YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 335 drug applications between 2 July 2025 and 8 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 66 drug names.

2025/07/02 – 2025/07/08

Period
2025/07/02 to 2025/07/08, 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
335
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
75

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

335filings, 96 of them generic

By application type

Application typeFilings
Supplement145
Generic96
New drug70
Import18
Import re-registration4
Unspecified2

By drug type

Drug typeFilings
Chemical drug229
Therapeutic biologic53
TCM50
Prophylactic biologic3

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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1瑞维那新吸入溶液 · No verified English name6653
2Dapoxetine Hydrochloride Tablets4220
3Acetylcysteine Injection3353
4Cefazolin Sodium for Injection3113
5Acyclovir Tablets316
6Metoclopramide Hydrochloride Injection226
7Iguratimod Tablets2223
8蔗糖羟基氧化铁咀嚼片 · No verified English name220
9Finerenone Tablets2269
10依伏卡塞片 · No verified English name219

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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Lai Bin Hu Lu Wa Pharma Co., Ltd. romanized660
2Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized660
3Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized540
4Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized530
5Shenzhen Xin Li Tai Pharma Co., Ltd. romanized520
6Celgene Corporation510
7Karuna Therapeutics Inc.510
8Guangdong He Xiang Biopharmaceuticals Co., Ltd. romanized440
9Hunan Ke Lun Pharmaceutical Co., Ltd. romanized430
10Eli Lilly Nederland B.V.420

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

117 this week

AcceptedDrugApplicants
2025/07/08Import · Class 1 ALXN2420注射液 · No verified English nameJXHL2500162 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/08Generic · Class 3 Bilastine Oral SolutionCYHS2502424 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2025/07/08Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2502423 Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized
2025/07/08Generic · Class 3 Fudosteine oral solutionCYHS2502419 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2025/07/08Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2502416 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2025/07/08Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2502410 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2025/07/08Generic · Class 3 Calcium Gluconate InjectionCYHS2502405 Henan Pu Rui Pharma Co., Ltd. romanized
2025/07/08Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2502403 Guangdong Nan Guo Pharma Co., Ltd. romanized
2025/07/08New drug · Class 1.1 ZY-A002 · No verified English nameCXZL2500046 Ya Bao Pharma Group Co., Ltd. romanized
2025/07/08New drug · Class 2.3 淫羊藿素软胶囊 · No verified English nameCXZL2500045 Name not romanized
2025/07/08New drug · Class 1 乐德奇拜单抗注射液 · No verified English nameCXSS2500074 Xian Sheng Pharma Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized
2025/07/08New drug · Class 1 乐德奇拜单抗注射液 · No verified English nameCXSS2500073 Xian Sheng Pharma Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized
2025/07/08New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSS2500072 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/07/08New drug · Class 1 注射用ZGGS34 · No verified English nameCXSL2500561 Name not romanized; Name not romanized
2025/07/08New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSL2500557 Guo Yao Group Kunming Xue Ye Zhi Pin Co., Ltd. romanized
2025/07/08New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSL2500556 Guo Yao Group Kunming Xue Ye Zhi Pin Co., Ltd. romanized
2025/07/08New drug · Class 3.3 仑卡奈单抗注射液 · No verified English nameCXSL2500555 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/07/08New drug · Class 3.3 甲型肝炎灭活疫苗(人二倍体细胞) · No verified English nameCXSL2500554 Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized; Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2025/07/08New drug · Class 1 GR1803注射液 · No verified English nameCXSL2500553 Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2025/07/08New drug · Class 1 自体自然杀伤细胞注射液 · No verified English nameCXSL2500552 Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized
2025/07/08New drug · Class 2.4 示踪用盐酸米托蒽醌注射液 · No verified English nameCXHS2500073 Shenzhen Hua Run Jiu Chuang Pharmaceuticals Co., Ltd. romanized; Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized
2025/07/08New drug · Class 1 TT-00420片 · No verified English nameCXHL2500658 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2025/07/08New drug · Class 1 TT-00420片 · No verified English nameCXHL2500657 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2025/07/08New drug · Class 1 TT-00420 片 · No verified English nameCXHL2500656 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2025/07/08New drug · Class 1 HRS-3095片 · No verified English nameCXHL2500655 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/07/08New drug · Class 1 HRS-3095片 · No verified English nameCXHL2500654 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/07/08New drug · Class 1 LSCCB-PtNNN注射液 · No verified English nameCXHL2500653 Jin Bo Pharma (Shenzhen) Co., Ltd. romanized
2025/07/08New drug · Class 2.2 盐酸右美托咪定微针贴剂 · No verified English nameCXHL2500652 Guangzhou Xin Ji Pharma Technology Co., Ltd. romanized
2025/07/08New drug · Class 2.2 盐酸右美托咪定微针贴剂 · No verified English nameCXHL2500651 Guangzhou Xin Ji Pharma Technology Co., Ltd. romanized
2025/07/07New drug · Class 3.3 QL2106注射液 · No verified English nameCXSL2500545 Qilu Pharmaceutical Co., Ltd.

87 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.