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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 342 drug applications between 26 October 2026 and 1 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 40 drug names.

2026/10/26 – 2026/11/01

Period
2026/10/26 to 2026/11/01, 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
342
Drugs with new generic filings (by drug name, de-duplicated)
40
Accepted this week, now under review
340

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

342filings, 60 of them generic

By application type

Application typeFilings
Supplement189
Generic60
New drug47
Import35
Import re-registration10
Unspecified1

By drug type

Drug typeFilings
Chemical drug171
TCM97
Therapeutic biologic68
Prophylactic biologic5
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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets4227
2氧 · No verified English name3315
3Vortioxetine Hydrobromide Tablets3110
4Oseltamivir Phosphate Capsules3139
5Polidocanol Injection3123
6Suvorexant Tablets313
7氟比洛芬凝胶贴膏 · No verified English name2216
8Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
9复方氨基酸注射液(17AA-SF) · No verified English name214
10复方电解质维持液 · No verified English name212

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

207 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company910
2Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized730
3Fresenius Kabi AB720
4Sichuan Qi Li Pharmaceutical Co., Ltd. romanized650
5MUNDIPHARMA GmbH610
6Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized610
7AstraZeneca AB530
8Merck Europe B.V.530
9Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized510
10Bard Pharmaceuticals Limited440

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

Entered review this week
346
Left the under-review list this week
376

Of these, NMPA published approval-document delivery for 100 (including 95 supplemental applications, not counted as new marketing approvals) and notification delivery for 3; the outcome of the other 273 is to be checked.

Most filings leaving review, by company

Most filings leaving review, by company
#Company (first applicant)FilingsDrugs
1Shanghai Min Wei Bio Technology Co., Ltd. romanized141
2Novo Nordisk A/S93
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized93
4AstraZeneca AB83
5Xin Da Bio Technology Co., Ltd. romanized81
6Eli Lilly Nederland B.V.61
7Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized55
8Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized52
9Shandong Lv Ye Pharmaceutical Co., Ltd. romanized52
10Jiangsu Hao Sen Pharma Group Co., Ltd. romanized52

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Eli Lilly and Company91
2Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized73
3Fresenius Kabi AB72
4Sichuan Qi Li Pharmaceutical Co., Ltd. romanized65
5MUNDIPHARMA GmbH61
6Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized61
7AstraZeneca AB53
8Merck Europe B.V.53
9Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized51
10Bard Pharmaceuticals Limited44

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

90 this week

AcceptedDrugApplicants
2026/10/30Import · Class 2.2 特泽利尤单抗注射液 · No verified English nameJXSS2600101 AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd.
2026/10/30Import · Class 2.2 特泽利尤单抗注射液 · No verified English nameJXSS2600100 AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd.
2026/10/30Import · Class 1 LY4086940片 · No verified English nameJXHL2600479 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片 · No verified English nameJXHL2600478 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片 · No verified English nameJXHL2600477 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片 · No verified English nameJXHL2600476 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片 · No verified English nameJXHL2600475 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片 · No verified English nameJXHL2600474 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片 · No verified English nameJXHL2600473 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片 · No verified English nameJXHL2600472 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片 · No verified English nameJXHL2600471 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2602662 Da Lian Bai Li Tian Hua Pharmaceutical Co., Ltd. romanized; Henan Hua Luo Kang Run Pharma Co., Ltd. romanized
2026/10/30Generic · Class 3 复方氨基酸注射液(17AA-SF) · No verified English nameCYHS2602661 Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized
2026/10/30Generic · Class 3 复方氨基酸注射液(17AA-SF) · No verified English nameCYHS2602660 Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized
2026/10/30Generic · Class 3 Pirfenidone TabletsCYHS2602658 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2026/10/30New drug · Class 3.1 三痹汤颗粒 · No verified English nameCXZS2600059 Guangxi Zhong Pharmaceuticals University Bai Nian Le Pharmaceutical Co., Ltd. romanized
2026/10/30New drug · Class 3.1 蠲痹汤颗粒 · No verified English nameCXZS2600058 Guangxi Zhong Pharmaceuticals University Bai Nian Le Pharmaceutical Co., Ltd. romanized
2026/10/30New drug · Class 1 注射用MHB039A · No verified English nameCXSL2601191 Ming Hui Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/10/30New drug · Class 1 注射用MHB046C · No verified English nameCXSL2601190 Ming Hui Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/10/30New drug · Class 1 HRS-4642注射液 · No verified English nameCXHL2601331 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/10/29Import · Class 2.4 Seladelpar胶囊 · No verified English nameJXHL2600470 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/10/29Import · Class 1 Cilofexor片 · No verified English nameJXHL2600469 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/10/29Import · Class 1 Cilofexor片 · No verified English nameJXHL2600468 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/10/29Import · Class 1 Casdatifan 片 · No verified English nameJXHL2600467 Arcus Biosciences Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2026/10/29Import · Class 1 Casdatifan 片 · No verified English nameJXHL2600466 Arcus Biosciences Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2026/10/29Generic · Class 3 硫酸锌注射液 · No verified English nameCYHS2602647 Shandong Qidu Pharmaceutical Co., Ltd.
2026/10/29Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2602641 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2026/10/29New drug · Class 2.2; 2.3 小儿清热消炎宁颗粒 · No verified English nameCXZS2600057 Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized
2026/10/29New drug · Class 3.3 度拉糖肽注射液 · No verified English nameCXSS2600176 Le Pu Pharma Co., Ltd. romanized; Le Pu (Beijing) Bio Technology Co., Ltd. romanized
2026/10/29New drug · Class 3.3 度拉糖肽注射液 · No verified English nameCXSS2600175 Le Pu Pharma Co., Ltd. romanized; Le Pu (Beijing) Bio Technology Co., Ltd. romanized

60 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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