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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 320 drug applications between 24 January 2026 and 30 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 52, covering 40 drug names.

2026/01/24 – 2026/01/30

Period
2026/01/24 to 2026/01/30, 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
320
Drugs with new generic filings (by drug name, de-duplicated)
40
Accepted this week, now under review
71

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

320filings, 52 of them generic

By application type

Application typeFilings
Supplement184
New drug65
Generic52
Import12
Import re-registration4
Unspecified3

By drug type

Drug typeFilings
Chemical drug175
TCM78
Therapeutic biologic60
Prophylactic biologic5
In vitro diagnostic reagent1
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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1醋酸艾司利卡西平片 · No verified English name414
2Cefmetazole Sodium for Injection317
3Perindopril tert-Butylamine Tablets215
4复方氨基酸注射液(17AA-Ⅲ) · No verified English name212
5左羟丙哌嗪口服溶液 · No verified English name218
6Budesonide Nasal Spray213
7注射用头孢他啶/氯化钠注射液 · No verified English name213
8Minoxidil Liniment2152
9Finerenone Tablets2169
10丁甘交联玻璃酸钠注射液 · No verified English name110

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

190 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1230
2Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized11110
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
4Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized660
5Shen Wei Pharma Group Co., Ltd. romanized440
6Sanofi Winthrop Industrie430
7Guangdong Wan Nian Qing Pharmaceutical Co., Ltd. romanized430
8Rui Yang Pharmaceutical Co., Ltd. romanized433
9Ha Yao Group Bio Gong Cheng Co., Ltd. romanized420
10CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420

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

95 this week

AcceptedDrugApplicants
2026/01/30Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2600316 Henan Run Hong Pharmaceutical Co., Ltd. romanized
2026/01/30New drug · Class 3.1 清骨散颗粒 · No verified English nameCXZS2600007 Shen Wei Pharma Group Co., Ltd. romanized
2026/01/30New drug · Class 1 CMG2349注射液 · No verified English nameCXSL2600156 Chengdu En Mu Bio Technology Co., Ltd. romanized
2026/01/30New drug · Class 1 注射用MK-1045 · No verified English nameCXSL2600155 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/01/30New drug · Class 1 注射用MK-1045 · No verified English nameCXSL2600154 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/01/30New drug · Class 1 SG301注射液 · No verified English nameCXSL2600152 Hangzhou Shang Jian Bio Technology Co., Ltd. romanized
2026/01/30New drug · Class 1 SYS6051 · No verified English nameCXSL2600151 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/01/30New drug · Class 1 注射用LY4170156 · No verified English nameCXSL2600149 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/01/30New drug · Class 2.4 注射用磷罗拉匹坦帕洛诺司琼 · No verified English nameCXHS2600019 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/30New drug · Class 2.4 氟[18F]妥司特注射液 · No verified English nameCXHL2600134 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2026/01/29Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600033 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/29Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600032 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/29Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600031 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/29Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600030 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/29Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600029 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/29Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600028 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/29Import · Class 3.1 呼吸道合胞病毒疫苗 · No verified English nameJXSL2600027 Pfizer Inc.; Pfizer Investment CO Ltd.
2026/01/29Import · Class 2.2 罗泽利昔珠单抗注射液 · No verified English nameJXSL2600026 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2026/01/29Generic · Class 3 Drotaverine Hydrochloride TabletsCYHS2600310 Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized
2026/01/29Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHS2600308 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2026/01/29Generic · Class 3 硫代硫酸钠注射液(Ⅱ) · No verified English nameCYHS2600304 Shanghai Shang Yao Innovation Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2026/01/29Generic · Class 3 Colchicine TabletsCYHS2600303 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2026/01/29Generic · Class 3 盐酸氨酮戊酸口服溶液用粉末 · No verified English nameCYHS2600302 Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized
2026/01/29Generic · Class 3 盐酸奥洛他定口崩片 · No verified English nameCYHS2600294 Jiangxi Shimei Pharmaceutical Co., Ltd
2026/01/29Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2600293 Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2026/01/29Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2600292 Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2026/01/29Generic · Class 3 Ramelteon TabletsCYHL2600016 Nanjing Si Tai Er Pharmaceuticals Technology Co., Ltd. romanized
2026/01/29New drug · Class 3.1 芍药甘草汤颗粒 · No verified English nameCXZS2600006 Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized
2026/01/29New drug · Class 1.1 白及创愈贴 · No verified English nameCXZL2600017 Shandong Han Fang Pharmaceutical Co., Ltd. romanized
2026/01/29New drug · Class 1.2 芦荟多糖提取物 · No verified English nameCXZL2600016 Guangzhou Shi Dong Yuan Pharma Technology Co., Ltd. romanized

65 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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