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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 419 drug applications between 30 October 2024 and 5 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 106, covering 76 drug names.

2024/10/30 – 2024/11/05

Period
2024/10/30 to 2024/11/05, 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
419
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
2

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

419filings, 106 of them generic

By application type

Application typeFilings
Supplement205
Generic106
New drug64
Import23
Unspecified11
Import re-registration10

By drug type

Drug typeFilings
Chemical drug280
TCM85
Therapeutic biologic40
Prophylactic biologic7
Biologic6
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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Doxofylline Tablets422
2Vonoprazan Fumarate Tablets4260
3Oseltamivir Phosphate For Oral Suspension322
4Mivacurium Chloride Injection323
5Ampicillin Sodium and Sulbactam Sodium for Injection3113
6Repaglinide Tablets316
7Acetylcysteine Solution For Inhalation224
8Diquafosol Sodium Eye Drops225
9Potassium Phosphates Injection222
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

237 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangdong Sunho Pharmaceutical Co., Ltd.22160
2Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized16120
3Novo Nordisk A/S1130
4Amgen Inc.720
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
6GE Healthcare AS610
7Teva Neuroscience Inc.610
8Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized610
9Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized440
10Ya Bao Pharma Group 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

126 this week

AcceptedDrugApplicants
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
2024/11/05Generic · Class 3 Diprophylline InjectionCYHS2403765 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2024/11/05Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2403764 Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/11/05Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2403763 Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/11/05Generic · Class 3 Torsemide InjectionCYHS2403762 Jiangsu Heng Xin Pharma Co., Ltd. romanized
2024/11/05Generic · Class 3 Oxacillin Sodium for InjectionCYHS2403761 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/11/05Generic · Class 3 甲苯磺酸艾多沙班口崩片 · No verified English nameCYHS2403760 Jiangsu He Chen Pharma Co., Ltd. romanized
2024/11/05Generic · Class 3 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2403756 Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2024/11/05Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2403750 Chengdu Giantech Hi-technology Development Co., Ltd.; Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanized
2024/11/05New drug · Class 3.1 五味消毒颗粒 · No verified English nameCXZS2400034 Nanjing Zhong Shan Pharmaceutical Co., Ltd. romanized
2024/11/05New drug · Class 1 HB0017注射液 · No verified English nameCXSL2400749 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized
2024/11/05New drug · Class 1 注射用YL201 · No verified English nameCXSL2400748 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2024/11/05New drug · Class 1 HSK39004吸入粉雾剂 · No verified English nameCXHL2401183 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/11/05New drug · Class 1 HSK39004吸入粉雾剂 · No verified English nameCXHL2401182 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/11/05New drug · Class 1 HSK39004吸入粉雾剂 · No verified English nameCXHL2401181 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/11/05New drug · Class 1 TM471-1胶囊 · No verified English nameCXHL2401180 Zhi Wei Biopharmaceuticals (Xin Xiang) Co., Ltd. romanized; Henan Shi Fan University romanized
2024/11/05New drug · Class 1 TM471-1胶囊 · No verified English nameCXHL2401179 Zhi Wei Biopharmaceuticals (Xin Xiang) Co., Ltd. romanized; Henan Shi Fan University romanized
2024/11/05New drug · Class 1 BGB-21447片 · No verified English nameCXHL2401178 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/05New drug · Class 1 BGB-21447片 · No verified English nameCXHL2401177 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/05New drug · Class 2.4 注射用艾博韦泰 · No verified English nameCXHL2401176 Qian Yan Bio Pharma (Nanjing) Co., Ltd. romanized
2024/11/05New drug · Class 1 JKN2306片 · No verified English nameCXHL2401175 Health Yuan Pharma Group Co., Ltd. romanized

96 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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