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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 339 drug applications between 26 July 2023 and 1 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 57 drug names.

2023/07/26 – 2023/08/01

Period
2023/07/26 to 2023/08/01, 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
339
Drugs with new generic filings (by drug name, de-duplicated)
57
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

339filings, 72 of them generic

By application type

Application typeFilings
Supplement186
Generic72
New drug55
Import18
Import re-registration5
Unspecified3

By drug type

Drug typeFilings
Chemical drug249
TCM44
Therapeutic biologic43
Prophylactic biologic3

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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Topiroxostat Tablets420
2Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution228
3Multiple Electrolytes Injection(Ⅱ)211
4Pravastatin Sodium Tablets212
5Carfilzomib For Injection210
6Cefuroxime Sodium for Injection218
7Neostigmine Methylsulfate Injection214
8Naloxone Hydrochloride Injection211
9Thioctic Acid Tablets214
10Mirabegron Extended-release Tablets211

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

185 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Qian Jiang Pharmaceutical Co., Ltd. romanized20180
2Bayer AG920
3Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized910
4Liaoning Hua Rui Joint Pharmaceutical Co., Ltd. romanized860
5BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED720
6Xian Jing Xi Shuang He Pharma Co., Ltd. romanized710
7Hong Xiang (Heilongjiang) Pharmaceutical Co., Ltd. romanized660
8Sanofi Winthrop Industrie510
9Sichuan He Zong Ze Hui Pharmaceuticals Technology Co., Ltd. romanized440
10Changsha Xin Lin Pharmaceutical Co., Ltd. romanized440

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

103 this week

AcceptedDrugApplicants
2023/08/01Import · Class 1 注射用佐妥昔单抗 · No verified English nameJXSS2300066 Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co. Ltd.
2023/08/01Import · Class 1 AAV5-hRKp.RPGR眼内注射溶液 · No verified English nameJXSL2300148 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/01Import · Class 1 AAV5-hRKp.RPGR眼内注射溶液 · No verified English nameJXSL2300147 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/01Import · Class 1 ES104 · No verified English nameJXSL2300146 Elpiscience Biopharmaceuticals Co. Limited; Elpiscience (Suzhou) Biopharma Ltd.
2023/08/01Import · Class 1 MK-0616 片 · No verified English nameJXHL2300180 Merck Sharp & Dohme LLC; Name not romanized
2023/08/01Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2302055 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/08/01Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2302054 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/08/01Generic · Class 3 福多司坦片 · No verified English nameCYHS2302051 Topfond Pharmaceutical Co., Ltd.
2023/08/01Generic · Class 3 Oxazepam TabletsCYHS2302048 Hunan Dong Ting Pharma Co., Ltd. romanized
2023/08/01Generic · Class 3 Furosemide InjectionCYHS2302046 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2023/08/01Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2302042 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/08/01Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2302041 Beijing Ya Bao Bio Pharma Co., Ltd. romanized
2023/08/01New drug · Class 1 依沃西单抗注射液 · No verified English nameCXSS2300061 Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized; Kang Fang Pharma Co., Ltd. romanized
2023/08/01New drug · Class 1 IBI343 · No verified English nameCXSL2300532 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/08/01New drug · Class 1 重组溶瘤腺病毒注射剂(KD01) · No verified English nameCXSL2300531 Wuhan Kai De Ji Nuo Bio Technology Co., Ltd. romanized
2023/08/01New drug · Class 2.2 赛帕利单抗注射液 · No verified English nameCXSL2300530 Guangzhou Yu Heng Bio Technology Co., Ltd. romanized
2023/08/01New drug · Class 3.4 人凝血因子IX · No verified English nameCXSL2300529 Guangdong Shuang Lin Biopharmaceutical Co., Ltd. romanized
2023/08/01New drug · Class 2.1 HZ-J001乳膏 · No verified English nameCXHL2300849 Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized
2023/08/01New drug · Class 2.1 HZ-J001乳膏 · No verified English nameCXHL2300848 Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized
2023/08/01New drug · Class 2.1 HZ-J001乳膏 · No verified English nameCXHL2300847 Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized
2023/08/01New drug · Class 2.1 HZ-J001乳膏 · No verified English nameCXHL2300846 Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized
2023/08/01New drug · Class 2.1 HZ-J001乳膏 · No verified English nameCXHL2300845 Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized
2023/08/01New drug · Class 2.1 HZ-J001乳膏 · No verified English nameCXHL2300844 Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized
2023/08/01New drug · Class 1 HR1405-01注射液 · No verified English nameCXHL2300843 Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized
2023/08/01New drug · Class 2.2 N2103肠溶胶囊 · No verified English nameCXHL2300842 Jiangsu Hui Ju Pharma Co., Ltd. romanized
2023/08/01New drug · Class 2.2 N2103肠溶胶囊 · No verified English nameCXHL2300841 Jiangsu Hui Ju Pharma Co., Ltd. romanized
2023/08/01New drug · Class 2.1 HZ-J001乳膏 · No verified English nameCXHL2300840 Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized
2023/08/01New drug · Class 2.1 HZ-J001乳膏 · No verified English nameCXHL2300839 Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized
2023/08/01New drug · Class 2.1 HZ-J001乳膏 · No verified English nameCXHL2300838 Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized
2023/07/31Generic · Class 3 Alprostadil InjectionCYHL2300094 Shijiazhuang No.4 Pharmaceutical Co., Ltd.

73 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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