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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 308 drug applications between 16 May 2024 and 22 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 56 drug names.

2024/05/16 – 2024/05/22

Period
2024/05/16 to 2024/05/22, 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
308
Drugs with new generic filings (by drug name, de-duplicated)
56
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

308filings, 75 of them generic

By application type

Application typeFilings
Supplement149
Generic75
New drug52
Import16
Import re-registration13
Unspecified3

By drug type

Drug typeFilings
Chemical drug203
TCM56
Therapeutic biologic44
Prophylactic biologic3
In vitro diagnostic reagent1
Biologic1

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
1Tadalafil Tablets3123
2Diprophylline Injection227
3盐酸纳美芬注射液 · No verified English name221
4Glyburide and Metformin Hydrochloride Tablets210
5利伐沙班干混悬剂 · No verified English name212
6Linagliptin and Metformin Hydrochloride Extended Release Tablets214
7Montelukast Sodium Orally Disintegrating Tablets210
8Vonoprazan Fumarate Tablets2160
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

193 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenzhen Xin Li Tai Pharma Co., Ltd. romanized820
2Sanofi Winthrop Industrie620
3Bracco Imaging S.P.A.610
4HUNAN WARRANT PHARMACEUTICAL CO.,LTD533
5Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized510
6Shanghai Wan Shi Cheng Pharma Co., Ltd. romanized440
7Anhui Zhong Chen Pharmaceutical Co., Ltd. romanized440
8Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized430
9Fresenius Kabi AB410
10Novartis Europharm Limited410

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

102 this week

AcceptedDrugApplicants
2024/05/22Import · Class 2.2 艾沙妥昔单抗注射液 · No verified English nameJXSS2400044 Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH
2024/05/22Import · Class 2.2 艾沙妥昔单抗注射液 · No verified English nameJXSS2400043 Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH
2024/05/22Import · Class 1 Englumafusp alfa注射液 · No verified English nameJXSL2400098 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2024/05/22Import · Class 1 ABBV-382注射液 · No verified English nameJXSL2400097 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/05/22Import · Class 1 VSA001注射液 · No verified English nameJXHL2400116 Arrowhead Pharmaceuticals Inc.; Sanofi (China) Investment Co. Ltd.
2024/05/22Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2401539 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/05/22Generic · Class 3 Famotidine InjectionCYHS2401538 Beijing Ge Lin Yi Rui Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2024/05/22Generic · Class 3 Famotidine InjectionCYHS2401537 Beijing Ge Lin Yi Rui Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2024/05/22Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2401536 Guangdong Nan Guo Pharma Co., Ltd. romanized
2024/05/22Generic · Class 3 Cimetidine InjectionCYHS2401535 Nanjing Si Tai Er Pharmaceuticals Technology Co., Ltd. romanized; Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2024/05/22Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2401534 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/05/22Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2401533 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/05/22Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2401529 Anhui Pioneer Pharmaceutical Co., Ltd
2024/05/22Generic · Class 3 Diprophylline InjectionCYHS2401528 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/05/22Generic · Class 3 洛索洛芬钠细粒剂 · No verified English nameCYHS2401527 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/05/22Generic · Class 3 Proparacaine Hydrochloride Eye DropsCYHS2401525 Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2024/05/22Generic · Class 3 平衡盐冲洗液 · No verified English nameCYHS2401523 Xian Jing Xi Shuang He Pharma Co., Ltd. romanized
2024/05/22Generic · Class 3 平衡盐冲洗液 · No verified English nameCYHS2401522 Xian Jing Xi Shuang He Pharma Co., Ltd. romanized
2024/05/22Generic · Class 3 Mannitol-S InjectionCYHL2400099 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2024/05/22New drug · Class 1 IBI354 · No verified English nameCXSL2400335 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/05/22New drug · Class 1 SHR-1819注射液 · No verified English nameCXSL2400334 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/22New drug · Class 2.2 水合氯醛口服溶液 · No verified English nameCXHS2400045 Chengdu Ya Zhong Biopharmaceutical Co., Ltd. romanized; Sichuan Guang Da Pharmaceutical Co., Ltd. romanized
2024/05/22New drug · Class 1 枸橼酸格来雷塞片 · No verified English nameCXHS2400044 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2024/05/22New drug · Class 1 HLX208片 · No verified English nameCXHL2400518 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2024/05/22New drug · Class 1 注射用WE011 · No verified English nameCXHL2400517 Shanghai Bao Long Pharma Co., Ltd. romanized
2024/05/22New drug · Class 2.3 SMF-215 · No verified English nameCXHL2400516 Jiangxi Shimei Pharmaceutical Co., Ltd
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

72 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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