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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 408 drug applications between 19 January 2025 and 25 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 143, covering 104 drug names.

2025/01/19 – 2025/01/25

Period
2025/01/19 to 2025/01/25, 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
408
Drugs with new generic filings (by drug name, de-duplicated)
104
Accepted this week, now under review
20

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

408filings, 143 of them generic

By application type

Application typeFilings
Supplement173
Generic143
New drug72
Import15
Unspecified5

By drug type

Drug typeFilings
Chemical drug275
TCM65
Therapeutic biologic56
Prophylactic biologic9
Biologic3

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

104 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets7327
2Levofloxacin Injection421
3Mivacurium Chloride Injection423
4Riociguat Tablets314
5Brexpiprazole Tablets3131
6Gadoteric Acid Meglumine Salt Injection311
7Lactulose Oral Solution2234
8Candesartan Cilexetil and Hydrochlorothiazide Tablets222
9Sodium Thiosulfate Injection223
10Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)223

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

268 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB750
2Anhui Jin Ma Pharma Co., Ltd. romanized550
3Hunan Xian Shi Pharmaceutical Co., Ltd. romanized531
4Nanjing Huang Long Bio Technology Co., Ltd. romanized525
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
6Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized440
7Guizhou Heng He Pharmaceutical Co., Ltd. romanized440
8Le Tai Pharma Co., Ltd. romanized430
9Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized432
10Jiangxi Ke Rui Pharma Co., Ltd. romanized432

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

152 this week

AcceptedDrugApplicants
2025/01/25Import · Class 2.2 本瑞利珠单抗注射液 · No verified English nameJXSL2500019 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/01/25Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2500494 Hebei Ji Hui Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2025/01/25Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2500493 Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2025/01/25Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCYHS2500492 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/01/25Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂(Ⅱ) · No verified English nameCYHS2500491 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/01/25Generic · Class 3 Brivaracetam Oral SolutionCYHS2500486 Jiangxi Ke Rui Pharma Co., Ltd. romanized
2025/01/25Generic · Class 3 Acetaminophen InjectionCYHS2500485 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/01/25Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2500484 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2025/01/25Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2500483 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2025/01/25Generic · Class 3 Sodium Bicarbonate InjectionCYHS2500481 Anhui Xin Shi Ji Pharma Co., Ltd. romanized; Ping Guang Pharmaceutical Co., Ltd. romanized
2025/01/25Generic · Class 3 Betaine anhydrous for oral solutionCYHL2500026 Yi Chun Wu Jia Can Pharma Co., Ltd. romanized
2025/01/25Generic · Class 3 Bempedoic Acid TabletsCYHL2500025 Hefei Li Fang Pharmaceutical Co., Ltd. romanized
2025/01/25New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSS2500016 Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized; Li Zhu Group Li Zhu Pharmaceutical Factory romanized
2025/01/25New drug · Class 1 伏欣奇拜单抗注射液 · No verified English nameCXSS2500015 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/01/25New drug · Class 1 RY_SW01细胞注射液 · No verified English nameCXSL2500082 Jiangsu Rui Yuan Bio Technology Co., Ltd. romanized
2025/01/25New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500081 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/01/25New drug · Class 1 RGL-270注射液 · No verified English nameCXSL2500080 Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized; Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized
2025/01/25New drug · Class 1 注射用DR30206 · No verified English nameCXSL2500079 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2025/01/25New drug · Class 2.2 BCM857 · No verified English nameCXHS2500015 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2025/01/25New drug · Class 2.2 BCM857 · No verified English nameCXHS2500014 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2025/01/25New drug · Class 1 INS018_055片 · No verified English nameCXHL2500120 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2025/01/25New drug · Class 2.2 双环醇缓释片 · No verified English nameCXHL2500119 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized
2025/01/25New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2500118 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2025/01/25New drug · Class 1 HX9428片 · No verified English nameCXHL2500117 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized
2025/01/25New drug · Class 1 HX9428片 · No verified English nameCXHL2500116 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized
2025/01/24Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSL2500018 MedImmune LLC; AstraZeneca Investment (China) Co. Ltd.
2025/01/24Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSL2500017 MedImmune LLC; AstraZeneca Investment (China) Co. Ltd.
2025/01/24Import · Class 2.4 Finerenone TabletsJXHS2500017 Bayer AG; Bayer Healthcare Company Ltd.
2025/01/24Import · Class 2.4 Finerenone TabletsJXHS2500016 Bayer AG; Bayer Healthcare Company Ltd.
2025/01/24Import · Class 2.4 Finerenone TabletsJXHS2500015 Bayer AG; Bayer Healthcare Company Ltd.

122 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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