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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 429 drug applications between 11 December 2024 and 17 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 117, covering 90 drug names.

2024/12/11 – 2024/12/17

Period
2024/12/11 to 2024/12/17, 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
429
Drugs with new generic filings (by drug name, de-duplicated)
90
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

429filings, 117 of them generic

By application type

Application typeFilings
Supplement181
Generic117
New drug98
Import21
Unspecified7
Import re-registration5

By drug type

Drug typeFilings
Chemical drug289
TCM71
Therapeutic biologic54
Prophylactic biologic10
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

90 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets6360
2Ambroxol Hydrochloride Oral Solution5146
3Nafamostat Mesilate for Injection4338
4醋酸兰瑞肽缓释注射液(预充式) · No verified English name310
5氟比洛芬凝胶贴膏 · No verified English name2216
6Rosuvastatin Calcium and Ezetimibe Tablets (I)229
7利伐沙班口崩片 · No verified English name214
8Diclofenac Diethylamine Emulgel2120
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

274 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized990
2Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized920
3Jiangsu Hao Sen Pharma Group Co., Ltd. romanized920
4Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized860
5Novo Nordisk A/S620
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

157 this week

AcceptedDrugApplicants
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
2024/12/17Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2400262 Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/17Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2400261 Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/17New drug · Class 1.1 散热止咳颗粒 · No verified English nameCXZL2400091 Xin Qi Kang Pharma Co., Ltd. romanized; Xinjiang Qi Mu Pharmaceuticals Research Institute (Co., Ltd.) romanized
2024/12/17New drug · Class 1 伊诺格鲁肽注射液 · No verified English nameCXSS2400141 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized; Mei Yao Xing (Nanjing) Pharmaceutical Co., Ltd. romanized
2024/12/17New drug · Class 1 伊诺格鲁肽注射液 · No verified English nameCXSS2400140 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized; Mei Yao Xing (Nanjing) Pharmaceutical Co., Ltd. romanized
2024/12/17New drug · Class 1 注射用BGB-C354 · No verified English nameCXSL2400877 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2024/12/17New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2400876 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2024/12/17New drug · Class 1 LP-003 注射液 · No verified English nameCXSL2400875 Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2024/12/17New drug · Class 3.3 水痘减毒活疫苗 · No verified English nameCXSL2400874 Zhejiang Tian Yuan Bio Pharma Co., Ltd. romanized
2024/12/17New drug · Class 1 SYS6002 · No verified English nameCXSL2400873 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/12/17New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2400872 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/12/17New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2400871 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/12/17New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2400870 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/12/17New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2400869 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/12/17New drug · Class 1 BIOT006片 · No verified English nameCXHL2401397 Xiamen Bao Tai Bio Technology Co., Ltd. romanized
2024/12/17New drug · Class 1 BIOT006片 · No verified English nameCXHL2401396 Xiamen Bao Tai Bio Technology Co., Ltd. romanized
2024/12/17New drug · Class 1 HW201877胶囊 · No verified English nameCXHL2401395 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized

127 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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