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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 299 drug applications between 19 May 2024 and 25 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 54 drug names.

2024/05/19 – 2024/05/25

Period
2024/05/19 to 2024/05/25, 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
299
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

299filings, 70 of them generic

By application type

Application typeFilings
Supplement155
Generic70
New drug41
Import re-registration17
Import11
Unspecified5

By drug type

Drug typeFilings
Chemical drug185
TCM64
Therapeutic biologic45
Prophylactic biologic3
In vitro diagnostic reagent1
Biologic1

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
1Bupivacaine Hydrochloride Injection424
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
3Glucosamine Sulfate Capsules2251
4复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液 · No verified English name210
5Nicergoline Tablets211
6Levetiracetam extended-release tablets210
7Baricitinib Tablets2132
8帕拉米韦氯化钠注射液 · No verified English name2117
9平衡盐冲洗液 · No verified English name210
10Famotidine Injection218

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

181 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Qin Huang Dao Shan Hai Guan Pharma Co., Ltd. romanized660
2Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized620
3Bracco Imaging S.P.A.610
4AbbVie Inc.530
5Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized520
6Shanghai Wan Shi Cheng Pharma Co., Ltd. romanized440
7Anhui Zhong Chen Pharmaceutical Co., Ltd. romanized440
8Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized430
9Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized420
10HUNAN WARRANT PHARMACEUTICAL CO.,LTD422

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

86 this week

AcceptedDrugApplicants
2024/05/25Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2401573 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2024/05/25Generic · Class 3 Acetylcysteine InjectionCYHS2401572 Hubei Jin Yao Pharma Co., Ltd. romanized
2024/05/25New drug · Class 1 LY01620 · No verified English nameCXSL2400349 Nanjing Ji Mai Bio Technology Co., Ltd. romanized
2024/05/25New drug · Class 1 注射用ZGGS18 · No verified English nameCXSL2400348 Name not romanized
2024/05/25New drug · Class 1 注射用ZG005 · No verified English nameCXSL2400347 Name not romanized
2024/05/25New drug · Class 1 RC148注射液 · No verified English nameCXSL2400346 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/05/25New drug · Class 1 注射用RC118 · No verified English nameCXSL2400345 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/05/25New drug · Class 2.4 青蒿琥酯片 · No verified English nameCXHL2400527 Gui Lin Nan Yao Co., Ltd. romanized; Shanghai Jiao Tong University romanized
2024/05/24Import · Class 1 Astegolimab注射液 · No verified English nameJXSL2400103 F. Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2024/05/24Import · Class 2.2 Epcoritamab注射用浓溶液 · No verified English nameJXSL2400102 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/05/24Import · Class 2.2 Epcoritamab注射用浓溶液 · No verified English nameJXSL2400101 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/05/24Import · Class 2.2 Epcoritamab注射液 · No verified English nameJXSL2400100 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/05/24Import · Class 2.2 Epcoritamab注射液 · No verified English nameJXSL2400099 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/05/24Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2401571 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2024/05/24Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2401570 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2024/05/24Generic · Class 3 Nicergoline TabletsCYHS2401569 Hainan Tong Yong San Yang Pharma Co., Ltd. romanized
2024/05/24Generic · Class 3 Nicergoline TabletsCYHS2401567 Hainan Tong Yong San Yang Pharma Co., Ltd. romanized
2024/05/24Generic · Class 3 Betahistine Dihydrochloride TabletsCYHS2401560 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2024/05/24Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2401557 Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2024/05/24Generic · Class 3 复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液 · No verified English nameCYHS2401556 Shandong Qidu Pharmaceutical Co., Ltd.
2024/05/24Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2401555 Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/05/24Generic · Class 3 复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液 · No verified English nameCYHS2401554 Shandong Qidu Pharmaceutical Co., Ltd.
2024/05/24Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2401553 Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/05/24Generic · Class 3 米诺地尔泡沫剂(女用) · No verified English nameCYHL2400101 Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized
2024/05/24Generic · Class 3 米诺地尔泡沫剂(男用) · No verified English nameCYHL2400100 Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized
2024/05/24New drug · Class 1 注射用HS-20124 · No verified English nameCXSL2400344 Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/05/24New drug · Class 1 GenSci098注射液 · No verified English nameCXSL2400343 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/05/24New drug · Class 1 JH013注射液 · No verified English nameCXSL2400342 Bai Tai Bio Pharma Co., Ltd. romanized; An Bo Tai Ke Pharma Co., Ltd. romanized
2024/05/24New drug · Class 1 SHR-3821注射液 · No verified English nameCXSL2400341 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/05/24New drug · Class 1.2 重组破伤风疫苗(大肠埃希菌) · No verified English nameCXSL2400340 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized

56 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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