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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 427 drug applications between 4 September 2025 and 10 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 80 drug names.

2025/09/04 – 2025/09/10

Period
2025/09/04 to 2025/09/10, 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
427
Drugs with new generic filings (by drug name, de-duplicated)
80
Accepted this week, now under review
122

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

427filings, 119 of them generic

By application type

Application typeFilings
Supplement185
Generic119
New drug74
Import37
Unspecified8
Import re-registration4

By drug type

Drug typeFilings
Chemical drug271
TCM81
Therapeutic biologic70
Biologic4
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

80 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
1Eli Lilly and Company1330
2Qilu Pharmaceutical Co., Ltd.1052
3Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized970
4Topfond Pharmaceutical Co., Ltd.770
5Pfizer Inc.730
6Janssen Research & Development LLC710
7AstraZeneca AB630
8Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized610
9Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized440
10Shanghai Ao Ke Da Pharmaceuticals Technology Co., Ltd. romanized410

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

150 this week

AcceptedDrugApplicants
2025/09/10Import · Class 1 Empasiprubart注射用浓溶液 · No verified English nameJXSL2500173 argenx BV; PPD Pharmaceutical Development(Beijing)Co.,Ltd.
2025/09/10Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHL2500275 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/10Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHL2500274 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/10Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHL2500273 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/10Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHL2500272 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/10Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHL2500271 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/10Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHL2500270 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/10Import · Class 1 PF-07799933片 · No verified English nameJXHL2500269 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/10Import · Class 1 PF-07799933片 · No verified English nameJXHL2500268 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/10Import · Class 1 PF-07799544片 · No verified English nameJXHL2500267 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/10Import · Class 1 PF-07799544片 · No verified English nameJXHL2500266 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/10Import · Class 1 PF-07799544片 · No verified English nameJXHL2500265 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/10Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2503357 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2025/09/10Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2503355 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized
2025/09/10Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2503354 Tianjin Bio Chemical Pharmaceutical Co., Ltd. romanized
2025/09/10Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2503352 Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2025/09/10Generic · Class 3 Dexamethasone Sodium Phosphate InjectionCYHS2503343 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/09/10Generic · Class 3 Dexamethasone Sodium Phosphate InjectionCYHS2503342 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/09/10New drug · Class 3.1 开心散 · No verified English nameCXZS2500037 Guo Yao Group Zhong Lian Pharma Co., Ltd. romanized
2025/09/10New drug · Class 1 注射用HMPL-A251 · No verified English nameCXSL2500784 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/09/10New drug · Class 1 FS-8002注射液 · No verified English nameCXSL2500783 Shanghai Pu Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/09/10New drug · Class 1 AWT020注射用无菌粉末 · No verified English nameCXSL2500782 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2025/09/10New drug · Class 2.1 SHR-A1811(sc)注射液 · No verified English nameCXSL2500781 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/09/10New drug · Class 1 注射用JS212 · No verified English nameCXSL2500780 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2025/09/10New drug · Class 1 注射用GEN1184 · No verified English nameCXSL2500779 Jin Mai An Bo Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/09/10New drug · Class 1 宫血间充质干细胞注射液 · No verified English nameCXSL2500778 Zhejiang Sheng Chuang Jing Zhun Medical Technology Co., Ltd. romanized
2025/09/10New drug · Class 1 AP-L1898胶囊 · No verified English nameCXHL2500988 Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2025/09/10New drug · Class 2.4 多黏菌素E甲磺酸钠吸入粉雾剂 · No verified English nameCXHL2500987 Jilin Tian Heng Pharma Co., Ltd. romanized
2025/09/10New drug · Class 1 JK0002乳膏 · No verified English nameCXHL2500986 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized
2025/09/10New drug · Class 1 JK0002乳膏 · No verified English nameCXHL2500985 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized

120 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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