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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 370 drug applications between 29 August 2024 and 4 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 114, covering 84 drug names.

2024/08/29 – 2024/09/04

Period
2024/08/29 to 2024/09/04, 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
370
Drugs with new generic filings (by drug name, de-duplicated)
84
Accepted this week, now under review
2

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

370filings, 114 of them generic

By application type

Application typeFilings
Supplement170
Generic114
New drug64
Import14
Import re-registration5
Unspecified3

By drug type

Drug typeFilings
Chemical drug246
TCM70
Therapeutic biologic45
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

84 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Rivaroxaban Tablets413
2维生素B6注射液 · No verified English name3310
3Bumetanide Injection3213
4Dapoxetine Hydrochloride Tablets3220
5Tadalafil Tablets3123
6Gadobutrol Injection318
7中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name227
8Formoterol Fumarate Inhalation Solution225
9氯化钙注射液 · No verified English name226
10Glucosamine Sulfate Capsules2251

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

231 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized11110
2Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized990
3Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized530
4Jiangsu Kang Yuan Pharma Co., Ltd. romanized520
5Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized444
6Qingdao Dong Hai Pharma Co., Ltd. romanized440
7Janssen-Cilag International NV420
8Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized414
9Jiangsu En Hua Pharma Co., Ltd. romanized410
10Anhui Xin Zhi Yuan Pharmaceuticals Co., Ltd. romanized330

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

112 this week

AcceptedDrugApplicants
2024/09/04Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2400071 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2024/09/04Import · Class 1 BI 765179 注射用粉末 · No verified English nameJXSL2400161 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/09/04Import · Class 1 AZD8630 · No verified English nameJXSL2400160 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/04Import · Class 1 AZD8630 · No verified English nameJXSL2400159 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/04Import · Class 1 AZD8630 · No verified English nameJXSL2400158 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/04Import · Class 1 Lunsekimig注射液 · No verified English nameJXSL2400157 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/09/04Import · Class 2.4 Atogepant Tablets · No verified English nameJXHL2400215 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/09/04Import · Class 1 AZD5004薄膜包衣片 · No verified English nameJXHL2400214 Eccogene Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/04Import · Class 1 AZD5004薄膜包衣片 · No verified English nameJXHL2400213 Eccogene Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/04Import · Class 1 AZD5004薄膜包衣片 · No verified English nameJXHL2400212 Eccogene Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/04Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2402911 Wu Hu Dao Run Pharma Co., Ltd. romanized
2024/09/04Generic · Class 3 Epalrestat TabletsCYHS2402910 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/09/04Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2402903 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/09/04Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2402900 Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Chang Jiang Pharma Co., Ltd. romanized
2024/09/04Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2402899 Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Chang Jiang Pharma Co., Ltd. romanized
2024/09/04Generic · Class 3 Bumetanide InjectionCYHS2402897 Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2024/09/04Generic · Class 3 Clonidine hydrochloride extended-release tabletsCYHS2402894 Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized
2024/09/04New drug · Class 1 注射用VRT106 · No verified English nameCXSL2400590 Guangzhou Wei Rong Te Pharmaceuticals Technology Co., Ltd. romanized
2024/09/04New drug · Class 1 注射用BB-1712 · No verified English nameCXSL2400589 Bai Li Si Kang Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2024/09/04New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2400588 Jian Da Biopharmaceuticals (Nanjing) Co., Ltd. romanized
2024/09/04New drug · Class 1.1 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2400587 Ji Nuo Wei (Hebei) Bio Technology Co., Ltd. romanized; Beijing Ji Nuo Wei Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Lang Fang Lin Kong Zi Mao Qu) Bio Zhi Pin Co., Ltd. romanized
2024/09/04New drug · Class 1 ABSK043片 · No verified English nameCXHL2400908 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2024/09/04New drug · Class 1 ABSK043片 · No verified English nameCXHL2400907 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2024/09/04New drug · Class 1 ND-003片 · No verified English nameCXHL2400906 Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized
2024/09/04New drug · Class 1 ND-003片 · No verified English nameCXHL2400905 Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized
2024/09/04New drug · Class 1 HY-072808软膏 · No verified English nameCXHL2400904 Hefei En Rui Te Pharma Co., Ltd. romanized; Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized
2024/09/04New drug · Class 1 HY-072808软膏 · No verified English nameCXHL2400903 Hefei En Rui Te Pharma Co., Ltd. romanized; Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized
2024/09/04New drug · Class 2.3 HQ2304胶囊 · No verified English nameCXHL2400902 Bai Cheng Pharmaceuticals (Zhuhai Heng Qin) Co., Ltd. romanized
2024/09/04New drug · Class 2.3 HQ2304胶囊 · No verified English nameCXHL2400901 Bai Cheng Pharmaceuticals (Zhuhai Heng Qin) Co., Ltd. romanized
2024/09/04New drug · Class 1 莫米司特片 · No verified English nameCXHL2400900 Gan Zhou He Mei Pharma Co., Ltd. romanized

82 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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