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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 343 drug applications between 6 November 2024 and 12 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 79 drug names.

2024/11/06 – 2024/11/12

Period
2024/11/06 to 2024/11/12, 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
343
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
6

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

343filings, 109 of them generic

By application type

Application typeFilings
Supplement143
Generic109
New drug66
Import10
Import re-registration9
Unspecified6

By drug type

Drug typeFilings
Chemical drug261
TCM40
Therapeutic biologic35
Prophylactic biologic5
Biologic2

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

79 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Nicergoline Tablets321
3Methotrexate Injection3211
4Crisaborole Ointment2226
5Dydrogesterone Tablets228
6Sodium sulfate, magnesium sulfate, and potassium chloride Tablets222
7Moxifloxacin Hydrochloride Tablets2211
8Iguratimod Tablets2223
9Multiple Electrolyte Additive For Injection222
10Piracetam Injection219

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

213 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
3SANOFI WINTHROP INDUSTRIE530
4Guangdong Sunho Pharmaceutical Co., Ltd.530
5Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized520
6Jiangsu Hao Sen Pharma Group Co., Ltd. romanized520
7AstraZeneca AB420
8Jiangxi Shimei Pharmaceutical Co., Ltd424
9Changchun Jin Sai Pharma Co., Ltd. romanized420
10Jiangsu En Hua Pharma Co., Ltd. romanized410

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

121 this week

AcceptedDrugApplicants
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
2024/11/12New drug · Class 1 注射用KY-0301 · No verified English nameCXSL2400767 Ke Yi (Zhejiang) Pharma Technology Co., Ltd. romanized
2024/11/12New drug · Class 1 UBT251注射液 · No verified English nameCXHL2401227 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2024/11/12New drug · Class 1 PLB1004胶囊 · No verified English nameCXHL2401226 An Shi Pharma (Ningbo) Co., Ltd. romanized
2024/11/12New drug · Class 1 PLB1004胶囊 · No verified English nameCXHL2401225 An Shi Pharma (Ningbo) Co., Ltd. romanized
2024/11/12New drug · Class 1 ANS014004片 · No verified English nameCXHL2401224 Beijing An Shi Bio Technology Co., Ltd. romanized
2024/11/12New drug · Class 1 ANS014004片 · No verified English nameCXHL2401223 Beijing An Shi Bio Technology Co., Ltd. romanized
2024/11/12New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2401222 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/12New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2401221 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/12New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2401220 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/12New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2401219 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/12New drug · Class 1 ICP-248片 · No verified English nameCXHL2401218 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2024/11/12New drug · Class 1 ICP-248片 · No verified English nameCXHL2401217 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized

91 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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