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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 56 drug applications between 2 October 2023 and 8 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 13, covering 11 drug names.

2023/10/02 – 2023/10/08

Period
2023/10/02 to 2023/10/08, 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
56
Drugs with new generic filings (by drug name, de-duplicated)
11
Accepted this week, now under review
0

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

56filings, 13 of them generic

By application type

Application typeFilings
Supplement22
Generic13
New drug9
Import re-registration8
Import2
Unspecified1
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug28
TCM16
Therapeutic biologic11
Prophylactic 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

11 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lacosamide Tablets210
2Iopromide Injection2127
3Ibuprofen Sustained Release Capsules113
4Pregabalin Oral Solution115
5Famotidine Injection118
6注射用亚胺培南西司他丁钠/氯化钠注射液 · No verified English name110
7Ceftazidime And Avibactam Sodium For Injection1112
8洛索洛芬钠凝胶贴膏 · No verified English name119
9盐酸毛果芸香碱滴眼液 · No verified English name115
10Hydroxychloroquine Sulfate Tablets112

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

40 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly Nederland B.V.410
2Jiangxi Qing Feng Pharma Co., Ltd. romanized330
3Chongqing Xi Er An Pharma Co., Ltd. romanized330
4Chugai Pharmaceutical Co. Ltd310
5Shanxi Fu Sheng Gong Da Pharmaceutical Factory Co., Ltd. romanized220
6Guangzhou Yue Hua Pharmaceutical Co., Ltd. romanized220
7Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized212
8Beijing SL Pharmaceutical Co., Ltd.210
9Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized212
10Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized210

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

13 this week

AcceptedDrugApplicants
2023/10/08Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2300172 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/10/08Generic · Class 3 Famotidine InjectionCYHS2302636 Chengdu Gui He Technology Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized
2023/10/08Generic · Class 3 Pregabalin Oral SolutionCYHS2302626 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2023/10/08Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2300125 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2023/10/08New drug · Class 1 BAT1308注射液 · No verified English nameCXSL2300669 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/10/08New drug · Class 1 SNC109注射液 · No verified English nameCXSL2300668 Shanghai Xian Bo Bio Technology Co., Ltd. romanized
2023/10/08New drug · Class 1.4 24价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2300667 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized; Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized
2023/10/08New drug · Class 1 注射用SKB264 · No verified English nameCXSL2300666 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2023/10/08New drug · Class 1 注射用FTL008.16 · No verified English nameCXSL2300665 Fei Tong (Chengdu) Bio Technology Co., Ltd. romanized
2023/10/08New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300664 Guizhou Zhong Guan Bio Technology Co., Ltd. romanized
2023/10/08New drug · Class 2.3 SMF-209 · No verified English nameCXHL2301043 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/10/08New drug · Class 1 YH001胶囊 · No verified English nameCXHL2301042 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized
2023/10/08New drug · Class 1 YH001胶囊 · No verified English nameCXHL2301041 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized

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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