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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 411 drug applications between 22 November 2024 and 28 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 74 drug names.

2024/11/22 – 2024/11/28

Period
2024/11/22 to 2024/11/28, 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
411
Drugs with new generic filings (by drug name, de-duplicated)
74
Accepted this week, now under review
7

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

411filings, 103 of them generic

By application type

Application typeFilings
Supplement192
Generic103
New drug58
Import re-registration30
Import18
Unspecified10

By drug type

Drug typeFilings
Chemical drug263
TCM87
Therapeutic biologic52
Biologic5
Prophylactic biologic4

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

74 drugs with new generic filings; top 10 listed

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

233 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fresenius Kabi Deutschland GmbH1810
2Novo Nordisk A/S1010
3AstraZeneca AB950
4Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized880
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized830
6Guangdong Dong Yang Guang Pharma Co., Ltd. romanized610
7Guangxi He Feng Pharma Co., Ltd. romanized550
8Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized550
9Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized540
10Amgen Inc.530

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

104 this week

AcceptedDrugApplicants
2024/11/28Import · Class 1 DS-1062a · No verified English nameJXSL2400231 Daiichi Sankyo Inc.
2024/11/28Import · Class 3.1 Eflapegrastim注射液 · No verified English nameJXSL2400230 Hanmi Pharm. Co. Ltd.; PAREXEL CHINA CO. LTD
2024/11/28Import · Class 2.2 注射用戈沙妥珠单抗 · No verified English nameJXSL2400229 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2024/11/28Generic · Class 3 Ketoconazole CreamCYHS2404101 Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized
2024/11/28Generic · Class 3 Ketoconazole CreamCYHS2404100 Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized
2024/11/28Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2404084 Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2024/11/28Generic · Class 3 Vitamin K1 InjectionCYHS2404082 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2024/11/28New drug · Class 3.1 枇杷清肺颗粒 · No verified English nameCXZS2400036 Hebei Wan Sui Pharma Co., Ltd. romanized
2024/11/28New drug · Class 1 IM19嵌合抗原受体T细胞注射液(IM19 CAR-T细胞注射液) · No verified English nameCXSS2400131 Beijing Yi Miao Shen Zhou Biopharmaceuticals Co., Ltd. romanized; Beijing Yi Miao Medical Technology Co., Ltd. romanized
2024/11/28New drug · Class 2.2 夫那奇珠单抗注射液 · No verified English nameCXSL2400806 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/11/28New drug · Class 2.2 夫那奇珠单抗注射液 · No verified English nameCXSL2400805 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/11/28New drug · Class 1 CM313(SC)注射液 · No verified English nameCXSL2400804 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2024/11/28New drug · Class 1 GenSci120注射液 · No verified English nameCXSL2400803 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/11/28New drug · Class 1 CM313(SC)注射液 · No verified English nameCXSL2400802 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2024/11/28New drug · Class 1 INV-6452片 · No verified English nameCXHL2401293 Guangdong Sheng Innovation Yao Zhuan Hua Yi Xue Research Institute Co., Ltd. romanized; Shenzhen Shi Yuan Li Sheng Ming Ke Xue Co., Ltd. romanized; Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized; Shanghai Ju Yuan Bio Technology Co., Ltd. romanized
2024/11/28New drug · Class 1 INV-6452片 · No verified English nameCXHL2401292 Guangdong Sheng Innovation Yao Zhuan Hua Yi Xue Research Institute Co., Ltd. romanized; Shenzhen Shi Yuan Li Sheng Ming Ke Xue Co., Ltd. romanized; Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized; Shanghai Ju Yuan Bio Technology Co., Ltd. romanized
2024/11/28New drug · Class 2.2; 2.4 注射用JP-1366 · No verified English nameCXHL2401291 Li Zhu Pharmaceuticals Group Co., Ltd. romanized
2024/11/28New drug · Class 2.2 利拉鲁肽注射液 · No verified English nameCXHL2401290 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2024/11/28New drug · Class 2.1 AY-1001 · No verified English nameCXHL2401289 An Yu Bio Technology (Hangzhou) Co., Ltd. romanized
2024/11/28New drug · Class 2.1 AY-1001 · No verified English nameCXHL2401288 An Yu Bio Technology (Hangzhou) Co., Ltd. romanized
2024/11/28New drug · Class 2.1 AY-1001 · No verified English nameCXHL2401287 An Yu Bio Technology (Hangzhou) Co., Ltd. romanized
2024/11/28New drug · Class 2.1 AY-1001 · No verified English nameCXHL2401286 An Yu Bio Technology (Hangzhou) Co., Ltd. romanized
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

74 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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