YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 393 drug applications between 31 July 2025 and 6 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 72 drug names.

2025/07/31 – 2025/08/06

Period
2025/07/31 to 2025/08/06, 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
393
Drugs with new generic filings (by drug name, de-duplicated)
72
Accepted this week, now under review
91

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

393filings, 99 of them generic

By application type

Application typeFilings
Supplement184
Generic99
New drug71
Import re-registration22
Import14
Unspecified3

By drug type

Drug typeFilings
Chemical drug233
TCM98
Therapeutic biologic59
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

72 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets6370
2Cefditoren Pivoxil Granules3218
3Dapagliflozin Tablets3284
4Finerenone Tablets3269
5Levetiracetam Tablets316
6Acetylcysteine Injection2253
7头孢克肟干混悬剂 · No verified English name223
8Trazodone Hydrochloride Sustained-release Tablets2220
9Bromhexine Hydrochloride Oral Solution2222
10Glucosamine Sulfate Capsules2251

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

234 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Kelun Pharmaceutical Co., Ltd.1230
2Shanxi Hua Kang Pharma Co., Ltd. romanized1080
3Qilu Pharmaceutical Co., Ltd.741
4Novo Nordisk A/S620
5AstraZeneca UK Limited610
6Bayer Inc.610
7Guizhou Hao Cheng Pharma Co., Ltd. romanized550
8Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized550
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized540
10Shanghai Shuo Di Bio Technology Co., Ltd. romanized510

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
2025/08/06Import · 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.
2025/08/05Import · Class 1 AZD0486 · No verified English nameJXSL2500138 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/05Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2502823 CISEN PHARMACEUTICAL CO., LTD.
2025/08/05Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2502821 Hebei Rui Jian Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2025/08/05Generic · Class 3 异丙托溴铵沙丁胺醇吸入喷雾剂 · No verified English nameCYHS2502820 Nanchang Gu Sen Biopharmaceutical Co., Ltd. romanized
2025/08/05Generic · Class 3 Ebastine Oral SolutionCYHS2502814 Chongqing Xi Er An Pharma Co., Ltd. romanized
2025/08/05Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2502813 Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Jiangxi He Ying Pharma Co., Ltd. romanized
2025/08/05New drug · Class 2.3 小儿肺热咳喘口服液 · No verified English nameCXZL2500062 Heilongjiang Kui Hua Pharma Co., Ltd. romanized
2025/08/05New drug · Class 1 QLS2309注射液 · No verified English nameCXSL2500659 Qilu Pharmaceutical Co., Ltd.
2025/08/05New drug · Class 1 SYS6010 · No verified English nameCXSL2500658 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/08/05New drug · Class 1 IBI3009 · No verified English nameCXSL2500657 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/08/05New drug · Class 1 SYS6043 · No verified English nameCXSL2500656 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/08/05New drug · Class 1 DP303c注射液 · No verified English nameCXSL2500655 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/08/05New drug · Class 1 SYS6002 · No verified English nameCXSL2500654 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/08/05New drug · Class 3.3 精蛋白人胰岛素混合注射液(30R) · No verified English nameCXSL2500653 Heng Jing He Chuang Biopharmaceuticals (Zhejiang) Co., Ltd. romanized
2025/08/05New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2500091 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL 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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