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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 414 drug applications between 26 June 2023 and 2 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 71 drug names.

2023/06/26 – 2023/07/02

Period
2023/06/26 to 2023/07/02, 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
414
Drugs with new generic filings (by drug name, de-duplicated)
71
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

414filings, 97 of them generic

By application type

Application typeFilings
Supplement203
Generic97
New drug65
Import26
Import re-registration18
Unspecified5

By drug type

Drug typeFilings
Chemical drug287
TCM78
Therapeutic biologic45
Prophylactic biologic3
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

71 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Perampanel Tablets422
2Minoxidil Liniment4252
3Lactulose Oral Solution3234
4Levofloxacin Eye Drops3216
5Aripiprazole Tablets322
6复方聚乙二醇(3350)电解质散 · No verified English name223
7Potassium Chloride Injection2210
8Dopamine Hydrochloride Injection223
9丁酸氯维地平注射用脂肪乳 · No verified English name210
10Tadalafil Tablets2123

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

224 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shi Qi Pharmaceutical (Guangdong) Co., Ltd. romanized23200
2Run Yuan Pharmaceutical Co., Ltd. romanized13130
3Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized11100
4Boehringer Ingelheim International GmbH820
5Hainan Ai Ke Pharmaceutical Co., Ltd. romanized720
6Hainan Brilliant Pharmaceutical Co., Ltd.622
7Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized610
8Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized550
9Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized550
10Shandong Da Yin Jin Kong Er Tong Pharmaceutical Co., Ltd. romanized530

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

114 this week

AcceptedDrugApplicants
2023/07/02New drug · Class 2.2 LPC-011口溶膜 · No verified English nameCXHL2300729 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/07/02New drug · Class 2.2 LPC-011口溶膜 · No verified English nameCXHL2300728 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/07/02New drug · Class 2.2 LPC-011口溶膜 · No verified English nameCXHL2300727 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/07/02New drug · Class 2.2 LPC-011口溶膜 · No verified English nameCXHL2300726 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/07/02New drug · Class 2.2 LPC-011口溶膜 · No verified English nameCXHL2300725 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/07/02New drug · Class 2.2 LPC-011口溶膜 · No verified English nameCXHL2300724 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/07/01Import · Class 1 ALPN-303注射液 · No verified English nameJXSL2300124 Alpine Immune Sciences Inc.; Name not romanized
2023/07/01Generic · Class 3 Potassium Chloride InjectionCYHS2301778 Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/07/01Generic · Class 3 丁酸氯维地平注射用脂肪乳 · No verified English nameCYHS2301777 Sichuan Kelun Pharmaceutical Co., Ltd.
2023/07/01Generic · Class 3 丁酸氯维地平注射用脂肪乳 · No verified English nameCYHS2301776 Sichuan Kelun Pharmaceutical Co., Ltd.
2023/07/01Generic · Class 3 Minoxidil LinimentCYHS2301775 Fu Yuan Pharma Co., Ltd. romanized
2023/07/01Generic · Class 3 Minoxidil LinimentCYHS2301774 Fu Yuan Pharma Co., Ltd. romanized
2023/07/01Generic · Class 3 Minoxidil LinimentCYHS2301771 Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd.
2023/07/01Generic · Class 3 Minoxidil LinimentCYHS2301770 Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd.
2023/07/01Generic · Class 3 Levetiracetam extended-release tabletsCYHS2301768 Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized
2023/07/01New drug · Class 1 QX005N注射液 · No verified English nameCXSL2300449 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2023/06/30Import · Class 1 BI 907828片 · No verified English nameJXHL2300153 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/06/30Import · Class 1 BI 907828片 · No verified English nameJXHL2300152 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/06/30Import · Class 1 BI 907828片 · No verified English nameJXHL2300151 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/06/30Generic · Class 3 Epalrestat TabletsCYHS2301765 Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2023/06/30Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2301763 Hainan Si Da Pharmaceutical Co., Ltd. romanized; Hainan Sai Li Ke Pharma Co., Ltd. romanized
2023/06/30Generic · Class 3 Pregabalin Orally Disintegrating TabletsCYHS2301762 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/06/30Generic · Class 3 Pregabalin Orally Disintegrating TabletsCYHS2301761 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/06/30Generic · Class 3 Pentoxifylline InjectionCYHS2301750 Henan Lang Guan Medicines Formulations Research Institute Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized
2023/06/30New drug · Class 1.2 射干止咳胶囊 · No verified English nameCXZL2300046 Liaoning Sheng Zhong Pharmaceuticals Research Institute (Liaoning Zhong Pharmaceuticals University Fu Shu Di Er Hospital) romanized
2023/06/30New drug · Class 1.2 射干提取物 · No verified English nameCXZL2300045 Liaoning Sheng Zhong Pharmaceuticals Research Institute (Liaoning Zhong Pharmaceuticals University Fu Shu Di Er Hospital) romanized
2023/06/30New drug · Class 1 注射用SBP101 · No verified English nameCXSL2300448 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2023/06/30New drug · Class 1 HH-003注射液 · No verified English nameCXSL2300447 Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized
2023/06/30New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300446 Wuhan Han Mi Dun Bio Technology Co., Ltd. romanized; Guangzhou Han Mi Dun Bio Technology Co., Ltd. romanized
2023/06/30New drug · Class 1 AM011注射液 · No verified English nameCXHL2300723 Shanghai Ai Mu Medical Technology Co., Ltd. romanized

84 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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