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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 400 drug applications between 28 November 2024 and 4 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 117, covering 94 drug names.

2024/11/28 – 2024/12/04

Period
2024/11/28 to 2024/12/04, 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
400
Drugs with new generic filings (by drug name, de-duplicated)
94
Accepted this week, now under review
12

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

400filings, 117 of them generic

By application type

Application typeFilings
Supplement197
Generic117
New drug64
Import15
Unspecified3
Import re-registration3
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug287
TCM62
Therapeutic biologic50
Prophylactic 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

94 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets5360
2Sacubitril Valsartan Sodium Tablets3170
3Procaterol Hydrochloride Granules312
4Polymyxin B sulfate for Injection226
5Isavuconazonium Sulfate for Injection2215
6Sodium Hyaluronate Eye Drops2230
7Glucosamine Sulfate Capsules2251
8Quetiapine Fumarate Extended-release Tablets210
9Brexpiprazole Tablets2131
10Sildenafil Citrate Tablets2112

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

250 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized1340
2Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized770
3The Wellcome Foundation Limited720
4Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized660
5Shandong Xin Shi Dai Pharma Co., Ltd. romanized620
6Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized620
7Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized555
8Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized535
9Hua Zhong Pharma Co., Ltd. romanized523
10Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized510

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

119 this week

AcceptedDrugApplicants
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
2024/12/04Generic · Class 3 Ibuprofen and Phenylephrine Hydrochloride TabletsCYHL2400242 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2024/12/04New drug · Class 2.3 恒古骨伤愈合剂 · No verified English nameCXZL2400086 Sai Ling Pharma Technology Group Co., Ltd. romanized
2024/12/04New drug · Class 2.3 恒古骨伤愈合剂 · No verified English nameCXZL2400085 Sai Ling Pharma Technology Group Co., Ltd. romanized
2024/12/04New drug · Class 2.3 恒古骨伤愈合剂 · No verified English nameCXZL2400084 Sai Ling Pharma Technology Group Co., Ltd. romanized
2024/12/04New drug · Class 1 重组质粒-肝细胞生长因子注射液 · No verified English nameCXSS2400137 Wuhan Guang Gu Ren Fu Biopharmaceuticals Co., Ltd. romanized; Jiangsu Yao Hai Biopharmaceutical Co., Ltd. romanized
2024/12/04New drug · Class 3.4 静注人免疫球蛋白(pH4) · No verified English nameCXSS2400136 Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized
2024/12/04New drug · Class 3.4 静注人免疫球蛋白(pH4) · No verified English nameCXSS2400135 Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized
2024/12/04New drug · Class 3.3 帕妥珠单抗注射液 · No verified English nameCXSS2400134 Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2024/12/04New drug · Class 2.2 依沃西单抗注射液 · No verified English nameCXSL2400821 Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized
2024/12/04New drug · Class 1 NCR101注射液 · No verified English nameCXSL2400820 Zhong Sheng Su Yuan (Guangzhou) Bio Technology Co., Ltd. romanized; Anhui Zhong Sheng Su Yuan Bio Technology Co., Ltd. romanized
2024/12/04New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400819 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/12/04New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400818 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/12/04New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400817 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/12/04New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400816 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/12/04New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400815 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/12/04New drug · Class 1 KNT-0916片 · No verified English nameCXHL2401315 Guangzhou Ke En Tai Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/04New drug · Class 1 KNT-0916片 · No verified English nameCXHL2401314 Guangzhou Ke En Tai Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/04New drug · Class 1 KNT-0916片 · No verified English nameCXHL2401313 Guangzhou Ke En Tai Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/04New drug · Class 1 注射用H1710 · No verified English nameCXHL2401312 Shenzhen Shi Hai Pu Rui Pharma Group Co., Ltd. romanized

89 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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