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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 317 drug applications between 24 October 2025 and 30 October 2025 (data as of 14 November 2026 06:00). Of these, generic applications numbered 58, covering 42 drug names.

2025/10/24 – 2025/10/30

Period
2025/10/24 to 2025/10/30, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
317
Drugs with new generic filings (by drug name, de-duplicated)
42
Accepted this week, now under review
74

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

317filings, 58 of them generic

By application type

Application typeFilings
Supplement170
Generic58
New drug53
Import14
Unspecified12
Import re-registration10

By drug type

Drug typeFilings
Chemical drug220
TCM62
Therapeutic biologic31
Biologic2
Unspecified1
Prophylactic 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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Finerenone Tablets5369
2Fluticasone Propionate Cream2212
3Crisaborole Ointment2226
4Lidocaine and Tetracaine Cream222
5Metoclopramide Hydrochloride Injection226
6Glucosamine Sulfate Capsules2251
7Cefditoren Pivoxil Granules2118
8Vonoprazan Fumarate Tablets2158
9Levothyroxine Sodium Tablets2111
10Pregabalin Capsules2112

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

196 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xinjiang Hua Shi Dan Pharma Co., Ltd. romanized1920
2Qilu Pharmaceutical (Hainan) Co., Ltd830
3Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized660
4Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized520
5Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized510
6Shi Yao Group En Bi Pu Pharma Co., Ltd. romanized510
7Ferring GmbH440
8Novartis Pharma Schweiz AG430
9McNeil Sweden AB410
10Nei Menggu Lan Tai Pharma 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

81 this week

AcceptedDrugApplicants
2025/10/30Import · Class 3.1 Nemolizumab注射液 · No verified English nameJXSL2500208 Galderma SA; Q-Med International Trading (Shanghai) Co. Ltd
2025/10/30Import · Class 1 GSK6042981片 · No verified English nameJXHL2500334 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2025/10/30New drug · Class 1.2 栀子西红花酸提取物(C2235) · No verified English nameCXZL2500106 Zhejiang Jian Feng Pharma Co., Ltd. romanized
2025/10/30New drug · Class 1 柯美奇拜单抗注射液 · No verified English nameCXSS2500116 Shanghai Mai Ji Pharmaceuticals Co., Ltd. romanized; Ding Kang (Wuhan) Biopharmaceuticals Co., Ltd. romanized
2025/10/30New drug · Class 1 注射用QLS5316 · No verified English nameCXSL2500934 Qilu Pharmaceutical Co., Ltd.
2025/10/30New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500133 Gansu Pu An Pharmaceutical Co., Ltd. romanized
2025/10/30New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500132 Gansu Pu An Pharmaceutical Co., Ltd. romanized
2025/10/30New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500131 Gansu Pu An Pharmaceutical Co., Ltd. romanized
2025/10/30New drug · Class 1 BGB-45035片 · No verified English nameCXHL2501194 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/10/30New drug · Class 1 BGB-45035片 · No verified English nameCXHL2501193 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/10/30New drug · Class 1 BGB-45035片 · No verified English nameCXHL2501192 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/10/30New drug · Class 1 HW221043片 · No verified English nameCXHL2501191 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2025/10/30New drug · Class 1 HW221043片 · No verified English nameCXHL2501190 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2025/10/29Import · Class 2.4 JNJ-90301900 (NBTXR3)注射液 · No verified English nameJXHL2500335 Johnson & Johnson Enterprise Innovation Inc.; Johnson & Johnson (China) Investment Ltd.
2025/10/29Generic · Class 3 洛索洛芬钠颗粒 · No verified English nameCYHS2503827 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/10/29Generic · Class 3 富马酸酮替芬滴眼液 · No verified English nameCYHS2503822 Guangdong Zhong Sheng Pharma Co., Ltd. romanized
2025/10/29Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2503819 Nanjing Hai Ke Rui Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Su Zhong Pharma Group Biopharmaceutical Co., Ltd. romanized
2025/10/29Generic · Class 3 尿素[13C]呼气试验诊断试剂盒 · No verified English nameCYHL2500194 Jiangsu Jin Bo Qi Tong Wei Su Technology Co., Ltd. romanized
2025/10/29New drug · Class 1.2 栀子西红花酸提取物肠溶片(C2235片) · No verified English nameCXZL2500105 Zhejiang Jian Feng Pharma Co., Ltd. romanized
2025/10/29New drug · Class 1.1 慢痞消颗粒 · No verified English nameCXZL2500104 Beijing Zhong Pharmaceuticals University romanized; Feng Huang Tian Dan (Beijing) Technology Co., Ltd. romanized
2025/10/29New drug · Class 2.2 盐酸奥洛他定口服溶液 · No verified English nameCXHS2500130 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2025/10/29New drug · Class 1 GH31胶囊 · No verified English nameCXHL2501189 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2025/10/29New drug · Class 1 GH31胶囊 · No verified English nameCXHL2501188 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2025/10/29New drug · Class 2.2 XJN026鼻喷雾剂 · No verified English nameCXHL2501187 Guangzhou Xin Ji Pharma Technology Co., Ltd. romanized
2025/10/29New drug · Class 1 YKYY018雾化吸入剂 · No verified English nameCXHL2501186 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized
2025/10/28Import · Class 3.1 尼塔奇单抗注射液 · No verified English nameJXSS2500135 Joint Stock Company“BIOCAD”(JSC“BIOCAD”); SPH-BIOCAD Biopharmaceuticals (SH) Co. Ltd.
2025/10/28Import · Class 1 Zilebesiran注射液 · No verified English nameJXHL2500332 Alnylam Pharmaceuticals Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd
2025/10/28Generic · Class 3 复方聚乙二醇电解质散(II) · No verified English nameCYHS2503815 Chongqing Xin He Bio Technology Co., Ltd. romanized; Chongqing Ke Rui Nan Hai Pharmaceutical Co., Ltd. romanized
2025/10/28Generic · Class 3 蔗糖羟基氧化铁颗粒 · No verified English nameCYHS2503810 Hunan Ming Rui Pharmaceutical Co., Ltd. romanized
2025/10/28Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHS2503805 Jiangxi Yi You Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized

51 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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