YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 303 drug applications between 31 May 2024 and 6 June 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 61 drug names.

2024/05/31 – 2024/06/06

Period
2024/05/31 to 2024/06/06, 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
303
Drugs with new generic filings (by drug name, de-duplicated)
61
Accepted this week, now under review
4

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

303filings, 78 of them generic

By application type

Application typeFilings
Supplement144
Generic78
New drug52
Import19
Import re-registration8
Unspecified2

By drug type

Drug typeFilings
Chemical drug208
TCM45
Therapeutic biologic41
Prophylactic biologic8
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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1二甲硅油乳剂 · No verified English name3114
2阿普米司特片 · No verified English name313
3Baricitinib Tablets2232
4Potassium Chloride Oral Solution2211
5Nicardipine Hydrochloride Injection2213
6维生素B6注射液 · No verified English name2210
7Bumetanide Injection2113
8Vortioxetine Hydrobromide Tablets2110
9Sacubitril Valsartan Sodium Tablets2170
10Methotrexate Injection2111

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

194 companies with new acceptances; top 10 listed

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

97 this week

AcceptedDrugApplicants
2024/06/06Import · Class 1 Bexotegrast片 · No verified English nameJXHL2400126 Pliant Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2024/06/06Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2401704 Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized
2024/06/06Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2401700 Health Yuan Pharma Group Co., Ltd. romanized; Health Yuan Hai Bin Pharma Co., Ltd. romanized
2024/06/06Generic · Class 3 烟酸缓释片 · No verified English nameCYHS2401697 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2024/06/06Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2401694 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/06/06Generic · Class 3 Chlorphenamine Maleate InjectionCYHS2401692 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2024/06/06New drug · Class 1 司普奇拜单抗注射液 · No verified English nameCXSS2400055 Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2024/06/06New drug · Class 2.2 外用红色诺卡氏菌细胞壁骨架 · No verified English nameCXSL2400369 Liaoning Tian An Biopharmaceutical Co., Ltd. romanized
2024/06/06New drug · Class 1.1 四价重组诺如病毒疫苗(汉逊酵母) · No verified English nameCXSL2400368 Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized
2024/06/06New drug · Class 1.1 四价重组诺如病毒疫苗(汉逊酵母) · No verified English nameCXSL2400367 Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized
2024/06/06New drug · Class 1 复迈替尼片 · No verified English nameCXHS2400049 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2024/06/06New drug · Class 1 复迈替尼片 · No verified English nameCXHS2400048 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2024/06/06New drug · Class 1 K-13片 · No verified English nameCXHL2400579 Shanghai Yi Feng Bio Technology Co., Ltd. romanized
2024/06/06New drug · Class 1 K-13片 · No verified English nameCXHL2400578 Shanghai Yi Feng Bio Technology Co., Ltd. romanized
2024/06/06New drug · Class 1 K-13片 · No verified English nameCXHL2400577 Shanghai Yi Feng Bio Technology Co., Ltd. romanized
2024/06/06New drug · Class 2.2; 2.4 PG-F01凝胶 · No verified English nameCXHL2400576 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2024/06/06New drug · Class 2.2; 2.4 PG-F01凝胶 · No verified English nameCXHL2400575 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2024/06/06New drug · Class 2.2; 2.4 PG-F01凝胶 · No verified English nameCXHL2400574 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2024/06/06New drug · Class 1 FP-208片 · No verified English nameCXHL2400573 Beijing Fu Long Kang Tai Bio Technology Co., Ltd. romanized
2024/06/06New drug · Class 1 FP-208片 · No verified English nameCXHL2400572 Beijing Fu Long Kang Tai Bio Technology Co., Ltd. romanized
2024/06/06New drug · Class 1 K-13片 · No verified English nameCXHL2400571 Shanghai Yi Feng Bio Technology Co., Ltd. romanized
2024/06/06New drug · Class 1 K-13片 · No verified English nameCXHL2400570 Shanghai Yi Feng Bio Technology Co., Ltd. romanized
2024/06/06New drug · Class 1 K-13片 · No verified English nameCXHL2400569 Shanghai Yi Feng Bio Technology Co., Ltd. romanized
2024/06/05Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2401689 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2024/06/05Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2401686 Sui Cheng Pharma Co., Ltd. romanized
2024/06/05Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2401684 Sui Cheng Pharma Co., Ltd. romanized
2024/06/05Generic · Class 3 Acetylcysteine InjectionCYHS2401681 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2024/06/05Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2401674 Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized
2024/06/05Generic · Class 3 Levofloxacin InjectionCYHS2401672 CISEN PHARMACEUTICAL CO., LTD.
2024/06/05Generic · Class 3 Sulfamethoxazole and Trimethoprim InjectionCYHS2401671 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized

67 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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