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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 291 drug applications between 16 July 2023 and 22 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 55, covering 42 drug names.

2023/07/16 – 2023/07/22

Period
2023/07/16 to 2023/07/22, 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
291
Drugs with new generic filings (by drug name, de-duplicated)
42
Accepted this week, now under review
1

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

291filings, 55 of them generic

By application type

Application typeFilings
Supplement139
Generic55
New drug54
Import27
Unspecified10
Import re-registration6

By drug type

Drug typeFilings
Chemical drug189
Therapeutic biologic51
TCM47
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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapoxetine Hydrochloride Tablets3220
2Ceftazidime And Avibactam Sodium For Injection2212
3Ethyl Iosapentate Capsules2127
4Piracetam Injection219
5Indobufen Tablets216
6Procaterol Hydrochloride Solution for Inhalation212
7Vonoprazan Fumarate Tablets2160
8Pravastatin Sodium Tablets212
9注射用头孢唑肟钠 · No verified English name214
10Minoxidil Liniment2152

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

179 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan He Li Xin Jian Pharma Co., Ltd. romanized13130
2AstraZeneca AB840
3Chengdu Di Yi Pharmaceutical Co., Ltd. romanized731
4Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized650
5Bristol-Myers Squibb Company620
6Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized610
7Takeda Development Center Americas Inc.520
8Hainan Tong Yong San Yang Pharma Co., Ltd. romanized510
9Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized430
10Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized430

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

99 this week

AcceptedDrugApplicants
2023/07/22Import · Class 1 Bemarituzumab注射液 · No verified English nameJXSL2300138 Amgen Inc.; Zai Lab (Shanghai) CO. Ltd.
2023/07/22Import · Class 1 Cetrelimab注射液 · No verified English nameJXSL2300137 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/07/22Import · Class 1 Cetrelimab注射液 · No verified English nameJXSL2300136 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/07/22Import · Class 2.2 Anifrolumab注射液 · No verified English nameJXSL2300135 AstraZeneca AB; AstraZeneca Investment (China)Co. Ltd
2023/07/22Import · Class 1 Forimtamig · No verified English nameJXSL2300134 F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd.
2023/07/22Import · Class 1 Forimtamig · No verified English nameJXSL2300133 F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd.
2023/07/22Import · Class 1 VAY736注射液 · No verified English nameJXSL2300132 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/07/22Import · Class 1 BMS-986278-01片 · No verified English nameJXHL2300175 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2023/07/22Import · Class 1 BMS-986278-01片 · No verified English nameJXHL2300174 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2023/07/22Import · Class 1 BMS-986278-01片 · No verified English nameJXHL2300173 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2023/07/22Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2301973 Chengdu Di Yi Pharmaceutical Co., Ltd. romanized
2023/07/22Generic · Class 3 Acetylcysteine InjectionCYHS2301972 Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2023/07/22Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2301970 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/07/22New drug · Class 3.4 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液 · No verified English nameCXSS2300056 Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized
2023/07/22New drug · Class 3.4 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液 · No verified English nameCXSS2300055 Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized
2023/07/22New drug · Class 1 NWRD08裸质粒DNA注射液 · No verified English nameCXSL2300507 Nuo Wei Bio Technology (Wuxi) Co., Ltd. romanized; Nuo Wei Technology (Beijing) Co., Ltd. romanized
2023/07/22New drug · Class 1 JYB1931注射液 · No verified English nameCXSL2300506 Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized
2023/07/22New drug · Class 1 TQ05105片 · No verified English nameCXHL2300809 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/07/22New drug · Class 1 TQB3909片 · No verified English nameCXHL2300808 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/07/21Import · Class 1 BMS-986278-01片 · No verified English nameJXHL2300172 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2023/07/21Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2301966 Yunnan Xian Shi Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/07/21Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHS2301965 Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/07/21Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHS2301964 Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/07/21Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301954 Shandong Lan Jing Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized
2023/07/21New drug · Class 1 IMD101注射液 · No verified English nameCXSL2300505 Shanghai Ying Mai De Medical Technology Co., Ltd. romanized
2023/07/21New drug · Class 1 IMD101注射液 · No verified English nameCXSL2300504 Shanghai Ying Mai De Medical Technology Co., Ltd. romanized
2023/07/21New drug · Class 1 人白介素-12注射液 · No verified English nameCXSL2300503 Kang Li Tai Biopharmaceuticals (Qingdao) Co., Ltd. romanized
2023/07/21New drug · Class 1 注射用重组人骨形态发生蛋白6 · No verified English nameCXSL2300502 An Ji Sheng Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2023/07/21New drug · Class 1 ELPIS人脐带间充质干细胞注射液 · No verified English nameCXSL2300501 Hua Xia Yuan (Shanghai) Bio Technology Co., Ltd. romanized; Jiangxi Hua Xia Yuan Bio Technology Co., Ltd. romanized
2023/07/21New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSL2300500 Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized

69 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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