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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 338 drug applications between 16 August 2025 and 22 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 63 drug names.

2025/08/16 – 2025/08/22

Period
2025/08/16 to 2025/08/22, 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
338
Drugs with new generic filings (by drug name, de-duplicated)
63
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

338filings, 86 of them generic

By application type

Application typeFilings
Supplement161
Generic86
New drug63
Import15
Unspecified7
Import re-registration6

By drug type

Drug typeFilings
Chemical drug214
TCM62
Therapeutic biologic54
Biologic5
Prophylactic biologic3

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

63 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
6Letermovir Tablets227
7瑞维那新吸入溶液 · No verified English name2253
8左乙拉西坦微片 · No verified English name212
9布比卡因脂质体注射液 · No verified English name217
10帕拉米韦氯化钠注射液 · No verified English name2117

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

224 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company820
2Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized620
3Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized550
4AstraZeneca AB430
5Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.410
6Le Pu Pharma Co., Ltd. romanized414
7Sichuan Pharmaceutical Formulations Co., Ltd. romanized410
8Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized410
9Zhi En Bio Technology Co., Ltd. romanized414
10Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410

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

110 this week

AcceptedDrugApplicants
2025/08/22Import · Class 2.4 尼拉帕利阿比特龙片 · No verified English nameJXHS2500089 Janssen-Cilag International NV; Patheon France; Xian Janssen Pharmaceutical Ltd.
2025/08/22Import · Class 2.4 尼拉帕利阿比特龙片 · No verified English nameJXHS2500088 Janssen-Cilag International NV; Patheon France; Xian Janssen Pharmaceutical Ltd.
2025/08/22Import · Class 1 LOXO-435片 · No verified English nameJXHL2500225 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/22Import · Class 1 LOXO-435片 · No verified English nameJXHL2500224 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/22Generic · Class 3 Fexofenadine Hydrochloride Oral SuspensionCYHS2503082 Hangzhou Hong You Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shuo De Pharma Co., Ltd. romanized
2025/08/22Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2503080 Zhejiang Hang Kang Pharma Co., Ltd. romanized
2025/08/22Generic · Class 3 注射用哌拉西林钠/氯化钠注射液 · No verified English nameCYHS2503074 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/08/22Generic · Class 3 注射用哌拉西林钠/氯化钠注射液 · No verified English nameCYHS2503073 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/08/22New drug · Class 3.1 一贯煎颗粒 · No verified English nameCXZS2500036 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2025/08/22New drug · Class 1 GA001注射液 · No verified English nameCXSL2500729 Jian Da Jiu Zhou (Beijing) Bio Technology Co., Ltd. romanized
2025/08/22New drug · Class 1 利福特尼唑胶囊 · No verified English nameCXHS2500103 Dan Nuo Pharmaceuticals (Suzhou) Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2025/08/22New drug · Class 1 LPM516000152盐酸盐胶囊 · No verified English nameCXHL2500881 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2025/08/22New drug · Class 1 LPM516000152盐酸盐胶囊 · No verified English nameCXHL2500880 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
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

80 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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