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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 298 drug applications between 5 July 2023 and 11 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 49 drug names.

2023/07/05 – 2023/07/11

Period
2023/07/05 to 2023/07/11, 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
298
Drugs with new generic filings (by drug name, de-duplicated)
49
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

298filings, 67 of them generic

By application type

Application typeFilings
Supplement149
Generic67
New drug47
Import13
Unspecified12
Import re-registration9
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug238
TCM29
Therapeutic biologic26
Prophylactic biologic4
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

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Oral Solution3211
2Gadoteric Acid Meglumine Salt Injection311
3阿普米司特片 · No verified English name313
4Dienogest Tablets222
5Sodium Hyaluronate Eye Drops2230
6Oseltamivir Phosphate For Oral Suspension222
7Methocarbamol Injection223
8Tadalafil Tablets2123
9Carbazochrome Sodium Sulfonate Injection211
10复方奥美拉唑干混悬剂 · No verified English name210

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

185 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Shuang He Hua Li Pharma Co., Ltd. romanized1740
2Hainan Brilliant Pharmaceutical Co., Ltd.1530
3AstraZeneca AB740
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
5Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized434
6United States Pharmacopeial Convention330
7Yi Chang Ren Fu Pharma Co., Ltd. romanized333
8Fujian Sheng Quan Zhou Ya Tai Pharmaceutical Co., Ltd. romanized330
9Aerovate Therapeutics Inc.310
10Pfizer Inc.310

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

85 this week

AcceptedDrugApplicants
2023/07/11Import · Class 3.1 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300056 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2023/07/11Import · Class 3.1 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300055 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2023/07/11Import · Class 2.2 Tezepelumab注射液 · No verified English nameJXSL2300127 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2023/07/11Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2301865 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/07/11Generic · Class 3 Potassium Phosphates InjectionCYHS2301864 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/07/11Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2301863 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Lang Ou Pharma Co., Ltd. romanized
2023/07/11Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2301862 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Lang Ou Pharma Co., Ltd. romanized
2023/07/11Generic · Class 3 Potassium Chloride Oral SolutionCYHS2301861 Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized
2023/07/11Generic · Class 3 Potassium Chloride Oral SolutionCYHS2301860 Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized
2023/07/11Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2301853 Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2023/07/11Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2301852 Hebei Long Hai Pharma Co., Ltd. romanized
2023/07/11Generic · Class 3 Potassium Chloride Oral SolutionCYHS2301850 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2023/07/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2300051 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2023/07/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2300050 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2023/07/11New drug · Class 1 注射用SHR-5495 · No verified English nameCXSL2300462 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/07/11New drug · Class 1 SCM-181注射液 · No verified English nameCXSL2300461 Yunnan Shun Xi Zai Sheng Yi Xue Gong Cheng Co., Ltd. romanized
2023/07/11New drug · Class 1 DXC006 · No verified English nameCXSL2300460 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2023/07/11New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2300459 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/07/11New drug · Class 1 ABSK-011胶囊 · No verified English nameCXHL2300763 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2023/07/11New drug · Class 1 ABSK-011胶囊 · No verified English nameCXHL2300762 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2023/07/11New drug · Class 1 NTQ1062片 · No verified English nameCXHL2300761 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2023/07/11New drug · Class 1 NTQ1062片 · No verified English nameCXHL2300760 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
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

55 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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