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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 328 drug applications between 16 April 2025 and 22 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 67 drug names.

2025/04/16 – 2025/04/22

Period
2025/04/16 to 2025/04/22, 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
328
Drugs with new generic filings (by drug name, de-duplicated)
67
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

328filings, 90 of them generic

By application type

Application typeFilings
Supplement146
Generic90
New drug55
Import18
Import re-registration14
Unspecified3
Drug-device combination2

By drug type

Drug typeFilings
Chemical drug226
TCM52
Therapeutic biologic49
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

67 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cefotaxime Sodium For Injection4114
2达普司他片 · No verified English name410
3蒙脱石混悬液 · No verified English name3331
4Riociguat Tablets314
5Ruxolitinib Phosphate Tablets3127
6Glucosamine Sulfate Capsules2251
7Tacrolimus Ointment216
8Deferasirox Granules212
9复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
10复方聚乙二醇(3350)电解质散 · No verified English name213

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

206 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized930
2Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized550
3AstraZeneca AB540
4Bristol-Myers Squibb Company520
5Qilu Pharmaceutical (Hainan) Co., Ltd524
6Kowa Company Ltd.510
7Rong Kang Group Guangxi Kang Shi Yuan Pharmaceutical Co., Ltd. romanized440
8AstraZeneca UK Limited410
9Yunnan Bai Yao Group Co., Ltd. romanized410
10Guangdong Yue He Ze Drug Research Co., Ltd. romanized414

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

111 this week

AcceptedDrugApplicants
2025/04/22Import · Class 1 SAR442970注射液 · No verified English nameJXSL2500062 Sanofi-Aventis Recherche & Développement; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2025/04/22Import · Class 2.1 Tarlatamab · No verified English nameJXSL2500061 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2025/04/22Generic · Class 3 Pregabalin Oral SolutionCYHS2501516 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2025/04/22Generic · Class 3 左卡尼汀咀嚼片 · No verified English nameCYHS2501515 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/04/22Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2501513 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/04/22Generic · Class 3 盐酸甲氧氯普胺口服溶液 · No verified English nameCYHS2501512 Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2025/04/22Generic · Class 3 Potassium Chloride InjectionCYHS2501510 Shandong Qidu Pharmaceutical Co., Ltd.
2025/04/22Generic · Class 3 Levofolinate Calcium for InjectionCYHS2501509 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/04/22Generic · Class 3 Rifapentine TabletsCYHS2501508 Zhuo He Pharma Group Co., Ltd. romanized; Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized
2025/04/22Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2501506 Hainan Nuo En Bio Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2025/04/22Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2501505 Hainan Nuo En Bio Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2025/04/22Generic · Class 3 黄体酮注射液(Ⅱ) · No verified English nameCYHS2501504 Shanxi Jin Xin Shuang He Pharma Co., Ltd. romanized
2025/04/22New drug · Class 1.2 银杏总内酯滴丸 · No verified English nameCXZS2500018 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2025/04/22New drug · Class 1.2 银杏总内酯 · No verified English nameCXZS2500017 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2025/04/22New drug · Class 1.1 香芩解热颗粒 · No verified English nameCXZL2500024 Yunnan Fang Sheng Rong He Pharma Co., Ltd. romanized; Yunnan Zhong Pharmaceuticals University romanized
2025/04/22New drug · Class 1.2 重组三价脊髓灰质炎疫苗(Sf-RVN细胞) · No verified English nameCXSL2500324 Kang Xi Nuo Bio Shareholding Company romanized; Kang Xi Nuo (Shanghai) Bio Technology Co., Ltd. romanized
2025/04/22New drug · Class 1 HCL001细胞注射液 · No verified English nameCXSL2500323 Shanghai Hui Cun Medical Technology Co., Ltd. romanized
2025/04/22New drug · Class 1 注射用XTL6001 · No verified English nameCXSL2500322 Shanghai Xi Tai Li Biopharmaceuticals Technology Co., Ltd. romanized
2025/04/22New drug · Class 1 XW003注射液 · No verified English nameCXSL2500321 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized
2025/04/22New drug · Class 1 XW003注射液 · No verified English nameCXSL2500320 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized
2025/04/22New drug · Class 1 KYS2301凝胶 · No verified English nameCXHL2500407 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2025/04/22New drug · Class 1 KYS2301凝胶 · No verified English nameCXHL2500406 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2025/04/22New drug · Class 1 KYS2301凝胶 · No verified English nameCXHL2500405 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2025/04/22New drug · Class 1 KC1086片 · No verified English nameCXHL2500404 Beijing Kang Chen Pharma Co., Ltd. romanized
2025/04/22New drug · Class 1 KC1086片 · No verified English nameCXHL2500403 Beijing Kang Chen Pharma Co., Ltd. romanized
2025/04/19Import · Class 1 SAR442970注射液 · No verified English nameJXSL2500059 Sanofi-Aventis Recherche & Développement; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2025/04/19Import · Class 2.2 诺西那生钠注射液 · No verified English nameJXHS2500049 Biogen Netherlands B.V.; Patheon Italia S.p.A.
2025/04/19Import · Class 2.2 诺西那生钠注射液 · No verified English nameJXHS2500048 Biogen Netherlands B.V.; Patheon Italia S.p.A.
2025/04/19Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide Tablets(II)CYHS2501500 Jiangsu He Chen Pharma Co., Ltd. romanized
2025/04/19Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2501488 Henan Hua Luo Kang Run Pharma Co., Ltd. romanized

81 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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