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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 397 drug applications between 22 May 2023 and 28 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 54 drug names.

2023/05/22 – 2023/05/28

Period
2023/05/22 to 2023/05/28, 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
397
Drugs with new generic filings (by drug name, de-duplicated)
54
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

397filings, 82 of them generic

By application type

Application typeFilings
Supplement213
Generic82
New drug62
Import re-registration18
Import16
Unspecified6

By drug type

Drug typeFilings
Chemical drug274
TCM73
Therapeutic biologic45
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

54 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Roxadustat Capsules12617
2Ropivacaine hydrochloride injection415
3Minoxidil Topical Solution320
4Sildenafil Citrate Tablets3112
5Tranexamic Acid Injection3111
6Carfilzomib For Injection310
7Oxacillin Sodium for Injection3113
8Phloroglucinol Injection222
9Nicorandil for Injection211
10盐酸左沙丁胺醇雾化吸入溶液 · 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

221 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Lang De Pharma Co., Ltd. romanized32140
2Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized12110
3Eli Lilly and Company610
4UCB Pharma SA610
5Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized610
6An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized550
7Guang Sheng Yuan Zhong Pharmaceuticals Co., Ltd. romanized530
8Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized440
9AstraZeneca AB420
10Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized420

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
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
2023/05/27Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2301432 Ningbo Mei Shu Pharmaceuticals Technology Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2023/05/27New drug · Class 1.1 参芪软斑颗粒 · No verified English nameCXZL2300038 Shandong Yu Ze Yao Kang Industry Technology Research Institute Co., Ltd. romanized
2023/05/27New drug · Class 3.4 注射用奥马珠单抗α · No verified English nameCXSL2300378 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2023/05/27New drug · Class 3.4 注射用奥马珠单抗α · No verified English nameCXSL2300377 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2023/05/26Generic · Class 3 Minoxidil Topical SolutionCYHS2301430 Jiangsu Run Bang Pharma Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/05/26Generic · Class 3 Minoxidil Topical SolutionCYHS2301429 Jiangsu Run Bang Pharma Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/05/26Generic · Class 3 Fluorouracil InjectionCYHS2301428 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2023/05/26Generic · Class 3 Pregabalin Oral SolutionCYHS2301427 Haerbin Shi Kang Long Pharma Co., Ltd. romanized
2023/05/26Generic · Class 3 Haloperidol Lactate InjectionCYHS2301426 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/05/26New drug · Class 1.1 麻荆宣肺颗粒 · No verified English nameCXZL2300037 Zhongguo Zhong Yi Ke College Xi Yuan Hospital romanized
2023/05/26New drug · Class 1.4 口服六价重配轮状病毒活疫苗(Vero细胞) · No verified English nameCXSS2300039 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/05/26New drug · Class 2.2 四价流感病毒亚单位疫苗(MDCK细胞) · No verified English nameCXSL2300376 Changchun Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/05/26New drug · Class 3.2 人纤溶酶原 · No verified English nameCXSL2300375 Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized
2023/05/26New drug · Class 1 KQ-2003自体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2300374 Shanghai Ke Qi Pharma Technology Co., Ltd. romanized
2023/05/26New drug · Class 1 JY03注射液 · No verified English nameCXSL2300373 Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized; Beijing Jing Yi Tai Xiang Technology Development Co., Ltd. romanized
2023/05/26New drug · Class 1 YH2000片 · No verified English nameCXHL2300580 Wuhan Shi Jin Nuo Sai Biopharmaceuticals Co., Ltd. romanized

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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