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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 59 drug applications between 2 October 2026 and 8 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 12, covering 10 drug names.

2026/10/02 – 2026/10/08

Period
2026/10/02 to 2026/10/08, 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
59
Drugs with new generic filings (by drug name, de-duplicated)
10
Accepted this week, now under review
54

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

59filings, 12 of them generic

By application type

Application typeFilings
Supplement30
Generic12
New drug12
Import5

By drug type

Drug typeFilings
Chemical drug27
TCM20
Therapeutic biologic12

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

10 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Procaterol Hydrochloride Oral Solution2112
2Ondansetron Hydrochloride Tablets216
3二硫化硒洗剂 · No verified English name1114
4Multiple Electrolytes Injection(Ⅱ)111
5复方聚乙二醇电解质散(III) · No verified English name113
6左氧氟沙星滴耳液 · No verified English name114
7Budesonide Nasal Spray113
8Rosuvastatin Calcium and Ezetimibe Tablets (I)119
9Benidipine Hydrochloride Tablets114
10Glucosamine Sulfate Capsules1151

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

41 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB420
2Dong E E Jiao Co., Ltd. romanized330
3Anhui Zhang Heng Chun Pharma Co., Ltd. romanized330
4Shandong Lv Ye Pharmaceutical Co., Ltd. romanized310
5Sichuan Di Fei Te Pharma Co., Ltd. romanized220
6Qinghai Bao Jian Tang Guo Yao Co., Ltd. romanized220
7Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized210
8Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized212
9Guangdong Nan Guo Pharma Co., Ltd. romanized212
10Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized210

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

21 this week

AcceptedDrugApplicants
2026/10/08Import · Class 1 BLVD101 · No verified English nameJXSL2600265 Boulevard Bio Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2026/10/08Import · Class 2.2 阿伏利尤单抗注射液 · No verified English nameJXSL2600264 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2026/10/08Import · Class 2.2 阿伏利尤单抗注射液 · No verified English nameJXSL2600263 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2026/10/08Import · Class 1 Laroprovstat瑞舒伐他汀片 · No verified English nameJXHL2600437 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/08Import · Class 1 Laroprovstat瑞舒伐他汀片 · No verified English nameJXHL2600436 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/08Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2602450 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized
2026/10/08Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2602449 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized
2026/10/08Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2602442 Hubei Fu Rui Long Pharma Co., Ltd. romanized; Shandong Nuo He Kang Pharma Co., Ltd. romanized
2026/10/08Generic · Class 3 左氧氟沙星滴耳液 · No verified English nameCYHL2600106 Guangzhou Shi Tong Hui Pharma Co., Ltd. romanized
2026/10/08New drug · Class 1.1 仙连解毒颗粒 · No verified English nameCXZL2600096 Nanjing Zhong Pharmaceuticals University romanized; China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Name not romanized; Shenzhen Shi Zhong Yao Zhi Zao Ye Innovation Center Co., Ltd. romanized
2026/10/08New drug · Class 3.4 聚乙二醇化人粒细胞刺激因子注射液 · No verified English nameCXSS2600161 Ke Xing Biopharmaceutical Co., Ltd. romanized
2026/10/08New drug · Class 1 注射用Sonesitatug Vedotin · No verified English nameCXSS2600160 A Si Li Kang Pharmaceutical Co., Ltd. romanized; Name not romanized; Changzhou He Quan Pharma Co., Ltd. (Zhu She Yong Sonesitatug Vedotin Drug - Lian Jie Zi Vedotin Shou Tuo Manufacturing) romanized
2026/10/08New drug · Class 2.2 司普奇拜单抗注射液 · No verified English nameCXSS2600159 Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2026/10/08New drug · Class 2.2 司普奇拜单抗注射液 · No verified English nameCXSS2600158 Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2026/10/08New drug · Class 1 LY3985297注射液 · No verified English nameCXSL2601083 Li Lai (Zhongguo) Research and Development Co., Ltd. romanized
2026/10/08New drug · Class 1 CBG002 CAR-T细胞注射液 · No verified English nameCXSL2601082 Zhejiang Kang Bai Yu Bio Technology Co., Ltd. romanized
2026/10/08New drug · Class 1 SYS6070注射液 · No verified English nameCXSL2601081 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/10/08New drug · Class 2.2 吡仑帕奈口溶膜 · No verified English nameCXHL2601224 Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2026/10/08New drug · Class 2.2 吡仑帕奈口溶膜 · No verified English nameCXHL2601223 Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2026/10/08New drug · Class 1 注射用BG136 · No verified English nameCXHL2601222 Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized; Zhongguo Hai Yang University romanized; Qingdao Hai Yang Biopharmaceuticals Research Institute romanized
2026/10/08New drug · Class 1 注射用BG136 · No verified English nameCXHL2601221 Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized; Zhongguo Hai Yang University romanized; Qingdao Hai Yang Biopharmaceuticals Research Institute romanized

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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