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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 370 drug applications between 31 October 2024 and 6 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 70 drug names.

2024/10/31 – 2024/11/06

Period
2024/10/31 to 2024/11/06, 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)
70
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

370filings, 99 of them generic

By application type

Application typeFilings
Supplement175
Generic99
New drug61
Import20
Import re-registration9
Unspecified6

By drug type

Drug typeFilings
Chemical drug266
TCM73
Therapeutic biologic24
Prophylactic biologic4
Biologic2
In vitro diagnostic reagent1

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

70 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Doxofylline Tablets422
2Vonoprazan Fumarate Tablets4260
3Methotrexate Injection3211
4Oseltamivir Phosphate For Oral Suspension322
5Mivacurium Chloride Injection323
6Ampicillin Sodium and Sulbactam Sodium for Injection3113
7Repaglinide Tablets316
8Acetylcysteine Solution For Inhalation224
9Pentoxifylline Modified Release Tablets226
10盐酸纳美芬注射液 · No verified English name221

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

220 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangdong Sunho Pharmaceutical Co., Ltd.19130
2Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized640
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
4GE Healthcare AS610
5Teva Neuroscience Inc.610
6Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized610
7Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized550
8Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized440
9Ya Bao Pharma Group Co., Ltd. romanized430
10Amgen Inc.420

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

121 this week

AcceptedDrugApplicants
2024/11/06Import · Class 3.1 艾可瑞妥单抗注射用浓溶液 · No verified English nameJXSS2400100 AbbVie Deutschland GmbH & Co. KG; Vetter Pharma-Fertigung GmbH & Co. KG; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/11/06Import · Class 1 Baxdrostat片 · No verified English nameJXHL2400264 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/11/06Import · Class 1 Baxdrostat片 · No verified English nameJXHL2400263 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/11/06Generic · Class 3 Carbocisteine Oral SolutionCYHS2403779 Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized
2024/11/06Generic · Class 3 Cimetidine InjectionCYHS2403778 Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized
2024/11/06Generic · Class 3 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2403776 Hainan Mei Kang Da Pharma Co., Ltd. romanized; Anhui Chang Jiang Pharma Co., Ltd. romanized
2024/11/06Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2403774 Yunnan Xian Shi Pharma Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2024/11/06Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2403772 HAINAN HUALON PHARMACEUTICAL CO.,LTD
2024/11/06New drug · Class 1 注射用SIBP-A18 · No verified English nameCXSL2400751 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/11/06New drug · Class 1 IBR900细胞注射液 · No verified English nameCXSL2400750 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2024/11/06New drug · Class 1 CYH001肠溶胶囊 · No verified English nameCXHL2401193 Beijing Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized
2024/11/06New drug · Class 1 CYH001肠溶胶囊 · No verified English nameCXHL2401192 Beijing Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized
2024/11/06New drug · Class 1 CVI-2742胶囊 · No verified English nameCXHL2401191 Xi Wei Ai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/11/06New drug · Class 1 CVI-2742胶囊 · No verified English nameCXHL2401190 Xi Wei Ai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/11/06New drug · Class 2.4 胶原酶软膏 · No verified English nameCXHL2401189 Yuan Da Sheng Ming Ke Xue (An Shan) Co., Ltd. romanized
2024/11/06New drug · Class 2.4 注射用紫杉醇阳离子脂质体 · No verified English nameCXHL2401188 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2024/11/06New drug · Class 1 注射用培泰菁绿 · No verified English nameCXHL2401187 Nanjing Nuo Yuan Medical Devices Co., Ltd. romanized
2024/11/06New drug · Class 1 DF-003胶囊 · No verified English nameCXHL2401186 Shanghai Yao Yuan Bio Technology Co., Ltd. romanized
2024/11/06New drug · Class 1 DF-003胶囊 · No verified English nameCXHL2401185 Shanghai Yao Yuan Bio Technology Co., Ltd. romanized
2024/11/06New drug · Class 1 DF-003胶囊 · No verified English nameCXHL2401184 Shanghai Yao Yuan Bio Technology Co., Ltd. romanized
2024/11/05Import · Class 1 PF-07868489 · No verified English nameJXSL2400216 Pfizer Inc.; Pfizer Investment CO. Ltd.
2024/11/05Import · Class 2.2 Tarlatamab · No verified English nameJXSL2400215 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2024/11/05Import · Class 2.2 Tarlatamab · No verified English nameJXSL2400214 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2024/11/05Import · Class 2.2 Tarlatamab · No verified English nameJXSL2400213 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2024/11/05Import · Class 3.1 Teprotumumab · No verified English nameJXSL2400212 Horizon Therapeutics Ireland DAC; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/11/05Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2403771 Changchun Hai Yue Pharma Co., Ltd. romanized
2024/11/05Generic · Class 3 Ursodeoxycholic Acid TabletsCYHS2403770 Mei Xiang Bio Technology (Hainan) Co., Ltd. romanized; Su Zhou Yi Fan Pharma Co., Ltd. romanized
2024/11/05Generic · Class 3 Thioctic Acid TabletsCYHS2403769 Jiangsu He Chen Pharma Co., Ltd. romanized
2024/11/05Generic · Class 3 Thioctic Acid TabletsCYHS2403768 Jiangsu He Chen Pharma Co., Ltd. romanized
2024/11/05Generic · Class 3 Potassium Phosphates InjectionCYHS2403766 Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized

91 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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