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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 320 drug applications between 29 June 2025 and 5 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 49 drug names.

2025/06/29 – 2025/07/05

Period
2025/06/29 to 2025/07/05, 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
320
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
51

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

320filings, 74 of them generic

By application type

Application typeFilings
Supplement168
Generic74
New drug56
Import15
Import re-registration5
Unspecified2

By drug type

Drug typeFilings
Chemical drug202
TCM64
Therapeutic biologic52
Prophylactic biologic2

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

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection6653
2Oseltamivir Phosphate Capsules5239
3瑞维那新吸入溶液 · No verified English name3353
4Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3223
5Cefazolin Sodium for Injection3113
6Acyclovir Tablets316
7蒙脱石混悬液 · No verified English name2231
8蔗糖羟基氧化铁咀嚼片 · No verified English name220
9帕拉米韦氯化钠注射液 · No verified English name2117
10Tranexamic Acid Tablets219

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

200 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Lai Bin Hu Lu Wa Pharma Co., Ltd. romanized660
2Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized650
3Yi Chang Ren Fu Pharma Co., Ltd. romanized530
4Celgene Corporation510
5Karuna Therapeutics Inc.510
6Guangdong He Xiang Biopharmaceuticals Co., Ltd. romanized440
7Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized440
8Hunan Ke Lun Pharmaceutical Co., Ltd. romanized430
9Shen Wei Pharma Group Co., Ltd. romanized430
10Eli Lilly Nederland B.V.420

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

97 this week

AcceptedDrugApplicants
2025/07/05Import · Class 1 乙磺酸LY4066434片 · No verified English nameJXHL2500161 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/05Import · Class 1 乙磺酸LY4066434片 · No verified English nameJXHL2500160 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/05Import · Class 1 乙磺酸LY4066434片 · No verified English nameJXHL2500159 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/05Generic · Class 3 Acyclovir TabletsCYHS2502385 Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2025/07/05Generic · Class 3 Acyclovir TabletsCYHS2502384 Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2025/07/05Generic · Class 3 Acyclovir TabletsCYHS2502383 Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2025/07/05Generic · Class 3 Pregabalin Oral SolutionCYHS2502378 Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2025/07/05New drug · Class 1.1 参榆消银软膏 · No verified English nameCXZL2500044 Beijing Si Li An Pharma Co., Ltd. romanized
2025/07/05New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2500551 Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized
2025/07/05New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2500550 Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized
2025/07/05New drug · Class 1 HEC-151注射液 · No verified English nameCXSL2500549 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2025/07/05New drug · Class 1 人脐带CD146间充质干细胞注射液 · No verified English nameCXSL2500548 Beijing San You Li Kang Xi Bao Technology Co., Ltd. romanized
2025/07/05New drug · Class 1 宫血间充质干细胞注射液 · No verified English nameCXSL2500547 Zhejiang Sheng Chuang Jing Zhun Medical Technology Co., Ltd. romanized
2025/07/05New drug · Class 1 QH104A细胞注射液 · No verified English nameCXSL2500546 Beijing Qing Hui Lian Nuo Bio Technology Co., Ltd. romanized
2025/07/05New drug · Class 1 IPG0521注射液 · No verified English nameCXSL2500544 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/05New drug · Class 1 GZR101-80注射液 · No verified English nameCXSL2500543 Gan Li Pharma Shandong Co., Ltd. romanized
2025/07/05New drug · Class 1 注射用MCLA-129 · No verified English nameCXSL2500542 Bei Da Pharma Co., Ltd. romanized
2025/07/05New drug · Class 1 人源化抗CD19 CAR-T细胞注射液 · No verified English nameCXSL2500541 Shenyang Jing Sheng Bio Technology Co., Ltd. romanized
2025/07/05New drug · Class 1 ZHB110舌下片 · No verified English nameCXSL2500540 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2025/07/05New drug · Class 1 ZHB110舌下片 · No verified English nameCXSL2500539 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2025/07/05New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500072 Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized; Shenzhen Shi Xin Yang Wei Kang Technology Co., Ltd. romanized
2025/07/05New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500071 Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized; Shenzhen Shi Xin Yang Wei Kang Technology Co., Ltd. romanized
2025/07/05New drug · Class 1 硫酸酯化聚古罗糖醛酸钠颗粒 · No verified English nameCXHL2500650 Zhongguo Ke College Shanghai Drug Research Institute romanized; Lv Gu (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2025/07/05New drug · Class 1 SYH2066片 · No verified English nameCXHL2500649 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/07/05New drug · Class 1 SYH2066片 · No verified English nameCXHL2500648 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/07/05New drug · Class 2.4 盐酸恩沙替尼胶囊 · No verified English nameCXHL2500647 Bei Da Pharma Co., Ltd. romanized
2025/07/05New drug · Class 2.4 盐酸恩沙替尼胶囊 · No verified English nameCXHL2500646 Bei Da Pharma Co., Ltd. romanized
2025/07/04Import · Class 2.3 迈之灵片 · No verified English nameJXZL2500002 Aescuven Pharma Deutschland GmbH & Co.KG; Shenzhen Xingyin Pharmaceutical Co. Ltd.
2025/07/04Import · Class 2.3 迈之灵片 · No verified English nameJXZL2500001 Aescuven Pharma Deutschland GmbH & Co. KG; Shenzhen Xingyin Pharmaceutical Co. Ltd.
2025/07/04Import · Class 1 Trontinemab注射液 · No verified English nameJXSL2500119 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.

67 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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