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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 367 drug applications between 18 July 2025 and 24 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 111, covering 79 drug names.

2025/07/18 – 2025/07/24

Period
2025/07/18 to 2025/07/24, 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
367
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
86

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

367filings, 111 of them generic

By application type

Application typeFilings
Supplement154
Generic111
New drug62
Import22
Unspecified12
Import re-registration6

By drug type

Drug typeFilings
Chemical drug270
TCM54
Therapeutic biologic29
Biologic7
Prophylactic biologic7

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

79 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapoxetine Hydrochloride Tablets4220
2苯磺酸左氨氯地平片 · No verified English name4245
3Mirogabalin Besilate Tablets4261
4Ruxolitinib Phosphate Tablets3127
5Upadacitinib Sustained-release Tablets2243
6Bumetanide Injection2213
7甘油磷酸钠注射液 · No verified English name227
8Bromhexine Hydrochloride Oral Solution2222
9Glucosamine Sulfate Capsules2251
10维生素B6注射液 · No verified English name2210

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

236 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Er Ye Pharmaceutical Co., Ltd. romanized633
2Eli Lilly and Company610
3Ningbo Tian Yi Pharma Technology Co., Ltd. romanized555
4Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized550
5Henan Zhen Shi Bio Technology Co., Ltd. romanized520
6Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized510
7Revance Therapeutics Inc.440
8Zhu Zhou Qian Jin Pharma Co., Ltd. romanized440
9Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized430
10Bristol-Myers Squibb Company420

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

116 this week

AcceptedDrugApplicants
2025/07/24Import · Class 2.1 ASP5541注射液 · No verified English nameJXHL2500200 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2025/07/24Generic · Class 3 盐酸丙卡特罗干糖浆 · No verified English nameCYHS2502690 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/07/24Generic · Class 3 Ebastine Oral SolutionCYHS2502684 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2025/07/24Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2502679 Henan Da Xin Pharma Co., Ltd. romanized
2025/07/24Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2502677 Hefei Yuan Zhi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2025/07/24Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2502675 Hainan Yun Ding Pharmaceuticals Technology Co., Ltd. romanized; Haikou Qi Li Pharmaceutical Co., Ltd. romanized
2025/07/24Generic · Class 3 盐酸多沙普仑注射液 · No verified English nameCYHS2502669 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2025/07/24New drug · Class 1 WSK-IM02 · No verified English nameCXSL2500615 Beijing Wei Si Ke Biopharmaceuticals Co., Ltd. romanized; Chengdu Wei Si Ke Biopharmaceuticals Co., Ltd. romanized; Wei Si Ke Biopharmaceuticals (Guangzhou) Co., Ltd. romanized
2025/07/24New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHS2500084 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ai Li Si Biopharmaceuticals Co., Ltd. romanized
2025/07/24New drug · Class 1 特里豚蝎肽凝胶 · No verified English nameCXHL2500755 Wuhan Mo Er Bio Technology Co., Ltd. romanized
2025/07/24New drug · Class 1 TSL2109胶囊 · No verified English nameCXHL2500754 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Zhongguo Yao Ke University romanized
2025/07/24New drug · Class 1 TSL2109胶囊 · No verified English nameCXHL2500753 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Zhongguo Yao Ke University romanized
2025/07/24New drug · Class 1 LBS-007注射溶液 · No verified English nameCXHL2500752 Beijing Xi Er Ou Biopharmaceuticals Kai Fa Co., Ltd. romanized
2025/07/24New drug · Class 1 HEP-50768片 · No verified English nameCXHL2500751 Hai Pai Tai Ke (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/24New drug · Class 1 HEP-50768片 · No verified English nameCXHL2500750 Hai Pai Tai Ke (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/24New drug · Class 1 HEP-50768片 · No verified English nameCXHL2500749 Hai Pai Tai Ke (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/24New drug · Class 1 HEP-50768片 · No verified English nameCXHL2500748 Hai Pai Tai Ke (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/24New drug · Class 1 BPR-6023021注射液 · No verified English nameCXHL2500747 Chengdu Xin Ke Pharmaceuticals Co., Ltd. romanized
2025/07/24New drug · Class 1 注射用ARTS-876 · No verified English nameCXHL2500746 An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2025/07/24New drug · Class 1 埃诺格鲁肽片 · No verified English nameCXHL2500745 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized
2025/07/24New drug · Class 1 埃诺格鲁肽片 · No verified English nameCXHL2500744 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized
2025/07/24New drug · Class 1 埃诺格鲁肽片 · No verified English nameCXHL2500743 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized
2025/07/24New drug · Class 1 埃诺格鲁肽片 · No verified English nameCXHL2500742 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized
2025/07/23Import · Class 1 Depemokimab注射液 · No verified English nameJXSL2500126 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2025/07/23Import · Class 1 PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2500125 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/07/23Import · Class 1 BAY 2927088片 · No verified English nameJXHS2500077 Bayer HealthCare Pharmaceuticals Inc.; Bayer AG; Bayer Healthcare Company Ltd.
2025/07/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500199 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500198 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500197 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500196 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.

86 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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