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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 186 drug applications between 21 March 2024 and 27 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 48 drug names.

2024/03/21 – 2024/03/27

Period
2024/03/21 to 2024/03/27, 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
186
Drugs with new generic filings (by drug name, de-duplicated)
48
Accepted this week, now under review
1

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

186filings, 57 of them generic

By application type

Application typeFilings
Supplement82
Generic57
New drug23
Import13
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug128
TCM27
Therapeutic biologic27
Biologic2
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

48 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Morinidazole and Sodium Chloride Injection229
2Potassium Phosphates Injection222
3Nicorandil for Injection221
4Glucosamine Sulfate Capsules2251
5Oseltamivir Phosphate Capsules2239
6Levothyroxine Sodium Tablets2112
7Brivaracetam Tablets2119
8Ambroxol Hydrochloride Oral Solution2146
9Sugammadex Sodium Injection216
10Crisaborole Ointment1126

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

132 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized550
2Yi Chang Nuo An Pharmaceutical Co., Ltd. romanized440
3Beijing Foyou Pharma CO.,LTD434
4Bai Ao Tai Biopharmaceutical Co., Ltd. romanized430
5Albireo AB410
6LG Chem Ltd.410
7He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized410
8Merck Sharp & Dohme LLC330
9Shanxi De Yuan Tang Pharma Co., Ltd. romanized331
10Shijiazhuang No.4 Pharmaceutical Co., Ltd.333

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

57 this week

AcceptedDrugApplicants
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.
2024/03/27Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSS2400028 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2024/03/27Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSS2400027 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2024/03/27Import · Class 1 MK-0616 片 · No verified English nameJXHL2400068 Merck Sharp & Dohme LLC; Name not romanized
2024/03/27Generic · Class 3 草酸艾司西酞普兰口服滴剂 · No verified English nameCYHS2400930 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2024/03/27Generic · Class 3 Epinastine Hydrochloride Eye DropsCYHS2400929 Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized; Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2024/03/27Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2400928 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/03/27Generic · Class 3 Minoxidil LinimentCYHS2400926 Guangzhou Hui Yuan Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized
2024/03/27Generic · Class 3 盐酸丙卡特罗干糖浆 · No verified English nameCYHS2400922 Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized
2024/03/27Generic · Class 3 Fudosteine oral solutionCYHS2400919 Jilin Chang Bai Shan Pharma Group Co., Ltd. romanized
2024/03/27Generic · Class 3 Famotidine InjectionCYHS2400916 Wuhan Fu Xing Bio Pharma Co., Ltd. romanized
2024/03/27New drug · Class 1 注射用HDM2005 · No verified English nameCXSL2400203 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2024/03/27New drug · Class 2.4 赛沃替尼片 · No verified English nameCXHS2400022 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2024/03/27New drug · Class 2.4 赛沃替尼片 · No verified English nameCXHS2400021 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2024/03/27New drug · Class 1 ASP3082注射液 · No verified English nameCXHL2400308 An Si Tai Lai (Zhongguo) Investment Co., Ltd. romanized
2024/03/27New drug · Class 2.2 HZ211口溶膜 · No verified English nameCXHL2400307 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2024/03/27New drug · Class 1 HSK42360片 · No verified English nameCXHL2400306 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/03/27New drug · Class 1 HSK42360片 · No verified English nameCXHL2400305 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/03/26Import · Class 2.4 LNP023胶囊 · No verified English nameJXHL2400067 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/03/26Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2400913 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2024/03/26Generic · Class 3 Milrinone InjectionCYHS2400910 Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized
2024/03/26Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2400907 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2024/03/26Generic · Class 3 Brivaracetam TabletsCYHL2400065 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/03/26Generic · Class 3 Brivaracetam TabletsCYHL2400064 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/03/26New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2400304 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/03/26New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2400303 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/03/26New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2400302 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/03/26New drug · Class 1 HRS7415片 · No verified English nameCXHL2400301 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/03/26New drug · Class 1 HRS-8080片 · No verified English nameCXHL2400300 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/26New drug · Class 1 HRS-8080片 · No verified English nameCXHL2400299 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized

27 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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