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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 335 drug applications between 25 July 2025 and 31 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 57 drug names.

2025/07/25 – 2025/07/31

Period
2025/07/25 to 2025/07/31, 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
335
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
68

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

335filings, 76 of them generic

By application type

Application typeFilings
Supplement155
Generic76
New drug65
Import31
Import re-registration4
Unspecified2
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug191
TCM86
Therapeutic biologic54
Unspecified3
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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lidocaine and Prilocaine Cream3224
2Brexpiprazole Tablets3131
3Tranexamic Acid Injection3111
4Pemafibrate Tablets2223
5Morinidazole and Sodium Chloride Injection229
6头孢克肟干混悬剂 · No verified English name223
7Rosuvastatin Calcium and Ezetimibe Tablets (I)229
8Mecobalamin Tablets2216
9硝普钠氯化钠注射液 · No verified English name223
10Cefditoren Pivoxil Granules2118

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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Hua Kang Pharma Co., Ltd. romanized10100
2CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD730
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized730
4Qilu Pharmaceutical Co., Ltd.730
5Yunnan Jin Bi Pharmaceutical Co., Ltd. romanized660
6Janssen Research & Development LLC630
7Henan Xin Xiang Hua Xing Pharmaceutical Factory romanized620
8Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized530
9AbbVie Inc.510
10Pharmathen International S.A.510

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

106 this week

AcceptedDrugApplicants
2025/07/31Import · Class 1 Icotrokinra片 · No verified English nameJXHL2500208 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/07/31Import · Class 1 Icotrokinra片 · No verified English nameJXHL2500207 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/07/31Import · Class 1 LOU064片 · No verified English nameJXHL2500206 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2025/07/31Generic · Class 3 硝普钠氯化钠注射液 · No verified English nameCYHS2502762 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Jiangsu Chang Jiang Pharma Co., Ltd. romanized
2025/07/31Generic · Class 3 头孢克肟干混悬剂 · No verified English nameCYHS2502761 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized
2025/07/31Generic · Class 3 头孢克肟干混悬剂 · No verified English nameCYHS2502757 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2025/07/31New drug · Class 1.1 益母妇炎颗粒 · No verified English nameCXZL2500058 Jian Min Pharma Group Co., Ltd. romanized
2025/07/31New drug · Class 3.2 注射用罗普司亭N01 · No verified English nameCXSL2500639 Qilu Pharmaceutical Co., Ltd.
2025/07/31New drug · Class 3.2 注射用罗普司亭N01 · No verified English nameCXSL2500638 Qilu Pharmaceutical Co., Ltd.
2025/07/31New drug · Class 1 人源多巴胺能前体细胞注射液 · No verified English nameCXSL2500637 Rui Jian Yi Lian Pharmaceuticals Technology (Chengdu) Co., Ltd. romanized; Rui Jian Pharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2025/07/31New drug · Class 1 EA5注射液皮下制剂 · No verified English nameCXSL2500635 Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized
2025/07/31New drug · Class 2.2 依达拉奉片 · No verified English nameCXHS2500088 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2025/07/31New drug · Class 2.1; 2.2; 2.4 注射用ADB116 · No verified English nameCXHL2500785 Jiangsu Ai Di Pharma Group Co., Ltd. romanized; Nanjing Nan Da Pharma Co., Ltd. romanized
2025/07/31New drug · Class 1 HSK42360-Na散 · No verified English nameCXHL2500784 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/07/31New drug · Class 1 HSK42360-Na散 · No verified English nameCXHL2500783 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/07/30Import · Class 3.1 注射用塔拉妥单抗 · No verified English nameJXSS2500105 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2025/07/30Import · Class 3.1 注射用塔拉妥单抗 · No verified English nameJXSS2500104 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2025/07/30Import · Class 1 Pasritamig注射液 · No verified English nameJXSL2500136 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/07/30Import · Class 1 Pasritamig注射液 · No verified English nameJXSL2500135 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/07/30Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2500134 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2025/07/30Import · Class 2.2 纳武利尤单抗注射液 · No verified English nameJXSL2500133 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/30Import · Class 1 BHV-8000缓释片 · No verified English nameJXHL2500205 Biohaven Therapeutics Ltd.; Hangzhou Highlightll Pharmaceutical Co. Ltd
2025/07/30Import · Class 1 BHV-8000缓释片 · No verified English nameJXHL2500204 Biohaven Therapeutics Ltd.; Hangzhou Highlightll Pharmaceutical Co. Ltd
2025/07/30Import · Class 1 PF-08049820水合物片 · No verified English nameJXHL2500203 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2025/07/30Import · Class 1 PF-08049820水合物片 · No verified English nameJXHL2500202 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2025/07/30Import · Class 2.2 甲磺酸贝舒地尔口服混悬剂 · No verified English nameJXHL2500201 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/07/30Generic · Class 3 硝普钠氯化钠注射液 · No verified English nameCYHS2502752 Nanjing Hai Chen Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/07/30Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2502745 Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Zhejiang Kang Run Pharmaceutical Co., Ltd. romanized
2025/07/30Generic · Class 3 多种微量元素注射液(I) · No verified English nameCYHS2502741 Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized
2025/07/30Generic · Class 3 Bifonazole SolutionCYHS2502740 Anhui Tai Du Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized

76 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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