YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 363 drug applications between 11 September 2025 and 17 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 64 drug names.

2025/09/11 – 2025/09/17

Period
2025/09/11 to 2025/09/17, 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
363
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
102

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

363filings, 84 of them generic

By application type

Application typeFilings
Supplement174
Generic84
New drug53
Import34
Import re-registration10
Unspecified8

By drug type

Drug typeFilings
Chemical drug195
Therapeutic biologic82
TCM75
Biologic6
Prophylactic biologic5

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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Buspirone Hydrochloride Tablets315
2Upadacitinib Sustained-release Tablets2243
3Loxoprofen Sodium Oral Solution226
4利伐沙班颗粒 · No verified English name212
5Levocarnitine Injection214
6帕拉米韦氯化钠注射液 · No verified English name2117
7Flomoxef Sodium for Injection219
8Loxoprofen Sodium Patches2130
9环硅酸锆钠散 · No verified English name2112
10Repaglinide Tablets216

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
1Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized1050
2Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized1040
3Beijing Si Huan Biopharmaceutical Co., Ltd. romanized1010
4Eli Lilly and Company830
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized740
6AstraZeneca AB640
7Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized610
8Yunnan Yong Zi Tang Pharmaceutical Co., Ltd. romanized550
9Pfizer Inc.540
10Sanofi Winthrop Industrie530

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
2025/09/17Import · 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.
2025/09/17Generic · Class 3 低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2503431 Anhui Feng Yuan Pharma Co., Ltd. romanized
2025/09/17Generic · Class 3 低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2503430 Anhui Feng Yuan Pharma Co., Ltd. romanized
2025/09/17Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2500168 Xizang Zhong Wei Cheng Kang Pharma Co., Ltd. romanized
2025/09/17New drug · Class 1.1 疏肝宁心颗粒 · No verified English nameCXZL2500082 Zhongguo Zhong Yi Ke College Zhong Yao Research Institute romanized
2025/09/17New drug · Class 1.1 消腺止鼾口服液 · No verified English nameCXZL2500081 Sichuan Sheng Xian Dai Zhong Yao Innovation Technology Co., Ltd. romanized; Chengdu Zhong Pharmaceuticals University romanized; Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized
2025/09/17New drug · Class 2.2 注射用瑞康曲妥珠单抗 · No verified English nameCXSS2500094 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/09/17New drug · Class 1 HX15001注射液 · No verified English nameCXSL2500800 Hua Shen Zhi Yao Bio Technology (Suzhou) Co., Ltd. romanized
2025/09/17New drug · Class 1 SHR-2906注射液 · No verified English nameCXSL2500799 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/09/17New drug · Class 1 QM101细胞注射液 · No verified English nameCXSL2500798 Beijing Qi Mai Yong Hua Bio Technology Co., Ltd. romanized
2025/09/17New drug · Class 1 注射用LBL-047 · No verified English nameCXSL2500797 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2025/09/17New drug · Class 1 甲苯磺酸艾贝司他片 · No verified English nameCXHS2500117 Xu Nuo Pharma (Nanjing) Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2025/09/17New drug · Class 1 HRS-6208胶囊 · No verified English nameCXHL2501014 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/17New drug · Class 1 HRS-6208胶囊 · No verified English nameCXHL2501013 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/17New drug · Class 1 HRS-6208胶囊 · No verified English nameCXHL2501012 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/17New drug · Class 1 注射用莱古比星 · No verified English nameCXHL2501011 Shanghai Qin He Li Biopharmaceuticals Technology 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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