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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 401 drug applications between 28 December 2024 and 3 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 128, covering 92 drug names.

2024/12/28 – 2025/01/03

Period
2024/12/28 to 2025/01/03, 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
401
Drugs with new generic filings (by drug name, de-duplicated)
92
Accepted this week, now under review
11

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

401filings, 128 of them generic

By application type

Application typeFilings
Supplement152
Generic128
New drug84
Import18
Unspecified16
Import re-registration3

By drug type

Drug typeFilings
Chemical drug296
TCM58
Therapeutic biologic40
Prophylactic biologic6
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

92 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets5360
2Tacrolimus Ointment426
3Tadalafil Tablets3123
4Topiroxostat Tablets310
5Paliperidone Palmitate Injection318
6Fusidic Acid Cream2215
7Formoterol Fumarate Inhalation Solution225
8盐酸多沙普仑注射液 · No verified English name222
9Glucosamine Sulfate Capsules2251
10Cimetidine Injection225

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

260 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized730
2Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized610
3Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized610
4Nei Menggu Da Tang Pharma Co., Ltd. romanized550
5Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized550
6Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized550
7Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized421
8Shionogi Co. Ltd.330
9Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized330
10Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized330

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

149 this week

AcceptedDrugApplicants
2025/01/03Import · Class 1 ABBV-400注射用粉末 · No verified English nameJXSL2500002 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/01/03Import · Class 1 注射用Budigalimab · No verified English nameJXSL2500001 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/01/03Import · Class 1 STX-241片 · No verified English nameJXHL2500003 Pierre Fabre Médicament; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2025/01/03Import · Class 1 STX-241片 · No verified English nameJXHL2500002 Pierre Fabre Médicament; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2025/01/03Import · Class 1 STX-241片 · No verified English nameJXHL2500001 Pierre Fabre Médicament; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2025/01/03Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2500037 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2025/01/03Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2500036 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2025/01/03Generic · Class 3 硫酸阿托品滴眼液 · No verified English nameCYHS2500031 Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized; Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized
2025/01/03Generic · Class 3 复方葡萄糖/电解质颅脑手术冲洗液 · No verified English nameCYHS2500030 Hua Run Shuang He Pharma Co., Ltd. romanized
2025/01/03Generic · Class 3 Sodium Lactate Ringer's Irrigation SolutionCYHS2500027 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2025/01/03Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2500026 Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized; Beijing Hua Jin Pharmaceutical Co., Ltd. romanized
2025/01/03Generic · Class 3 Fudosteine oral solutionCYHS2500024 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2025/01/03Generic · Class 3 Fudosteine oral solutionCYHS2500023 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2025/01/03Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHS2500016 Yangtze River Pharmaceutical Group Co., Ltd
2025/01/03Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2500009 Hebei Zhi Heng Pharmaceuticals Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2025/01/03Generic · Class 3 Metaraminol Tartrate InjectionCYHS2500007 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/01/03Generic · Class 3 Potassium Aspartate InjectionCYHS2500006 Beijing Xin Mei Tai Ke Pharmaceuticals Technology Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2025/01/03Generic · Class 3 Topiroxostat TabletsCYHL2500005 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2025/01/03Generic · Class 3 Topiroxostat TabletsCYHL2500004 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2025/01/03Generic · Class 3 Topiroxostat TabletsCYHL2500003 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2025/01/03Generic · Class 3 Mannitol-S InjectionCYHL2500002 Hainan Ru Kang Bio Technology Co., Ltd. romanized
2025/01/03New drug · Class 1.1 ZYY-742凝胶 · No verified English nameCXZL2500001 Yang Zi Jiang Pharma Group Jiangsu Long Feng Tang Zhong Yao Co., Ltd. romanized; Nanjing Hai Ling Zhong Yao Pharmaceutical Gong Yi Technology Research Co., Ltd. romanized
2025/01/03New drug · Class 1 注射用SSS59 · No verified English nameCXSL2500006 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/01/03New drug · Class 2.1 注射用重组人血小板生成素 · No verified English nameCXSL2500005 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/01/03New drug · Class 1 注射用TQB2101 · No verified English nameCXSL2500004 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/01/03New drug · Class 1.2 冻干带状疱疹mRNA疫苗 · No verified English nameCXSL2500003 Suzhou Ai Bo Bio Technology Co., Ltd. romanized; Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized
2025/01/03New drug · Class 1.2 冻干带状疱疹mRNA疫苗 · No verified English nameCXSL2500002 Suzhou Ai Bo Bio Technology Co., Ltd. romanized; Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized
2025/01/03New drug · Class 1.2 冻干带状疱疹mRNA疫苗 · No verified English nameCXSL2500001 Suzhou Ai Bo Bio Technology Co., Ltd. romanized; Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized
2025/01/03New drug · Class 2.3 BCM882胶囊 · No verified English nameCXHL2500006 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2025/01/03New drug · Class 2.3 BCM882胶囊 · No verified English nameCXHL2500005 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized

119 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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