YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 406 drug applications between 3 July 2025 and 9 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 115, covering 82 drug names.

2025/07/03 – 2025/07/09

Period
2025/07/03 to 2025/07/09, 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
406
Drugs with new generic filings (by drug name, de-duplicated)
82
Accepted this week, now under review
93

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

406filings, 115 of them generic

By application type

Application typeFilings
Supplement173
Generic115
New drug86
Import23
Import re-registration6
Unspecified3

By drug type

Drug typeFilings
Chemical drug285
Therapeutic biologic63
TCM55
Prophylactic biologic2
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

82 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1瑞维那新吸入溶液 · No verified English name5553
2Dapoxetine Hydrochloride Tablets4220
3Quetiapine Fumarate Extended-release Tablets410
4Cefazolin Sodium for Injection3113
5Acyclovir Tablets316
6Acetylcysteine Injection2253
7Pregabalin Oral Solution225
8Iguratimod Tablets2223
9蔗糖羟基氧化铁咀嚼片 · No verified English name220
10Finerenone Tablets2269

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

251 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized940
2Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized870
3Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized660
4Celgene Corporation610
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized610
6Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized530
7Shenzhen Xin Li Tai Pharma Co., Ltd. romanized520
8Karuna Therapeutics Inc.510
9Topfond Pharmaceutical Co., Ltd.440
10Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized440

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

142 this week

AcceptedDrugApplicants
2025/07/09Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHL2500168 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/09Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHL2500167 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/09Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHL2500166 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/09Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHL2500165 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/09Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHL2500164 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/09Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHL2500163 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2502453 Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/07/09Generic · Class 3 Pregabalin Oral SolutionCYHS2502452 Zhejiang Zhi Xin Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2025/07/09Generic · Class 3 Loxoprofen sodium hydrate gelCYHS2502451 Shanghai Yan An Pharmaceuticals Yang Pu Co., Ltd. romanized; Shanghai Yan An Pharma (Hubei) Co., Ltd. romanized
2025/07/09Generic · Class 3 硝酸咪康唑乳膏 · No verified English nameCYHS2502449 Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized
2025/07/09Generic · Class 3 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2502447 Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized
2025/07/09Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2502444 Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2025/07/09Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2502439 Xian An Jian Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2025/07/09Generic · Class 3 Vitamin K1 InjectionCYHS2502437 Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2025/07/09Generic · Class 3 醋酸钠林格葡萄糖注射液(Ⅰ) · No verified English nameCYHS2502429 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/07/09Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHS2502428 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Jin Yao Yong Guang (Hebei) Pharmaceutical Co., Ltd. romanized
2025/07/09Generic · Class 3 Deferasirox GranulesCYHS2502427 Yu Song Yuan Pharma Co., Ltd. romanized
2025/07/09New drug · Class 1 HC006注射液 · No verified English nameCXSL2500567 Shanghai Hong Cheng Pharma Co., Ltd. romanized
2025/07/09New drug · Class 1 注射用HC010 · No verified English nameCXSL2500566 Shanghai Hong Cheng Pharma Co., Ltd. romanized
2025/07/09New drug · Class 1 VGN-R08b · No verified English nameCXSL2500565 Shanghai Tian Ze Yun Tai Biopharmaceuticals Co., Ltd. romanized; Tian Ze Yun Tai (Shenzhen) Biopharmaceuticals Co., Ltd. romanized
2025/07/09New drug · Class 1 Astem-101人脐带间充质干细胞(hUC-MSCs)注射液 · No verified English nameCXSL2500564 Name not romanized
2025/07/09New drug · Class 1 VGN-R08b · No verified English nameCXSL2500563 Shanghai Tian Ze Yun Tai Biopharmaceuticals Co., Ltd. romanized; Tian Ze Yun Tai (Shenzhen) Biopharmaceuticals Co., Ltd. romanized
2025/07/09New drug · Class 1 脐带间充质干细胞注射液 · No verified English nameCXSL2500562 Shandong Bai Hong Gan Xi Bao Bio Technology Co., Ltd. romanized; Guangdong Bai Hong Gan Xi Bao Zai Sheng Yi Xue Co., Ltd. romanized; Shaanxi Bai Hong Gan Xi Bao Bio Technology Co., Ltd. romanized
2025/07/09New drug · Class 1 LBM801 · No verified English nameCXSL2500560 Shanghai Li Kang Rui Bio Gong Cheng Co., Ltd. romanized; Shanghai Bo Sai Mei Bio Technology Co., Ltd. romanized
2025/07/09New drug · Class 1 NGGT006注射液 · No verified English nameCXSL2500559 Suzhou Nuo Jie Bei Bio Technology Co., Ltd. romanized
2025/07/09New drug · Class 1 SHR-4298注射液 · No verified English nameCXSL2500558 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/07/09New drug · Class 2.2 硫酸阿托品滴眼液 · No verified English nameCXHS2500078 Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized; Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized
2025/07/09New drug · Class 2.4 Fulvestrant InjectionCXHS2500077 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/07/09New drug · Class 1 库莫西利胶囊 · No verified English nameCXHS2500076 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/07/09New drug · Class 1 库莫西利胶囊 · No verified English nameCXHS2500075 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized

112 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.