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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 394 drug applications between 19 August 2025 and 25 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 98, covering 69 drug names.

2025/08/19 – 2025/08/25

Period
2025/08/19 to 2025/08/25, 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
394
Drugs with new generic filings (by drug name, de-duplicated)
69
Accepted this week, now under review
103

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

394filings, 98 of them generic

By application type

Application typeFilings
Supplement188
Generic98
New drug66
Import28
Unspecified9
Import re-registration5

By drug type

Drug typeFilings
Chemical drug265
TCM68
Therapeutic biologic51
Biologic6
Prophylactic biologic3
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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1卡格列净二甲双胍缓释片 · No verified English name415
2Fexofenadine Hydrochloride Tablets4110
3Vonoprazan Fumarate Tablets3260
4Magnesium Sulfate Injection327
5Mirogabalin Besilate Tablets3261
6Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)3217
7Memantine Hydrochloride OD Tablets312
8Letermovir Tablets227
9Potassium Chloride Injection2210
10瑞维那新吸入溶液 · No verified English name2253

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

247 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company1920
2NAPP PHARMACEUTICALS LIMITED910
3CSPC OUYI PHARMACEUTICAL CO., LTD.655
4Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized620
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized550
6Changchun Jin Sai Pharma Co., Ltd. romanized541
7BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED530
8Janssen-Cilag International NV520
9AstraZeneca AB430
10Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.410

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

127 this week

AcceptedDrugApplicants
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500237 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500236 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500235 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500234 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500233 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500232 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500231 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500230 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 2.4 英克司兰钠注射液 · No verified English nameJXHL2500229 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/08/25Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2503113 Hefei Hua Wei Pharma Co., Ltd. romanized
2025/08/25New drug · Class 1 SBK008注射液 · No verified English nameCXHL2500887 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2025/08/23Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSS2500110 Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2025/08/23Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500228 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/23Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500227 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/23Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500226 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/23Generic · Class 3 Memantine Hydrochloride OD TabletsCYHS2503099 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/08/23Generic · Class 3 Memantine Hydrochloride OD TabletsCYHS2503098 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/08/23Generic · Class 3 Memantine Hydrochloride OD TabletsCYHS2503097 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/08/23Generic · Class 3 利伐沙班口崩片 · No verified English nameCYHS2503096 Hefei En Rui Te Pharma Co., Ltd. romanized
2025/08/23Generic · Class 3 利伐沙班口崩片 · No verified English nameCYHS2503095 Hefei En Rui Te Pharma Co., Ltd. romanized
2025/08/23Generic · Class 3 复方氨基酸注射液(18AA-X) · No verified English nameCYHS2503093 Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized
2025/08/23Generic · Class 3 Magnesium Sulfate InjectionCYHS2503089 Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized
2025/08/23Generic · Class 3 Potassium Chloride InjectionCYHS2503088 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/08/23Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2503087 Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2025/08/23Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2503086 Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2025/08/23New drug · Class 1.1 卿芷软膏 · No verified English nameCXZL2500067 Guangzhou Bo Ji Xin Yao Lin Chuang Research Center Co., Ltd. romanized
2025/08/23New drug · Class 2.2 贝莫苏拜单抗注射液 · No verified English nameCXSS2500085 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/08/23New drug · Class 1 LBM801 · No verified English nameCXSL2500734 Shanghai Bo Sai Mei Bio Technology Co., Ltd. romanized; Shanghai Li Kang Rui Bio Gong Cheng Co., Ltd. romanized
2025/08/23New drug · Class 1 SR604注射液 · No verified English nameCXSL2500733 Shanghai Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized
2025/08/23New drug · Class 1.1 冻干结核病mRNA疫苗 · No verified English nameCXSL2500732 Rui Ji (Beijing) Bio Technology Co., Ltd. romanized; Shenzhen Rui Ji Bio Technology Co., Ltd. romanized; Wuhan Rui Ji Bio Technology Co., Ltd. romanized

97 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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