YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 475 drug applications between 25 June 2026 and 1 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 53 drug names.

2026/06/25 – 2026/07/01

Period
2026/06/25 to 2026/07/01, 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
475
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
139

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

475filings, 72 of them generic

By application type

Application typeFilings
Supplement305
Generic72
New drug57
Import22
Unspecified10
Import re-registration9

By drug type

Drug typeFilings
Chemical drug238
TCM180
Therapeutic biologic53
Biologic4

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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nafamostat Mesilate for Injection7438
2Dopamine Hydrochloride Injection313
3Adapalene And Benzoyl Peroxide Gel3130
4Landiolol Hydrochloride for Injection2219
5Lactulose Oral Solution2134
6Eplerenone Tablets214
7环索奈德吸入气雾剂 · No verified English name210
8Tetracaine Hydrochloride Gel215
9Isoprenaline Hydrochloride Injection217
10Bromhexine Hydrochloride Oral Solution2122

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

296 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized1780
2Yan Tai Xin Ke Si Da Pharmaceuticals Technology Co., Ltd. romanized770
3Xizang Gan Lu Zang Yao Co., Ltd. romanized750
4Mu Dan Jiang Ling Tai Pharma Co., Ltd. romanized660
5Shi Ze Bio Pharma (Shanghai) Co., Ltd. romanized520
6Jiangsu Fu Bang Pharma Co., Ltd. romanized525
7Shandong Xin Shi Dai Pharma Co., Ltd. romanized440
8Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized440
9Gansu He Xi Pharmaceutical Co., Ltd. romanized440
10AstraZeneca AB430

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

113 this week

AcceptedDrugApplicants
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
2026/07/01Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2601545 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/07/01Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2601544 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/07/01Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2601543 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/07/01Generic · Class 3 Ketorolac Trometamol TabletsCYHS2601541 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2026/07/01Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2601540 Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized
2026/07/01New drug · Class 2.3 骨龙胶囊 · No verified English nameCXZL2600057 Dong E E Jiao Co., Ltd. romanized
2026/07/01New drug · Class 1 注射用VDJ010 · No verified English nameCXSL2600687 Beijing Wei De Jie Bio Technology Co., Ltd. romanized
2026/07/01New drug · Class 1 NW-301V注射液 · No verified English nameCXSL2600686 Xin Jing Zhi Yuan Bio Technology (Suzhou) Co., Ltd. romanized
2026/07/01New drug · Class 2.2 注射用HHK101 · No verified English nameCXHL2600783 Zhuhai Shi Hua Hai Kang Pharmaceuticals Technology Co., Ltd. romanized
2026/07/01New drug · Class 1 HS-10582片 · No verified English nameCXHL2600782 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2026/07/01New drug · Class 1 HS-10582片 · No verified English nameCXHL2600781 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2026/07/01New drug · Class 1 注射用PTT-121 · No verified English nameCXHL2600780 Beijing Yan Ming Bio Technology Co., Ltd. romanized
2026/07/01New drug · Class 1 AHB-137注射液 · No verified English nameCXHL2600779 Hangzhou Hao Bo Pharmaceuticals Co., Ltd. romanized
2026/07/01New drug · Class 1 YF550片 · No verified English nameCXHL2600778 Yi Qi Bio Technology (Beijing) Co., Ltd. romanized
2026/07/01New drug · Class 1 YF550片 · No verified English nameCXHL2600777 Yi Qi Bio Technology (Beijing) Co., Ltd. romanized
2026/06/30Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2600237 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/30Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2600236 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/30Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2600235 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/30Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2600234 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/30Import · Class 1 BMS-986458片 · No verified English nameJXHL2600233 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/30Import · Class 1 BMS-986458片 · No verified English nameJXHL2600232 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/30Import · Class 2.4 Rilzabrutinib片 · No verified English nameJXHL2600231 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.

83 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.