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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 323 drug applications between 23 August 2024 and 29 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 60 drug names.

2024/08/23 – 2024/08/29

Period
2024/08/23 to 2024/08/29, 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
323
Drugs with new generic filings (by drug name, de-duplicated)
60
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

323filings, 80 of them generic

By application type

Application typeFilings
Supplement143
Generic80
New drug57
Import18
Unspecified13
Import re-registration12

By drug type

Drug typeFilings
Chemical drug198
TCM66
Therapeutic biologic45
Prophylactic biologic8
Biologic6

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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bumetanide Injection6313
2Riociguat Tablets314
3洛索洛芬钠凝胶贴膏 · No verified English name229
4Nicardipine Hydrochloride Injection2213
5Salbutamol Sulfate injection221
6维生素B12滴眼液 · No verified English name222
7Lactulose Oral Solution2134
8Brexpiprazole Tablets2131
9Empagliflozin Tablets2118
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

210 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen Research & Development LLC720
2Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized650
3Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized610
4Novo Nordisk A/S510
5Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized440
6Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized440
7Sichuan Kelun Pharmaceutical Co., Ltd.432
8Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized420
9Novo Nordisk Pharma AG410
10Haerbin Mei Jun Pharmaceutical Co., Ltd. romanized330

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

102 this week

AcceptedDrugApplicants
2024/08/29Generic · Class 3 Fludeoxyglucose[18F] InjectionCYHS2402816 Guangzhou Shi Yuan Zi Gao Ke Tong Wei Su Pharmaceuticals Co., Ltd. romanized
2024/08/29Generic · Class 3 Diprophylline InjectionCYHS2402813 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/08/29Generic · Class 3 Pregabalin Oral SolutionCYHS2402812 Guangdong He Wei Pharmaceutical Co., Ltd. romanized
2024/08/29Generic · Class 3 Magnesium Sulfate InjectionCYHS2402809 Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/08/29Generic · Class 3 Bumetanide InjectionCYHS2402806 Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2024/08/29Generic · Class 3 Bumetanide InjectionCYHS2402805 Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2024/08/29New drug · Class 2.2 九价人乳头瘤病毒疫苗(大肠埃希菌) · No verified English nameCXSL2400580 Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized; Xiamen University romanized
2024/08/29New drug · Class 1 KQ-2002 CAR-T细胞注射液 · No verified English nameCXSL2400579 Ke Yi (Zhejiang) Pharma Technology Co., Ltd. romanized
2024/08/29New drug · Class 1 KQ-2002 CAR-T细胞注射液 · No verified English nameCXSL2400578 Ke Yi (Zhejiang) Pharma Technology Co., Ltd. romanized
2024/08/29New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2400577 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/08/29New drug · Class 1 注射用SHR-9839 · No verified English nameCXSL2400576 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/08/29New drug · Class 1 SHR-7367注射液 · No verified English nameCXSL2400575 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/08/29New drug · Class 1 TQC2731注射液 · No verified English nameCXSL2400574 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/08/29New drug · Class 1 注射用甲苯磺酸钠烟酰胺腙聚乙二醇双环RGD肽 · No verified English nameCXHS2400087 Fo Shan Rui Di Ao Pharmaceuticals Co., Ltd. romanized; Beijing Shi Hong Pharma Co., Ltd. romanized
2024/08/29New drug · Class 1 锝[99mTc]肼基烟酰胺聚乙二醇双环RGD肽注射液 · No verified English nameCXHS2400086 Fo Shan Rui Di Ao Pharmaceuticals Co., Ltd. romanized; Jiangsu Hua Yi Technology Co., Ltd. romanized
2024/08/29New drug · Class 1 琥珀八氢氨吖啶片 · No verified English nameCXHS2400085 Tong Hua Jin Ma Pharma Group Co., Ltd. romanized
2024/08/29New drug · Class 1 琥珀八氢氨吖啶片 · No verified English nameCXHS2400084 Tong Hua Jin Ma Pharma Group Co., Ltd. romanized
2024/08/29New drug · Class 1 LDR2402注射液 · No verified English nameCXHL2400881 Chengdu Xian Yan Bio Technology Co., Ltd. romanized
2024/08/29New drug · Class 1 AC-201片 · No verified English nameCXHL2400880 Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2024/08/29New drug · Class 1 TQH3906胶囊 · No verified English nameCXHL2400879 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/08/29New drug · Class 1 TQH3906胶囊 · No verified English nameCXHL2400878 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/08/29New drug · Class 1 HRS-4642注射液 · No verified English nameCXHL2400877 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/08/29New drug · Class 1 注射用JMKX003676 · No verified English nameCXHL2400876 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2024/08/29New drug · Class 2.2 HQ2216注射液 · No verified English nameCXHL2400875 Bai Cheng Pharmaceuticals (Zhuhai Heng Qin) Co., Ltd. romanized
2024/08/29New drug · Class 1 SBK007片 · No verified English nameCXHL2400874 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/28Import · Class 3.1 替利珠单抗注射液 · No verified English nameJXSS2400070 Provention Bio Inc.; Ajinomoto Althea Inc.; Sanofi (China) Investment Co. Ltd.
2024/08/28Import · Class 1 BI 1015550 片 · No verified English nameJXHL2400210 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/28Import · Class 1 BI 1015550 片 · No verified English nameJXHL2400209 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/28Generic · Class 3 硝苯地平缓释片(Ⅱ) · No verified English nameCYHS2402802 Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2024/08/28Generic · Class 3 Bumetanide InjectionCYHS2402798 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized

72 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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