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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 453 drug applications between 20 August 2026 and 26 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 58 drug names.

2026/08/20 – 2026/08/26

Period
2026/08/20 to 2026/08/26, 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
453
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
251

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

453filings, 79 of them generic

By application type

Application typeFilings
Supplement253
Generic79
New drug70
Import32
Unspecified13
Import re-registration6

By drug type

Drug typeFilings
Chemical drug227
TCM124
Therapeutic biologic85
Prophylactic biologic15
Biologic2

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

58 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

252 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Gao Miao Pharma Co., Ltd. romanized39350
2Luo Yang Yi Long Pharma Co., Ltd. romanized10100
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized1030
4AbbVie Inc.930
5AstraZeneca AB640
6Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized640
7Pfizer Inc.630
8Chengdu Brilliant Pharmaceutical Co., Ltd.631
9Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized630
10Eli Lilly Italia S.p.A.610

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

126 this week

AcceptedDrugApplicants
2026/08/26Import · Class 1 INCA33890注射液 · No verified English nameJXSL2600230 Incyte Corporation; Incyte Biosciences (Shanghai) Co. Ltd.
2026/08/26Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600229 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/08/26Import · Class 1 ARGX-121注射液 · No verified English nameJXSL2600228 argenx BV; PPD Pharmaceutical Development (Beijing) Co. Ltd
2026/08/26Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2602131 Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized
2026/08/26Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2602130 Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized
2026/08/26Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2602127 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized
2026/08/26Generic · Class 3 Furosemide InjectionCYHS2602123 Anhui Shuang He Pharma Co., Ltd. romanized
2026/08/26New drug · Class 1 RC148注射液 · No verified English nameCXSL2600919 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2026/08/26New drug · Class 1 RC148注射液 · No verified English nameCXSL2600918 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2026/08/26New drug · Class 1 MK-2010注射液 · No verified English nameCXSL2600917 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/08/26New drug · Class 1 注射用GB268 · No verified English nameCXSL2600916 Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized
2026/08/26New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2600915 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/08/26New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2600914 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/08/26New drug · Class 1.1 重组3型副流感病毒疫苗(CHO细胞) · No verified English nameCXSL2600913 Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Hua Ren Kang Bio Technology Co., Ltd. romanized
2026/08/26New drug · Class 1.1 重组3型副流感病毒疫苗(CHO细胞) · No verified English nameCXSL2600912 Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Hua Ren Kang Bio Technology Co., Ltd. romanized
2026/08/26New drug · Class 1.1 重组3型副流感病毒疫苗(CHO细胞) · No verified English nameCXSL2600911 Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Hua Ren Kang Bio Technology Co., Ltd. romanized
2026/08/26New drug · Class 1 BA2201注射液 · No verified English nameCXSL2600910 Shandong Bo An Bio Technology Co., Ltd. romanized
2026/08/26New drug · Class 1 RG002-03注射液 · No verified English nameCXSL2600909 Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized
2026/08/26New drug · Class 1 注射用QHL-1031 · No verified English nameCXHL2601045 Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized
2026/08/25Generic · Class 3 琥珀酸地文拉法辛缓释片 · No verified English nameCYHS2602120 Zhi En Bio Technology Co., Ltd. romanized
2026/08/25Generic · Class 3 琥珀酸地文拉法辛缓释片 · No verified English nameCYHS2602119 Zhi En Bio Technology Co., Ltd. romanized
2026/08/25Generic · Class 3 Ferrous Succinate TabletsCYHS2602118 TC Pharmaceuticals (Jiangsu) Co., Ltd
2026/08/25Generic · Class 3 Bifonazole SolutionCYHS2602117 Anhui Pioneer Pharmaceutical Co., Ltd
2026/08/25Generic · Class 3 Bifonazole SolutionCYHS2602116 Anhui Pioneer Pharmaceutical Co., Ltd
2026/08/25Generic · Class 3 Ketoprofen PatchesCYHL2600091 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2026/08/25New drug · Class 1 哌普锐基注射液 · No verified English nameCXSS2600132 Beijing Zhong Yin Technology Co., Ltd. romanized; He Yuan Zhi Zao (Shanghai) Ji Yin Technology Co., Ltd. romanized
2026/08/25New drug · Class 1 注射用AN4035 · No verified English nameCXSL2600908 Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized
2026/08/25New drug · Class 1 人源羊膜3D 间充质基质细胞注射液 · No verified English nameCXSL2600907 Jiangxi Bei Zheng Gan Xi Bao Bio Technology Co., Ltd. romanized
2026/08/25New drug · Class 1 注射用SKB500 · No verified English nameCXSL2600906 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/08/25New drug · Class 1 SKB118注射液 · No verified English nameCXSL2600905 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized

96 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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