules2251
3Clindamycin Injection214
4Cefditoren Pivoxil Granules2118
5Levothyroxine Sodium Tablets2112
6Imipenem and Cilastatin Sodium for Injection216
7注射用托伐普坦磷酸钠 · No verified English name2115
8Fosfomycin Sodium For Injection2116
9Safinamide Methansulfonate Tablets2120
10Promethazine Hydrochloride Injection2111

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

172 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized14140
2Xinjiang Hua Shi Dan Pharma Co., Ltd. romanized1210
3Jiangsu Si Jia Wei Kang Pharmaceuticals Technology Co., Ltd. romanized910
4Qilu Pharmaceutical (Hainan) Co., Ltd830
5Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized760
6Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized660
7Boehringer Ingelheim International GmbH520
8Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized440
9Tong Hua Si Wei Pharma Co., Ltd. romanized440
10Pfizer Europe MA EEIG410

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

84 this week

AcceptedDrugApplicants
2025/10/24Import · Class 2.4 伊那利塞片 · No verified English nameJXHL2500327 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/10/24Import · Class 2.4 伊那利塞片 · No verified English nameJXHL2500326 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/10/24Import · Class 1 Nucresiran注射液 · No verified English nameJXHL2500325 Alnylam Pharmaceuticals Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2025/10/24Import · Class 1 TAK-279胶囊 · No verified English nameJXHL2500324 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2025/10/24Import · Class 1 TAK-279胶囊 · No verified English nameJXHL2500323 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2025/10/24Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2503795 Jiangsu Deyuan Pharmaceutical Co.,Ltd.
2025/10/24Generic · Class 3 Olopatadine Hydrochloride GranulesCYHS2503792 Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized
2025/10/24Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2503790 Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/10/24Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2503789 Hebei Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized; Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanized
2025/10/24Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2503788 Hebei Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized; Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanized
2025/10/24New drug · Class 1 B023细胞注射液 · No verified English nameCXSL2500924 Shanghai Pharmaceuticals Group Bio Zhi Liao Technology Co., Ltd. romanized
2025/10/24New drug · Class 1 注射用MK-1045 · No verified English nameCXSL2500923 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2025/10/24New drug · Class 1 注射用MK-1045 · No verified English nameCXSL2500922 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2025/10/24New drug · Class 1 SV-1993 胶囊 · No verified English nameCXHL2501166 Beijing Sen Miao Bio Technology Co., Ltd. romanized
2025/10/24New drug · Class 1 SV-1993 胶囊 · No verified English nameCXHL2501165 Beijing Sen Miao Bio Technology Co., Ltd. romanized
2025/10/23Import · Class 1 BI764198 片 · No verified English nameJXHL2500328 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/10/23Import · Class 1 Balinatunfib · No verified English nameJXHL2500322 Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2025/10/23Import · Class 1 Balinatunfib · No verified English nameJXHL2500321 Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2025/10/23Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2503777 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2025/10/23Generic · Class 3 Oxytocin InjectionCYHS2503776 Wuhan Ren Fu Pharma Co., Ltd. romanized
2025/10/23Generic · Class 3 Oxytocin InjectionCYHS2503775 Wuhan Ren Fu Pharma Co., Ltd. romanized
2025/10/23Generic · Class 3 Clindamycin InjectionCYHS2503768 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2025/10/23Generic · Class 3 Clindamycin InjectionCYHS2503767 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2025/10/23Generic · Class 3 利非司特滴眼液 · No verified English nameCYHL2500190 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2025/10/23New drug · Class 1 注射用QLS2313 · No verified English nameCXSL2500921 Qilu Pharmaceutical Co., Ltd.
2025/10/23New drug · Class 1.2 RSV mRNA疫苗(JCXH-108注射液) · No verified English nameCXSL2500920 Jia Chen Xi Hai (Hangzhou) Bio Technology Co., Ltd. romanized
2025/10/23New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500919 Jiangsu Sai Yi Bio Technology Co., Ltd. romanized
2025/10/23New drug · Class 2.2 复方α-酮酸颗粒 · No verified English nameCXHS2500128 Beijing Fei Sen You Si Ka Bi Pharmaceuticals Co., Ltd. romanized
2025/10/23New drug · Class 1 HS-10365胶囊 · No verified English nameCXHS2500127 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2025/10/23New drug · Class 1 注射用RAB001 · No verified English nameCXHL2501164 Zhong Shan Lai Bo Rui Chen Biopharmaceuticals Co., Ltd. romanized

54 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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