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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 308 drug applications between 15 July 2023 and 21 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 59, covering 40 drug names.

2023/07/15 – 2023/07/21

Period
2023/07/15 to 2023/07/21, 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
308
Drugs with new generic filings (by drug name, de-duplicated)
40
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

308filings, 59 of them generic

By application type

Application typeFilings
Supplement152
Generic59
New drug54
Import18
Unspecified13
Import re-registration12

By drug type

Drug typeFilings
Chemical drug211
TCM50
Therapeutic biologic43
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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1注射用头孢唑肟钠 · No verified English name424
2Dapoxetine Hydrochloride Tablets3220
3Vortioxetine Hydrobromide Tablets3110
4Ceftazidime And Avibactam Sodium For Injection2212
5瑞巴派特片 · No verified English name224
6Ethyl Iosapentate Capsules2127
7Piracetam Injection219
8Indobufen Tablets216
9Procaterol Hydrochloride Solution for Inhalation212
10Vonoprazan Fumarate Tablets2160

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

192 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan He Li Xin Jian Pharma Co., Ltd. romanized13130
2Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized870
3AstraZeneca AB730
4Boehringer Ingelheim International GmbH640
5Chengdu Di Yi Pharmaceutical Co., Ltd. romanized620
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
10Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized410

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

86 this week

AcceptedDrugApplicants
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
2023/07/21New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSL2300499 Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized
2023/07/21New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSL2300498 Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized
2023/07/21New drug · Class 1 ETH-155036胶囊 · No verified English nameCXHL2300807 Cheng Ke Pharma (Jiangsu) Co., Ltd. romanized
2023/07/21New drug · Class 1 ETH-155036胶囊 · No verified English nameCXHL2300806 Cheng Ke Pharma (Jiangsu) Co., Ltd. romanized
2023/07/21New drug · Class 1 CVL237片 · No verified English nameCXHL2300803 Fu Kang (Shanghai) Health Technology Co., Ltd. romanized; Zhejiang Fu Kang Pharmaceutical Co., Ltd. romanized
2023/07/20Import · Class 1 MEDI5752 · No verified English nameJXSL2300131 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/07/20Import · Class 1 Zipalertinib片 · No verified English nameJXHL2300171 Taiho Oncology Inc.; Zai Lab (Shanghai) CO. Ltd.
2023/07/20Generic · Class 3 聚乙二醇4000散(儿童型) · No verified English nameCYHS2301944 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2023/07/20New drug · Class 2.3 HYR04胶囊 · No verified English nameCXZL2300051 Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized
2023/07/20New drug · Class 1.1 补肺益肾颗粒 · No verified English nameCXZL2300050 Zhongguo Zhong Yi Ke College Zhong Yao Research Institute romanized; Hunan Sheng Zhong Pharmaceuticals Research Institute romanized
2023/07/20New drug · Class 1 注射用MR001双特异性抗体 · No verified English nameCXSL2300497 Shenzhen Shi Mai Jia Rui Bio Technology Co., Ltd. romanized
2023/07/20New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2300802 Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized
2023/07/20New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2300801 Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized
2023/07/20New drug · Class 1 GLB-002胶囊 · No verified English nameCXHL2300800 Hangzhou Ge Bo Biopharmaceuticals Co., Ltd. romanized
2023/07/20New drug · Class 1 GLB-002胶囊 · No verified English nameCXHL2300799 Hangzhou Ge Bo Biopharmaceuticals Co., Ltd. romanized
2023/07/19Generic · Class 3 Minoxidil LinimentCYHS2301940 Hangzhou Min Sheng Health Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/07/19Generic · Class 3 Minoxidil LinimentCYHS2301939 Hangzhou Min Sheng Health Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/07/19Generic · Class 3 Piracetam InjectionCYHS2301938 Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized
2023/07/19Generic · Class 3 Piracetam InjectionCYHS2301937 Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized

56 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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