YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 380 drug applications between 12 September 2025 and 18 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 74 drug names.

2025/09/12 – 2025/09/18

Period
2025/09/12 to 2025/09/18, 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
380
Drugs with new generic filings (by drug name, de-duplicated)
74
Accepted this week, now under review
112

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

380filings, 96 of them generic

By application type

Application typeFilings
Supplement186
Generic96
New drug48
Import34
Import re-registration9
Unspecified7

By drug type

Drug typeFilings
Chemical drug203
TCM90
Therapeutic biologic75
Prophylactic biologic6
Biologic5
In vitro diagnostic reagent1

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

74 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Safinamide Methansulfonate Tablets4220
2Buspirone Hydrochloride Tablets315
3注射用盐酸地尔硫? · No verified English nameThe source text contains a character that cannot be displayed.229
4利伐沙班颗粒 · No verified English name212
5Levocarnitine Injection214
6Brexpiprazole Orally Disintegrating Tablets2110
7帕拉米韦氯化钠注射液 · No verified English name2117
8Flomoxef Sodium for Injection219
9Loxoprofen Sodium Patches2130
10环硅酸锆钠散 · No verified English name2112

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
1Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized1050
2Beijing Si Huan Biopharmaceutical Co., Ltd. romanized1010
3Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized830
4Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized770
5Gansu Fu Zheng Pharma Technology Co., Ltd. romanized760
6AstraZeneca AB750
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized740
8Eli Lilly and Company720
9Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized610
10Yunnan Yong Zi Tang Pharmaceutical Co., Ltd. romanized550

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

112 this week

AcceptedDrugApplicants
2025/09/18Import · Class 1 CVM-1118胶囊 · No verified English nameJXHL2500294 TaiRx Inc.; TaiRx Pharmaceutical (Kunshan). Ltd.
2025/09/18Import · Class 2.2; 2.4 双醋瑞因软膏 · No verified English nameJXHL2500293 TWi Biotechnology Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2025/09/18Generic · Class 3 Nefopam Hydrochloride InjectionCYHS2503457 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2025/09/18Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2503453 Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2025/09/18Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2503451 Yan Tai Ju Xian Pharma Co., Ltd. romanized
2025/09/18Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2503450 Yan Tai Ju Xian Pharma Co., Ltd. romanized
2025/09/18Generic · Class 3 Trihexyphenidyl Hydrochloride TabletsCYHS2503445 Yun Peng Pharmaceuticals Group Co., Ltd. romanized
2025/09/18Generic · Class 3 Sodium Nitroprusside InjectionCYHS2503444 Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized
2025/09/18Generic · Class 3 盐酸羟甲唑啉滴眼液 · No verified English nameCYHL2500170 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/09/18Generic · Class 3 酮洛芬凝胶贴膏 · No verified English nameCYHL2500169 Fu Yuan Pharma Co., Ltd. romanized
2025/09/18New drug · Class 3.1 半夏白术天麻颗粒 · No verified English nameCXZS2500040 Hainan Si Da Pharmaceutical Co., Ltd. romanized; Anhui Hong Xin Pharma Development Co., Ltd. romanized
2025/09/18New drug · Class 3.1 芍药甘草颗粒 · No verified English nameCXZS2500039 Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized
2025/09/18New drug · Class 2 人细小病毒B19核酸检测试剂盒(PCR-荧光法) · No verified English nameCXSS2500095 Beijing Wan Tai Bio Pharma Co., Ltd. romanized
2025/09/18New drug · Class 1 VBC103 · No verified English nameCXSL2500801 Shanghai Cheng Fan Pharmaceuticals Co., Ltd. romanized
2025/09/18New drug · Class 1 177Lu-PSMA-VG01注射液 · No verified English nameCXHL2501015 Shandong Wei Zhi Zhi Ke Pharma Co., Ltd. romanized
2025/09/17Import · Class 1 prasinezumab注射液 · No verified English nameJXSL2500181 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/09/17Import · Class 2.2 Amivantamab注射液(皮下注射) · No verified English nameJXSL2500180 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/09/17Import · Class 2.2 Amivantamab注射液(皮下注射) · No verified English nameJXSL2500178 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/09/17Import · Class 2.4 布地格福吸入气雾剂 · No verified English nameJXHS2500105 AstraZeneca AB; ASTRAZENECA DUNKERQUE PRODUCTION; AstraZeneca Investment (China) Co. Ltd.
2025/09/17Import · Class 2.4 布地格福吸入气雾剂 · No verified English nameJXHS2500104 AstraZeneca AB; ASTRAZENECA DUNKERQUE PRODUCTION; AstraZeneca Investment (China) Co. Ltd.
2025/09/17Import · Class 1 Gadoquatrane 注射液 · No verified English nameJXHS2500103 Bayer AG; Bayer Healthcare Company Ltd.
2025/09/17Import · Class 1 Gadoquatrane 注射液 · No verified English nameJXHS2500102 Bayer AG; Bayer Healthcare Company Ltd.
2025/09/17Import · Class 2.4 达罗他胺片 · No verified English nameJXHL2500292 Bayer HealthCare Pharmaceuticals Inc.; Bayer Healthcare Company Ltd.
2025/09/17Import · Class 1 Olomorasib胶囊 · No verified English nameJXHL2500291 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/17Import · Class 1 Olomorasib胶囊 · No verified English nameJXHL2500290 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/17Import · Class 1 DZR123片 · No verified English nameJXHL2500289 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/09/17Import · Class 1 JSB462片 · No verified English nameJXHL2500288 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/09/17Import · Class 1 DZR123片 · No verified English nameJXHL2500287 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/09/17Import · Class 1 DZR123片 · No verified English nameJXHL2500286 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/09/17Import · Class 1 DZR123片 · No verified English nameJXHL2500285 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.

82 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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