YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 387 drug applications between 2 July 2024 and 8 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 78 drug names.

2024/07/02 – 2024/07/08

Period
2024/07/02 to 2024/07/08, 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
387
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
5

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

387filings, 109 of them generic

By application type

Application typeFilings
Supplement189
Generic109
New drug41
Import25
Import re-registration15
Unspecified8

By drug type

Drug typeFilings
Chemical drug284
Therapeutic biologic48
TCM47
Prophylactic biologic8

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

78 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapoxetine Hydrochloride Tablets5320
2Epalrestat Tablets331
3Diquafosol Sodium Eye Drops325
4Minoxidil Liniment3252
5地氯雷他定口服溶液 · No verified English name3126
6Potassium Phosphates Injection222
7Vortioxetine Hydrobromide Tablets2210
8Nicardipine Hydrochloride Injection2213
9维生素B12滴眼液 · No verified English name222
10Acetylcysteine Granules214

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
1Luo Yang Hao Long Pharma Co., Ltd. romanized1780
2Janssen Research & Development LLC930
3Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized640
4AstraZeneca AB630
5Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized510
6Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized433
7Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized434
8Sanofi Winthrop Industrie420
9Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized424
10Chengdu Di Yi Pharmaceutical 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

106 this week

AcceptedDrugApplicants
2024/07/08Import · Class 1 PF-06821497片 · No verified English nameJXHL2400166 Pfizer Inc.; Pfizer Investment Co. Ltd.
2024/07/08Import · Class 1 PF-06821497片 · No verified English nameJXHL2400165 Pfizer Inc.; Pfizer Investment Co. Ltd.
2024/07/08Generic · Class 3 Potassium Phosphates InjectionCYHS2402065 Shijiazhuang Di Si Kai Wei Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2024/07/08Generic · Class 3 Minoxidil LinimentCYHS2402064 Wuhan Hua Er Bio Technology Co., Ltd. romanized; Jiangxi De Cheng Pharmaceutical Co., Ltd. romanized
2024/07/08Generic · Class 3 Minoxidil LinimentCYHS2402063 Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized; Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized
2024/07/08Generic · Class 3 Minoxidil LinimentCYHS2402062 Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized; Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized
2024/07/08Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402061 Ji Chuan Pharma Group Co., Ltd. romanized
2024/07/08Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2402058 Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/07/08New drug · Class 1 SCTB35注射液 · No verified English nameCXSL2400435 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/07/08New drug · Class 3.2 皮下注射人免疫球蛋白 · No verified English nameCXSL2400434 Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized
2024/07/08New drug · Class 1 TDI01混悬液 · No verified English nameCXHL2400663 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2024/07/08New drug · Class 1 HBW-004285片 · No verified English nameCXHL2400662 Chengdu Hai Bo Wei Pharma Co., Ltd. romanized
2024/07/08New drug · Class 1 注射用NC527-X · No verified English nameCXHL2400661 Zhejiang Hai Bai Bio Technology Co., Ltd. romanized
2024/07/06Import · Class 1 Bleximenib片 · No verified English nameJXHL2400164 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/06Import · Class 1 Bleximenib片 · No verified English nameJXHL2400163 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/06Import · Class 1 Bleximenib片 · No verified English nameJXHL2400162 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/06Generic · Class 3 Pregabalin Oral SolutionCYHS2402049 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/07/06Generic · Class 3 Tebipenem Pivoxil Fine GranulesCYHL2400135 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2024/07/06Generic · Class 3 Ibuprofen and Phenylephrine Hydrochloride TabletsCYHL2400134 Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized
2024/07/06New drug · Class 1 ZL-1218注射液 · No verified English nameCXSL2400433 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2024/07/06New drug · Class 3.3 注射用人生长激素 · No verified English nameCXSL2400432 Changchun Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/07/06New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2400431 Fu Xing Ya Li Feng (Da Lian) Biopharmaceutical Co., Ltd. romanized
2024/07/06New drug · Class 2.2 三价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2400430 Chengdu Ou Lin Bio Technology Co., Ltd. romanized; Lanzhou Bai Ling Bio Technology Co., Ltd. romanized; Chengdu Xin Nuo Ming Bio Technology Co., Ltd. romanized
2024/07/06New drug · Class 1 SDTM001注射液 · No verified English nameCXSL2400429 Sai De Te Biopharmaceutical Co., Ltd. romanized
2024/07/06New drug · Class 1 DX1002片 · No verified English nameCXHL2400660 Guangzhou An Hao Pharmaceuticals Technology Co., Ltd. romanized
2024/07/06New drug · Class 1 DX1002片 · No verified English nameCXHL2400659 Guangzhou An Hao Pharmaceuticals Technology Co., Ltd. romanized
2024/07/05Import · Class 2.4 DS-3201b片 · No verified English nameJXHL2400161 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/07/05Import · Class 2.4 DS-3201b片 · No verified English nameJXHL2400160 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/07/05Generic · Class 3 Amoxicillin and Clavulanate Potassium TabletsCYHS2402042 Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized
2024/07/05Generic · Class 3 Ferrous Succinate TabletsCYHS2402039 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.

76 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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