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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 269 drug applications between 29 May 2024 and 4 June 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 54 drug names.

2024/05/29 – 2024/06/04

Period
2024/05/29 to 2024/06/04, 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
269
Drugs with new generic filings (by drug name, de-duplicated)
54
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

269filings, 71 of them generic

By application type

Application typeFilings
Supplement121
Generic71
New drug53
Import19
Import re-registration5

By drug type

Drug typeFilings
Chemical drug180
Therapeutic biologic47
TCM39
Prophylactic biologic2
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

54 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution5234
2二甲硅油乳剂 · No verified English name3114
3阿普米司特片 · No verified English name313
4Potassium Chloride Oral Solution2211
5Bumetanide Injection2113
6Sacubitril Valsartan Sodium Tablets2170
7Minocycline Hydrochloride Capsules2119
8Thioctic Acid Tablets214
9Ioversol Injection219
10Vitamin K1 Injection216

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

172 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guizhou Rui He Pharmaceutical Co., Ltd. romanized10100
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized840
3Henan Hua Feng Pharmaceutical Co., Ltd. romanized550
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
5Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized510
6Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized444
7Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized424
8AbbVie Inc.320
9Novartis Europharm Limited320
10Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized320

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

90 this week

AcceptedDrugApplicants
2024/06/04Import · Class 2.2 利生奇珠单抗注射液 · No verified English nameJXSS2400047 AbbVie Inc.; Patheon Italia S.p.A.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/06/04Import · Class 2.2 利生奇珠单抗注射液(皮下注射) · No verified English nameJXSS2400046 AbbVie Inc.; Patheon Italia S.p.A.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/06/04Import · Class 2.2 利生奇珠单抗注射液(皮下注射) · No verified English nameJXSS2400045 AbbVie Inc.; Patheon Italia S.p.A.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/06/04Import · Class 1 注射用AZD7798 · No verified English nameJXSL2400110 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/06/04Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400109 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/06/04Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400108 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/06/04Generic · Class 3 Salbutamol Sulfate injectionCYHS2401659 Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/06/04Generic · Class 3 Activated Charcoal CapsulesCYHS2401658 Hainan Ye Hui Yuan Pharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2024/06/04Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2401657 Zhejiang Kai Run Pharma Co., Ltd. romanized
2024/06/04Generic · Class 3 Potassium Chloride Oral SolutionCYHS2401656 Anhui Mao Kang Pharma Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2024/06/04Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2401655 Jinan Jing Sheng Technology Co., Ltd. romanized; Wei Fang Zhong Shi Pharmaceutical Co., Ltd. romanized
2024/06/04Generic · Class 3 Potassium Chloride Oral SolutionCYHS2401653 Sui Cheng Pharma Co., Ltd. romanized
2024/06/04Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2401652 Sui Cheng Pharma Co., Ltd. romanized
2024/06/04Generic · Class 3 Colistimethate Sodium for InjectionCYHL2400103 Health Yuan Hai Bin Pharma Co., Ltd. romanized
2024/06/04New drug · Class 1 CC312冻干粉针剂 · No verified English nameCXSL2400366 Hui He Bio Technology (Shanghai) Co., Ltd. romanized
2024/06/04New drug · Class 3.3 门冬胰岛素30注射液 · No verified English nameCXSL2400365 Ningbo Kun Peng Bio Technology Co., Ltd. romanized
2024/06/04New drug · Class 1 GKL-006注射液 · No verified English nameCXSL2400364 Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized
2024/06/04New drug · Class 1 BGC515胶囊 · No verified English nameCXHL2400562 Suzhou Qiao Ji Bio Technology Co., Ltd. romanized
2024/06/04New drug · Class 1 BGC515胶囊 · No verified English nameCXHL2400561 Suzhou Qiao Ji Bio Technology Co., Ltd. romanized
2024/06/04New drug · Class 1 BGC515胶囊 · No verified English nameCXHL2400560 Suzhou Qiao Ji Bio Technology Co., Ltd. romanized
2024/06/04New drug · Class 1 TLL-041片 · No verified English nameCXHL2400559 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2024/06/04New drug · Class 1 TLL-041片 · No verified English nameCXHL2400558 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2024/06/04New drug · Class 1 TLL-041片 · No verified English nameCXHL2400557 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2024/06/04New drug · Class 1 注射用SC-102 · No verified English nameCXHL2400556 Tianjin Xing Lian Tai Bio Technology Co., Ltd. romanized
2024/06/04New drug · Class 1 DAT-2645片 · No verified English nameCXHL2400555 Beijing Dan Qing Pharmaceuticals Technology Co., Ltd. romanized
2024/06/04New drug · Class 1 DAT-2645片 · No verified English nameCXHL2400554 Beijing Dan Qing Pharmaceuticals Technology Co., Ltd. romanized
2024/06/03Import · Class 1 伊那利塞片 · No verified English nameJXHS2400038 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd.
2024/06/03Import · Class 1 伊那利塞片 · No verified English nameJXHS2400037 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd.
2024/06/01Import · Class 3.1 呼吸道合胞病毒疫苗 · No verified English nameJXSL2400107 Pfizer Inc.; Pfizer Investment CO Ltd.
2024/06/01Import · Class 2.2; 2.4 克拉屈滨胶囊 · No verified English nameJXHL2400125 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd

60 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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