YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 334 drug applications between 23 October 2025 and 29 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 49 drug names.

2025/10/23 – 2025/10/29

Period
2025/10/23 to 2025/10/29, 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
334
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
84

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

334filings, 69 of them generic

By application type

Application typeFilings
Supplement177
Generic69
New drug55
Import15
Unspecified11
Import re-registration7

By drug type

Drug typeFilings
Chemical drug235
TCM71
Therapeutic biologic24
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

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Finerenone Tablets5369
2Glucosamine Sulfate Capsules3351
3Fluticasone Propionate Cream2212
4Lidocaine and Tetracaine Cream222
5Metoclopramide Hydrochloride Injection226
6Iguratimod Tablets2223
7Clindamycin Injection214
8Cefditoren Pivoxil Granules2118
9Vonoprazan Fumarate Tablets2160
10Levothyroxine Sodium Tablets2112

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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xinjiang Hua Shi Dan Pharma Co., Ltd. romanized1920
2Jiangsu Si Jia Wei Kang Pharmaceuticals Technology Co., Ltd. romanized910
3Qilu Pharmaceutical (Hainan) Co., Ltd830
4Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized760
5Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized660
6Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized652
7Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized520
8Shi Yao Group En Bi Pu Pharma Co., Ltd. romanized510
9Ferring GmbH440
10McNeil Sweden AB410

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
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
2025/10/28Generic · Class 3 Sodium Nitroprusside InjectionCYHS2503804 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/10/28Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2500193 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2025/10/28Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2500192 Hubei Heng An Fu Lin Pharma Co., Ltd. romanized
2025/10/28New drug · Class 1.1 清血败毒丸 · No verified English nameCXZL2500103 Jiangsu Zhong Yong Hong Rui Pharmaceutical Co., Ltd. romanized
2025/10/28New drug · Class 2.2; 2.4 注射用重组A型肉毒毒素 · No verified English nameCXSL2500933 Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized
2025/10/28New drug · Class 2.2; 2.4 注射用重组A型肉毒毒素 · No verified English nameCXSL2500932 Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized
2025/10/28New drug · Class 2.2; 2.4 注射用重组A型肉毒毒素 · No verified English nameCXSL2500931 Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized
2025/10/28New drug · Class 1 注射用SKB105 · No verified English nameCXSL2500930 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2025/10/28New drug · Class 1 注射用重组人白介素22-Fc融合蛋白 · No verified English nameCXSL2500929 Yi Yi Biopharmaceuticals Kai Fa (Shanghai) Co., Ltd. romanized; Yi Yi Biopharmaceutical (Beijing) Co., Ltd. romanized
2025/10/28New drug · Class 1 重组人GM-CSF溶瘤II型单纯疱疹病毒(OH2)注射液(Vero细胞) · No verified English nameCXSL2500928 Bin Hui Bio Technology (Beijing) Co., Ltd. romanized
2025/10/28New drug · Class 1 注射用7MW3711 · No verified English nameCXSL2500927 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2025/10/28New drug · Class 1 注射用JS207 · No verified English nameCXSL2500926 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2025/10/28New drug · Class 1 宫血间充质干细胞注射液 · No verified English nameCXSL2500925 Zhejiang Sheng Chuang Jing Zhun Medical Technology Co., Ltd. romanized

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.

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.