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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 310 drug applications between 4 July 2023 and 10 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 52 drug names.

2023/07/04 – 2023/07/10

Period
2023/07/04 to 2023/07/10, 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
310
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
0

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

310filings, 66 of them generic

By application type

Application typeFilings
Supplement169
Generic66
New drug42
Import18
Unspecified9
Import re-registration4
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug231
TCM52
Therapeutic biologic24
Prophylactic biologic2
Biologic1

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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Gadoteric Acid Meglumine Salt Injection311
2阿普米司特片 · No verified English name313
3Dienogest Tablets222
4Sodium Hyaluronate Eye Drops2230
5Methocarbamol Injection223
6Tadalafil Tablets2123
7复方奥美拉唑干混悬剂 · No verified English name210
8头孢羟氨苄片 · No verified English name210
9Levofloxacin Tablets217
10Esomeprazole Magnesium Enteric-Coated Capsules214

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

183 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized19190
2Henan Shuang He Hua Li Pharma Co., Ltd. romanized1630
3Heilongjiang Can Ge Pharma Co., Ltd. romanized880
4AstraZeneca AB630
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
6Hua Ren Pharma Co., Ltd. romanized550
7AbbVie Inc.430
8Shandong Xin Shi Dai Pharma Co., Ltd. romanized423
9Anhui Yu Heng Bio Technology Co., Ltd. romanized410
10Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized330

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

77 this week

AcceptedDrugApplicants
2023/07/10Generic · Class 3 复方奥美拉唑干混悬剂 · No verified English nameCYHS2301849 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/07/10Generic · Class 3 复方奥美拉唑干混悬剂 · No verified English nameCYHS2301848 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/07/08Import · Class 3.1 艾加莫德α注射液(皮下注射) · No verified English nameJXSS2300054 argenx BV; Patheon Italia S.p.A.; Zai Lab (Shanghai) Co. Ltd.
2023/07/08Import · Class 1 MBG453 · No verified English nameJXSL2300126 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/07/08Generic · Class 3 Eptazocine Hydrobromide InjectionCYHS2301841 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2023/07/08Generic · Class 3 Nimodipine Oral SolutionCYHS2301838 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/07/08Generic · Class 3 Arformoterol Tartrate Inhalation SolutionCYHL2300082 Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/07/08New drug · Class 1 注射用SIBP-A13 · No verified English nameCXSL2300458 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/07/08New drug · Class 1 注射用HS-20105 · No verified English nameCXSL2300457 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2023/07/08New drug · Class 1 重组人nsIL12溶瘤腺病毒注射液 · No verified English nameCXSL2300456 Beijing Chui Te Bio Technology Co., Ltd. romanized
2023/07/08New drug · Class 1 重组抗IL-4Rα人源化单克隆抗体注射液 · No verified English nameCXSL2300455 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2023/07/08New drug · Class 1 LF0315片 · No verified English nameCXHL2300759 Wuxi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized
2023/07/08New drug · Class 1 LV232胶囊 · No verified English nameCXHL2300758 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Nan Tong He Feng Lian Wang Pharmaceuticals Technology Co., Ltd. romanized
2023/07/08New drug · Class 1 LV232胶囊 · No verified English nameCXHL2300757 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Nan Tong He Feng Lian Wang Pharmaceuticals Technology Co., Ltd. romanized
2023/07/08New drug · Class 1 BGB-30813片 · No verified English nameCXHL2300756 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/07/08New drug · Class 1 BGB-30813片 · No verified English nameCXHL2300755 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/07/08New drug · Class 1 BGB-30813片 · No verified English nameCXHL2300754 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/07/08New drug · Class 1 BGB-30813片 · No verified English nameCXHL2300753 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/07/08New drug · Class 1 HJ787软膏 · No verified English nameCXHL2300752 Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized
2023/07/08New drug · Class 1 HJ787软膏 · No verified English nameCXHL2300751 Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized
2023/07/08New drug · Class 2.2 LN006干混悬剂 · No verified English nameCXHL2300750 Shanghai Hui Yong Pharmaceutical Co., Ltd. romanized
2023/07/08New drug · Class 1 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2300749 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized; Zhuhai Ao Ke Da Technology Research Institute romanized
2023/07/08New drug · Class 1 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2300748 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized; Zhuhai Ao Ke Da Technology Research Institute romanized
2023/07/07Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2301835 Guangzhou Xin Ji Pharma Technology Co., Ltd. romanized; Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/07/07Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2301834 Guangzhou Xin Ji Pharma Technology Co., Ltd. romanized; Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/07/07Generic · Class 3 Timolol Maleate Eye DropsCYHS2301833 Hefei Li Fang Pharmaceutical Co., Ltd. romanized; Anhui Sheng Shuang Ke Pharma Co., Ltd. romanized
2023/07/07Generic · Class 3 头孢羟氨苄片 · No verified English nameCYHS2301830 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2023/07/07Generic · Class 3 头孢羟氨苄片 · No verified English nameCYHS2301829 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2023/07/07Generic · Class 3 Methocarbamol InjectionCYHS2301827 Hangzhou Duan Ben Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/07/07Generic · Class 3 Methocarbamol InjectionCYHS2301826 Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized

47 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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