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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 347 drug applications between 14 January 2025 and 20 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 67 drug names.

2025/01/14 – 2025/01/20

Period
2025/01/14 to 2025/01/20, 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
347
Drugs with new generic filings (by drug name, de-duplicated)
67
Accepted this week, now under review
8

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

347filings, 96 of them generic

By application type

Application typeFilings
Supplement163
Generic96
New drug60
Import21
Import re-registration4
Unspecified3

By drug type

Drug typeFilings
Chemical drug261
TCM50
Therapeutic biologic30
Biologic3
Prophylactic 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

67 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Mivacurium Chloride Injection423
2Ruxolitinib Phosphate Tablets3127
3Ethyl Iosapentate Capsules2227
4Pentoxifylline Modified Release Tablets226
5Sildenafil Citrate Oral Disintegrating Tablets228
6Isavuconazonium Sulfate for Injection2215
7Tedizolid Phosphate For Injection223
8聚乙二醇钠钾散 · No verified English name223
9Benzbromarone Tablets224
10Sitagliptin and Metformin Hydrochloride Extended-release Tablets2212

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

206 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized18130
2Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized12120
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized830
4Anhui Shuang He Pharma Co., Ltd. romanized820
5Yunnan Yi Zhi Hao Pharmaceutical Co., Ltd. romanized640
6Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized630
7Fresenius Kabi AB510
8Hebei Guang Xiang Pharmaceuticals Technology Co., Ltd. romanized430
9Chengdu Rong Sheng Pharma Co., Ltd. romanized420
10Hainan Brilliant Pharmaceutical Co., Ltd.424

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

107 this week

AcceptedDrugApplicants
2025/01/18Import · Class 3.1 艾加莫德α注射液 · No verified English nameJXSL2500011 argenx BV; ICON Clinical Research (Beijing No. 2) Co. Ltd.
2025/01/18Import · Class 1 HCB301注射液 · No verified English nameJXSL2500010 FBD Biologics Limited; Shanghai Hanchor Biotech Inc.
2025/01/18Import · Class 1 艾曲帕米鼻喷雾剂 · No verified English nameJXHS2500007 Milestone Pharmaceuticals Inc.; Catalent Pharma Solutions LLC; Corxel Pharmaceuticals (Shanghai) Co. Ltd
2025/01/18Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2500353 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/01/18Generic · Class 3 Metronidazole Vaginal GelCYHS2500352 Hangzhou Shang He Health Technology Co., Ltd. romanized; Zhejiang Ding Tai Pharma Co., Ltd. romanized
2025/01/18Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2500350 Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
2025/01/18Generic · Class 3 Brivaracetam Oral SolutionCYHL2500019 Jiangxi Ke Rui Pharma Co., Ltd. romanized
2025/01/18New drug · Class 2.2 注射用重组人TNK组织型纤溶酶原激活剂 · No verified English nameCXSL2500054 Shi Yao Group Ming Fu Le Pharma (Guangzhou) Co., Ltd. romanized
2025/01/18New drug · Class 1 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2500053 Shanghai Bang Yao Bio Technology Co., Ltd. romanized
2025/01/18New drug · Class 2.2 MIRSRT缓释片 · No verified English nameCXHL2500098 Jilin Tian Heng Pharma Co., Ltd. romanized
2025/01/18New drug · Class 2.2 MIRSRT缓释片 · No verified English nameCXHL2500097 Jilin Tian Heng Pharma Co., Ltd. romanized
2025/01/18New drug · Class 2.2 MIRSRT缓释片 · No verified English nameCXHL2500096 Jilin Tian Heng Pharma Co., Ltd. romanized
2025/01/18New drug · Class 1 DNV001注射液 · No verified English nameCXHL2500095 Hangzhou Ding Le Xin Wei Bio Technology Co., Ltd. romanized
2025/01/18New drug · Class 1 HRS-6719片 · No verified English nameCXHL2500094 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/01/18New drug · Class 1 奥格特韦钠胶囊 · No verified English nameCXHL2500093 Zhejiang Ai Sen Pharma Co., Ltd. romanized
2025/01/18New drug · Class 1 HRS-6719片 · No verified English nameCXHL2500092 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/01/18New drug · Class 1 SYH2046片 · No verified English nameCXHL2500091 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/01/18New drug · Class 1 SYH2046片 · No verified English nameCXHL2500090 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/01/17Import · Class 1 Zasocitinib (TAK-279) 片 · No verified English nameJXHL2500012 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2025/01/17Import · Class 1 Zasocitinib (TAK-279) 片 · No verified English nameJXHL2500011 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2025/01/17Generic · Class 3 Folic Acid TabletsCYHS2500342 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2025/01/17Generic · Class 3 Sulfasalazine Oral SuspensionCYHS2500341 Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized
2025/01/17Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2500337 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2025/01/17Generic · Class 3 Piracetam InjectionCYHS2500336 Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized
2025/01/17Generic · Class 3 Bumetanide InjectionCYHS2500331 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/01/17Generic · Class 3 Bumetanide InjectionCYHS2500330 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/01/17Generic · Class 3 富马酸酮替芬滴眼液 · No verified English nameCYHS2500329 Shijiazhuang Gree Pharmaceutical Co., Ltd
2025/01/17Generic · Class 3 富马酸酮替芬滴眼液 · No verified English nameCYHS2500328 Shijiazhuang Gree Pharmaceutical Co., Ltd
2025/01/17Generic · Class 3 醋酸地非法林注射液 · No verified English nameCYHL2500018 Shandong Qidu Pharmaceutical Co., Ltd.
2025/01/17New drug · Class 1 注射用ZL-1310 · No verified English nameCXSL2500052 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized

77 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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