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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 351 drug applications between 28 October 2023 and 3 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 54 drug names.

2023/10/28 – 2023/11/03

Period
2023/10/28 to 2023/11/03, 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
351
Drugs with new generic filings (by drug name, de-duplicated)
54
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

351filings, 70 of them generic

By application type

Application typeFilings
Supplement179
Generic70
New drug69
Import re-registration20
Import8
Unspecified5

By drug type

Drug typeFilings
Chemical drug236
TCM62
Therapeutic biologic45
Prophylactic biologic5
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

54 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Piracetam Injection429
2Benidipine Hydrochloride Tablets324
3Minoxidil Liniment3252
4Perindopril tert-Butylamine Tablets315
5Betamethasone Sodium Phosphate Injection215
6Procaterol Hydrochloride Solution for Inhalation212
7Doxofylline Tablets212
8Brivaracetam Tablets2119
9Potassium Chloride Granules214
10Roxadustat Capsules2117

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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Shuang Yan Pharma Co., Ltd. romanized2890
2Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized660
3Guangdong Tuan Li Pharmaceutical Co., Ltd. romanized550
4Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized540
5Janssen-Cilag International NV520
6Merck Sharp & Dohme B.V.510
7Haerbin Han Bang Medical Technology Co., Ltd. romanized510
8Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized510
9Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized510
10Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized420

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

110 this week

AcceptedDrugApplicants
2023/11/03Import · Class 1 盐酸BAY 3283142片 · No verified English nameJXHL2300271 Bayer AG; Bayer Healthcare Company Ltd.
2023/11/03Import · Class 1 盐酸BAY 3283142片 · No verified English nameJXHL2300270 Bayer AG; Bayer Healthcare Company Ltd.
2023/11/03Generic · Class 3 Glycerol Fructose And Sodium Chloride InjectionCYHS2302989 Hubei Mei Lin Pharma Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/11/03Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2302987 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/11/03Generic · Class 3 Potassium Chloride InjectionCYHS2302986 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/11/03New drug · Class 1 伊基奥仑赛注射液 · No verified English nameCXSL2300759 Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized
2023/11/03New drug · Class 1 PD-1基因编辑T细胞注射液 · No verified English nameCXSL2300758 Mei Jie Sai Er (Beijing) Bio Technology Co., Ltd. romanized
2023/11/03New drug · Class 1 YTS104细胞注射液 · No verified English nameCXSL2300757 Hua Xia Ying Tai (Beijing) Bio Technology Co., Ltd. romanized
2023/11/03New drug · Class 1 BST02注射液 · No verified English nameCXSL2300756 Guangzhou Bai Ji Biopharmaceutical Co., Ltd. romanized
2023/11/03New drug · Class 1 ARC01注射液 · No verified English nameCXSL2300755 Nanjing Ao Luo Bio Technology Co., Ltd. romanized
2023/11/03New drug · Class 1 TQB3909片 · No verified English nameCXHL2301214 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/11/03New drug · Class 1 HY-0902片 · No verified English nameCXHL2301213 Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized; Shandong University romanized
2023/11/03New drug · Class 1 HY-0902片 · No verified English nameCXHL2301212 Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized; Shandong University romanized
2023/11/03New drug · Class 2.3 Y-4片 · No verified English nameCXHL2301211 Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized
2023/11/03New drug · Class 2.3 Y-4片 · No verified English nameCXHL2301210 Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized
2023/11/03New drug · Class 2.4 Azacitidine For InjectionCXHL2301209 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/11/03New drug · Class 1 XH-S004片 · No verified English nameCXHL2301207 Zhejiang Xing Hao Peng Bo Pharmaceuticals Co., Ltd. romanized
2023/11/02Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2300190 Sanofi-Aventis Recherche & Développement; Sanofi(China) Investment Co. LTD
2023/11/02Generic · Class 3 Sodium Bicarbonate InjectionCYHS2302985 Name not romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2023/11/02Generic · Class 3 Ferrous Succinate TabletsCYHS2302983 Jiangsu Zhong Tian Pharma Co., Ltd. romanized
2023/11/02Generic · Class 3 Methocarbamol InjectionCYHS2302977 Jiangsu Shen Long Pharma Co., Ltd. romanized
2023/11/02Generic · Class 3 Acetylcysteine InjectionCYHS2302976 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/11/02Generic · Class 3 Minoxidil LinimentCYHS2302974 Le Tai Pharma Co., Ltd. romanized; Le Tai Pharma (Lan Xi) Co., Ltd. romanized
2023/11/02Generic · Class 3 Minoxidil LinimentCYHS2302973 Le Tai Pharma Co., Ltd. romanized; Le Tai Pharma (Lan Xi) Co., Ltd. romanized
2023/11/02Generic · Class 3 Minoxidil LinimentCYHS2302972 Le Xin Le Mei (Hainan) Bio Technology Co., Ltd. romanized; Su Zhou Yi Fan Pharma Co., Ltd. romanized
2023/11/02Generic · Class 3 Brivaracetam TabletsCYHL2300134 Chengdu Ao Bang Pharma Co., Ltd. romanized
2023/11/02Generic · Class 3 Brivaracetam TabletsCYHL2300133 Chengdu Ao Bang Pharma Co., Ltd. romanized
2023/11/02New drug · Class 3.1 温经汤颗粒 · No verified English nameCXZS2300022 Guo Yao Group De Zhong (Fo Shan) Pharma Co., Ltd. romanized
2023/11/02New drug · Class 1.1 莎毕娅片 · No verified English nameCXZL2300068 Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized
2023/11/02New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300754 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized

80 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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