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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 361 drug applications between 7 November 2024 and 13 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 82 drug names.

2024/11/07 – 2024/11/13

Period
2024/11/07 to 2024/11/13, 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
361
Drugs with new generic filings (by drug name, de-duplicated)
82
Accepted this week, now under review
9

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

361filings, 119 of them generic

By application type

Application typeFilings
Supplement157
Generic119
New drug59
Import11
Import re-registration10
Unspecified5

By drug type

Drug typeFilings
Chemical drug270
TCM44
Therapeutic biologic36
Prophylactic biologic9
In vitro diagnostic reagent1
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

82 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Fluoxetine Hydrochloride Oral Solution410
3Nicergoline Tablets321
4Crisaborole Ointment2226
5Dydrogesterone Tablets228
6Sodium sulfate, magnesium sulfate, and potassium chloride Tablets222
7Formoterol Fumarate Inhalation Solution225
8Bisoprolol Fumarate and Amlodipine Besylate Tablets229
9Isavuconazonium Sulfate for Injection2215
10Moxifloxacin Hydrochloride Tablets2211

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

224 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized14130
2Qilu Pharmaceutical Co., Ltd.742
3Chengdu Di Kang Pharma Co., Ltd. romanized550
4SANOFI WINTHROP INDUSTRIE530
5Guangdong Sunho Pharmaceutical Co., Ltd.530
6Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized520
7Jiangsu Hao Sen Pharma Group Co., Ltd. romanized520
8Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized430
9Jiangxi Shimei Pharmaceutical Co., Ltd424
10Changchun Jin Sai Pharma Co., Ltd. romanized420

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

113 this week

AcceptedDrugApplicants
2024/11/13Generic · Class 3 Fluoxetine Hydrochloride Oral SolutionCYHS2403883 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/11/13Generic · Class 3 Fluoxetine Hydrochloride Oral SolutionCYHS2403882 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/11/13Generic · Class 3 Fluoxetine Hydrochloride Oral SolutionCYHS2403881 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/11/13Generic · Class 3 Fluoxetine Hydrochloride Oral SolutionCYHS2403880 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/11/13Generic · Class 3 复方维生素C聚乙二醇(3350)钠钾散 · No verified English nameCYHS2403878 Hubei Lai Kang Medical Technology Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanized
2024/11/13Generic · Class 3 达普司他片 · No verified English nameCYHL2400222 Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized
2024/11/13Generic · Class 3 Tartilelin TabletsCYHL2400221 Jiangsu Du Rui Pharmaceutical Co., Ltd. romanized
2024/11/13New drug · Class 1 注射用维拉苷酶β · No verified English nameCXSS2400119 Bei Hai Kang Cheng (Shanghai) Bio Technology Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized
2024/11/13New drug · Class 3.3 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSL2400772 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/11/13New drug · Class 1 HBM9378(SKB378)注射液 · No verified English nameCXSL2400771 He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized; Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2024/11/13New drug · Class 1 AZD0022 · No verified English nameCXHL2401229 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2024/11/13New drug · Class 1 AZD0022 · No verified English nameCXHL2401228 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2024/11/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400219 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/11/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400218 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/11/12Generic · Class 3 Famotidine InjectionCYHS2403872 Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized
2024/11/12Generic · Class 3 Paracetamol and Caffeine TabletsCYHS2403871 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2024/11/12Generic · Class 3 Potassium Chloride Oral SolutionCYHS2403868 Henan Hua Luo Kang Run Pharma Co., Ltd. romanized
2024/11/12Generic · Class 3 Cilnidipine TabletsCYHS2403862 Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/11/12Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2403861 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/11/12Generic · Class 3 Aceclofenac TabletsCYHS2403858 Guangdong Mai Heng Pharmaceuticals Research and Development Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/11/12Generic · Class 3 Acetylcysteine TabletsCYHS2403857 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2024/11/12Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2403856 Anhui Shuang He Pharma Co., Ltd. romanized
2024/11/12Generic · Class 3 Potassium Aspartate And Magnesium Aspartate InjectionCYHS2403855 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2024/11/12Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHL2400220 Jiangxi Shimei Pharmaceutical Co., Ltd
2024/11/12Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHL2400219 Jiangxi Shimei Pharmaceutical Co., Ltd
2024/11/12Generic · Class 3 Cyclobenzaprine hydrochloride extended-release capsulesCYHL2400218 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2024/11/12Generic · Class 3 Cyclobenzaprine hydrochloride extended-release capsulesCYHL2400217 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2024/11/12New drug · Class 1 注射用聚乙二醇化促血小板生成肽 · No verified English nameCXSL2400770 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2024/11/12New 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 nameCXSL2400769 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2024/11/12New drug · Class 1 IBI3014 · No verified English nameCXSL2400768 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized

83 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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