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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 558 drug applications between 21 January 2025 and 27 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 195, covering 137 drug names.

2025/01/21 – 2025/01/27

Period
2025/01/21 to 2025/01/27, 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
558
Drugs with new generic filings (by drug name, de-duplicated)
137
Accepted this week, now under review
26

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

558filings, 195 of them generic

By application type

Application typeFilings
Supplement216
Generic195
New drug116
Import19
Unspecified6
Import re-registration6

By drug type

Drug typeFilings
Chemical drug392
Therapeutic biologic82
TCM73
Prophylactic biologic8
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

137 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets6360
2Azilsartan Medoxomil Potassium Tablets6335
3Ruxolitinib Phosphate Tablets5327
4Levofloxacin Injection421
5Edoxaban Tosilate Tablets429
6Mivacurium Chloride Injection423
7Finerenone Tablets3269
8Riociguat Tablets314
9Brexpiprazole Orally Disintegrating Tablets3110
10Brexpiprazole Tablets3131

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

354 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB750
2Qilu Pharmaceutical Co., Ltd.651
3Anhui Jin Ma Pharma Co., Ltd. romanized550
4Hunan Xian Shi Pharmaceutical Co., Ltd. romanized531
5Nanjing Huang Long Bio Technology Co., Ltd. romanized525
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
7Hainan Zhong He Pharma Co., Ltd. romanized520
8Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized510
9Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized440
10Guizhou Heng He Pharmaceutical Co., Ltd. romanized440

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

217 this week

AcceptedDrugApplicants
2025/01/27Import · Class 1 普乐司兰钠注射液 · No verified English nameJXHS2500018 Arrowhead Pharmaceuticals Inc.; Ajinomoto Althea Inc.; Visirna Therapeutics (Suzhou) Co. Ltd.
2025/01/27Generic · Class 3 Sodium Cromoglicate Eye DropsCYHS2500545 Wuhan Xin Rui Pharmaceuticals Technology Co., Ltd. romanized; Wuhan Wu Jing Pharma Co., Ltd. romanized
2025/01/27Generic · Class 3 Potassium Chloride Oral SolutionCYHS2500535 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized
2025/01/27Generic · Class 3 Potassium Chloride Oral SolutionCYHS2500533 Hefei Hua Wei Pharma Co., Ltd. romanized
2025/01/27Generic · Class 3 多种微量元素注射液(Ⅳ) · No verified English nameCYHS2500521 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/01/27Generic · Class 3 Doxylamine Succinate TabletsCYHS2500515 Nanjing Ji Qun Pharmaceuticals Technology Co., Ltd. romanized; Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized
2025/01/27Generic · Class 3 Doxylamine Succinate TabletsCYHS2500514 Nanjing Ji Qun Pharmaceuticals Technology Co., Ltd. romanized; Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized
2025/01/27Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2500513 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/01/27Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2500512 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/01/27Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2500511 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/01/27Generic · Class 3 Colchicine TabletsCYHS2500508 Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2025/01/27Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2500506 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2025/01/27Generic · Class 3 Acetylcysteine TabletsCYHS2500502 Guangdong Tai Lai Run Zhi Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2025/01/27Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2500499 Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized
2025/01/27Generic · Class 3 Calcitriol Oral SolutionCYHS2500498 Beijing Ren Zhong Pharma Co., Ltd. romanized; Hubei Xin Ze Fei Pharma Co., Ltd. romanized
2025/01/27Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2500497 Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2025/01/27Generic · Class 3 伏环孢素软胶囊 · No verified English nameCYHL2500031 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2025/01/27Generic · Class 3 Flurbiprofen PatchesCYHL2500030 Jiangxi Kang En Bei Zhong Yao Co., Ltd. romanized
2025/01/27Generic · Class 3 帕立骨化醇软胶囊 · No verified English nameCYHL2500029 Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized
2025/01/27Generic · Class 3 帕立骨化醇软胶囊 · No verified English nameCYHL2500028 Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized
2025/01/27Generic · Class 3 双氯芬酸钠贴剂 · No verified English nameCYHL2500027 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/01/27New drug · Class 1.1 反流清颗粒 · No verified English nameCXZL2500005 Jiangxi Yin Tao Pharma Co., Ltd. romanized
2025/01/27New drug · Class 1 古莫奇单抗注射液 · No verified English nameCXSS2500021 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized; Kang Fang Pharma Co., Ltd. romanized
2025/01/27New drug · Class 1 古莫奇单抗注射液 · No verified English nameCXSS2500020 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized; Kang Fang Pharma Co., Ltd. romanized
2025/01/27New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSS2500019 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2025/01/27New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSS2500018 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2025/01/27New drug · Class 2.2 冻干人用狂犬病疫苗(无血清Vero细胞) · No verified English nameCXSS2500017 Ke Xing (Chengdu) Bio Zhi Pin Co., Ltd. romanized
2025/01/27New drug · Class 1 人自体多克隆调节性T细胞注射液 · No verified English nameCXSL2500094 Shanghai Sai Er Xin Bio Medical Technology Co., Ltd. romanized
2025/01/27New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500093 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/01/27New drug · Class 1 注射用ASKG915 · No verified English nameCXSL2500092 Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized

187 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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