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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 220 drug applications between 22 March 2024 and 28 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 54 drug names.

2024/03/22 – 2024/03/28

Period
2024/03/22 to 2024/03/28, 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
220
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

220filings, 67 of them generic

By application type

Application typeFilings
Supplement89
Generic67
New drug31
Import20
Import re-registration7
Unspecified6

By drug type

Drug typeFilings
Chemical drug154
Therapeutic biologic33
TCM28
Biologic3
Prophylactic biologic2

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
1Bumetanide Injection3213
2Nicorandil for Injection221
3Glucosamine Sulfate Capsules2251
4Oseltamivir Phosphate Capsules2239
5Levothyroxine Sodium Tablets2112
6Ibuprofen Injection218
7Brivaracetam Tablets2119
8Ticagrelor Tablets2110
9Neostigmine Methylsulfate Injection214
10Ambroxol Hydrochloride Oral Solution2146

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

150 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Merck Sharp & Dohme LLC550
2Shijiazhuang No.4 Pharmaceutical Co., Ltd.555
3Hunan Ke Lun Pharmaceutical Co., Ltd. romanized520
4Yi Chang Nuo An Pharmaceutical Co., Ltd. romanized440
5Albireo AB410
6LG Chem Ltd.410
7He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized410
8Shanxi De Yuan Tang Pharma Co., Ltd. romanized331
9Janssen-Cilag International NV320
10Beijing Foyou Pharma CO.,LTD323

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

79 this week

AcceptedDrugApplicants
2024/03/28Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2400033 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2024/03/28Import · Class 3.1 冻干膀胱灌注用卡介苗(日本株) · No verified English nameJXSS2400032 Japan BCG Laboratory; Japan BCG Laboratory,Kiyose Plant; Name not romanized
2024/03/28Import · Class 3.1 注射用维恩妥尤单抗 · No verified English nameJXSS2400031 Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co. Ltd.
2024/03/28Import · Class 3.1 注射用维恩妥尤单抗 · No verified English nameJXSS2400030 Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co Ltd.
2024/03/28Import · Class 1 Balcinrenone达格列净胶囊 · No verified English nameJXHL2400070 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/03/28Import · Class 1 Balcinrenone达格列净胶囊 · No verified English nameJXHL2400069 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/03/28Generic · Class 3 Bumetanide InjectionCYHS2400947 Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized
2024/03/28Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2400946 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/03/28Generic · Class 3 Haloperidol TabletsCYHS2400944 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2024/03/28Generic · Class 3 Bumetanide InjectionCYHS2400943 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2024/03/28Generic · Class 3 Bumetanide InjectionCYHS2400942 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2024/03/28Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2400940 Hainan Mei Kang Da Pharma Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/03/28Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2400939 Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/03/28Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2400938 Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/03/28Generic · Class 3 Minoxidil LinimentCYHS2400936 Guangzhou Hui Yuan Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized
2024/03/28Generic · Class 3 Diprophylline InjectionCYHS2400931 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/03/28Generic · Class 3 Ibuprofen InjectionCYHL2400067 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2024/03/28Generic · Class 3 Ibuprofen InjectionCYHL2400066 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2024/03/28New drug · Class 1 注射用聚乙二醇化促血小板生成肽 · No verified English nameCXSL2400205 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2024/03/28New drug · Class 1 注射用重组酰化胰高血糖素样肽2类似物 · No verified English nameCXSL2400204 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2024/03/28New drug · Class 1 SK-08片 · No verified English nameCXHL2400317 Kang Chen Pharma (Nei Menggu) Co., Ltd. romanized
2024/03/28New drug · Class 1 SK-08片 · No verified English nameCXHL2400316 Kang Chen Pharma (Nei Menggu) Co., Ltd. romanized
2024/03/28New drug · Class 1 SK-08片 · No verified English nameCXHL2400315 Kang Chen Pharma (Nei Menggu) Co., Ltd. romanized
2024/03/28New drug · Class 2.2 磷酸奥司他韦口溶膜 · No verified English nameCXHL2400314 Gansu Pu Di An Pharmaceutical Co., Ltd. romanized
2024/03/28New drug · Class 2.2 磷酸奥司他韦口溶膜 · No verified English nameCXHL2400313 Gansu Pu Di An Pharmaceutical Co., Ltd. romanized
2024/03/28New drug · Class 2.2 磷酸奥司他韦口溶膜 · No verified English nameCXHL2400312 Gansu Pu Di An Pharmaceutical Co., Ltd. romanized
2024/03/28New drug · Class 1 AXT-1003胶囊 · No verified English nameCXHL2400311 Ai Si Tuo Kang Pharmaceuticals Technology (Beijing) Co., Ltd. romanized
2024/03/28New drug · Class 1 JAB-30355片 · No verified English nameCXHL2400310 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2024/03/28New drug · Class 1 JAB-30355片 · No verified English nameCXHL2400309 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2024/03/27Import · Class 2.1; 2.2 古塞奇尤单抗注射液(静脉输注) · No verified English nameJXSS2400029 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.

49 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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