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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 193 drug applications between 6 October 2025 and 12 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 40 drug names.

2025/10/06 – 2025/10/12

Period
2025/10/06 to 2025/10/12, 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
193
Drugs with new generic filings (by drug name, de-duplicated)
40
Accepted this week, now under review
52

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

193filings, 46 of them generic

By application type

Application typeFilings
Supplement95
Generic46
New drug35
Import12
Import re-registration4
Unspecified1

By drug type

Drug typeFilings
Chemical drug110
TCM49
Therapeutic biologic32
In vitro diagnostic reagent1
Biologic1

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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Furosemide Injection226
2Dotinurad Tablets2155
3Paracetamol Tablets216
4枸橼酸西地那非口溶膜 · No verified English name218
5Lercanidipine Hydrochloride Tablets216
6Nicardipine Hydrochloride Injection2113
7Fluticasone Propionate Cream1112
8Calcium Folinate Injection114
9Crisaborole Ointment1126
10Calcipotriol Ointment115

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

131 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized630
2Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized550
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized440
4Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized440
5Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized440
6AbbVie Deutschland GmbH & Co. KG410
7Bristol-Myers Squibb Company410
8Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized410
9Sichuan Tai Hua Tang Pharmaceutical Co., Ltd. romanized330
10Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized333

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

59 this week

AcceptedDrugApplicants
2025/10/12New drug · Class 1.1 复方南藤胶囊 · No verified English nameCXZL2500094 Nanjing Zhong Pharmaceuticals University romanized; Jiangsu Jin Shi Dan Technology Co., Ltd. romanized
2025/10/12New drug · Class 3.4 抗五步蛇毒血清 · No verified English nameCXSL2500869 Jiangxi Bio Zhi Pin Research Institute Co., Ltd. romanized
2025/10/12New drug · Class 2.2 注射用硼[10B]法仑 · No verified English nameCXHL2501079 Shenzhen Shi Zhong He Hai De Wei Bio Technology Co., Ltd. romanized
2025/10/12New drug · Class 1 注射用HSK55718 · No verified English nameCXHL2501078 Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized
2025/10/12New drug · Class 1 注射用HSK55718 · No verified English nameCXHL2501077 Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized
2025/10/12New drug · Class 1 RTX-117片 · No verified English nameCXHL2501076 Xi Li Technology (Shenzhen) Co., Ltd. romanized
2025/10/12New drug · Class 1 RTX-117片 · No verified English nameCXHL2501075 Xi Li Technology (Shenzhen) Co., Ltd. romanized
2025/10/12New drug · Class 1 ICP-332 · No verified English nameCXHL2501074 Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2025/10/11Import · Class 3.4 注射用A型肉毒毒素 · No verified English nameJXSS2500130 Daewoong Pharmaceutical Co. Ltd.; Beijing Daewoong Pharmaceutical R&D Center Co. Ltd.
2025/10/11Import · Class 2.4 Entrectinib胶囊 · No verified English nameJXHL2500309 F. Hoffmann-La Roche Ltd
2025/10/11Generic · Class 3 Doxofylline TabletsCYHS2503631 Hefei He Yuan Pharma Co., Ltd. romanized
2025/10/11Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2503629 Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized; Hefei Si Pu Rui Pharma Co., Ltd. romanized
2025/10/11Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2503628 Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized; Hefei Si Pu Rui Pharma Co., Ltd. romanized
2025/10/11Generic · Class 3 Sodium Thiosulfate InjectionCYHS2503624 Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/10/11Generic · Class 3 Furosemide InjectionCYHS2503622 Ya Bang Pharmaceuticals Co., Ltd. romanized
2025/10/11Generic · Class 3 Ketoprofen PatchesCYHL2500179 Hainan He Rui Pharmaceutical Co., Ltd. romanized
2025/10/11New drug · Class 2.2 TQA凝胶贴膏 · No verified English nameCXZL2500093 Sai Ling Pharma Technology Group Co., Ltd. romanized
2025/10/11New drug · Class 1 注射用ISH0688 · No verified English nameCXSL2500868 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2025/10/11New drug · Class 1 YF-3注射液 · No verified English nameCXSL2500865 Suzhou Yong Xin Bio Technology Co., Ltd. romanized
2025/10/11New drug · Class 1 人前/中脑神经前体细胞注射液 · No verified English nameCXSL2500864 Zhejiang Quan Sheng Bio Technology Co., Ltd. romanized
2025/10/11New drug · Class 1 注射用SHR-4394 · No verified English nameCXSL2500863 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/10/11New drug · Class 1 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2500862 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2025/10/11New drug · Class 1 HSK45019片 · No verified English nameCXHL2501073 Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized
2025/10/11New drug · Class 1 HSK45019片 · No verified English nameCXHL2501072 Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized
2025/10/11New drug · Class 1 HRL1101散 · No verified English nameCXHL2501071 Beijing Hua Rui Ding Xin Technology Co., Ltd. romanized; Hunan Ming Rui Pharmaceutical Co., Ltd. romanized
2025/10/11New drug · Class 2.2 1861B · No verified English nameCXHL2501070 Pu Zhao Guo Kang (Hubei) Pharma Co., Ltd. romanized
2025/10/11New drug · Class 2.4 泽美妥司他片 · No verified English nameCXHL2501069 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/10/11New drug · Class 1 HRS-5041片 · No verified English nameCXHL2501068 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/10/11New drug · Class 2.4 瑞维鲁胺片 · No verified English nameCXHL2501067 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/10/11New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2501066 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized

29 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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