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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 462 drug applications between 3 April 2025 and 9 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 135, covering 97 drug names.

2025/04/03 – 2025/04/09

Period
2025/04/03 to 2025/04/09, 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
462
Drugs with new generic filings (by drug name, de-duplicated)
97
Accepted this week, now under review
35

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

462filings, 135 of them generic

By application type

Application typeFilings
Supplement230
Generic135
New drug51
Import30
Unspecified9
Import re-registration7

By drug type

Drug typeFilings
Chemical drug281
TCM116
Therapeutic biologic63
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

97 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets5223
2Brexpiprazole Tablets4231
3Vonoprazan Fumarate Tablets3260
4Oxacillin Sodium for Injection3113
5Letermovir Injection226
6氯化钙注射液 · No verified English name226
7Rosuvastatin Calcium and Ezetimibe Tablets (I)225
8维生素B6注射液 · No verified English name2210
9Iguratimod Tablets2223
10Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)225

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 Pan Long Pharma Group Co., Ltd. romanized13110
2Ningbo Tian Yi Pharma Technology Co., Ltd. romanized12612
3Guo Yao Group Beijing Hua Miao Pharma Co., Ltd. romanized11100
4Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized860
5Shenyang Dong Xin Pharma Co., Ltd. romanized750
6Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized660
7AstraZeneca AB630
8Bayer Inc.610
9Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized550
10Shandong Er Ye Pharmaceutical Co., Ltd. romanized540

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
2025/04/09Import · Class 3.1 注射用阿帕达酶α · No verified English nameJXSS2500044 Takeda Pharmaceuticals U.S.A. Inc.; Takeda Manufacturing Austria AG
2025/04/09Import · Class 3.1 注射用阿帕达酶α · No verified English nameJXSS2500043 Takeda Pharmaceuticals U.S.A. Inc.; Takeda Manufacturing Austria AG
2025/04/09Import · Class 1 VAY736注射液 · No verified English nameJXSL2500057 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/04/09Import · Class 1 MEDI5752 · No verified English nameJXSL2500056 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/04/09Import · Class 1 ABBV-324注射用粉末 · No verified English nameJXSL2500055 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/04/09Import · Class 1 Casdatifan 片 · No verified English nameJXHL2500076 Arcus Biosciences Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2025/04/09Import · Class 1 BI1815368 片 · No verified English nameJXHL2500075 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (Cnina) Investment Co. Ltd.
2025/04/09Import · Class 1 BI1815368 片 · No verified English nameJXHL2500074 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (Cnina) Investment Co. Ltd.
2025/04/09Import · Class 1 BI 690517片 · No verified English nameJXHL2500073 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/04/09Import · Class 1 BI 690517片 · No verified English nameJXHL2500072 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/04/09Generic · Class 3 黄体酮注射液(Ⅱ) · No verified English nameCYHS2501363 Guangzhou Bai Yun Shan Ming Xing Pharmaceutical Co., Ltd. romanized
2025/04/09Generic · Class 3 Luliconazole CreamCYHS2501361 Guangdong Hua Run Shun Feng Pharma Co., Ltd. romanized
2025/04/09Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2501357 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Henan Pu Rui Pharma Co., Ltd. romanized
2025/04/09Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2501356 Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized
2025/04/09Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2501355 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Henan Pu Rui Pharma Co., Ltd. romanized
2025/04/09Generic · Class 3 碳酸氢钠血滤置换液(无钾、无钙、0.6mmol/L镁) · No verified English nameCYHS2501352 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/04/09Generic · Class 3 碳酸氢钠血滤置换液(钾4mmol/L无钙) · No verified English nameCYHS2501351 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/04/09Generic · Class 3 碳酸氢钠血滤置换液(钾2mmol/L 无钙) · No verified English nameCYHS2501350 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/04/09Generic · Class 3 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2501342 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/04/09Generic · Class 3 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2501341 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/04/09Generic · Class 3 酮洛芬凝胶贴膏 · No verified English nameCYHL2500078 Hunan Pai Ge Lan Pharma Co., Ltd. romanized
2025/04/09Generic · Class 3 镥[177Lu]氧奥曲肽注射液 · No verified English nameCYHL2500076 Mai De Nuo Medical Technology Group Co., Ltd. romanized
2025/04/09New drug · Class 1.1 三贝苎鼾胶囊 · No verified English nameCXZS2500016 Zhejiang Bao Ren Tang Pharma Co., Ltd. romanized; Beijing Ya Dong Biopharmaceutical Co., Ltd. romanized
2025/04/09New drug · Class 1 舒欣瑞纳注射液 · No verified English nameCXSL2500280 Jiangsu Gui Qiong Pharma Co., Ltd. romanized; Jiangsu He Tai Bio Co., Ltd. romanized
2025/04/09New drug · Class 1 XLH01片 · No verified English nameCXHL2500367 Shandong Run Zhong Pharma Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized
2025/04/09New drug · Class 1 XLH01片 · No verified English nameCXHL2500366 Shandong Run Zhong Pharma Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized
2025/04/09New drug · Class 1 WEYZ-1乳膏 · No verified English nameCXHL2500365 Nanjing Wei Er You Zhong Pharmaceuticals Co., Ltd. romanized
2025/04/09New drug · Class 1 DAT-1604片 · No verified English nameCXHL2500364 Beijing Dan Qing Pharmaceuticals Technology Co., Ltd. romanized
2025/04/09New drug · Class 1 DAT-1604片 · No verified English nameCXHL2500363 Beijing Dan Qing Pharmaceuticals Technology Co., Ltd. romanized
2025/04/09New drug · Class 2.2 BCM957 · No verified English nameCXHL2500362 Shanghai Yun Cheng Yan Xin Bio 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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