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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 185 drug applications between 3 October 2026 and 9 October 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 34, covering 25 drug names.

2026/10/03 – 2026/10/09

Period
2026/10/03 to 2026/10/09, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
185
Drugs with new generic filings (by drug name, de-duplicated)
25
Accepted this week, now under review
168

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

185filings, 34 of them generic

By application type

Application typeFilings
Supplement97
New drug38
Generic34
Import7
Import re-registration6
Unspecified3

By drug type

Drug typeFilings
Chemical drug103
TCM55
Therapeutic biologic26
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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ixazomib Citrate Capsules317
2Dihydrocodeine Tartrate Sustained Realese Tablets313
3Brivaracetam Tablets2119
4Procaterol Hydrochloride Oral Solution2112
5Ondansetron Hydrochloride Tablets216
6盐酸沙瑞环素片 · No verified English name213
7苯磺酸左氨氯地平片 · No verified English name2145
8二硫化硒洗剂 · No verified English name1114
9Carbetocin Injection116
10Multiple Electrolytes Injection(Ⅱ)111

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

118 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Dong E E Jiao Co., Ltd. romanized11110
2Upjohn Manufacturing Ireland Unlimited Company610
3AstraZeneca AB420
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
5Yunnan Bai Yao Group Co., Ltd. romanized330
6Anhui Zhang Heng Chun Pharma Co., Ltd. romanized330
7Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized320
8Hangzhou Ai De Cheng Pharmaceuticals Technology Co., Ltd. romanized320
9Bayer AG310
10JING DU YANG SHENG TANG CHINESE HERBAL MANUFACTURING LIMITED310

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

57 this week

AcceptedDrugApplicants
2026/10/09Import · Class 1 Trontinemab注射液 · No verified English nameJXSL2600266 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/10/09Import · Class 2.3; 2.4 MRG-001注射液 · No verified English nameJXHL2600438 MEDREGEN LLC; Hangzhou Tigermed Consulting Co. Ltd.
2026/10/09Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2602462 Jiangsu Chang Jiang Pharma Co., Ltd. romanized
2026/10/09Generic · Class 3 Doxercalciferol InjectionCYHS2602460 Nanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanized
2026/10/09Generic · Class 3 Brivaracetam TabletsCYHS2602456 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2026/10/09Generic · Class 3 Brivaracetam TabletsCYHS2602455 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2026/10/09Generic · Class 3 Thioctic Acid TabletsCYHS2602451 Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2026/10/09Generic · Class 3 Dihydrocodeine Tartrate Sustained Realese TabletsCYHL2600109 Qinghai Pharmaceutical Co., Ltd. romanized
2026/10/09Generic · Class 3 Dihydrocodeine Tartrate Sustained Realese TabletsCYHL2600108 Qinghai Pharmaceutical Co., Ltd. romanized
2026/10/09Generic · Class 3 Dihydrocodeine Tartrate Sustained Realese TabletsCYHL2600107 Qinghai Pharmaceutical Co., Ltd. romanized
2026/10/09New drug · Class 2.2; 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 nameCXSL2601090 Suzhou Ruo Yi Bio Technology Co., Ltd. romanized
2026/10/09New drug · Class 1 注射用VRT106 · No verified English nameCXSL2601089 Guangzhou Wei Rong Te Pharmaceuticals Technology Co., Ltd. romanized
2026/10/09New drug · Class 1 ELPIS人脐带间充质干细胞注射液 · No verified English nameCXSL2601088 Beijing Shun Xin Xiang Yu Bio Technology Co., Ltd. romanized
2026/10/09New drug · Class 1 DMR2301注射液 · No verified English nameCXSL2601087 Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized
2026/10/09New drug · Class 1 DY-01乳杆菌活菌胶囊 · No verified English nameCXSL2601085 Shenzhen Shi Dun Yan Wei Bio Technology Co., Ltd. romanized; Nan Tong Shi Wei Shu Bio Technology Co., Ltd. romanized
2026/10/09New drug · Class 1 GenSci161注射液 · No verified English nameCXSL2601084 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/10/09New drug · Class 2.2 艾拉莫德缓释片 · No verified English nameCXHL2601244 Tai Zhou Yue Yang Pharmaceuticals Kai Fa Co., Ltd. romanized
2026/10/09New drug · Class 1 HRS-5041片 · No verified English nameCXHL2601243 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/10/09New drug · Class 1 HRS-5041片 · No verified English nameCXHL2601242 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/10/09New drug · Class 1 HS-10502片 · No verified English nameCXHL2601241 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/10/09New drug · Class 1 HS-10502片 · No verified English nameCXHL2601240 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/10/09New drug · Class 1 注射用DMR3608 · No verified English nameCXHL2601239 Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized
2026/10/09New drug · Class 1 注射用DMR3608 · No verified English nameCXHL2601238 Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized
2026/10/09New drug · Class 1 ATH-097胶囊 · No verified English nameCXHL2601237 Shanghai Ai Si Long Pharmaceuticals Technology Co., Ltd. romanized
2026/10/09New drug · Class 1 ATH-097胶囊 · No verified English nameCXHL2601236 Shanghai Ai Si Long Pharmaceuticals Technology Co., Ltd. romanized
2026/10/09New drug · Class 1 马来酸阿比替尼胶囊 · No verified English nameCXHL2601235 Zhejiang Ai Sen Pharma Co., Ltd. romanized
2026/10/09New drug · Class 1 TQH3906胶囊 · No verified English nameCXHL2601234 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/10/09New drug · Class 1 TQH3906胶囊 · No verified English nameCXHL2601233 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/10/09New drug · Class 1 UBT251注射液 · No verified English nameCXHL2601232 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2026/10/09New drug · Class 1 UBT251注射液 · No verified English nameCXHL2601231 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized

27 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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