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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 458 drug applications between 18 August 2026 and 24 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 54 drug names.

2026/08/18 – 2026/08/24

Period
2026/08/18 to 2026/08/24, 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
458
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
240

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

458filings, 77 of them generic

By application type

Application typeFilings
Supplement242
Generic77
New drug68
Import49
Unspecified14
Import re-registration8

By drug type

Drug typeFilings
Chemical drug230
TCM136
Therapeutic biologic78
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

54 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

261 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Gao Miao Pharma Co., Ltd. romanized23190
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized1030
3Eli Lilly and Company820
4Jilin Dao Jun Pharma Co., Ltd. romanized770
5AstraZeneca AB740
6Pfizer Inc.740
7Novo Nordisk A/S710
8Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized640
9AbbVie Inc.620
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
2026/08/24Import · 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
2026/08/24Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2602101 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/08/24Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2602100 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/08/24Generic · Class 3 Folic Acid TabletsCYHS2602096 Beijing Heng Sheng Pharma Co., Ltd. romanized
2026/08/24Generic · Class 3 Raltitrexed for InjectionCYHS2602095 Sichuan Shuang Tong Medical Technology Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2026/08/24Generic · Class 3 Methocarbamol TabletsCYHS2602094 Le Sheng Pharma Shijiazhuang Co., Ltd. romanized
2026/08/24Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2602093 Liao Cheng Gao Xin Bio Technology Co., Ltd. romanized; Jin Cheng Hai Si Pharmaceutical Co., Ltd. romanized
2026/08/24Generic · Class 3 Dapagliflozin and Saxagliptin TabletsCYHL2600089 Hefei He Yuan Pharma Co., Ltd. romanized
2026/08/24New drug · Class 1.1 芪珀生脉颗粒 · No verified English nameCXZL2600080 Beijing Chun Feng Pharma Co., Ltd. romanized
2026/08/24New drug · Class 1 注射用ZL-1310 · No verified English nameCXSL2600904 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/08/24New drug · Class 1 GA002注射液 · No verified English nameCXSL2600903 Jian Da Jiu Zhou (Beijing) Bio Technology Co., Ltd. romanized
2026/08/24New drug · Class 2.2 奥妥珠单抗β注射液 · No verified English nameCXSL2600902 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2026/08/24New drug · Class 1 重组NV-A01腺病毒注射液 · No verified English nameCXSL2600901 Nanjing Nuo Wei Bio Technology Co., Ltd. romanized
2026/08/24New drug · Class 2.2 奥妥珠单抗β注射液 · No verified English nameCXSL2600900 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2026/08/24New drug · Class 2.4 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2600899 Suzhou Ruo Yi Bio Technology Co., Ltd. romanized
2026/08/24New drug · Class 1 RC148注射液 · No verified English nameCXSL2600898 Rong Chang Biopharmaceutical (Yan Tai) 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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