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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 370 drug applications between 20 November 2024 and 26 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 107, covering 84 drug names.

2024/11/20 – 2024/11/26

Period
2024/11/20 to 2024/11/26, 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
370
Drugs with new generic filings (by drug name, de-duplicated)
84
Accepted this week, now under review
5

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

370filings, 107 of them generic

By application type

Application typeFilings
Supplement155
Generic107
New drug58
Import re-registration25
Import15
Unspecified10

By drug type

Drug typeFilings
Chemical drug269
TCM57
Therapeutic biologic38
Prophylactic biologic6

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

84 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Mivacurium Chloride Injection423
2Adapalene Gel3330
3Sodium Valproate Sustained-release Tablets(I)224
4Glucosamine Sulfate Capsules2251
5Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution228
6双氯芬酸钠贴剂 · No verified English name210
7Vonoprazan Fumarate Tablets2160
8Bumetanide Injection2113
9Lamotrigine Tablets210
10注射用阿立哌唑 · No verified English name214

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

218 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized1360
2Fresenius Kabi Deutschland GmbH1210
3AstraZeneca AB730
4Heilongjiang Sheng Fu Le Kang Pharma Co., Ltd. romanized650
5Guangdong Dong Yang Guang Pharma Co., Ltd. romanized610
6Guangxi He Feng Pharma Co., Ltd. romanized550
7Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized550
8Hunan Dong Ting Pharma Co., Ltd. romanized530
9Boehringer Ingelheim International GmbH510
10Novo Nordisk A/S510

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

111 this week

AcceptedDrugApplicants
2024/11/26Import · Class 1 盐酸阿曲生坦片 · No verified English nameJXHS2400103 Novartis Pharma Schweiz AG; AbbVie Ireland NL B.V.
2024/11/26Import · Class 1 Fosmanogepix注射液 · No verified English nameJXHL2400273 Basilea Pharmaceutica International Ltd Allschwil; PAREXEL CHINA CO. LTD
2024/11/26Import · Class 1 Fosmanogepix片 · No verified English nameJXHL2400272 Basilea Pharmaceutica International Ltd Allschwil; PAREXEL CHINA CO. LTD
2024/11/26Import · Class 1 Fosmanogepix片 · No verified English nameJXHL2400271 Basilea Pharmaceutica International Ltd Allschwil; PAREXEL CHINA CO. LTD
2024/11/26Generic · Class 3 Pamidronate Disodium InjectionCYHS2404061 Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2024/11/26Generic · Class 3 Minoxidil LinimentCYHS2404057 Hefei Yuan Zhi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized
2024/11/26Generic · Class 3 Benazepril Hydrochloride and Hydrochlorothiazide TabletsCYHS2404056 Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2024/11/26Generic · Class 3 Bumetanide InjectionCYHS2404055 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2024/11/26Generic · Class 3 Bumetanide InjectionCYHS2404054 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2024/11/26New drug · Class 3.3 乌司奴单抗注射液 · No verified English nameCXSS2400130 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/11/26New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSL2400800 Zhengzhou Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized
2024/11/26New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSL2400799 Zhengzhou Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized
2024/11/26New drug · Class 2.4 注射用BAT1006 · No verified English nameCXSL2400798 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/11/26New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2400126 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2024/11/26New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2400125 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2024/11/26New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2400124 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2024/11/26New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2400123 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2024/11/26New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2400122 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2024/11/26New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2400121 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2024/11/26New drug · Class 1 HPB-143片 · No verified English nameCXHL2401282 Hangzhou Duo Yu Bio Technology Co., Ltd. romanized
2024/11/26New drug · Class 1 HPB-143片 · No verified English nameCXHL2401281 Hangzhou Duo Yu Bio Technology Co., Ltd. romanized
2024/11/25Generic · Class 3 Levofloxacin InjectionCYHS2404048 Jiangsu Chang Jiang Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/11/25Generic · Class 3 Thioctic Acid TabletsCYHS2404041 Beijing SL Pharmaceutical Co., Ltd.
2024/11/25New drug · Class 3.1 桃红四物颗粒 · No verified English nameCXZS2400035 Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized
2024/11/25New drug · Class 1.4 吸附无细胞百(三组分)白破b型流感嗜血杆菌(结合)-ACYW135群脑膜炎球菌(结合)联合疫苗 · No verified English nameCXSL2400797 Kang Xi Nuo Bio Shareholding Company romanized
2024/11/25New drug · Class 2.2 ZL2301 · No verified English nameCXHL2401280 Guangdong Zhong Li Pharmaceuticals Technology Co., Ltd. romanized
2024/11/25New drug · Class 1 XH-S004片 · No verified English nameCXHL2401279 Zhejiang Xing Hao Peng Bo Pharmaceuticals Co., Ltd. romanized
2024/11/25New drug · Class 1 XH-S004片 · No verified English nameCXHL2401278 Zhejiang Xing Hao Peng Bo Pharmaceuticals Co., Ltd. romanized
2024/11/25New drug · Class 2.1 GW901肠溶软胶囊 · No verified English nameCXHL2401277 Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized
2024/11/23Import · Class 2.2 罗莫索珠单抗注射液 · No verified English nameJXSL2400227 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.

81 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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