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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 317 drug applications between 31 October 2023 and 6 November 2023 (data as of 14 November 2026 06:00). Of these, generic applications numbered 74, covering 57 drug names.

2023/10/31 – 2023/11/06

Period
2023/10/31 to 2023/11/06, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
317
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

317filings, 74 of them generic

By application type

Application typeFilings
Supplement149
Generic74
New drug66
Import re-registration18
Import8
Unspecified2

By drug type

Drug typeFilings
Chemical drug204
TCM67
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
1Sodium Hyaluronate Eye Drops3232
2Minoxidil Liniment3252
3Perindopril tert-Butylamine Tablets315
4Potassium Phosphates Injection222
5Carbazochrome Sodium Sulfonate Injection211
6Procaterol Hydrochloride Solution for Inhalation212
7Doxofylline Tablets212
8Olmesartan Medoxomil Tablets211
9Vonoprazan Fumarate Tablets2158
10Brivaracetam Tablets2119

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

201 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized990
2Guangdong Tuan Li Pharmaceutical Co., Ltd. romanized550
3Bai Ao Tai Biopharmaceutical Co., Ltd. romanized530
4Janssen-Cilag International NV520
5Merck Sharp & Dohme B.V.510
6Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized510
7Wuhan Lang Lai Technology Development Co., Ltd. romanized420
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
9Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized424
10Shang Qiu Shi Xin Ma Bio Technology 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

106 this week

AcceptedDrugApplicants
2023/11/06Generic · Class 3 Potassium Phosphates InjectionCYHS2303010 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/11/06New drug · Class 1 QR056240CR片 · No verified English nameCXHL2301223 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/11/06New drug · Class 1 QR056240CR片 · No verified English nameCXHL2301222 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/11/06New drug · Class 1 BGB-43395片 · No verified English nameCXHL2301221 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/11/06New drug · Class 1 BGB-43395片 · No verified English nameCXHL2301220 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/11/06New drug · Class 1 BGB-43395片 · No verified English nameCXHL2301219 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/11/04Generic · Class 3 Potassium Phosphates InjectionCYHS2303008 Chengdu Giantech Hi-technology Development Co., Ltd.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/11/04Generic · Class 3 富马酸酮替芬滴眼液 · No verified English nameCYHS2303005 Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/11/04Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2303003 Hebei Chuang Jian Pharma Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/11/04Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2303002 Hebei Chuang Jian Pharma Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/11/04Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2303001 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2023/11/04Generic · Class 3 小儿复方氨基酸注射液(20AA) · No verified English nameCYHS2302930 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/11/04New drug · Class 2.4 BAT4706注射液 · No verified English nameCXSL2300764 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/11/04New drug · Class 2.4 BAT4706注射液 · No verified English nameCXSL2300763 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/11/04New drug · Class 1 BAT7104注射液 · No verified English nameCXSL2300762 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/11/04New drug · Class 1 GMCN-508B自体造血干祖细胞注射液 · No verified English nameCXSL2300761 Zhong Ji Zhi Yao (Nanjing) Bio Technology Co., Ltd. romanized
2023/11/04New drug · Class 1 注射用间充质干细胞(脐带) · No verified English nameCXSL2300760 Tianjin Ang Sai Xi Bao Ji Yin Gong Cheng Co., Ltd. romanized
2023/11/04New drug · Class 1 SHR0302片 · No verified English nameCXHS2300097 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/11/04New drug · Class 1 GH2616片 · No verified English nameCXHL2301218 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2023/11/04New drug · Class 1 GH2616片 · No verified English nameCXHL2301217 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2023/11/04New drug · Class 2.3 SZJ-208 · No verified English nameCXHL2301216 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/11/04New drug · Class 1 注射用双利司他 · No verified English nameCXHL2301215 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
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

76 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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