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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 301 drug applications between 14 May 2024 and 20 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 56 drug names.

2024/05/14 – 2024/05/20

Period
2024/05/14 to 2024/05/20, 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
301
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
3

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

301filings, 75 of them generic

By application type

Application typeFilings
Supplement121
Generic75
New drug68
Import re-registration15
Import14
Unspecified5
Drug-device combination product3

By drug type

Drug typeFilings
Chemical drug202
Therapeutic biologic54
TCM34
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

56 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets3260
2Tadalafil Tablets3123
3复方聚乙二醇(3350)电解质散 · No verified English name223
4洛索洛芬钠凝胶贴膏 · No verified English name229
5Phenylephrine Hydrochloride Injection225
6Glyburide and Metformin Hydrochloride Tablets210
7Tacrolimus Sustained-release Capsules216
8利伐沙班干混悬剂 · No verified English name212
9Linagliptin and Metformin Hydrochloride Extended Release Tablets214
10Montelukast Sodium Orally Disintegrating Tablets210

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

190 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Pfizer Inc.630
2Shenzhen Xin Li Tai Pharma Co., Ltd. romanized610
3Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized510
4Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized510
5Beijing Bai Ao Pharma Co., Ltd. romanized434
6Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized420
7Fresenius Kabi AB410
8Sanofi Winthrop Industrie410
9Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized410
10Guangxi Xin Hai Pharma Technology Co., Ltd. romanized410

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

108 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

78 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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