YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 448 drug applications between 19 August 2026 and 25 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 56 drug names.

2026/08/19 – 2026/08/25

Period
2026/08/19 to 2026/08/25, 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
448
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
243

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

448filings, 76 of them generic

By application type

Application typeFilings
Supplement238
Generic76
New drug73
Import42
Unspecified11
Import re-registration8

By drug type

Drug typeFilings
Chemical drug230
TCM124
Therapeutic biologic80
Prophylactic biologic12
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

56 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

250 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Gao Miao Pharma Co., Ltd. romanized29250
2Luo Yang Yi Long Pharma Co., Ltd. romanized10100
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized1030
4AstraZeneca AB850
5AbbVie Inc.830
6Novo Nordisk A/S710
7Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized640
8Pfizer Inc.630
9Chengdu Brilliant Pharmaceutical Co., Ltd.631
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

137 this week

AcceptedDrugApplicants
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
2026/08/25New drug · Class 1 ST-1703片 · No verified English nameCXHL2601044 Beijing Sai Te Ming Qiang Pharmaceuticals Technology Co., Ltd. romanized
2026/08/25New drug · Class 2.2 秋水仙碱缓释胶囊 · No verified English nameCXHL2601043 Zhongguo Ren Min Jie Fang Jun Jun Shi Ke College Jun Shi Yi Xue Research Institute romanized
2026/08/25New drug · Class 2.2 秋水仙碱缓释胶囊 · No verified English nameCXHL2601042 Zhongguo Ren Min Jie Fang Jun Jun Shi Ke College Jun Shi Yi Xue Research Institute romanized
2026/08/25New drug · Class 2.2 秋水仙碱缓释胶囊 · No verified English nameCXHL2601041 Zhongguo Ren Min Jie Fang Jun Jun Shi Ke College Jun Shi Yi Xue Research Institute romanized
2026/08/24Import · Class 1 依赛弗酶α注射液(皮下注射) · No verified English nameJXSS2600078 Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd.
2026/08/24Import · Class 1 依赛弗酶α注射液(皮下注射) · No verified English nameJXSS2600077 Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd.
2026/08/24Import · Class 1 依赛弗酶α注射液(皮下注射) · No verified English nameJXSS2600076 Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd.
2026/08/24Import · Class 3.1 13价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2600227 Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd.
2026/08/24Import · Class 3.1 20价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2600226 Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd.
2026/08/24Import · Class 1 ARVN901 · No verified English nameJXSL2600225 Arctic Vision (Hong Kong) Limited; Arctic Vision (Shanghai) Biotechnology Co. Ltd.
2026/08/24Import · Class 1 DS-3939a · No verified English nameJXSL2600224 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2026/08/24Import · Class 1 AZD8205 · No verified English nameJXSL2600223 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/08/24Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600222 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/08/24Import · Class 1 AZD9574 · No verified English nameJXHL2600362 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/08/24Import · Class 1 AZD9574 · No verified English nameJXHL2600361 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/08/24Import · Class 1 CBL-514注射液 · No verified English nameJXHL2600360 Caliway Biopharmaceuticals Co. Ltd.; Hangzhou Tigermed Consulting Co. Ltd.
2026/08/24Generic · Class 3 Ibuprofen InjectionCYHS2602108 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2026/08/24Generic · Class 3 Ibuprofen InjectionCYHS2602107 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2026/08/24Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCYHS2602102 Changzhou Rui Ming Pharma Co., Ltd. romanized

107 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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