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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 236 drug applications between 13 May 2021 and 19 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 25 drug names.

2021/05/13 – 2021/05/19

Period
2021/05/13 to 2021/05/19, 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
236
Drugs with new generic filings (by drug name, de-duplicated)
25
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

236filings, 38 of them generic

By application type

Application typeFilings
Supplement107
New drug58
Generic38
Import23
Unspecified7
Import re-registration3

By drug type

Drug typeFilings
Chemical drug177
Therapeutic biologic40
TCM12
Prophylactic biologic4
In vitro diagnostic reagent2
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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4323
2Propofol Medium And Long Chain Fat Emulsion Injection313
3Clindamycin Injection314
4Brexpiprazole Tablets3131
5阿普斯特片 · No verified English name310
6Ambroxol Hydrochloride Injection229
7硫酸特布他林雾化吸入用溶液 · No verified English name211
8Sodium Valproate Concentrated Solution for Injection110
9Linagliptin Tablets112
10地氯雷他定口服溶液 · No verified English name1126

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

150 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.15100
2Qilu Pharmaceutical Co., Ltd.631
3Takeda Development Center Americas Inc.520
4Xian Li Bang Pharmaceutical Co., Ltd. romanized523
5Shandong Luo Xin Pharma Group Co., Ltd. romanized420
6Wei Shi Pharma (Ru Gao) Co., Ltd. romanized410
7Shenzhen Xin Li Tai Pharma Co., Ltd. romanized410
8Pfizer Europe MA EEIG320
9Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized320
10Tianjin Tian Shi Li (Liaoning) Pharmaceutical Co., Ltd. romanized320

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

92 this week

AcceptedDrugApplicants
2021/05/19Import · Class 1 BR55 · No verified English nameJXHL2101044 Bracco International B.V.; Bracco Imaging Medical Technologies(Shanghai) Co. Ltd.
2021/05/19Import · Class 2.4 注射用依拉环素 · No verified English nameJXHL2101043 Everest Medicines (US) Limited; EverID Medicines (Beijing) Limited
2021/05/19Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2101179 Changchun Hai Yue Pharma Co., Ltd. romanized
2021/05/19Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2101178 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2021/05/19Generic · Class 3 Leflunomide TabletsCYHS2101172 Mei Luo Pharma Co., Ltd. romanized
2021/05/19Generic · Class 3 聚普瑞锌颗粒? · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2101166 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2021/05/19New drug · Class 1 PA3-17注射液 · No verified English nameCXSL2101087 Bo Sheng Ji Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2021/05/19New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2101086 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/05/19New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2101083 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/05/19New drug · Class 2.4 注射用培尿酸酶 · No verified English nameCXSL2101071 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2021/05/19New drug · Class 1 全人源抗CD19和CD22自体T细胞注射液 · No verified English nameCXSL2101070 Nanjing Xun Lu Medical Technology Co., Ltd. romanized
2021/05/19New drug · Class 1 ASC40片 · No verified English nameCXHL2101139 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2021/05/19New drug · Class 1 ASC40片 · No verified English nameCXHL2101138 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2021/05/19New drug · Class 1 ASC40片 · No verified English nameCXHL2101137 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2021/05/19New drug · Class 1 注射用聚乙二醇伊立替康 · No verified English nameCXHL2101136 Tianjin Jian Kai Technology Co., Ltd. romanized
2021/05/19New drug · Class 1 XG005片 · No verified English nameCXHL2101135 Chang Yu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/05/19New drug · Class 1 盐酸伊非尼酮片 · No verified English nameCXHL2101134 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/05/19New drug · Class 1 盐酸伊非尼酮片 · No verified English nameCXHL2101133 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/05/18Import · Class 3.1 注射用戈沙妥组单抗 · No verified English nameJXSS2101007 Immunomedics Inc.; BSP Pharmaceuticals S.p.A.; Everest Medicines (Suzhou) Inc.
2021/05/18Import · Class 1 MK-1026片 · No verified English nameJXHL2101041 Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/05/18Import · Class 1 MK-1026片 · No verified English nameJXHL2101040 Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/05/18Generic · Class 3 Succinylcholine Chloride InjectionCYHS2101170 Nanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanized
2021/05/18Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCYHS2101169 Ji Ning Hua Neng Pharmaceutical Factory Co., Ltd. romanized
2021/05/18Generic · Class 3 Chlorphenamine Maleate InjectionCYHS2101157 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2021/05/18Generic · Class 3 阿普斯特片 · No verified English nameCYHS2101156 Hua Run Shuang He Pharma Co., Ltd. romanized; Nanjing Hai Jing Pharma Co., Ltd. romanized
2021/05/18Generic · Class 3 阿普斯特片 · No verified English nameCYHS2101155 Hua Run Shuang He Pharma Co., Ltd. romanized; Nanjing Hai Jing Pharma Co., Ltd. romanized
2021/05/18Generic · Class 3 阿普斯特片 · No verified English nameCYHS2101154 Hua Run Shuang He Pharma Co., Ltd. romanized; Nanjing Hai Jing Pharma Co., Ltd. romanized
2021/05/18New drug · Class 1.1 理中消痞颗粒 · No verified English nameCXZL2101008 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2021/05/18New drug 人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法) · No verified English nameCXSS2101002 Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized
2021/05/18New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2101084 Sichuan Bai Li Pharma Co., Ltd. romanized

62 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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