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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 389 drug applications between 10 May 2025 and 16 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 70 drug names.

2025/05/10 – 2025/05/16

Period
2025/05/10 to 2025/05/16, 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
389
Drugs with new generic filings (by drug name, de-duplicated)
70
Accepted this week, now under review
53

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

389filings, 103 of them generic

By application type

Application typeFilings
Supplement199
Generic103
New drug57
Import18
Unspecified8
Import re-registration4

By drug type

Drug typeFilings
Chemical drug247
TCM76
Therapeutic biologic62
Biologic2
Prophylactic biologic2

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

70 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1复方电解质醋酸钠葡萄糖注射液 · No verified English name4222
2Minoxidil Liniment4252
3Risperidone Oral Solution416
4Calcium Acetate Oral Solution411
5Aripiprazole Oral Solution414
6Metoclopramide Hydrochloride Injection336
7Riociguat Tablets314
8Brexpiprazole Tablets3131
9Drotaverine Hydrochloride Injection223
10Nintedanib Esilate Soft Capsules216

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

218 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Dong Xin Pharma Co., Ltd. romanized13130
2Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized13413
3Jiangxi Qing Feng Pharma Co., Ltd. romanized1090
4AstraZeneca AB870
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized730
6Hong Tao Kai Pharma Co., Ltd. romanized660
7Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized650
8Sanofi Winthrop Industrie610
9Shaanxi Pan Long Pharma Group Co., Ltd. romanized550
10Qilu Pharmaceutical Co., Ltd.520

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

122 this week

AcceptedDrugApplicants
2025/05/16Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2501787 Chongqing Sai Nuo Bio Pharma Co., Ltd. romanized
2025/05/16Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2501786 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/16Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2501785 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/16Generic · Class 3 福多司坦片 · No verified English nameCYHS2501784 Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
2025/05/16Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2501777 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized
2025/05/16New drug · Class 3.1 苓桂术甘颗粒 · No verified English nameCXZS2500019 Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized
2025/05/16New drug · Class 1 ABO2102注射剂 · No verified English nameCXSL2500388 Suzhou Ai Bo Bio Technology Co., Ltd. romanized; Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized
2025/05/16New drug · Class 1 GB261注射液 · No verified English nameCXSL2500387 Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized; Jia He Bio Pharma Co., Ltd. romanized
2025/05/16New drug · Class 1 NW-101C注射液 · No verified English nameCXSL2500386 Xin Jing Zhi Yuan Bio Technology (Suzhou) Co., Ltd. romanized
2025/05/16New drug · Class 1 NW-101C注射液 · No verified English nameCXSL2500385 Xin Jing Zhi Yuan Bio Technology (Suzhou) Co., Ltd. romanized
2025/05/16New drug · Class 1 HRN77片 · No verified English nameCXHL2500483 Beijing Hua Rui Ding Xin Technology Co., Ltd. romanized; Hunan Ming Rui Pharmaceutical Co., Ltd. romanized
2025/05/16New drug · Class 1 HRN77片 · No verified English nameCXHL2500482 Hunan Ming Rui Pharmaceutical Co., Ltd. romanized; Beijing Hua Rui Ding Xin Technology Co., Ltd. romanized
2025/05/16New drug · Class 2.2 帕拉米韦吸入溶液 · No verified English nameCXHL2500481 Hunan Xian Shi Pharmaceutical Co., Ltd. romanized
2025/05/16New drug · Class 2.2 帕拉米韦吸入溶液 · No verified English nameCXHL2500480 Hunan Xian Shi Pharmaceutical Co., Ltd. romanized
2025/05/16New drug · Class 1 ACE-232片 · No verified English nameCXHL2500479 You Ling Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/05/16New drug · Class 1 ACE-232片 · No verified English nameCXHL2500478 You Ling Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/05/15Import · Class 1 那米司特片 · No verified English nameJXHS2500058 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/05/15Import · Class 1 那米司特片 · No verified English nameJXHS2500057 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/05/15Import · Class 1 Cenerimod片 · No verified English nameJXHL2500111 Idorsia Pharmaceuticals Ltd; Viatris Pharmaceuticals Co. Ltd.
2025/05/15Import · Class 2.2 CHF1535-II · No verified English nameJXHL2500110 CHIESI FARMACEUTICI SPA; Chiesi Pharmaceutical Consulting (Shanghai) Co. Ltd.
2025/05/15Generic · Class 3 Clindamycin Palmitate Hydrochloride GranulesCYHS2501776 Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 维生素B12注射液 · No verified English nameCYHS2501770 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2501769 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2501766 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2501765 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/05/15Generic · Class 3 Aripiprazole Oral SolutionCYHS2501763 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 Aripiprazole Oral SolutionCYHS2501762 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 Aripiprazole Oral SolutionCYHS2501761 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 Aripiprazole Oral SolutionCYHS2501760 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/05/15Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2501759 Zhejiang Hua Hai Pharmaceutical Technology Co., Ltd. romanized

92 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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