YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 261 drug applications between 24 May 2023 and 30 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 46 drug names.

2023/05/24 – 2023/05/30

Period
2023/05/24 to 2023/05/30, 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
261
Drugs with new generic filings (by drug name, de-duplicated)
46
Accepted this week, now under review
3

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

261filings, 66 of them generic

By application type

Application typeFilings
Supplement127
Generic66
New drug33
Import16
Import re-registration14
Unspecified5

By drug type

Drug typeFilings
Chemical drug181
TCM48
Therapeutic biologic27
Prophylactic biologic4
In vitro diagnostic reagent1

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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oxacillin Sodium for Injection5213
2Roxadustat Capsules4217
3Phloroglucinol Injection332
4Selexipag Tablets3124
5Sildenafil Citrate Tablets3112
6Tranexamic Acid Injection3111
7Carfilzomib For Injection310
8Doxofylline Injection215
9Naloxone Hydrochloride Injection211
10Minoxidil Topical Solution210

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

176 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company610
2Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized610
3An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized550
4Pfizer Inc.420
5NAPP PHARMACEUTICALS LIMITED410
6Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized330
7HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.320
8Anhui Lei Yun Shang Pharma Co., Ltd. romanized320
9Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized320
10Qilu Pharmaceutical Co., Ltd.322

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

74 this week

AcceptedDrugApplicants
2023/05/30Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2300040 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2023/05/30Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2300133 AbbVie Inc.
2023/05/30Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2300132 AbbVie Inc.
2023/05/30Generic · Class 3 Furosemide InjectionCYHS2301453 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2023/05/30Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2301452 Shijiazhuang Kang Li Pharma Co., Ltd. romanized
2023/05/30Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2301451 Shenzhen Shi Bei Mei Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/05/30Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301449 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/05/30Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301448 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/05/30Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2301447 Zhejiang Pu Li Pharma Co., Ltd. romanized
2023/05/30Generic · Class 3 Magnesium Sulfate InjectionCYHS2301445 Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Ji Chuan Pharma Group Co., Ltd. romanized
2023/05/30Generic · Class 3 去氧肾上腺素酮咯酸溶液 · No verified English nameCYHS2301443 Suzhou Lang Yi Biopharmaceuticals Research Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/05/30New drug · Class 1 QL1706H注射液 · No verified English nameCXSL2300380 Qilu Pharmaceutical Co., Ltd.
2023/05/30New drug · Class 1 血液净化用间充质干细胞 · No verified English nameCXSL2300379 Guangdong Qian Hui Bio Technology Co., Ltd. romanized
2023/05/30New drug · Class 1 sbk002片 · No verified English nameCXHS2300051 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized; HAINAN HUALON PHARMACEUTICAL CO.,LTD
2023/05/30New drug · Class 2.3 B0125 · No verified English nameCXHL2300582 Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/05/30New drug · Class 2.3 B0125 · No verified English nameCXHL2300581 Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/05/27Import · Class 1 OMTX705注射用浓溶液 · No verified English nameJXSL2300098 InxMed (Hong Kong) Limited; InxMed (Nanjing) Co. Ltd
2023/05/27Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300131 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/05/27Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300130 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/05/27Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300129 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/05/27Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300128 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/05/27Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300127 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/05/27Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300126 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/05/27Import · Class 2.4 盐酸醋克利定滴眼液 · No verified English nameJXHL2300125 LENZ Therapeutics Inc.; Ji Xing Pharmaceuticals (Shanghai) Co.,Ltd
2023/05/27Import · Class 2.3; 2.4 醋克利定溴莫尼定滴眼液 · No verified English nameJXHL2300124 LENZ Therapeutics Inc.; Ji Xing Pharmaceuticals (Shanghai) Co.,Ltd
2023/05/27Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2301442 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/05/27Generic · Class 3 Indobufen TabletsCYHS2301441 Shandong Lu Sheng Pharmaceutical Co., Ltd. romanized
2023/05/27Generic · Class 3 Carbocisteine Oral SolutionCYHS2301440 Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2023/05/27Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2301439 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2023/05/27Generic · Class 3 Famotidine InjectionCYHS2301437 Nanjing Kang Fa Bio Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized

44 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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