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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 289 drug applications between 21 May 2025 and 27 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 47 drug names.

2025/05/21 – 2025/05/27

Period
2025/05/21 to 2025/05/27, 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
289
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
40

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

289filings, 65 of them generic

By application type

Application typeFilings
Supplement148
Generic65
New drug55
Import10
Unspecified7
Import re-registration4

By drug type

Drug typeFilings
Chemical drug182
Therapeutic biologic51
TCM49
Prophylactic biologic6
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

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Adapalene And Benzoyl Peroxide Gel6330
2Brexpiprazole Orally Disintegrating Tablets3110
3Potassium Chloride Oral Solution3111
4维立西呱片 · No verified English name318
5Iguratimod Tablets2223
6Aspirin Enteric-coated Tablets2210
7丙戊酸钠缓释微片 · No verified English name210
8利伐沙班口崩片 · No verified English name214
9地氯雷他定口服溶液 · No verified English name2126
10Dapagliflozin Tablets2184

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

181 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized13130
2Guangdong Sunho Pharmaceutical Co., Ltd.630
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
4Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized610
5Zhong Mei Shanghai Shi Gui Bao Pharmaceutical Co., Ltd. romanized440
6Jilin Sheng Qi Ke Pharma Co., Ltd. romanized440
7Haerbin Tong Yi Tang Pharma Co., Ltd. romanized440
8Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440
9Guizhou Sheng Shi Long Fang Pharmaceutical Co., Ltd. romanized440
10AstraZeneca AB420

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

87 this week

AcceptedDrugApplicants
2025/05/27Import · Class 3.1 比奇珠单抗注射液 · No verified English nameJXSS2500065 UCB Pharma S.A.; Vetter Pharma- Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd
2025/05/27Import · Class 3.1 比奇珠单抗注射液 · No verified English nameJXSS2500064 UCB Pharma S.A.; Vetter Pharma-Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd
2025/05/27Generic · Class 3 利伐沙班口崩片 · No verified English nameCYHS2501884 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/05/27Generic · Class 3 利伐沙班口崩片 · No verified English nameCYHS2501883 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/05/27Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂(II) · No verified English nameCYHS2501882 Yu Song Yuan Pharma Co., Ltd. romanized
2025/05/27Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2501876 Hunan Run Xing Pharma Co., Ltd. romanized; Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized
2025/05/27Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2501874 Jinan Zhong Yu Run Pharmaceuticals Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2025/05/27New drug · Class 1 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSS2500054 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized; Beijing Hua Fang Tian Shi Biopharmaceutical Co., Ltd. romanized
2025/05/27New drug · Class 1 重组人PD-L1/CD3 双抗溶瘤II型单纯疱疹病毒注射液(Vero细胞) · No verified English nameCXSL2500425 Wuhan Bin Hui Bio Technology Co., Ltd. romanized
2025/05/27New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500424 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2025/05/27New drug · Class 1 注射用RMMV疫苗 · No verified English nameCXSL2500423 Changchun Kang Yue Bio Technology Co., Ltd. romanized
2025/05/27New drug · Class 1 注射用IMD303 · No verified English nameCXSL2500422 Qin He Li (Chengdu) Pharma Co., Ltd. romanized
2025/05/24Import · Class 1 注射用Felzartamab · No verified English nameJXSL2500082 Biogen Idec Research Limited
2025/05/24New drug · Class 2.2 瑞基奥仑赛注射液 · No verified English nameCXSS2500053 Shanghai Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized; Suzhou Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized
2025/05/24New drug · Class 1 IBI363 · No verified English nameCXSL2500421 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/24New drug · Class 1 IBI363 · No verified English nameCXSL2500420 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/24New drug · Class 1 SSGJ-706注射液 · No verified English nameCXSL2500419 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/05/24New drug · Class 1 SSGJ-706注射液 · No verified English nameCXSL2500418 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/05/24New drug · Class 1 VB19055片 · No verified English nameCXHL2500509 Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized
2025/05/24New drug · Class 1 VB19055片 · No verified English nameCXHL2500508 Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized
2025/05/24New drug · Class 1 VB19055片 · No verified English nameCXHL2500507 Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized
2025/05/24New drug · Class 1 VB19055片 · No verified English nameCXHL2500506 Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized
2025/05/24New drug · Class 2.2 HKG-456 · No verified English nameCXHL2500505 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized
2025/05/23Import · Class 1 GHZ339注射液 · No verified English nameJXSL2500081 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/05/23Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2501864 Hangzhou He Kang Pharma Co., Ltd. romanized
2025/05/23Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2501863 Hangzhou He Kang Pharma Co., Ltd. romanized
2025/05/23Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2501862 Hangzhou He Kang Pharma Co., Ltd. romanized
2025/05/23Generic · Class 3 Hydrotalcite SuspensionCYHS2501860 Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/23Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2501853 Hubei Tian Sheng Pharma Co., Ltd. romanized
2025/05/23Generic · Class 3 Potassium Phosphates InjectionCYHS2501851 Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Xi Er Kang Tai Pharma Co., Ltd. romanized

57 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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