YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 357 drug applications between 24 July 2025 and 30 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 89, covering 72 drug names.

2025/07/24 – 2025/07/30

Period
2025/07/24 to 2025/07/30, 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
357
Drugs with new generic filings (by drug name, de-duplicated)
72
Accepted this week, now under review
81

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

357filings, 89 of them generic

By application type

Application typeFilings
Supplement156
Generic89
New drug72
Import29
Import re-registration7
Unspecified2
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug224
TCM76
Therapeutic biologic53
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

72 drugs with new generic filings; top 10 listed

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

226 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
4Yunnan Jin Bi Pharmaceutical Co., Ltd. romanized660
5Henan Xin Xiang Hua Xing Pharmaceutical Factory romanized620
6Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized530
7AbbVie Inc.510
8Pharmathen International S.A.510
9Jiangsu Vanguard Pharmaceutical Co., Ltd.442
10Janssen Research & Development LLC420

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

114 this week

AcceptedDrugApplicants
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
2025/07/30Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2502728 Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized
2025/07/30Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2502724 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.; Hangzhou Minsheng Pharmaceutical Co., Ltd
2025/07/30Generic · Class 3 Fosphenytoin Sodium InjectionCYHS2502721 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2025/07/30Generic · Class 3 铜[64Cu]氧奥曲肽注射液 · No verified English nameCYHL2500135 Tong Rui Biopharmaceutical (Chengdu) Co., Ltd. romanized
2025/07/30Generic · Class 3 甲苯磺酸卢美哌隆胶囊 · No verified English nameCYHL2500134 Sichuan Kelun Pharmaceutical Co., Ltd.
2025/07/30Generic · Class 3 利非司特滴眼液 · No verified English nameCYHL2500133 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized
2025/07/30New drug · Class 1 注射用BG-T187(皮下注射) · No verified English nameCXSL2500636 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/07/30New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2500634 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2025/07/30New drug · Class 1 JL19001注射液 · No verified English nameCXSL2500633 Jie Ku (Shanghai) Biopharmaceuticals Research Co., Ltd. romanized; Jie Ke (Tianjin) Biopharmaceuticals Co., Ltd. romanized
2025/07/30New drug · Class 1 HSK47388片(I) · No verified English nameCXHL2500780 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/07/30New drug · Class 1 BGB-58067片 · No verified English nameCXHL2500779 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/07/30New drug · Class 1 BGB-58067片 · No verified English nameCXHL2500778 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/07/30New drug · Class 1 BG-89894片 · No verified English nameCXHL2500777 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/07/30New drug · Class 1 BG-89894片 · No verified English nameCXHL2500776 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/07/30New drug · Class 1 TQB3201片 · No verified English nameCXHL2500775 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized

84 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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