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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 449 drug applications between 26 June 2026 and 2 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 52 drug names.

2026/06/26 – 2026/07/02

Period
2026/06/26 to 2026/07/02, 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
449
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
131

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

449filings, 75 of them generic

By application type

Application typeFilings
Supplement277
Generic75
New drug55
Import18
Unspecified16
Import re-registration8

By drug type

Drug typeFilings
Chemical drug232
TCM167
Therapeutic biologic43
Biologic7

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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1司美格鲁肽注射液 · No verified English name5192
2Nafamostat Mesilate for Injection4238
3Adapalene And Benzoyl Peroxide Gel4230
4Dopamine Hydrochloride Injection313
5Landiolol Hydrochloride for Injection2219
6Lactulose Oral Solution2134
7依折麦布阿托伐他汀钙片(Ⅰ)、(Ⅱ) · No verified English name212
8Eplerenone Tablets214
9Dotinurad Tablets2155
10环索奈德吸入气雾剂 · No verified English name210

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

289 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized1670
2Yan Tai Xin Ke Si Da Pharmaceuticals Technology Co., Ltd. romanized770
3Xizang Gan Lu Zang Yao Co., Ltd. romanized750
4Lan Yun Zhi He Bio Technology Co., Ltd. romanized660
5Shandong Xin Shi Dai Pharma Co., Ltd. romanized650
6Bristol-Myers Squibb Company520
7Jiangsu Fu Bang Pharma Co., Ltd. romanized525
8Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized515
9Gansu He Xi Pharmaceutical Co., Ltd. romanized440
10Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa 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

108 this week

AcceptedDrugApplicants
2026/07/02Import · Class 1 Rinzimetostat (ORIC-944) · No verified English nameJXHL2600240 ORIC Pharmaceuticals Inc.; ICON Clinical Research (Beijing No. 2) Co. Ltd.
2026/07/02Generic · Class 3 司美格鲁肽注射液 · No verified English nameCYHS2601574 Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized; Shenzhen Han Yu Pharma Co., Ltd. romanized
2026/07/02Generic · Class 3 司美格鲁肽注射液 · No verified English nameCYHS2601573 Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized; Shenzhen Han Yu Pharma Co., Ltd. romanized
2026/07/02Generic · Class 3 司美格鲁肽注射液 · No verified English nameCYHS2601572 Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized; Shenzhen Han Yu Pharma Co., Ltd. romanized
2026/07/02Generic · Class 3 司美格鲁肽注射液 · No verified English nameCYHS2601571 Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized; Shenzhen Han Yu Pharma Co., Ltd. romanized
2026/07/02Generic · Class 3 司美格鲁肽注射液 · No verified English nameCYHS2601570 Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized; Shenzhen Han Yu Pharma Co., Ltd. romanized
2026/07/02Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2601564 Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2026/07/02New drug · Class 3.1 桃红四物汤颗粒 · No verified English nameCXZS2600035 Zhu Zhou Qian Jin Pharma Co., Ltd. romanized
2026/07/02New drug · Class 1.1 柴芍肠宁颗粒 · No verified English nameCXZL2600058 Yu Sen (Fo Shan) Xin Yao Research and Development Co., Ltd. romanized
2026/07/02New drug · Class 1 HXN6005注射液 · No verified English nameCXSL2600691 Hua Shen Zhi Yao Bio Technology (Suzhou) Co., Ltd. romanized
2026/07/02New drug · Class 1 乐德奇拜单抗注射液 · No verified English nameCXSL2600690 Xian Sheng Pharma Co., Ltd. romanized
2026/07/02New drug · Class 1 乐德奇拜单抗注射液 · No verified English nameCXSL2600689 Xian Sheng Pharma Co., Ltd. romanized
2026/07/02New drug · Class 1 EA5注射液皮下制剂 · No verified English nameCXSL2600688 Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized
2026/07/02New drug · Class 1 注射用JY1001 · No verified English nameCXHL2600792 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2026/07/02New drug · Class 2.2; 2.4 F2008吸入粉雾剂 · No verified English nameCXHL2600791 Suzhou Yi He Pharmaceuticals Co., Ltd. romanized
2026/07/02New drug · Class 1 QLS1510片 · No verified English nameCXHL2600790 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized
2026/07/02New drug · Class 1 QLS1510片 · No verified English nameCXHL2600789 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized
2026/07/02New drug · Class 1 MDR-001片 · No verified English nameCXHL2600788 Hangzhou De Rui Zhi Yao Technology Co., Ltd. romanized
2026/07/02New drug · Class 1 MDR-001片 · No verified English nameCXHL2600787 Hangzhou De Rui Zhi Yao Technology Co., Ltd. romanized
2026/07/02New drug · Class 2.2; 2.4 SQ-23082滴眼液 · No verified English nameCXHL2600786 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2026/07/02New drug · Class 2.2; 2.4 SQ-23082滴眼液 · No verified English nameCXHL2600785 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2026/07/02New drug · Class 2.2; 2.4 SQ-23082滴眼液 · No verified English nameCXHL2600784 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2026/07/01Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2600056 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2026/07/01Import · Class 2.4 那米司特片 · No verified English nameJXHL2600239 Boehringer lngelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/07/01Import · Class 2.4 那米司特片 · No verified English nameJXHL2600238 Boehringer lngelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/07/01Generic · Class 3 Bilastine Oral SolutionCYHS2601558 Zhuhai Bei Shan Bio Technology Co., Ltd. romanized; Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized
2026/07/01Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601557 Kang Pu Pharma Co., Ltd. romanized
2026/07/01Generic · Class 3 Peramivir InjectionCYHS2601554 CISEN PHARMACEUTICAL CO., LTD.
2026/07/01Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2601553 Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2026/07/01Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2601552 Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized

78 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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