YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 98 drug applications between 30 September 2025 and 6 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 16, covering 13 drug names.

2025/09/30 – 2025/10/06

Period
2025/09/30 to 2025/10/06, 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
98
Drugs with new generic filings (by drug name, de-duplicated)
13
Accepted this week, now under review
19

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

98filings, 16 of them generic

By application type

Application typeFilings
Supplement58
New drug17
Generic16
Import3
Unspecified2
Import re-registration2

By drug type

Drug typeFilings
Chemical drug53
Therapeutic biologic24
TCM20
Unspecified1

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

13 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
2Bumetanide Injection2113
3Rosuvastatin Calcium Tablets2118
4倍氯米松福莫特罗吸入气雾剂 · No verified English name110
5Diclofenac Diethylamine Emulgel1120
6Letermovir Tablets117
7Hydrocortisone Sodium Succinate for Injection1116
8Lercanidipine Hydrochloride Tablets116
9Lidocaine Hydrochloride Injection116
10Ambroxol Hydrochloride Oral Solution1146

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

62 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized530
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
3Hubei Rui Ze Pharma Co., Ltd. romanized410
4Jilin Bai Qi Pharma Co., Ltd. romanized330
5Janssen-Cilag AG320
6Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized320
7Guangdong Jiu Ming Pharmaceutical Co., Ltd. romanized310
8Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized310
9Hefei Kai Hua Pharmaceutical Co., Ltd. romanized220
10Haerbin Yi Da Pharma Co., Ltd. romanized220

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

23 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
2025/09/30Import · Class 1 MK-1084片 · No verified English nameJXHL2500304 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/09/30Import · Class 1 MK-1084片 · No verified English nameJXHL2500303 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/09/30Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2503584 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2025/09/30Generic · Class 3 Bumetanide InjectionCYHS2503579 Shandong Yi Jian Pharma Co., Ltd. romanized
2025/09/30Generic · Class 3 Bumetanide InjectionCYHS2503578 Shandong Yi Jian Pharma Co., Ltd. romanized
2025/09/30New drug · Class 1.1 精芪化浊颗粒 · No verified English nameCXZL2500091 Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized
2025/09/30New drug · Class 3.2 尼妥珠单抗注射液 · No verified English nameCXSS2500105 Bai Tai Bio Pharma Co., Ltd. romanized
2025/09/30New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSS2500104 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/09/30New drug · Class 1 伊立芙普α眼内注射液 · No verified English nameCXSS2500103 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/09/30New drug · Class 1 HY001N细胞注射液 · No verified English nameCXSL2500854 He Yuan Bio Technology (Tianjin) Co., Ltd. romanized; Guangdong He Yuan Biopharmaceuticals Co., Ltd. romanized
2025/09/30New drug · Class 1 注射用TQB2102 · No verified English nameCXSL2500853 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/09/30New drug · Class 1 注射用BG-C137 · No verified English nameCXSL2500852 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/09/30New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2500851 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/09/30New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2500850 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/09/30New drug · Class 2.4 苹果酸法米替尼胶囊 · No verified English nameCXHS2500122 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/30New drug · Class 2.4 GEN-725片 · No verified English nameCXHL2501058 Henan Zhen Shi Bio Technology Co., Ltd. romanized
2025/09/30New drug · Class 2.4 GEN-725片 · No verified English nameCXHL2501057 Henan Zhen Shi 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.

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