YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 186 drug applications between 27 January 2025 and 2 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 46 drug names.

2025/01/27 – 2025/02/02

Period
2025/01/27 to 2025/02/02, 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
186
Drugs with new generic filings (by drug name, de-duplicated)
46
Accepted this week, now under review
6

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

186filings, 65 of them generic

By application type

Application typeFilings
Generic65
Supplement59
New drug50
Import re-registration6
Import4
Unspecified2

By drug type

Drug typeFilings
Chemical drug142
Therapeutic biologic30
TCM11
Prophylactic biologic2
Biologic1

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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Azilsartan Medoxomil Potassium Tablets4235
3Finerenone Tablets3269
4Brexpiprazole Orally Disintegrating Tablets3110
5Polidocanol Injection3123
6Potassium Chloride Oral Solution2211
7帕立骨化醇软胶囊 · No verified English name210
8Amoxicillin Sodium and Clavulanate Potassium for Injection214
9Loxoprofen Sodium Patches2130
10Doxylamine Succinate Tablets210

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

123 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized510
2Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized424
3Boehringer Ingelheim International GmbH410
4GUERBET410
5Shenyang San Sheng Pharmaceutical Co., Ltd. romanized410
6Hainan Zhong He Pharma Co., Ltd. romanized410
7Eli Lilly Nederland B.V.310
8Nanjing Hai Na Pharmaceutical Co., Ltd. romanized313
9Tong Lu Biopharmaceutical Co., Ltd. romanized310
10Haikou Shi Pharmaceutical Factory Co., Ltd. romanized310

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

75 this week

AcceptedDrugApplicants
2025/01/28Generic · Class 3 Calcium Acetate Oral SolutionCYHS2500553 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/01/28Generic · Class 3 Oxytocin InjectionCYHS2500550 Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized
2025/01/28Generic · Class 3 碳酸氢钠/葡萄糖2mmol/L钾电解质血滤置换液 · No verified English nameCYHS2500549 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/01/28Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2500547 Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2025/01/28New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSS2500022 Kang Xi Nuo Bio Shareholding Company romanized
2025/01/28New drug · Class 1 重组抗人EGFR抗体/IL-10双特异Fc融合蛋白注射液 · No verified English nameCXSL2500098 Shi Hui Da Pharma Group (Jilin) Co., Ltd. romanized
2025/01/28New drug · Class 1 注射用SIM0686 · No verified English nameCXSL2500097 Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized
2025/01/28New drug · Class 1 BNT327 · No verified English nameCXSL2500096 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2025/01/28New drug · Class 1 BNT326 · No verified English nameCXSL2500095 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2025/01/28New drug · Class 1 HRS-9813胶囊 · No verified English nameCXHL2500147 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
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

45 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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