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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 402 drug applications between 18 July 2024 and 24 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 129, covering 79 drug names.

2024/07/18 – 2024/07/24

Period
2024/07/18 to 2024/07/24, 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
402
Drugs with new generic filings (by drug name, de-duplicated)
79
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

402filings, 129 of them generic

By application type

Application typeFilings
Supplement147
Generic129
New drug66
Unspecified31
Import re-registration15
Import14

By drug type

Drug typeFilings
Chemical drug280
TCM59
Therapeutic biologic39
Biologic15
Prophylactic biologic9

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

79 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brexpiprazole Tablets19731
2Nicardipine Hydrochloride Injection3313
3Bumetanide Injection3213
4Brexpiprazole Orally Disintegrating Tablets3110
5恩那度司他片 · No verified English name310
6Tobramycin Eye Drops222
7氟比洛芬凝胶贴膏 · No verified English name2216
8氧(液态) · No verified English name2213
9维生素B6注射液 · No verified English name2210
10丁酸氯维地平注射用乳剂 · No verified English name210

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

248 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1560
2Qilu Pharmaceutical Co., Ltd.1046
3Hainan Zhuo Tai Pharmaceutical Co., Ltd. romanized730
4Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized660
5Nitto Denko Corporation610
6Suzhou Lang Ke Bio Technology Co., Ltd. romanized545
7Yunnan Te An Na Pharmaceutical Co., Ltd. romanized440
8Shanxi Huang He Zhong Yao Co., Ltd. romanized440
9Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized434
10Chengdu Easton Biopharmaceuticals Co.,Ltd.424

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

125 this week

AcceptedDrugApplicants
2024/07/24Import · Class 1 注射用MK-1022 · No verified English nameJXSL2400129 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/07/24Generic · Class 3 Pentoxifylline InjectionCYHS2402334 Ben Xi Jiang Cheng Pharmaceuticals Technology Co., Ltd. romanized; Ben Xi Heng Kang Pharmaceutical Co., Ltd. romanized
2024/07/24Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHS2402326 Qilu Pharmaceutical (Hainan) Co., Ltd
2024/07/24New drug · Class 1 注射用TQB2102 · No verified English nameCXSL2400478 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/07/24New drug · Class 1 注射用尤莱利单抗 · No verified English nameCXSL2400477 Tian Jing Bio Technology (Shanghai) Co., Ltd. romanized
2024/07/24New drug · Class 1 Domvanalimab注射液 · No verified English nameCXSL2400476 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/07/24New drug · Class 2.2 赛帕利单抗注射液 · No verified English nameCXSL2400475 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/07/23Import · Class 1 SAR443765注射液 · No verified English nameJXSL2400128 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/07/23Import · Class 1 沃拉德单抗注射液 · No verified English nameJXSL2400127 REMD Biotherapeutics Inc.; Beijing Cosci-REMD Biotherapeutics Inc.
2024/07/23Import · Class 1 BT8009 · No verified English nameJXHL2400183 BicycleTx Limited; Beijing Medpace Ltd.
2024/07/23Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402325 Guangdong Sunho Pharmaceutical Co., Ltd.
2024/07/23Generic · Class 3 Indobufen TabletsCYHS2402322 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2024/07/23Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402321 Henan Jun Shan Bio Technology Co., Ltd. romanized; Henan Tian Zhi Pharma Co., Ltd. romanized
2024/07/23Generic · Class 3 Potassium Chloride GranulesCYHS2402314 Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2024/07/23Generic · Class 3 Potassium Chloride GranulesCYHS2402312 Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2024/07/23Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2402304 Chongqing Sai Nuo Bio Pharma Co., Ltd. romanized; Chongqing He Ping Pharmaceutical Co., Ltd. romanized
2024/07/23Generic · Class 3 Aceclofenac TabletsCYHS2402302 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/07/23Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2402301 Zhejiang Ding Tai Pharma Co., Ltd. romanized
2024/07/23Generic · Class 3 Dyclonine Topical SolutionCYHL2400155 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2024/07/23Generic · Class 3 Landiolol Hydrochloride for InjectionCYHL2400154 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2024/07/23New drug · Class 3.4 人凝血因子Ⅷ · No verified English nameCXSS2400077 Bo Hui Biopharmaceutical (Hebei) Co., Ltd. romanized
2024/07/23New drug · Class 1 MG-K10人源化单抗注射液 · No verified English nameCXSL2400474 Shanghai Mai Ji Bio Technology Co., Ltd. romanized
2024/07/23New drug · Class 2.2 JMHJ01 · No verified English nameCXHL2400752 Hunan Jiudian Pharmaceutical Co., Ltd
2024/07/23New drug · Class 2.3 ITR2202乳胶 · No verified English nameCXHL2400751 Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized
2024/07/23New drug · Class 2.3 ITR2202乳胶 · No verified English nameCXHL2400750 Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized
2024/07/23New drug · Class 2.3 ITR2202乳胶 · No verified English nameCXHL2400749 Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized
2024/07/23New drug · Class 1 SYN818片 · No verified English nameCXHL2400748 Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized
2024/07/23New drug · Class 1 SYN818片 · No verified English nameCXHL2400747 Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized
2024/07/23New drug · Class 1 HRS-9563注射液 · No verified English nameCXHL2400746 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/07/23New drug · Class 1 JFAN-1001甲磺酸盐胶囊 · No verified English nameCXHL2400745 Zhejiang Jian Feng Yi En Bio Technology Co., Ltd. romanized

95 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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