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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 363 drug applications between 15 August 2025 and 21 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 69 drug names.

2025/08/15 – 2025/08/21

Period
2025/08/15 to 2025/08/21, 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)
69
Accepted this week, now under review
97

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, 95 of them generic

By application type

Application typeFilings
Supplement165
Generic95
New drug74
Import15
Unspecified8
Import re-registration6

By drug type

Drug typeFilings
Chemical drug225
Therapeutic biologic66
TCM62
Biologic5
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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1卡格列净二甲双胍缓释片 · No verified English name415
2Fexofenadine Hydrochloride Tablets4110
3Bifonazole Solution3315
4Vonoprazan Fumarate Tablets3260
5Mirogabalin Besilate Tablets3261
6Lactulose Oral Solution3134
7Ruxolitinib Phosphate Tablets3127
8Letermovir Tablets227
9左乙拉西坦微片 · No verified English name212
10布比卡因脂质体注射液 · No verified English name217

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

232 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized620
2Eli Lilly and Company610
3Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized510
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440
5AstraZeneca AB430
6Bristol-Myers Squibb Pharma EEIG420
7Novartis Pharma Schweiz AG420
8Eli Lilly Nederland B.V.410
9Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.410
10Le Pu Pharma Co., Ltd. romanized414

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

119 this week

AcceptedDrugApplicants
2025/08/21Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500223 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/21Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500222 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/21Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500221 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/21Generic · Class 3 Fexofenadine Hydrochloride TabletsCYHS2503071 Zhi En Bio Technology Co., Ltd. romanized
2025/08/21Generic · Class 3 Fexofenadine Hydrochloride TabletsCYHS2503070 Zhi En Bio Technology Co., Ltd. romanized
2025/08/21Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2503065 Hunan Ou Ya Pharma Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized
2025/08/21Generic · Class 3 甲磺酸亮丙瑞林注射乳剂 · No verified English nameCYHL2500148 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/08/21New drug · Class 1 注射用GenSci143 · No verified English nameCXSL2500728 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/08/20Import · Class 3.1 阿伏利尤单抗注射液 · No verified English nameJXSS2500109 AstraZeneca AB; AstraZeneca Nijmegen B.V.; AstraZeneca Investment (China) Co. Ltd.
2025/08/20Import · Class 1 AZD2936 · No verified English nameJXSL2500156 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/20Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500220 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/20Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500219 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/20Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500218 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/20Generic · Class 3 Sodium Nitroprusside InjectionCYHS2503066 Hua Run Shuang He Pharma Co., Ltd. romanized
2025/08/20Generic · Class 3 Potassium Chloride InjectionCYHS2503058 Xian Jing Xi Shuang He Pharma Co., Ltd. romanized
2025/08/20Generic · Class 3 Magnesium Sulfate InjectionCYHS2503057 Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/08/20Generic · Class 3 Magnesium Sulfate InjectionCYHS2503055 Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/08/20Generic · Class 3 左乙拉西坦微片 · No verified English nameCYHS2503054 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2025/08/20Generic · Class 3 左乙拉西坦微片 · No verified English nameCYHS2503053 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2025/08/20Generic · Class 3 Pentoxifylline InjectionCYHS2503052 Dan Dong Yi Chuang Pharma Co., Ltd. romanized
2025/08/20Generic · Class 3 Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2503051 Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized
2025/08/20New drug · Class 3.1 保元汤颗粒 · No verified English nameCXZS2500035 Shandong Qidu Pharmaceutical Co., Ltd.
2025/08/20New drug · Class 1 注射用CS2009 · No verified English nameCXSL2500727 Shen Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanized; Ji Shi Pharma (Suzhou) Co., Ltd. romanized
2025/08/20New drug · Class 1 AZD0901 · No verified English nameCXSL2500726 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2025/08/20New drug · Class 1 AZD0901 · No verified English nameCXSL2500725 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2025/08/20New drug · Class 1.3 吸附无细胞百(二组分)白破联合疫苗(成人及青少年用) · No verified English nameCXSL2500724 Changchun Bai Ke Bio Technology Shareholding Company romanized
2025/08/20New drug · Class 3.3 PJ021注射液 · No verified English nameCXSL2500723 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2025/08/20New drug · Class 1 SYS6010 · No verified English nameCXSL2500722 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/08/20New drug · Class 1 NH600001乳状注射液 · No verified English nameCXHS2500099 Jiangsu En Hua Pharma Co., Ltd. romanized
2025/08/20New drug · Class 1 齐瑞索韦肠溶胶囊 · No verified English nameCXHS2500098 Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized

89 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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