YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 329 drug applications between 1 April 2026 and 7 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 28, covering 22 drug names.

2026/04/01 – 2026/04/07

Period
2026/04/01 to 2026/04/07, 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
329
Drugs with new generic filings (by drug name, de-duplicated)
22
Accepted this week, now under review
78

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

329filings, 28 of them generic

By application type

Application typeFilings
Supplement230
New drug41
Generic28
Import18
Unspecified6
Import re-registration6

By drug type

Drug typeFilings
TCM142
Chemical drug133
Therapeutic biologic53
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

22 drugs with new generic filings; top 10 listed

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

180 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Tai Zi Pharma Co., Ltd. romanized11110
2Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized10100
3Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized1010
4Ha Yao Group Bio Gong Cheng Co., Ltd. romanized930
5Merck Sharp & Dohme B.V.820
6Jiangsu Ke Lun Pharma Co., Ltd. romanized810
7Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized650
8Zhejiang Guo Jing Pharma Co., Ltd. romanized610
9Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized550
10Hainan Pharmaceutical Factory Co., Ltd. Pharmaceutical Er Factory 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

62 this week

AcceptedDrugApplicants
2026/04/07Generic · Class 3 盐酸他喷他多口服溶液 · No verified English nameCYHL2600038 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/04/07New drug · Class 1 SYS6041 · No verified English nameCXSL2600381 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/04/07New drug · Class 1 ANS02胶囊 · No verified English nameCXHL2600414 Beijing An Shi Bio Technology Co., Ltd. romanized
2026/04/07New drug · Class 1 ANS02胶囊 · No verified English nameCXHL2600413 Beijing An Shi Bio Technology Co., Ltd. romanized
2026/04/07New drug · Class 1 68Ga-NYM096注射液制备用药盒 · No verified English nameCXHL2600409 Anhui Nuo Yu Biopharmaceutical Co., Ltd. romanized
2026/04/07New drug · Class 1 LT-010391片 · No verified English nameCXHL2600408 Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized
2026/04/07New drug · Class 1 LT-010391片 · No verified English nameCXHL2600407 Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized
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

32 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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