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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 359 drug applications between 12 May 2024 and 18 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 89, covering 65 drug names.

2024/05/12 – 2024/05/18

Period
2024/05/12 to 2024/05/18, 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)
65
Accepted this week, now under review
5

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, 89 of them generic

By application type

Application typeFilings
Supplement146
Generic89
New drug81
Import20
Import re-registration15
Unspecified5
Drug-device combination product3

By drug type

Drug typeFilings
Chemical drug249
Therapeutic biologic59
TCM40
Prophylactic biologic8
Drug-device combination3

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

65 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets3260
2Sacubitril Valsartan Sodium Tablets3270
3Tadalafil Tablets3123
4复方聚乙二醇(3350)电解质散 · No verified English name223
5Famotidine Injection228
6洛索洛芬钠凝胶贴膏 · No verified English name229
7Phenylephrine Hydrochloride Injection225
8Glyburide and Metformin Hydrochloride Tablets210
9Tacrolimus Sustained-release Capsules216
10利伐沙班干混悬剂 · No verified English name212

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

215 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized1020
2Hainan Huluwa Pharmaceutical Group Co., Ltd.745
3Yi Chang Ren Fu Pharma Co., Ltd. romanized720
4Pfizer Inc.630
5Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized610
6Shenzhen Xin Li Tai Pharma Co., Ltd. romanized610
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
8Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized510
9Beijing Bai Ao Pharma Co., Ltd. romanized434
10Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized430

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

131 this week

AcceptedDrugApplicants
2024/05/18Import · Class 2.4 甲磺酸贝舒地尔片 · No verified English nameJXHL2400115 Kadmon Pharmaceuticals LLC; Sanofi (China) Investment Co. Ltd.
2024/05/18Import · Class 2.4 Fezolinetant片 · No verified English nameJXHL2400114 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2024/05/18Generic · Class 3 Acetylcysteine InjectionCYHS2401507 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/05/18Generic · Class 3 乌苯美司胶囊 · No verified English nameCYHS2401505 Xian Wan Long Pharmaceutical Co., Ltd. romanized
2024/05/18Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2401502 Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2024/05/18Generic · Class 3 Linagliptin and Metformin Hydrochloride Extended Release TabletsCYHS2401498 Hubei Guang Chen Pharma Co., Ltd. romanized
2024/05/18Generic · Class 3 Linagliptin and Metformin Hydrochloride Extended Release TabletsCYHS2401497 Hubei Guang Chen Pharma Co., Ltd. romanized
2024/05/18Generic · Class 3 丁酸氯维地平注射用乳剂 · No verified English nameCYHS2401496 Qilu Pharmaceutical (Hainan) Co., Ltd
2024/05/18Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2401493 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/05/18Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2401489 Hubei Lai Kang Medical Technology Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanized
2024/05/18Generic · Class 3 Dexketoprofen Trometamol InjectionCYHL2400098 Beijing Bai Ao Pharma Co., Ltd. romanized
2024/05/18New drug · Class 1.2 JKN2303 · No verified English nameCXZL2400029 Jiangxi Zhong Pharmaceuticals University romanized; Guangxi Xin Hai Pharma Technology Co., Ltd. romanized
2024/05/18New drug · Class 1.2 JKN2303吸入溶液 · No verified English nameCXZL2400028 Guangxi Xin Hai Pharma Technology Co., Ltd. romanized; Health Yuan Pharma Group Co., Ltd. romanized
2024/05/18New drug · Class 1.2 JKN2303吸入溶液 · No verified English nameCXZL2400027 Guangxi Xin Hai Pharma Technology Co., Ltd. romanized; Health Yuan Pharma Group Co., Ltd. romanized
2024/05/18New drug · Class 1.2 JKN2303吸入溶液 · No verified English nameCXZL2400026 Guangxi Xin Hai Pharma Technology Co., Ltd. romanized; Health Yuan Pharma Group Co., Ltd. romanized
2024/05/18New drug · Class 1.2 JKN2303吸入溶液 · No verified English nameCXZL2400025 Guangxi Xin Hai Pharma Technology Co., Ltd. romanized; Health Yuan Pharma Group Co., Ltd. romanized
2024/05/18New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSL2400331 Shenzhen Kang Tai Bio Zhi Pin Co., Ltd. romanized
2024/05/18New drug · Class 1 PM1032注射液 · No verified English nameCXSL2400330 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2024/05/18New drug · Class 2.2 SL001 · No verified English nameCXHL2400511 Sichuan Sheng San Xing Dui Pharmaceutical Co., Ltd. romanized
2024/05/17Import · Class 1 注射用M9140 · No verified English nameJXSL2400096 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2024/05/17Import · Class 2.2 Dostarlimab注射液 · No verified English nameJXSL2400095 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. LTD
2024/05/17Import · Class 2.2 Dostarlimab注射液 · No verified English nameJXSL2400094 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2024/05/17Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400093 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/05/17Generic · Class 3 Amisulpride InjectionCYHS2401488 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2024/05/17Generic · Class 3 Amisulpride InjectionCYHS2401487 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2024/05/17Generic · Class 3 Bumetanide InjectionCYHS2401480 Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized
2024/05/17Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2401479 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/05/17Generic · Class 3 Metaraminol Tartrate InjectionCYHS2401477 Guangzhou Hui Feng De Bio Technology Co., Ltd. romanized; Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2024/05/17Generic · Class 3 Glyburide and Metformin Hydrochloride TabletsCYHS2401476 Tong Hua Wan Tong Pharma Co., Ltd. romanized
2024/05/17Generic · Class 3 Glyburide and Metformin Hydrochloride TabletsCYHS2401475 Tong Hua Wan Tong Pharma Co., Ltd. romanized

101 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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