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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 330 drug applications between 18 March 2026 and 24 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 37 drug names.

2026/03/18 – 2026/03/24

Period
2026/03/18 to 2026/03/24, 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
330
Drugs with new generic filings (by drug name, de-duplicated)
37
Accepted this week, now under review
75

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

330filings, 43 of them generic

By application type

Application typeFilings
Supplement211
New drug52
Generic43
Import13
Unspecified7
Import re-registration4

By drug type

Drug typeFilings
Chemical drug174
TCM121
Therapeutic biologic30
Biologic4
Prophylactic 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

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Levofloxacin Eye Drops3116
2Selexipag Tablets2124
3培美曲塞二钠注射液 · No verified English name212
4头孢地尼颗粒 · No verified English name213
5Lacidipine Tablets217
6Ethyl Iosapentate Capsules1127
7二硫化硒洗剂 · No verified English name1114
8伏硫西汀滴剂 · No verified English name111
9依非米替片(I) · No verified English name112
10Lidocaine Cataplasms117

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

187 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized1090
2Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized910
3Shaanxi Pan Long Pharma Group Co., Ltd. romanized880
4HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.710
5Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized550
6Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized550
7Qilu Pharmaceutical Co., Ltd.540
8Amgen Inc.520
9Nanjing Tong Ren Tang Pharma Co., Ltd. romanized440
10Tian Sheng Pharmaceutical Group 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

79 this week

AcceptedDrugApplicants
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
2026/03/24New drug · Class 1 HB0056注射液 · No verified English nameCXSL2600344 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/03/24New drug · Class 1 治疗用(合成肽)乙型肝炎疫苗 · No verified English nameCXSL2600343 Nuo He Tai Bio Technology (Chongqing) Co., Ltd. romanized
2026/03/24New drug · Class 1 ODV混悬滴眼液 · No verified English nameCXHL2600366 Shenzhen Ruo Jian Hui Tong Bio Technology Co., Ltd. romanized
2026/03/24New drug · Class 1 ODV混悬滴眼液 · No verified English nameCXHL2600365 Shenzhen Ruo Jian Hui Tong Bio Technology Co., Ltd. romanized
2026/03/24New drug · Class 1 ODV混悬滴眼液 · No verified English nameCXHL2600364 Shenzhen Ruo Jian Hui Tong Bio Technology Co., Ltd. romanized
2026/03/24New drug · Class 1 XNW5004片 · No verified English nameCXHL2600363 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/03/24New drug · Class 1 XNW5004片 · No verified English nameCXHL2600362 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/03/24New drug · Class 1 ANS014004片 · No verified English nameCXHL2600358 Beijing An Shi Bio Technology Co., Ltd. romanized
2026/03/24New drug · Class 1 ANS014004片 · No verified English nameCXHL2600357 Beijing An Shi Bio Technology Co., Ltd. romanized
2026/03/23Import · Class 2.4 那米司特片 · No verified English nameJXHL2600090 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/03/23Import · Class 2.4 那米司特片 · No verified English nameJXHL2600089 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/03/23Import · Class 2.4 那米司特片 · No verified English nameJXHL2600088 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/03/23Generic · Class 3 头孢克肟干混悬剂 · No verified English nameCYHS2600697 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Jin Hong Pharma Co., Ltd. romanized
2026/03/23Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2600696 Suzhou Hong Sen Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2026/03/23New drug · Class 2.2 DMI019鼻喷雾剂 · No verified English nameCXHL2600361 Jiangsu De Mai Pharma Co., Ltd. romanized
2026/03/23New drug · Class 2.2 DMI019鼻喷雾剂 · No verified English nameCXHL2600360 Jiangsu De Mai Pharma Co., Ltd. romanized
2026/03/23New drug · Class 2.2 DMI019鼻喷雾剂 · No verified English nameCXHL2600359 Jiangsu De Mai Pharma Co., Ltd. romanized
2026/03/21Import · Class 2.1 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2600084 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2026/03/21Import · Class 2.1 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2600083 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2026/03/21Import · Class 1 MK-1084片 · No verified English nameJXHL2600087 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/03/21Import · Class 1 MK-1084片 · No verified English nameJXHL2600086 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd

49 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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