YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 27 drug applications between 1 October 2025 and 7 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 8, covering 6 drug names.

2025/10/01 – 2025/10/07

Period
2025/10/01 to 2025/10/07, 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
27
Drugs with new generic filings (by drug name, de-duplicated)
6
Accepted this week, now under review
9

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

27filings, 8 of them generic

By application type

Application typeFilings
Supplement14
Generic8
New drug5

By drug type

Drug typeFilings
Chemical drug14
Therapeutic biologic11
TCM2

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

6 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
2Rosuvastatin Calcium Tablets2118
3倍氯米松福莫特罗吸入气雾剂 · No verified English name110
4Lidocaine Hydrochloride Injection116
5盐酸赛洛唑啉鼻用喷雾剂 · No verified English name112
6Arginine and Ibuprofen Granules1111

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

18 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangdong Jiu Ming Pharmaceutical Co., Ltd. romanized310
2Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized310
3Amgen Inc.210
4Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized210
5Shanxi Fen He Pharmaceutical Co., Ltd. romanized212
6Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized212
7Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized210
8Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized110
9Yuan Ben (Zhuhai Heng Qin) Bio Technology Co., Ltd. romanized110
10Sichuan Pu Rui Te Pharma Co., Ltd. romanized111

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

6 this week

AcceptedDrugApplicants
2025/10/01Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2503595 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2025/10/01New drug · Class 2.3 荆防合剂 · No verified English nameCXZL2500092 Lu Nan Hou Pu Pharmaceutical Co., Ltd. romanized
2025/10/01New drug · Class 1 瑞西奇拜单抗注射液 · No verified English nameCXSS2500106 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Zhejiang Hua Hai Bio Technology Co., Ltd. romanized
2025/10/01New drug · Class 1 XLS-103注射液 · No verified English nameCXSL2500857 Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized
2025/10/01New drug · Class 1 XLS-103注射液 · No verified English nameCXSL2500856 Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized
2025/10/01New drug · Class 1 注射用YB-01 · No verified English nameCXSL2500855 Yuan Ben (Zhuhai Heng Qin) Bio Technology Co., Ltd. romanized

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.