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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 408 drug applications between 24 November 2024 and 30 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 67 drug names.

2024/11/24 – 2024/11/30

Period
2024/11/24 to 2024/11/30, 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
408
Drugs with new generic filings (by drug name, de-duplicated)
67
Accepted this week, now under review
9

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

408filings, 92 of them generic

By application type

Application typeFilings
Supplement207
Generic92
New drug54
Import re-registration27
Import18
Unspecified10

By drug type

Drug typeFilings
Chemical drug279
TCM82
Therapeutic biologic40
Biologic5
Prophylactic biologic2

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

67 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

229 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fresenius Kabi Deutschland GmbH1810
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized1440
3Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized990
4AstraZeneca AB740
5The Wellcome Foundation Limited720
6Hunan Dong Ting Pharma Co., Ltd. romanized640
7Guangdong Dong Yang Guang Pharma Co., Ltd. romanized610
8Guangxi He Feng Pharma Co., Ltd. romanized550
9Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized540
10Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized530

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

94 this week

AcceptedDrugApplicants
2024/11/30Import · Class 1 镥[177Lu]Lu-NeoB注射液 · No verified English nameJXHL2400281 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/11/30Import · Class 1 用于制备放射性药物[68Ga]Ga-NeoB注射液的药盒 · No verified English nameJXHL2400280 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/11/30Import · Class 1 注射用JX10 · No verified English nameJXHL2400279 Corxel Pharmaceuticals Inc.; Corxel Pharmaceuticals (Shanghai) Co. Ltd
2024/11/30Generic · Class 3 Hydrotalcite SuspensionCYHS2404126 Hefei Yuan Zhi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2024/11/30Generic · Class 3 Memantine Hydrochloride OD TabletsCYHS2404125 Chongqing Ben Li Fang Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2024/11/30Generic · Class 3 Lanthanum Carbonate Hydrate GranulesCYHS2404124 HAINAN HUALON PHARMACEUTICAL CO.,LTD
2024/11/30Generic · Class 3 Enalapril Maleate Oral SolutionCYHS2404123 Beijing Hai Yi Pharma Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2024/11/30Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2404122 Guangdong Nan Guo Pharma Co., Ltd. romanized
2024/11/30Generic · Class 3 Paracetamol GranulesCYHS2404121 Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized
2024/11/30Generic · Class 3 吲哚美辛凝胶贴膏 · No verified English nameCYHL2400238 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2024/11/30Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400237 Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized
2024/11/30New drug · Class 1 LYN101注射液 · No verified English nameCXSL2400810 Shanghai Cai Zhi Yao Cheng Bio Technology Co., Ltd. romanized
2024/11/30New drug · Class 1 NKC007细胞注射液 · No verified English nameCXSL2400809 Guangzhou En Kai Sai Bio Technology Co., Ltd. romanized
2024/11/30New drug · Class 1 KYS202002A注射液 · No verified English nameCXSL2400808 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2024/11/30New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2401304 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/30New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2401303 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/30New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2401302 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/30New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2401301 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/30New drug · Class 1 HS-10502片 · No verified English nameCXHL2401300 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/11/30New drug · Class 1 HS-10502片 · No verified English nameCXHL2401299 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/11/30New drug · Class 2.4 泽布替尼胶囊 · No verified English nameCXHL2401298 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/30New drug · Class 2.4 泽布替尼胶囊 · No verified English nameCXHL2401297 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/30New drug · Class 1 F1F3软膏 · No verified English nameCXHL2401296 Zhong Ao Biopharmaceuticals Technology (Guangdong) Co., Ltd. romanized
2024/11/30New drug · Class 1 F1F3软膏 · No verified English nameCXHL2401295 Zhong Ao Biopharmaceuticals Technology (Guangdong) Co., Ltd. romanized
2024/11/30New drug · Class 2.4 天麻素注射液 · No verified English nameCXHL2401294 Kun Yao Group Co., Ltd. romanized; Kun Yao Group (Zhuhai Heng Qin) Technology Co., Ltd. romanized
2024/11/29Import · Class 2.4 DS-3201b片 · No verified English nameJXHL2400278 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/11/29Import · Class 2.4 DS-3201b片 · No verified English nameJXHL2400277 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/11/29Import · Class 2.4 DS-3201b片 · No verified English nameJXHL2400276 Daiichi Sankyo Inc; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/11/29Import · Class 1 BAY 2927088片 · No verified English nameJXHL2400275 Bayer AG; Bayer Healthcare Company Ltd.
2024/11/29Import · Class 1 BAY 2927088片 · No verified English nameJXHL2400274 Bayer AG; Bayer Healthcare Company Ltd.

64 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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