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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 556 drug applications between 25 February 2026 and 3 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 89 drug names.

2026/02/25 – 2026/03/03

Period
2026/02/25 to 2026/03/03, 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
556
Drugs with new generic filings (by drug name, de-duplicated)
89
Accepted this week, now under review
193

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

556filings, 119 of them generic

By application type

Application typeFilings
Supplement242
New drug135
Generic119
Import36
Unspecified16
Import re-registration8

By drug type

Drug typeFilings
Chemical drug347
Therapeutic biologic121
TCM77
Prophylactic biologic7
Biologic3
In vitro diagnostic reagent1

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

89 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Rosuvastatin Calcium Tablets4218
2Cariprazine hydrochloride Capsules313
3Fluocinolone Acetonide,Hydroquinone And Tretinoin Cream221
4注射用甲苯磺酸奥马环素 · No verified English name229
5盐酸氮?斯汀滴眼液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.226
6Iguratimod Tablets2223
7Tadalafil Tablets2123
8Eplerenone Tablets214
9Diclofenac Sodium Sustained Release Tablets2110
10Dotinurad Tablets2155

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

317 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized960
2Amgen Inc.930
3Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized740
4Novartis Pharma AG730
5The Wellcome Foundation Limited720
6Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized660
7Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized640
8Qilu Pharmaceutical Co., Ltd.640
9Takeda Development Center Americas Inc.620
10Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized620

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

212 this week

AcceptedDrugApplicants
2026/03/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2600019 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2026/03/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2600018 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2026/03/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2600017 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2026/03/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2600016 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2026/03/03Import · Class 3.1 司美格鲁肽注射液 · No verified English nameJXSS2600015 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd
2026/03/03Import · Class 3.1 来瑞奇珠单抗注射液 · No verified English nameJXSS2600014 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/03New drug · Class 1 GA002注射液 · No verified English nameCXSL2600299 Jian Da Jiu Zhou (Beijing) Bio Technology Co., Ltd. romanized
2026/03/03New drug · Class 1 注射用BAT8013 · No verified English nameCXSL2600298 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2026/03/03New drug · Class 1 注射用BR111 · No verified English nameCXSL2600295 Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2026/03/03New drug · Class 3.3 特立帕肽注射液 · No verified English nameCXSL2600294 Yi Fan Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/03/03New drug · Class 3.3 古塞奇尤单抗注射液 · No verified English nameCXSL2600293 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/03/03New drug · Class 1 HS-20117-2注射液 · No verified English nameCXSL2600290 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/03/03New drug · Class 1 QLS1413片 · No verified English nameCXHL2600264 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized
2026/03/03New drug · Class 1 QLS1413片 · No verified English nameCXHL2600263 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized
2026/03/03New drug · Class 2.2 玛硒洛沙韦干混悬剂 · No verified English nameCXHL2600262 Zheng Xiang Pharmaceuticals (Nanjing) Group Co., Ltd. romanized
2026/03/03New drug · Class 1 JYP0061片 · No verified English nameCXHL2600261 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2026/03/03New drug · Class 1 JYP0061片 · No verified English nameCXHL2600260 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2026/03/02Import · Class 3.1 尘螨变应原舌下片 (Actair) · No verified English nameJXSL2600061 STALLERGENES; Nuance Pharma(Beijing)Co. Ltd
2026/03/02Import · Class 3.1 尘螨变应原舌下片 (Actair) · No verified English nameJXSL2600060 STALLERGENES; Nuance Pharma(Beijing)Co. Ltd
2026/03/02Generic · Class 3 Hydrotalcite SuspensionCYHS2600606 Anhui Kang Rong Pharma Co., Ltd. romanized
2026/03/02Generic · Class 3 Methenamine Hippurate TabletsCYHS2600602 Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized
2026/03/02Generic · Class 3 Amisulpride Oral SolutionCYHS2600599 Sichuan Sen Ke Pharmaceutical Co., Ltd. romanized
2026/03/02Generic · Class 3 洛度沙胺氨丁三醇滴眼液 · No verified English nameCYHS2600598 Shijiazhuang No.4 Pharmaceutical Co., Ltd.; Jiangxi Ke Lun Pharma Co., Ltd. romanized
2026/03/02New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSS2600034 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized
2026/03/02New drug · Class 2 乙型肝炎病毒、丙型肝炎病毒、人类免疫缺陷病毒(1+2型)核酸检测试剂盒(PCR-荧光法) · No verified English nameCXSS2600033 Shandong Jian Wei Bio Technology Co., Ltd. romanized
2026/03/02New drug · Class 1 SKB118注射液 · No verified English nameCXSL2600292 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/03/02New drug · Class 1 注射用BG-C0979 · No verified English nameCXSL2600291 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2026/03/02New drug · Class 2.2 三价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2600289 Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized
2026/03/02New drug · Class 1 注射用RC288 · No verified English nameCXSL2600288 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2026/03/02New drug · Class 2.1; 2.2 伏欣奇拜单抗注射液 · No verified English nameCXSL2600285 Changchun Jin Sai Pharma Co., Ltd. romanized

182 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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