YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 412 drug applications between 21 November 2024 and 27 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 83 drug names.

2024/11/21 – 2024/11/27

Period
2024/11/21 to 2024/11/27, 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
412
Drugs with new generic filings (by drug name, de-duplicated)
83
Accepted this week, now under review
4

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

412filings, 109 of them generic

By application type

Application typeFilings
Supplement182
Generic109
New drug61
Import re-registration30
Import16
Unspecified14

By drug type

Drug typeFilings
Chemical drug279
TCM77
Therapeutic biologic46
Biologic5
Prophylactic biologic5

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

83 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Mivacurium Chloride Injection423
2Azilsartan Medoxomil Potassium Tablets4235
3氧 · No verified English name3315
4Sildenafil Citrate Oral Disintegrating Tablets228
5Oxybuprocaine Hydrochloride Eye Drops2210
6Glucosamine Sulfate Capsules2251
7Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution228
8Adapalene Gel2230
9双氯芬酸钠贴剂 · No verified English name210
10Bumetanide Injection2113

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

230 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fresenius Kabi Deutschland GmbH1810
2Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized1360
3Novo Nordisk A/S1010
4AstraZeneca AB730
5Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized660
6Heilongjiang Sheng Fu Le Kang Pharma Co., Ltd. romanized650
7Guangdong Dong Yang Guang Pharma Co., Ltd. romanized610
8Guangxi He Feng Pharma Co., Ltd. romanized550
9Yangtze River Pharmaceutical Group Co., Ltd550
10Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized550

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

113 this week

AcceptedDrugApplicants
2024/11/27Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSS2400104 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2024/11/27Import · Class 1 Riliprubart注射液 · No verified English nameJXSL2400228 Sanofi-aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2024/11/27Generic · Class 3 Morphine Sulfate and Naltrexone Hydrochloride Extended-release CapsulesCYHS2404077 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2024/11/27Generic · Class 3 Morphine Sulfate and Naltrexone Hydrochloride Extended-release CapsulesCYHS2404075 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2024/11/27Generic · Class 3 美洛昔康纳米晶注射液 · No verified English nameCYHS2404070 Health Yuan Pharma Group Co., Ltd. romanized; Health Yuan Hai Bin Pharma Co., Ltd. romanized
2024/11/27New drug · Class 1.1 星蒌承气颗粒 · No verified English nameCXZL2400080 Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized
2024/11/27New drug · Class 1 SCT650C 注射液 · No verified English nameCXSL2400801 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/11/27New drug · Class 2.4 甲磺酸阿美替尼片 · No verified English nameCXHS2400127 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2024/11/27New drug · Class 2.4 Chidamide TabletsCXHL2401285 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2024/11/27New drug · Class 1 TYK-00540片 · No verified English nameCXHL2401284 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2024/11/27New drug · Class 1 TYK-00540片 · No verified English nameCXHL2401283 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
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

83 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.