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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 422 drug applications between 12 December 2024 and 18 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 111, covering 87 drug names.

2024/12/12 – 2024/12/18

Period
2024/12/12 to 2024/12/18, 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
422
Drugs with new generic filings (by drug name, de-duplicated)
87
Accepted this week, now under review
4

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

422filings, 111 of them generic

By application type

Application typeFilings
Supplement190
Generic111
New drug81
Import27
Unspecified7
Import re-registration6

By drug type

Drug typeFilings
Chemical drug272
TCM87
Therapeutic biologic53
Biologic5
Prophylactic biologic5

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

87 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride Oral Solution5146
2Nafamostat Mesilate for Injection4338
3醋酸兰瑞肽缓释注射液(预充式) · No verified English name310
4阿贝西利片 · No verified English name312
5Fusidic Acid Cream2215
6氟比洛芬凝胶贴膏 · No verified English name2216
7Rosuvastatin Calcium and Ezetimibe Tablets (I)229
8利伐沙班口崩片 · No verified English name214
9布比卡因脂质体注射液 · No verified English name217
10Metformin Hydrochloride And Empagliflozin Extended Release Tablets2112

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

269 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized12100
2Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized920
3Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized660
4Novo Nordisk A/S620
5Jiangsu Hao Sen Pharma Group Co., Ltd. romanized610
6Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized550
7Hainan Si Da Pharmaceutical Co., Ltd. romanized515
8Jiangxi Cheng Zhi Yong Feng Pharma Co., Ltd. romanized440
9Shijiazhuang No.4 Pharmaceutical Co., Ltd.443
10Fu Yuan Pharma Co., Ltd. romanized441

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

147 this week

AcceptedDrugApplicants
2024/12/18Import · Class 1 AZD4360 · No verified English nameJXSL2400241 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/12/18Import · Class 2.4 硫酸瑞美吉泮口崩片 · No verified English nameJXHL2400296 Pfizer Inc.; Pfizer Investment CO. Ltd.
2024/12/18Import · Class 1 KFA115 · No verified English nameJXHL2400295 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/12/18Import · Class 1 KFA115 · No verified English nameJXHL2400294 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/12/18Import · Class 1 KFA115 · No verified English nameJXHL2400293 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/12/18Import · Class 1 KFA115 · No verified English nameJXHL2400292 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/12/18Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2404400 Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized
2024/12/18Generic · Class 3 Ursodeoxycholic Acid TabletsCYHS2404398 Zhong Shan Bai Ling Bio Technology Co., Ltd. romanized; An Shi Pharmaceutical (Zhong Shan) Co., Ltd. romanized
2024/12/18Generic · Class 3 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2404396 Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/12/18Generic · Class 3 Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2404392 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2024/12/18Generic · Class 3 聚乙二醇4000散(儿童型) · No verified English nameCYHS2404390 Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized
2024/12/18Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2404387 Hubei Jin Yao Pharma Co., Ltd. romanized
2024/12/18New drug · Class 1.1 仁术健胃颗粒 · No verified English nameCXZS2400037 Nanjing Zhong Shan Pharmaceutical Co., Ltd. romanized
2024/12/18New drug · Class 1.2 白头翁皂苷B4 · No verified English nameCXZL2400093 Jiangxi Zhong Pharmaceuticals University romanized; Guangxi Xin Hai Pharma Technology Co., Ltd. romanized
2024/12/18New drug · Class 1.2 白头翁皂苷B4栓 · No verified English nameCXZL2400092 Jiangxi Zhong Pharmaceuticals University romanized; Guangxi Xin Hai Pharma Technology Co., Ltd. romanized
2024/12/18New drug · Class 1 MWN105注射液 · No verified English nameCXSL2400879 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2024/12/18New drug · Class 1 注射用PCNAT-01 · No verified English nameCXSL2400878 An Da Bio Drug Kai Fa (Shenzhen) Co., Ltd. romanized
2024/12/17Import · Class 1 SAR402663注射液 · No verified English nameJXSL2400240 Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD
2024/12/17Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2404385 Hubei Xin Ze Fei Pharma Co., Ltd. romanized
2024/12/17Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2404384 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/12/17Generic · Class 3 Trimebutine Maleate TabletsCYHS2404381 Zhejiang Nord Pharmaceutical Co., Ltd
2024/12/17Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2404375 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/12/17Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2404373 Shandong Li Nuo Pharmaceutical Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized
2024/12/17Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2404372 Shandong Li Nuo Pharmaceutical Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized
2024/12/17Generic · Class 3 Sodium Thiosulfate InjectionCYHS2404371 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2024/12/17Generic · Class 3 Epinephrine InjectionCYHS2404369 Wuhan Jiu An Drug Research Institute Co., Ltd. romanized; Wuhan Jiu An Pharma Co., Ltd. romanized
2024/12/17Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2404368 Hubei Min Kang Pharma Group Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/12/17Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2404367 Hubei Min Kang Pharma Group Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/12/17Generic · Class 3 Oxycodone And Acetaminophen TabletsCYHS2404364 Beijing Hua Su Pharmaceutical Co., Ltd. romanized
2024/12/17Generic · Class 3 Terlipressin Acetate InjectionCYHS2404363 Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized

117 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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