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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 359 drug applications between 26 February 2024 and 3 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 46 drug names.

2024/02/26 – 2024/03/03

Period
2024/02/26 to 2024/03/03, 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
359
Drugs with new generic filings (by drug name, de-duplicated)
46
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

359filings, 57 of them generic

By application type

Application typeFilings
Supplement222
Generic57
New drug46
Import17
Unspecified12
Import re-registration5

By drug type

Drug typeFilings
Chemical drug205
TCM99
Therapeutic biologic51
Prophylactic biologic3
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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diprophylline Injection447
2Calcium Folinate Injection224
3Vonoprazan Fumarate Tablets2160
4Bisoprolol Fumarate Tablets216
5Enzalutamide Tablets212
6Sildenafil Citrate Tablets2112
7盐酸维洛沙秦缓释胶囊 · No verified English name210
8长链脂肪乳注射液(OO) · No verified English name210
9Fluvoxamine Maleate Tablets210
10Ezetimibe and Simvastatin Tablets114

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

184 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized62470
2Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized13130
3EUROAPI Germany GmbH550
4SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED542
5Dr. Falk Pharma GmbH520
6CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
7Myokardia Inc.510
8Jilin Sheng Li Sheng Pharmaceutical Co., Ltd. romanized440
9Sichuan Kelun Pharmaceutical Co., Ltd.424
10Guo Yao Group Guizhou Biopharmaceutical 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

86 this week

AcceptedDrugApplicants
2024/03/02Import · Class 3.1 注射用利纳西普 · No verified English nameJXSS2400016 Kiniksa Pharmaceuticals (UK) Ltd.; Jubilant HollisterStier LLC; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICALS CO. LTD
2024/03/02Import · Class 1 RO7435846片 · No verified English nameJXHL2400051 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2024/03/02Import · Class 1 RO7435846片 · No verified English nameJXHL2400050 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2024/03/02Import · Class 1 RO7435846片 · No verified English nameJXHL2400049 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2024/03/02Generic · Class 3 Delafloxacin for InjectionCYHS2400746 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2024/03/02Generic · Class 3 复方电解质注射液(V) · No verified English nameCYHS2400745 Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/03/02Generic · Class 3 盐酸维洛沙秦缓释胶囊 · No verified English nameCYHL2400050 Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized
2024/03/02Generic · Class 3 盐酸维洛沙秦缓释胶囊 · No verified English nameCYHL2400049 Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized
2024/03/02New drug · Class 1 SSGJ-707注射液 · No verified English nameCXSL2400171 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2024/03/02New drug · Class 1 盐酸去甲乌药碱注射液 · No verified English nameCXHS2400019 Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized
2024/03/01Import · Class 2.4 米罗那非片 · No verified English nameJXHL2400048 AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd.
2024/03/01Import · Class 2.4 米罗那非片 · No verified English nameJXHL2400047 AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd.
2024/03/01Generic · Class 3 Diprophylline InjectionCYHS2400741 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/03/01Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2400738 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/03/01Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2400734 Ha Yao Group Technology Center romanized
2024/03/01Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2400733 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized
2024/03/01Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2400730 Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/03/01Generic · Class 3 Diprophylline InjectionCYHS2400728 Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized; Dan Dong Yi Chuang Pharma Co., Ltd. romanized
2024/03/01Generic · Class 3 Diprophylline InjectionCYHS2400727 Shandong Rui Yi Pharmaceuticals Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/03/01Generic · Class 3 Diprophylline InjectionCYHS2400726 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/03/01New drug · Class 1.1 通络健脑片 · No verified English nameCXZS2400010 Guangzhou Yue Kang Biopharmaceutical Co., Ltd. romanized
2024/03/01New drug · Class 1.1 紫花温肺止嗽颗粒 · No verified English nameCXZS2400009 Guangzhou Yue Kang Biopharmaceutical Co., Ltd. romanized
2024/03/01New drug · Class 1 注射用KKD001 · No verified English nameCXSL2400170 Shang Rao Shi Kang Ke De Bio Technology Co., Ltd. romanized
2024/03/01New drug · Class 1 RBD1016注射液 · No verified English nameCXHL2400235 Suzhou Rui Bo Bio Technology Co., Ltd. romanized
2024/03/01New drug · Class 1 HRS-5346片 · No verified English nameCXHL2400234 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2024/03/01New drug · Class 1 HRS-5346片 · No verified English nameCXHL2400233 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/01New drug · Class 1 TQ05105片 · No verified English nameCXHL2400232 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/03/01New drug · Class 1 TQ05105片 · No verified English nameCXHL2400231 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/02/29Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400054 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/02/29Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400053 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD

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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