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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 356 drug applications between 4 February 2025 and 10 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 135, covering 93 drug names.

2025/02/04 – 2025/02/10

Period
2025/02/04 to 2025/02/10, 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
356
Drugs with new generic filings (by drug name, de-duplicated)
93
Accepted this week, now under review
15

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

356filings, 135 of them generic

By application type

Application typeFilings
Generic135
Supplement110
New drug80
Import15
Import re-registration11
Unspecified5

By drug type

Drug typeFilings
Chemical drug266
Therapeutic biologic54
TCM30
Prophylactic biologic4
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

93 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets11760
2Brexpiprazole Tablets6231
3Tacrolimus Capsules422
4盐酸纳美芬注射液 · No verified English name321
5Polidocanol Injection3123
6Tofacitinib Citrate Extended Release tablets222
7Sacubitril Valsartan Sodium Tablets2270
8Cetrorelix Acetate for Injection224
9Rosuvastatin Calcium and Ezetimibe Tablets (I)229
10盐酸舍曲林口服浓缩液 · No verified English name223

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

222 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Hao Sen Pharma Group Co., Ltd. romanized1130
2Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized930
3Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized550
4Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized545
5Sichuan Kelun Pharmaceutical Co., Ltd.532
6Beijing Hua Shen Pharmaceutical Co., Ltd. romanized440
7Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized420
8Jiangsu Kang Yuan Pharma Co., Ltd. romanized424
9Jinan Gao Hua Pharmaceutical Co., Ltd. romanized424
10Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized420

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

128 this week

AcceptedDrugApplicants
2025/02/10New drug · Class 1.1 复方芎蕲软胶囊 · No verified English nameCXZL2500008 Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized; Zhongguo Ke College Lanzhou Chemical Wu Li Research Institute romanized
2025/02/10New drug · Class 1 自体淋巴细胞注射液 · No verified English nameCXSL2500131 Kang Ai Rui Hao Biopharmaceuticals (Zhejiang) Co., Ltd. romanized
2025/02/10New drug · Class 2.3 DYTH201片 · No verified English nameCXHL2500184 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2025/02/10New drug · Class 2.3 DYTH201片 · No verified English nameCXHL2500183 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2025/02/09Import · Class 1 Bleximenib片 · No verified English nameJXHL2500023 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/02/09Import · Class 1 Bleximenib片 · No verified English nameJXHL2500022 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/02/09Import · Class 1 Bleximenib片 · No verified English nameJXHL2500021 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/02/09Import · Class 2.4 放射性药物镓[68Ga]oxodotreotide注射液配制用药盒 · No verified English nameJXHL2500020 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/02/09Import · Class 2.4 镥[177Lu]oxodotreotide注射液 · No verified English nameJXHL2500019 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/02/09Generic · Class 3 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2500685 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/02/09Generic · Class 3 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2500677 Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized
2025/02/09Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2500675 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2025/02/09Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2500673 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2025/02/09Generic · Class 3 山梨醇甘露醇冲洗剂 · No verified English nameCYHS2500672 Qingdao Ao Rui Sen Medical Technology Co., Ltd. romanized; Qingdao Rui Nai Medical Technology Co., Ltd. romanized
2025/02/09Generic · Class 3 美沙拉秦肠溶缓释胶囊 · No verified English nameCYHS2500660 Chengdu Brilliant Pharmaceutical Co., Ltd.
2025/02/09Generic · Class 3 贝派度酸依折麦布片 · No verified English nameCYHL2500034 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/02/09Generic · Class 3 Mannitol-S InjectionCYHL2500033 Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2025/02/09New drug · Class 3.1 芍药甘草颗粒 · No verified English nameCXZS2500004 Shandong Run Zhong Pharma Co., Ltd. romanized
2025/02/09New drug · Class 1.1 七福饮颗粒 · No verified English nameCXZL2500007 Henan Fu Di Bio Technology Co., Ltd. romanized
2025/02/09New drug · Class 1.2 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSS2500027 Lv Zhu Biopharmaceutical (Zhuhai Shi) Co., Ltd. romanized
2025/02/09New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSS2500026 Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2025/02/09New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSS2500025 Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2025/02/09New drug · Class 1.2 YKYY025注射液 · No verified English nameCXSL2500130 Hangzhou Tian Long Pharma Co., Ltd. romanized
2025/02/09New drug · Class 1 人牙囊间充质干细胞注射液 · No verified English nameCXSL2500129 Chengdu Shi Lian Kang Jian Bio Technology Co., Ltd. romanized
2025/02/09New drug · Class 1 注射用KJ103 · No verified English nameCXSL2500128 Shanghai Bao Ji Pharma Co., Ltd. romanized
2025/02/09New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSL2500127 Hua Lan Ji Yin Gong Cheng (Henan) Co., Ltd. romanized; Hua Lan Ji Yin Gong Cheng Co., Ltd. romanized
2025/02/09New drug · Class 1 NCR201注射液 · No verified English nameCXSL2500126 Zhong Sheng Su Yuan (Guangzhou) Bio Technology Co., Ltd. romanized; Anhui Zhong Sheng Su Yuan Bio Technology Co., Ltd. romanized
2025/02/09New drug · Class 1 HWS116注射液 · No verified English nameCXSL2500125 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized
2025/02/09New drug · Class 1 DNTH103注射液 · No verified English nameCXSL2500124 Yuan Yi Bio Technology (Shanghai) Co., Ltd. romanized
2025/02/09New drug · Class 1 IBI3020 · No verified English nameCXSL2500123 Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized

98 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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