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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 375 drug applications between 18 January 2025 and 24 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 134, covering 95 drug names.

2025/01/18 – 2025/01/24

Period
2025/01/18 to 2025/01/24, 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
375
Drugs with new generic filings (by drug name, de-duplicated)
95
Accepted this week, now under review
18

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

375filings, 134 of them generic

By application type

Application typeFilings
Supplement145
Generic134
New drug70
Import23
Unspecified2
Import re-registration1

By drug type

Drug typeFilings
Chemical drug268
Therapeutic biologic50
TCM48
Prophylactic biologic9

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

95 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets7327
2Levofloxacin Injection421
3Mivacurium Chloride Injection423
4Brexpiprazole Tablets3131
5Gadoteric Acid Meglumine Salt Injection311
6Lactulose Oral Solution2234
7Candesartan Cilexetil and Hydrochlorothiazide Tablets222
8盐酸纳美芬注射液 · No verified English name221
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

249 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
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
5Bristol-Myers Squibb Company440
6Guizhou Heng He Pharmaceutical Co., Ltd. romanized440
7Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized432
8Jiangxi Ke Rui Pharma Co., Ltd. romanized432
9Qilu Pharmaceutical Co., Ltd.431
10Jilin Sheng Xi Dian Pharma Technology Development 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

145 this week

AcceptedDrugApplicants
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.
2025/01/24Generic · Class 3 Risedronate Sodium TabletsCYHS2500475 Beijing Foyou Pharma CO.,LTD
2025/01/24Generic · Class 3 头孢克肟胶囊 · No verified English nameCYHS2500468 Nanjing Rui Jie Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ya Bang Qiang Sheng Pharma Co., Ltd. romanized
2025/01/24Generic · Class 3 Pentoxifylline InjectionCYHS2500467 Chu Xiong He Chuang Pharma Co., Ltd. romanized
2025/01/24Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2500461 Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized
2025/01/24Generic · Class 3 Potassium Chloride GranulesCYHS2500460 Nanjing Huang Long Bio Technology Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2025/01/24Generic · Class 3 Levofloxacin InjectionCYHS2500459 Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized
2025/01/24Generic · Class 3 Levofloxacin InjectionCYHS2500458 Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized
2025/01/24Generic · Class 3 Potassium Chloride GranulesCYHS2500457 Nanjing Huang Long Bio Technology Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2025/01/24Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2500451 Zhengzhou Wei Xian Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2025/01/24Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2500448 Shanghai Zhao Hui Pharma Co., Ltd. romanized
2025/01/24Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2500447 Shanghai Zhao Hui Pharma Co., Ltd. romanized
2025/01/24Generic · Class 3 Ketoprofen PatchesCYHL2500023 Hebei Yi Pin Pharmaceutical Co., Ltd. romanized
2025/01/24New drug · Class 3.1 苓桂术甘颗粒 · No verified English nameCXZS2500003 Hunan Yi Neng Biopharmaceuticals Co., Ltd. romanized; Hunan Kang Shou Pharmaceutical Co., Ltd. romanized
2025/01/24New drug · Class 1.1 吾斯提库都斯颗粒 · No verified English nameCXZL2500004 He Tian Wei Wu Er Pharma Co., Ltd. romanized
2025/01/24New drug · Class 3.2 长效重组人促卵泡激素注射液 · No verified English nameCXSS2500014 Beijing SL Pharmaceutical Co., Ltd.
2025/01/24New drug · Class 3.2 长效重组人促卵泡激素注射液 · No verified English nameCXSS2500013 Beijing SL Pharmaceutical Co., Ltd.
2025/01/24New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSS2500012 Cheng Da Bio (Ben Xi) Co., Ltd. romanized
2025/01/24New drug · Class 1 舒地胰岛素注射液 · No verified English nameCXSS2500011 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/01/24New drug · Class 1 舒地胰岛素注射液 · No verified English nameCXSS2500010 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/01/24New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500009 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized
2025/01/24New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500008 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized
2025/01/24New drug · Class 1 FT-017注射液 · No verified English nameCXSL2500078 Fang Tuo Bio Technology (Shanghai) Co., Ltd. romanized
2025/01/24New drug · Class 1 HiCM388注射液 · No verified English nameCXSL2500077 Ai Er Pu Zai Sheng Yi Xue Technology (Shenzhen) Co., Ltd. romanized
2025/01/24New drug · Class 2.2 纳基奥仑赛注射液 · No verified English nameCXSL2500076 Guangdong He Yuan Biopharmaceuticals Co., Ltd. romanized; He Yuan Bio Technology (Tianjin) Co., Ltd. romanized
2025/01/24New drug · Class 1 UTAA09注射液 · No verified English nameCXSL2500075 Bo Sheng Ji Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized; Bo Sheng Ji An Ke Xi Bao Technology Co., Ltd. romanized

115 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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