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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 404 drug applications between 29 March 2026 and 4 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 32 drug names.

2026/03/29 – 2026/04/04

Period
2026/03/29 to 2026/04/04, 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
404
Drugs with new generic filings (by drug name, de-duplicated)
32
Accepted this week, now under review
100

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

404filings, 43 of them generic

By application type

Application typeFilings
Supplement274
New drug53
Generic43
Import18
Unspecified8
Import re-registration8

By drug type

Drug typeFilings
TCM175
Chemical drug166
Therapeutic biologic61
Biologic1
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

32 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2Arginine and Ibuprofen Granules3111
3Linagliptin and Metformin Hydrochloride Extended Release Tablets214
4Carboplatin Injection2110
5Diclofenac Diethylamine Emulgel2120
6Montelukast Sodium Chewable Tablets214
7Epinastine Hydrochloride Tablets212
8Labetalol Hydrochloride Tablets213
9褪黑素颗粒 · No verified English name2112
10Acetylcysteine Injection1153

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

222 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ha Yao Group Bio Gong Cheng Co., Ltd. romanized1450
2Hubei Tai Zi Pharma Co., Ltd. romanized12120
3Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized10100
4Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized1010
5Merck Sharp & Dohme B.V.820
6Jiangsu Ke Lun Pharma Co., Ltd. romanized810
7Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized760
8Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized660
9Zhejiang Guo Jing Pharma Co., Ltd. romanized610
10Henan Ling Rui Pharmaceutical 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
2026/04/04Import · Class 2.2 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600031 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/04Import · Class 2.2 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600030 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/04Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600029 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/04Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600028 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/04Generic · Class 3 Olopatadine Hydrochloride GranulesCYHS2600785 Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2026/04/04New drug · Class 2.3 椿乳凝胶 · No verified English nameCXZL2600034 Zhu Zhou Qian Jin Pharma Co., Ltd. romanized
2026/04/04New drug · Class 1 SK-NK注射液 · No verified English nameCXSL2600380 Sai Ao Si Bo Bio Technology (Beijing) Co., Ltd. romanized; Sai Ao Si Bo Bio Technology (Zhengzhou) Co., Ltd. romanized
2026/04/03Import · Class 2.2 注射用维恩妥尤单抗 · No verified English nameJXSL2600091 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2026/04/03Import · Class 2.2 注射用维恩妥尤单抗 · No verified English nameJXSL2600090 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2026/04/03Import · Class 1 Baxdrostat片 · No verified English nameJXHL2600099 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/04/03Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2600784 Anhui Yuan Wang Le Huan Pharma Co., Ltd. romanized
2026/04/03New drug · Class 1 GT307注射液 · No verified English nameCXSL2600379 Beijing Sha Li Biopharmaceuticals Co., Ltd. romanized
2026/04/03New drug · Class 1 SAR445877注射用浓溶液 · No verified English nameCXSL2600378 Sai Nuo Fei (Zhongguo) Investment Co., Ltd. romanized
2026/04/03New drug · Class 1 ATTO-1310注射液 · No verified English nameCXSL2600377 Ai Tuo Wei Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/04/03New drug · Class 1 9MW5211注射液 · No verified English nameCXSL2600376 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2026/04/03New drug · Class 1 注射用DXC018 · No verified English nameCXSL2600375 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2026/04/03New drug · Class 1 注射用SIM0689 · No verified English nameCXSL2600374 Shanghai Xian Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/04/03New drug · Class 1 艾普美妥司他片 · No verified English nameCXHS2600047 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2026/04/03New drug · Class 1 艾普美妥司他片 · No verified English nameCXHS2600046 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2026/04/03New drug · Class 1 伊托法替布软膏 · No verified English nameCXHS2600045 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2026/04/03New drug · Class 1 D-0120-NA片 · No verified English nameCXHL2600406 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2026/04/03New drug · Class 1 VC005凝胶 · No verified English nameCXHL2600405 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2026/04/03New drug · Class 2.2 优替德隆胶囊 · No verified English nameCXHL2600404 Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized; Beijing Hua Hao Zhong Tian Biopharmaceuticals Co., Ltd. romanized
2026/04/02Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600027 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S. p. A.; MSD R&D (China) Co. Ltd
2026/04/02Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600026 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/02Import · Class 2.2 奥妥珠单抗注射液 · No verified English nameJXSS2600025 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2026/04/02Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSS2600024 Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2026/04/02Import · Class 1 PF-08634404 · No verified English nameJXSL2600089 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/04/02Import · Class 1 AZD8965片 · No verified English nameJXHL2600098 AstraZeneca AB; Name not romanized
2026/04/02Import · Class 1 AZD8965片 · No verified English nameJXHL2600097 AstraZeneca AB; Name not romanized

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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