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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 276 drug applications between 15 May 2024 and 21 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 43 drug names.

2024/05/15 – 2024/05/21

Period
2024/05/15 to 2024/05/21, 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
276
Drugs with new generic filings (by drug name, de-duplicated)
43
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

276filings, 60 of them generic

By application type

Application typeFilings
Supplement130
Generic60
New drug52
Import re-registration14
Import12
Unspecified5
Drug-device combination product3

By drug type

Drug typeFilings
Chemical drug174
Therapeutic biologic50
TCM43
Prophylactic biologic5
Drug-device combination3
In vitro diagnostic reagent1

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

43 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets3260
2Tadalafil Tablets3123
3洛索洛芬钠凝胶贴膏 · No verified English name229
4Glyburide and Metformin Hydrochloride Tablets210
5Tacrolimus Sustained-release Capsules216
6利伐沙班干混悬剂 · No verified English name212
7Linagliptin and Metformin Hydrochloride Extended Release Tablets214
8Montelukast Sodium Orally Disintegrating Tablets210
9Levetiracetam extended-release tablets210
10Paliperidone Extend-release Tablets212

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

170 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenzhen Xin Li Tai Pharma Co., Ltd. romanized820
2Pfizer Inc.630
3Bracco Imaging S.P.A.610
4Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized510
5Shanghai Wan Shi Cheng Pharma Co., Ltd. romanized440
6Beijing Bai Ao Pharma Co., Ltd. romanized434
7Fresenius Kabi AB410
8Novartis Europharm Limited410
9Sanofi Winthrop Industrie410
10Kai Si Kai Di (Shanghai) Pharmaceuticals 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

85 this week

AcceptedDrugApplicants
2024/05/21Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2401521 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2024/05/21Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2401520 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2024/05/21Generic · Class 3 Levetiracetam extended-release tabletsCYHS2401519 Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized
2024/05/21Generic · Class 3 Levetiracetam extended-release tabletsCYHS2401517 Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized
2024/05/21New drug · Class 1.2 CRA · No verified English nameCXZL2400031 Xing Lin Zhong Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2024/05/21New drug · Class 1.2 CRA片 · No verified English nameCXZL2400030 Xing Lin Zhong Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2024/05/21New drug · Class 2.1 替妥尤单抗注射液 · No verified English nameCXSS2400050 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/05/21New drug · Class 1 SYS6020注射液 · No verified English nameCXSL2400333 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2024/05/21New drug · Class 1 mp105 · No verified English nameCXSL2400332 Shenzhen Ying Cheng Biopharmaceuticals Co., Ltd. romanized
2024/05/21New drug · Class 2.2 HKG-319 · No verified English nameCXHL2400515 Guo Yao Rui Fu Lai Pharma Co., Ltd. romanized
2024/05/21New drug · Class 2.2 HKG-319 · No verified English nameCXHL2400514 Guo Yao Rui Fu Lai Pharma Co., Ltd. romanized
2024/05/21New drug · Class 1 SAL0120片 · No verified English nameCXHL2400513 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2024/05/21New drug · Class 1 SAL0120片 · No verified English nameCXHL2400512 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
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

55 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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