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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 418 drug applications between 6 October 2023 and 12 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 104, covering 79 drug names.

2023/10/06 – 2023/10/12

Period
2023/10/06 to 2023/10/12, 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
418
Drugs with new generic filings (by drug name, de-duplicated)
79
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

418filings, 104 of them generic

By application type

Application typeFilings
Supplement187
Generic104
New drug80
Import20
Import re-registration16
Unspecified10
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug305
Therapeutic biologic56
TCM51
Prophylactic biologic6

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
1Edoxaban Tosilate Tablets629
2Lactulose Oral Solution4334
3Nicorandil for Injection321
4Minoxidil Liniment3252
5Diquafosol Sodium Eye Drops225
6Famotidine Injection228
7Phenylephrine Hydrochloride Injection225
8Clindamycin Phosphate Topical Solution211
9Lacosamide Tablets210
10昂丹司琼口溶膜 · No verified English name212

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

246 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Jin Xing Pharmaceutical Co., Ltd. romanized17170
2CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD1451
3Sichuan Sen Ke Pharmaceutical Co., Ltd. romanized650
4Jiangsu En Hua Pharma Co., Ltd. romanized620
5Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized535
6Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized510
7AstraZeneca AB440
8Janssen-Cilag SpA420
9Sichuan Kelun Pharmaceutical Co., Ltd.422
10CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.421

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

131 this week

AcceptedDrugApplicants
2023/10/12Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2300251 AbbVie Inc.
2023/10/12Import · Class 2.4 镥(177Lu)vipivotide tetraxetan注射液 · No verified English nameJXHL2300250 Advanced Accelerator Applications USA Inc. A Novartis Company; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/10/12Generic · Class 3 Nicergoline TabletsCYHS2302722 Jiangxi Da Sheng Pharmaceuticals Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2023/10/12Generic · Class 3 Verapamil Hydrochloride InjectionCYHS2302717 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/10/12Generic · Class 3 Nicorandil for InjectionCYHS2302713 Kang Pu Pharma Co., Ltd. romanized
2023/10/12Generic · Class 3 Nicorandil for InjectionCYHS2302711 Kang Pu Pharma Co., Ltd. romanized
2023/10/12Generic · Class 3 Isoniazid InjectionCYHS2302710 Hainan Qiu Shi Pharmaceuticals Technology Co., Ltd. romanized; Henan Run Hong Pharmaceutical Co., Ltd. romanized
2023/10/12Generic · Class 3 Famotidine InjectionCYHS2302706 Jiangsu Shen Long Pharma Co., Ltd. romanized
2023/10/12Generic · Class 3 Peramivir InjectionCYHS2302704 Shanghai Hua Yuan Anhui Jin Hui Pharmaceutical Co., Ltd. romanized
2023/10/12Generic · Class 3 Potassium Chloride InjectionCYHS2302703 Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized
2023/10/12New drug · Class 1 GC001溶瘤痘苗病毒注射液 · No verified English nameCXSL2300689 Hangzhou Gong Chu Bio Technology Co., Ltd. romanized
2023/10/12New drug · Class 1 注射用TQB2922 · No verified English nameCXSL2300688 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/10/12New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSL2300687 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2023/10/12New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2300686 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/10/12New drug · Class 1 锝[99mTc]-H7ND注射液 · No verified English nameCXHL2301094 Jia Xing Fa Bo Xin Tian Pharmaceuticals Technology Co., Ltd. romanized
2023/10/12New drug · Class 1 KC1036片 · No verified English nameCXHL2301093 Beijing Kang Chen Pharma Co., Ltd. romanized
2023/10/12New drug · Class 1 KC1036片 · No verified English nameCXHL2301092 Beijing Kang Chen Pharma Co., Ltd. romanized
2023/10/12New drug · Class 1 [177Lu]Lu-XT117注射液 · No verified English nameCXHL2301091 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2023/10/12New drug · Class 1 [64Cu]Cu-XT117注射液 · No verified English nameCXHL2301090 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2023/10/12New drug · Class 1 QB0208-1胶囊 · No verified English nameCXHL2301089 Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized
2023/10/12New drug · Class 1 QB0208-1胶囊 · No verified English nameCXHL2301088 Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized
2023/10/12New drug · Class 1 GFH009注射液 · No verified English nameCXHL2301087 Zhejiang Jin Fang Pharma Co., Ltd. romanized
2023/10/12New drug · Class 1 HSK39297片 · No verified English nameCXHL2301086 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/10/12New drug · Class 1 HSK39297片 · No verified English nameCXHL2301085 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/10/12New drug · Class 1 注射用BL0006 · No verified English nameCXHL2301084 Shanghai Bi Ling Bio Technology Co., Ltd. romanized
2023/10/11Import · Class 1 Lebrikizumab注射液 · No verified English nameJXSL2300178 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/10/11Import · Class 1 AMG 509 · No verified English nameJXSL2300177 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/10/11Import · Class 1 VAY736注射液 · No verified English nameJXSL2300176 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/10/11Import · Class 1 Nemtabrutinib片 · No verified English nameJXHL2300248 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2023/10/11Import · Class 1 Nemtabrutinib片 · No verified English nameJXHL2300247 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.

101 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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