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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 391 drug applications between 10 March 2025 and 16 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 104, covering 70 drug names.

2025/03/10 – 2025/03/16

Period
2025/03/10 to 2025/03/16, 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
391
Drugs with new generic filings (by drug name, de-duplicated)
70
Accepted this week, now under review
22

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

391filings, 104 of them generic

By application type

Application typeFilings
Supplement173
Generic104
New drug50
Import re-registration24
Unspecified20
Import20

By drug type

Drug typeFilings
Chemical drug299
TCM49
Therapeutic biologic38
Prophylactic biologic3
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地氯雷他定口服溶液 · No verified English name4226
2Sacubitril Valsartan Sodium Tablets4270
3Mivacurium Chloride Injection423
4Dapagliflozin Tablets4284
5Lactulose Oral Solution3234
6甲氧氯普胺片 · No verified English name323
7Riociguat Tablets314
8Levofloxacin and Sodium Chloride Injection3114
9腺苷钴胺胶囊 · No verified English name228
10Multiple Vitamins Injection214

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

220 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized17160
2Bracco Imaging S.P.A.1310
3Fresenius Kabi Deutschland GmbH1220
4Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized630
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
6AstraZeneca AB530
7Sanofi Winthrop Industrie530
8SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED532
9Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized522
10Zhongguo Ke College Shanghai Drug Research Institute romanized430

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

104 this week

AcceptedDrugApplicants
2025/03/15Import · Class 2.2 度普利尤单抗注射液 · No verified English nameJXSS2500026 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/03/15Import · Class 2.2 度普利尤单抗注射液 · No verified English nameJXSS2500025 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/03/15Import · Class 1 ADI-001 · No verified English nameJXSL2500038 Adicet Therapeutics Inc.; Shanghai Adicet Biotechnology Co. Ltd.
2025/03/15Import · Class 1 VSA001注射液 · No verified English nameJXHL2500045 Arrowhead Pharmaceuticals Inc.; Sanofi (China) Investment Co. Ltd.
2025/03/15Generic · Class 3 Lanthanum Carbonate Hydrate GranulesCYHS2501085 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/03/15Generic · Class 3 Lanthanum Carbonate Hydrate GranulesCYHS2501084 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/03/15Generic · Class 3 聚乙二醇3350散 · No verified English nameCYHS2501080 Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized
2025/03/15Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2501078 Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized
2025/03/15Generic · Class 3 Nimodipine Oral SolutionCYHS2501074 Shijiazhuang No.4 Pharmaceutical Co., Ltd.; Zhejiang Guo Jing Pharma Co., Ltd. romanized
2025/03/15New drug · Class 1.2 SOC201胶囊 · No verified English nameCXZL2500017 Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhi Jiang Run Tian Tian Cha Bio Technology Co., Ltd. romanized
2025/03/15New drug · Class 1.2 SOC201提取物 · No verified English nameCXZL2500016 Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhi Jiang Run Tian Tian Cha Bio Technology Co., Ltd. romanized
2025/03/15New drug · Class 1.1 小儿热立清颗粒 · No verified English nameCXZL2500015 Qi Zheng (Zhuhai Shi Heng Qin) International Pharmaceuticals Co., Ltd. romanized; Gansu Qi Zheng Zang Yao Co., Ltd. romanized
2025/03/15New drug · Class 1 注射用AK146D1 · No verified English nameCXSL2500227 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2025/03/15New drug · Class 1 JWK002注射液 · No verified English nameCXSL2500225 Wuhan Jin Wei Ke Bio Technology Co., Ltd. romanized; Chengdu Jin Wei Ke Bio Technology Co., Ltd. romanized
2025/03/15New drug · Class 1 GLS-W1100胶囊 · No verified English nameCXSL2500224 Hangzhou Yuan Da Biopharmaceutical Co., Ltd. romanized
2025/03/15New drug · Class 1 玛氘诺沙韦片 · No verified English nameCXHS2500022 Jia Xing An Di Kang Bio Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2025/03/15New drug · Class 1 塞拉维诺片 · No verified English nameCXHL2500291 Zhongguo Ke College Shanghai Drug Research Institute romanized; Shou Du Yi Ke University Fu Shu Beijing Tian Tan Hospital romanized
2025/03/15New drug · Class 1 塞拉维诺片 · No verified English nameCXHL2500290 Zhongguo Ke College Shanghai Drug Research Institute romanized; Shou Du Yi Ke University Fu Shu Beijing Tian Tan Hospital romanized
2025/03/15New drug · Class 2.2 PDX-04 · No verified English nameCXHL2500289 Hunan Jiudian Pharmaceutical Co., Ltd
2025/03/15New drug · Class 2.2 PDX-04 · No verified English nameCXHL2500288 Hunan Jiudian Pharmaceutical Co., Ltd
2025/03/15New drug · Class 1 伊匹乌肽散剂 · No verified English nameCXHL2500287 Yi Cheng Kang Tai (Xiamen) Bio Technology Co., Ltd. romanized
2025/03/15New drug · Class 1 ZYS-1肠溶片 · No verified English nameCXHL2500286 Beijing Ke You Ai Technology Co., Ltd. romanized
2025/03/15New drug · Class 2.2 KEM2414直服颗粒 · No verified English nameCXHL2500285 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/03/15New drug · Class 1 PLB1004胶囊 · No verified English nameCXHL2500284 An Shi Pharma (Ningbo) Co., Ltd. romanized
2025/03/15New drug · Class 1 PLB1004胶囊 · No verified English nameCXHL2500283 An Shi Pharma (Ningbo) Co., Ltd. romanized
2025/03/14Import · Class 1 TQJ230注射液 · No verified English nameJXHL2500044 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/03/14Import · Class 1 ELVN-001胶囊 · No verified English nameJXHL2500043 Enliven Therapeutics Inc.; R&G PharmaStudies Co. Ltd.
2025/03/14Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2501064 Shandong Yi Kang Pharma Co., Ltd. romanized
2025/03/14Generic · Class 3 Famotidine InjectionCYHS2501060 Anhui Mei Lai Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2025/03/14Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2501059 Shijiazhuang No.4 Pharmaceutical Co., Ltd.

74 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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