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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 381 drug applications between 11 January 2025 and 17 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 116, covering 81 drug names.

2025/01/11 – 2025/01/17

Period
2025/01/11 to 2025/01/17, 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
381
Drugs with new generic filings (by drug name, de-duplicated)
81
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

381filings, 116 of them generic

By application type

Application typeFilings
Supplement185
Generic116
New drug58
Import16
Unspecified3
Import re-registration3

By drug type

Drug typeFilings
Chemical drug285
TCM59
Therapeutic biologic33
Biologic3
Prophylactic biologic1

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

81 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Mivacurium Chloride Injection423
2Isavuconazonium Sulfate for Injection3315
3Pentoxifylline Modified Release Tablets226
4Sildenafil Citrate Oral Disintegrating Tablets228
5Bisoprolol Fumarate and Amlodipine Besylate Tablets229
6Tedizolid Phosphate For Injection223
7Sodium Hyaluronate Eye Drops2230
8聚乙二醇钠钾散 · No verified English name223
9Benzbromarone Tablets224
10Escitalopram Oxalate Tablets226

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

215 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. romanized940
4Anhui Shuang He Pharma Co., Ltd. romanized820
5Shandong Qidu Pharmaceutical Co., Ltd.664
6Lang Li Biopharmaceuticals (Wuhan) Co., Ltd. romanized660
7Yunnan Yi Zhi Hao Pharmaceutical Co., Ltd. romanized640
8Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized640
9Takeda Development Center Americas Inc.520
10Fresenius Kabi AB510

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

116 this week

AcceptedDrugApplicants
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
2025/01/17New drug · Class 1 IMP1707片 · No verified English nameCXHL2500089 Shanghai Ying Pai Pharma Co., Ltd. romanized
2025/01/17New drug · Class 1 IMP1707片 · No verified English nameCXHL2500088 Shanghai Ying Pai Pharma Co., Ltd. romanized
2025/01/17New drug · Class 2.2 RHYK2021 · No verified English nameCXHL2500087 Ren He Yi Kang Group Co., Ltd. romanized
2025/01/17New drug · Class 2.2 RHYK2021 · No verified English nameCXHL2500086 Ren He Yi Kang Group Co., Ltd. romanized
2025/01/17New drug · Class 1 GW5282片 · No verified English nameCXHL2500085 Ge Wu Bio Technology (Jiangsu) Co., Ltd. romanized
2025/01/17New drug · Class 1 GW5282片 · No verified English nameCXHL2500084 Ge Wu Bio Technology (Jiangsu) Co., Ltd. romanized
2025/01/17New drug · Class 2.2 ASKC635干混悬剂 · No verified English nameCXHL2500083 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2025/01/17New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHL2500082 Gansu Pu An Pharmaceutical Co., Ltd. romanized
2025/01/17New drug · Class 1 GenSci128片 · No verified English nameCXHL2500081 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/01/17New drug · Class 1 GenSci128片 · No verified English nameCXHL2500080 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/01/17New drug · Class 1 GenSci128片 · No verified English nameCXHL2500079 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/01/17New drug · Class 1 RN1871 注射液 · No verified English nameCXHL2500078 Da Rui Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/01/16Import · Class 1 Tozorakimab注射液 · No verified English nameJXSL2500009 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/16Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2500327 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2025/01/16Generic · Class 3 Benzbromarone TabletsCYHS2500326 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2025/01/16Generic · Class 3 Benzbromarone TabletsCYHS2500325 Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/01/16Generic · Class 3 Zoledronic Acid InjectionCYHS2500323 Sichuan Tai Ping Yang Pharma Co., Ltd. romanized
2025/01/16Generic · Class 3 Fluorouracil InjectionCYHS2500317 Hainan Brilliant Pharmaceutical Co., Ltd.

86 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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