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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 327 drug applications between 20 March 2026 and 26 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 39, covering 35 drug names.

2026/03/20 – 2026/03/26

Period
2026/03/20 to 2026/03/26, 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
327
Drugs with new generic filings (by drug name, de-duplicated)
35
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

327filings, 39 of them generic

By application type

Application typeFilings
Supplement210
New drug54
Generic39
Import10
Import re-registration8
Unspecified6

By drug type

Drug typeFilings
Chemical drug170
TCM134
Therapeutic biologic21
Biologic2

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

35 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Selexipag Tablets2124
2培美曲塞二钠注射液 · No verified English name212
3头孢地尼颗粒 · No verified English name213
4Baricitinib Tablets2132
5Ethyl Iosapentate Capsules1127
6二硫化硒洗剂 · No verified English name1114
7Pemafibrate Tablets1123
8依非米替片(I) · No verified English name112
9Lidocaine and Prilocaine Cream1124
10双氯芬酸钠搽剂 · No verified English name111

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

192 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Yi Chun Kang Er Xin Pharma Co., Ltd. romanized11100
2Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized910
3Shaanxi Pan Long Pharma Group Co., Ltd. romanized880
4Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized770
5Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized760
6HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.710
7Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized660
8Dong E E Jiao Co., Ltd. romanized440
9CISEN PHARMACEUTICAL CO., LTD.432
10Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized420

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

74 this week

AcceptedDrugApplicants
2026/03/26Generic · Class 3 碘化钾片 · No verified English nameCYHS2600721 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2026/03/26Generic · Class 3 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2600717 Beijing Foyou Pharma CO.,LTD; Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized
2026/03/26New drug · Class 1 QLS2311注射液 · No verified English nameCXSL2600353 Qilu Pharmaceutical Co., Ltd.
2026/03/26New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600351 An Ming Kang Yuan Pharmaceutical (Jilin) Co., Ltd. romanized; An Kang Yuan Bio Technology (Jilin) Co., Ltd. romanized
2026/03/26New drug · Class 1 注射用SKB571 · No verified English nameCXSL2600350 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/03/26New drug · Class 1 ATG-201注射液 · No verified English nameCXSL2600349 De Qi (Hangzhou) Bio Co., Ltd. romanized
2026/03/26New drug · Class 1 BY101921片 · No verified English nameCXHL2600379 Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/26New drug · Class 1 BY101921片 · No verified English nameCXHL2600378 Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/26New drug · Class 1 APH03571片 · No verified English nameCXHL2600374 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2026/03/26New drug · Class 1 APH03571片 · No verified English nameCXHL2600373 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2026/03/26New drug · Class 1 VCT220片 · No verified English nameCXHL2600372 Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/03/26New drug · Class 1 VCT220片 · No verified English nameCXHL2600371 Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/03/26New drug · Class 1 VCT220片 · No verified English nameCXHL2600370 Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/03/26New drug · Class 1 CH3127片 · No verified English nameCXHL2600369 Suzhou Chun Hai Biopharmaceuticals Co., Ltd. romanized
2026/03/26New drug · Class 1 CH3127片 · No verified English nameCXHL2600368 Suzhou Chun Hai Biopharmaceuticals Co., Ltd. romanized
2026/03/26New drug · Class 1 CH3127片 · No verified English nameCXHL2600367 Suzhou Chun Hai Biopharmaceuticals Co., Ltd. romanized
2026/03/25Import · Class 1 注射用precemtabart tocentecan · No verified English nameJXSL2600085 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2026/03/25New drug · Class 2.4 重组人白蛋白注射液 · No verified English nameCXSS2600050 Tong Hua An Rui Te Biopharmaceutical Co., Ltd. romanized
2026/03/25New drug · Class 1 TUL321胶囊 · No verified English nameCXHL2600377 Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2026/03/25New drug · Class 1 TUL321胶囊 · No verified English nameCXHL2600376 Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2026/03/25New drug · Class 1 TUL321胶囊 · No verified English nameCXHL2600375 Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2026/03/24Generic · Class 3 培美曲塞二钠注射液 · No verified English nameCYHS2600712 Sichuan Shuang Tong Medical Technology Co., Ltd. romanized; Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized
2026/03/24Generic · Class 3 培美曲塞二钠注射液 · No verified English nameCYHS2600711 Sichuan Shuang Tong Medical Technology Co., Ltd. romanized; Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized
2026/03/24Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2600709 Beijing SL Pharmaceutical Co., Ltd.
2026/03/24Generic · Class 3 双氯芬酸钠搽剂 · No verified English nameCYHS2600704 Jing Shi (Hangzhou) Pharma Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2026/03/24Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2600703 Ying Ke Rui (Zhuhai Jin Wan) Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2026/03/24New drug · Class 1 注射用BL-M08D1 · No verified English nameCXSL2600348 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/03/24New drug · Class 1 GenSci161注射液 · No verified English nameCXSL2600347 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/03/24New drug · Class 1 IBR854细胞注射液 · No verified English nameCXSL2600346 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2026/03/24New drug · Class 1 IBR854细胞注射液 · No verified English nameCXSL2600345 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized

44 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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