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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 389 drug applications between 1 August 2025 and 7 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 74 drug names.

2025/08/01 – 2025/08/07

Period
2025/08/01 to 2025/08/07, 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
389
Drugs with new generic filings (by drug name, de-duplicated)
74
Accepted this week, now under review
96

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

389filings, 99 of them generic

By application type

Application typeFilings
Supplement178
Generic99
New drug73
Import re-registration23
Import13
Unspecified3

By drug type

Drug typeFilings
Chemical drug235
TCM89
Therapeutic biologic61
Prophylactic biologic3
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

74 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets4270
2Cefditoren Pivoxil Granules3218
3Dapagliflozin Tablets3284
4Finerenone Tablets3269
5Levetiracetam Tablets316
6Acetylcysteine Injection2253
7Trazodone Hydrochloride Sustained-release Tablets2220
8Bromhexine Hydrochloride Oral Solution2222
9Glucosamine Sulfate Capsules2251
10Tacrolimus Ointment216

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

237 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Kelun Pharmaceutical Co., Ltd.1230
2Shanxi Hua Kang Pharma Co., Ltd. romanized1190
3Novo Nordisk A/S620
4AstraZeneca UK Limited610
5Bayer Inc.610
6Guizhou Hao Cheng Pharma Co., Ltd. romanized550
7Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized550
8Shanghai Shuo Di Bio Technology Co., Ltd. romanized510
9Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized440
10Shi Yao Group Ju Shi Biopharmaceutical 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

107 this week

AcceptedDrugApplicants
2025/08/07Import · Class 1 ALXN1920注射液 · No verified English nameJXSL2500142 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/07Import · Class 1 MK-1084片 · No verified English nameJXHL2500209 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/08/07Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2502856 Qian Hai Shi De Tang (He Bi) Pharmaceutical Co., Ltd. romanized
2025/08/07Generic · Class 3 氢溴酸加兰他敏口服溶液(Ⅱ) · No verified English nameCYHS2502854 Hubei Min Kang Pharmaceutical Co., Ltd. romanized
2025/08/07New drug · Class 1.1 川芎定痛颗粒 · No verified English nameCXZL2500064 Beijing Yang Guang He He Zhong Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/08/07New drug · Class 2.2 20价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2500667 Ai Mei Tan Suo Zhe Sheng Ming Ke Xue Research and Development Co., Ltd. romanized; Ai Mei Jian Chi Biopharmaceutical Co., Ltd. romanized; Ai Mei Ze Ren Biopharmaceutical (Liaoning) Co., Ltd. romanized; Ai Mei Yi Miao Co., Ltd. romanized
2025/08/07New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2500666 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2025/08/07New drug · Class 1 异体自然杀伤(NK)细胞注射液 · No verified English nameCXSL2500665 Suzhou Mai De Tong Pharmaceuticals Technology Co., Ltd. romanized
2025/08/07New drug · Class 1 异体自然杀伤(NK)细胞注射液 · No verified English nameCXSL2500664 Suzhou Mai De Tong Pharmaceuticals Technology Co., Ltd. romanized
2025/08/07New drug · Class 1 异体自然杀伤(NK)细胞注射液 · No verified English nameCXSL2500663 Suzhou Mai De Tong Pharmaceuticals Technology Co., Ltd. romanized
2025/08/07New drug · Class 1 HM2002注射液 · No verified English nameCXSL2500662 Shanghai Huan Ma Biopharmaceuticals Co., Ltd. romanized
2025/08/07New drug · Class 1 注射用TQB3142 · No verified English nameCXHL2500819 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/08/07New drug · Class 1 HECN30227注射液 · No verified English nameCXHL2500818 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2025/08/07New drug · Class 1 ZN-F-6418胶囊 · No verified English nameCXHL2500817 Suzhou Zan Rong Pharmaceuticals Technology Co., Ltd. romanized
2025/08/07New drug · Class 1 ZN-F-6418胶囊 · No verified English nameCXHL2500816 Suzhou Zan Rong Pharmaceuticals Technology Co., Ltd. romanized
2025/08/06Import · Class 1 BAY 3401016 注射液 · No verified English nameJXSL2500141 Bayer AG; Bayer Healthcare Company Ltd.
2025/08/06Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2502844 Guangdong Nan Guo Pharma Co., Ltd. romanized
2025/08/06Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2502839 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.; Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized
2025/08/06Generic · Class 3 Piracetam InjectionCYHS2502825 Hua Zhong Pharma Co., Ltd. romanized
2025/08/06Generic · Class 3 Piracetam InjectionCYHS2502824 Hua Zhong Pharma Co., Ltd. romanized
2025/08/06New drug · Class 3.1 清肺汤颗粒 · No verified English nameCXZS2500032 Jiangxi Yao Dou Zhang Shu Pharmaceutical Co., Ltd. romanized
2025/08/06New drug · Class 1.1 黄葶肺心平颗粒 · No verified English nameCXZL2500063 Chongqing Xi Er An Pharma Co., Ltd. romanized
2025/08/06New drug · Class 3.4 破伤风人免疫球蛋白 · No verified English nameCXSS2500078 Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized
2025/08/06New drug · Class 1 注射用间充质干细胞(脐带) · No verified English nameCXSL2500661 Tianjin Ang Sai Xi Bao Ji Yin Gong Cheng Co., Ltd. romanized
2025/08/06New drug · Class 1 IBI3026 · No verified English nameCXSL2500660 Xin Da Bio Technology Co., Ltd. romanized
2025/08/06New drug · Class 2.4 瑞维鲁胺片 · No verified English nameCXHL2500815 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/06New drug · Class 1 IPG7236片 · No verified English nameCXHL2500814 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2025/08/06New drug · Class 1 IPG7236片 · No verified English nameCXHL2500813 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2025/08/05Import · Class 2.2 Lebrikizumab注射液 · No verified English nameJXSL2500140 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/05Import · Class 1 AZD0486 · No verified English nameJXSL2500139 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.

77 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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