YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 396 drug applications between 31 December 2024 and 6 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 130, covering 92 drug names.

2024/12/31 – 2025/01/06

Period
2024/12/31 to 2025/01/06, 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
396
Drugs with new generic filings (by drug name, de-duplicated)
92
Accepted this week, now under review
12

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

396filings, 130 of them generic

By application type

Application typeFilings
Supplement174
Generic130
New drug67
Import16
Unspecified6
Import re-registration3

By drug type

Drug typeFilings
Chemical drug282
TCM57
Therapeutic biologic50
Prophylactic biologic7

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

92 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets5360
2Tacrolimus Ointment426
3Lidocaine and Prilocaine Cream3224
4Mivacurium Chloride Injection323
5Tadalafil Tablets3123
6Topiroxostat Tablets310
7Paliperidone Palmitate Injection318
8Lactulose Oral Solution2234
9Fusidic Acid Cream2215
10Formoterol Fumarate Inhalation Solution225

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

254 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Pfizer Europe MA EEIG730
2Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized730
3Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized650
4ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.545
5Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized520
6Nei Menggu Da Tang Pharma Co., Ltd. romanized440
7Jin Hong Pharma Co., Ltd. romanized421
8GlaxoSmithKline Trading Services Limited410
9Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized330
10Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized330

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

120 this week

AcceptedDrugApplicants
2025/01/06Generic · Class 3 Bilastine Oral SolutionCYHS2500069 Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2025/01/06Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2500068 Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2025/01/06Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2500067 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/01/06Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2404437 Nanjing Hai Jing Pharma Co., Ltd. romanized
2025/01/06New drug · Class 2.2 康柏西普眼用注射液 · No verified English nameCXSS2500001 Chengdu Kang Hong Bio Technology Co., Ltd. romanized
2025/01/06New drug · Class 1 MNO-863肠溶胶囊 · No verified English nameCXSL2500011 Mu En (Guangzhou) Bio Technology Co., Ltd. romanized
2025/01/06New drug · Class 1 MNO-863肠溶胶囊 · No verified English nameCXSL2500010 Mu En (Guangzhou) Bio Technology Co., Ltd. romanized
2025/01/06New drug · Class 1 MNO-863肠溶胶囊 · No verified English nameCXSL2500009 Mu En (Guangzhou) Bio Technology Co., Ltd. romanized
2025/01/06New drug · Class 1 SIR2501片 · No verified English nameCXHL2500009 Wei Tai Rui Long (Beijing) Bio Technology Co., Ltd. romanized
2025/01/06New drug · Class 1 SIR2501片 · No verified English nameCXHL2500008 Wei Tai Rui Long (Beijing) Bio Technology Co., Ltd. romanized
2025/01/04Import · Class 1 德莫奇单抗注射液 · No verified English nameJXSS2500002 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Limited trading as Glaxo Wellcome Operations; GlaxoSmithKline (China) Investment Co. Ltd.
2025/01/04Import · Class 1 德莫奇单抗注射液 · No verified English nameJXSS2500001 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Limited trading as Glaxo Wellcome Operations; GlaxoSmithKline (China) Investment Co. Ltd.
2025/01/04Import · Class 1 VG901注射液 · No verified English nameJXSL2500003 ViGeneron GmbH; WuXi Clinical Development Services(Shanghai) Co. Ltd
2025/01/04Generic · Class 3 Benazepril Hydrochloride and Hydrochlorothiazide TabletsCYHS2500058 Anhui Jia He Pharma Co., Ltd. romanized
2025/01/04Generic · Class 3 Potassium Aspartate And Magnesium Aspartate InjectionCYHS2500049 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized
2025/01/04Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2500046 Jiangxi Yi You Pharma Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2025/01/04Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2500044 Jiangsu He Chen Pharma Co., Ltd. romanized
2025/01/04Generic · Class 3 Calcitriol Oral SolutionCYHS2500040 Henan Tai Feng Bio Technology Co., Ltd. romanized
2025/01/04Generic · Class 3 Indocyaninegreen for InjectionCYHS2500039 Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized
2025/01/04New drug · Class 1 HLX79 注射液 · No verified English nameCXSL2500008 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2025/01/04New drug · Class 1.3 三价流感病毒裂解疫苗(ZFA02佐剂) · No verified English nameCXSL2500007 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2025/01/04New drug · Class 2.2 苯扎溴铵无菌溶液 · No verified English nameCXHS2500002 Guangdong Mai Heng Pharmaceuticals Research and Development Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2025/01/04New drug · Class 2.2 苯扎溴铵无菌溶液 · No verified English nameCXHS2500001 Guangdong Mai Heng Pharmaceuticals Research and Development Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2025/01/04New drug · Class 2.2 JC005 · No verified English nameCXHL2500007 Beijing Jia Cheng Biopharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/01/03Import · Class 1 ABBV-400注射用粉末 · No verified English nameJXSL2500002 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/01/03Import · Class 1 注射用Budigalimab · No verified English nameJXSL2500001 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/01/03Import · Class 1 STX-241片 · No verified English nameJXHL2500003 Pierre Fabre Médicament; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2025/01/03Import · Class 1 STX-241片 · No verified English nameJXHL2500002 Pierre Fabre Médicament; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2025/01/03Import · Class 1 STX-241片 · No verified English nameJXHL2500001 Pierre Fabre Médicament; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2025/01/03Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2500037 Changzhou Pharmaceutical Factory Co., Ltd. romanized

90 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.