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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 370 drug applications between 24 June 2023 and 30 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 66 drug names.

2023/06/24 – 2023/06/30

Period
2023/06/24 to 2023/06/30, 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
370
Drugs with new generic filings (by drug name, de-duplicated)
66
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

370filings, 86 of them generic

By application type

Application typeFilings
Supplement178
Generic86
New drug58
Import25
Import re-registration18
Unspecified5

By drug type

Drug typeFilings
Chemical drug255
TCM69
Therapeutic biologic42
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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Perampanel Tablets422
2Lactulose Oral Solution3234
3Levofloxacin Eye Drops3216
4Aripiprazole Tablets322
5复方聚乙二醇(3350)电解质散 · No verified English name223
6Dopamine Hydrochloride Injection223
7Tadalafil Tablets2123
8Carbazochrome Sodium Sulfonate Injection211
9Bisoprolol Fumarate Tablets216
10Pregabalin Orally Disintegrating Tablets213

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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shi Qi Pharmaceutical (Guangdong) Co., Ltd. romanized23200
2Run Yuan Pharmaceutical Co., Ltd. romanized13130
3Boehringer Ingelheim International GmbH820
4Hainan Ai Ke Pharmaceutical Co., Ltd. romanized720
5Hainan Brilliant Pharmaceutical Co., Ltd.622
6Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized550
7Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized550
8Shandong Da Yin Jin Kong Er Tong Pharmaceutical Co., Ltd. romanized530
9Guangxi Jin Kang Pharma Co., Ltd. romanized530
10Novo Nordisk A/S510

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

98 this week

AcceptedDrugApplicants
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
2023/06/30New drug · Class 1 AM011注射液 · No verified English nameCXHL2300722 Shanghai Ai Mu Medical Technology Co., Ltd. romanized
2023/06/30New drug · Class 2.2 盐酸表柔比星脂质体注射液 · No verified English nameCXHL2300721 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/06/30New drug · Class 2.2 LPC-006口溶膜 · No verified English nameCXHL2300720 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2023/06/30New drug · Class 2.2 LPC-006口溶膜 · No verified English nameCXHL2300719 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2023/06/30New drug · Class 1 BW-00163注射液 · No verified English nameCXHL2300718 Hangzhou Bo Lin Pharmaceuticals Technology Co., Ltd. romanized
2023/06/29Import · Class 3.1 本瑞利珠单抗注射液 · No verified English nameJXSS2300050 AstraZeneca AB; Name not romanized
2023/06/29Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300123 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/06/29Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300122 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/06/29Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300121 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/06/29Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300120 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/06/29Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300119 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/06/29Import · Class 2.2 注射用罗特西普 · No verified English nameJXSL2300118 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2023/06/29Import · Class 2.2 注射用罗特西普 · No verified English nameJXSL2300117 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2023/06/29Import · Class 1 MEDI5752 · No verified English nameJXSL2300116 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/06/29Import · Class 1 瑞普替尼胶囊 · No verified English nameJXHS2300056 Bristol-Myers Squibb Company; Patheon Inc.
2023/06/29Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2301749 Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized

68 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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