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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 361 drug applications between 29 November 2024 and 5 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 113, covering 91 drug names.

2024/11/29 – 2024/12/05

Period
2024/11/29 to 2024/12/05, 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
361
Drugs with new generic filings (by drug name, de-duplicated)
91
Accepted this week, now under review
11

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

361filings, 113 of them generic

By application type

Application typeFilings
Supplement162
Generic113
New drug59
Import17
Import re-registration5
Unspecified4
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug254
TCM59
Therapeutic biologic43
Prophylactic biologic3
Biologic2

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

91 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3223
2Oxcarbazepine Extended-release Tablets310
3Procaterol Hydrochloride Granules312
4Polymyxin B sulfate for Injection226
5Isavuconazonium Sulfate for Injection2215
6Sodium Hyaluronate Eye Drops2230
7Vonoprazan Fumarate Tablets2160
8Quetiapine Fumarate Extended-release Tablets210
9Budesonide Nasal Spray213
10Brexpiprazole Tablets2131

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

233 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized13130
2The Wellcome Foundation Limited720
3Shandong Xin Shi Dai Pharma Co., Ltd. romanized620
4Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized620
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
6Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized555
7Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized440
8Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized424
9Takeda Manufacturing Austria AG410
10Novartis Pharma AG330

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

116 this week

AcceptedDrugApplicants
2024/12/05Import · Class 1 PF-07934040片 · No verified English nameJXHL2400286 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/12/05Import · Class 1 PF-07934040片 · No verified English nameJXHL2400285 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/12/05Import · Class 1 PF-07934040片 · No verified English nameJXHL2400284 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/12/05Generic · Class 3 多索茶碱口服溶液 · No verified English nameCYHS2404206 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/12/05Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2404201 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2024/12/05Generic · Class 3 Gabexate Mesilate For InjectionCYHS2404194 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/12/05Generic · Class 3 Oxcarbazepine Extended-release TabletsCYHL2400247 Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized
2024/12/05Generic · Class 3 Oxcarbazepine Extended-release TabletsCYHL2400246 Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized
2024/12/05Generic · Class 3 Oxcarbazepine Extended-release TabletsCYHL2400245 Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized
2024/12/05New drug · Class 3.3 三价流感病毒亚单位疫苗 · No verified English nameCXSL2400826 Beijing Bai Hui Bio Technology Co., Ltd. romanized; Bo Hui Biopharmaceutical Co., Ltd. romanized
2024/12/05New drug · Class 1.4 24价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2400825 Fu Xing An Te Jin (Chengdu) Biopharmaceutical Co., Ltd. romanized
2024/12/05New drug · Class 1 HB0056注射液 · No verified English nameCXSL2400824 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized
2024/12/05New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2400823 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/12/05New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2400822 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/12/05New drug · Class 1 XNW5004片 · No verified English nameCXHL2401320 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2024/12/05New drug · Class 1 XNW5004片 · No verified English nameCXHL2401319 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2024/12/05New drug · Class 1 HRS-1301片 · No verified English nameCXHL2401318 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/05New drug · Class 1 HRS-1301片 · No verified English nameCXHL2401317 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/05New drug · Class 1 HRS-1301片 · No verified English nameCXHL2401316 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/04Import · Class 1 Deucrictibant缓释片 · No verified English nameJXHL2400283 Pharvaris Netherlands B.V.; Novotech Clinical Services (Shanghai) Co. Ltd.
2024/12/04Import · Class 1 Sepantronium Bromide注射液 · No verified English nameJXHL2400282 Cothera Bioscience Inc.; Beijing Percans Oncology Co. Ltd.
2024/12/04Generic · Class 3 Piracetam TabletsCYHS2404192 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2024/12/04Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2404191 Hefei Hua Wei Pharma Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2024/12/04Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2404186 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/12/04Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2404185 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/12/04Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2404183 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/12/04Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2404181 Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized
2024/12/04Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2404176 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2024/12/04Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2404175 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2024/12/04Generic · Class 3 Amisulpride Oral SolutionCYHS2404171 Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized

86 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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