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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 344 drug applications between 6 July 2023 and 12 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 53 drug names.

2023/07/06 – 2023/07/12

Period
2023/07/06 to 2023/07/12, 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
344
Drugs with new generic filings (by drug name, de-duplicated)
53
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

344filings, 73 of them generic

By application type

Application typeFilings
Supplement181
Generic73
New drug56
Import17
Import re-registration9
Unspecified8

By drug type

Drug typeFilings
Chemical drug269
Therapeutic biologic35
TCM32
Prophylactic biologic8

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

53 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
5Oseltamivir Phosphate For Oral Suspension222
6Methocarbamol Injection223
7Tadalafil Tablets2123
8Carbazochrome Sodium Sulfonate Injection211
9复方奥美拉唑干混悬剂 · No verified English name210
10头孢羟氨苄片 · 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

200 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
5Upjohn Manufacturing Ireland Unlimited Company610
6An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized440
7Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized434
8Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized422
9United States Pharmacopeial Convention330
10Shanghai Xin Yi Jin Zhu 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

102 this week

AcceptedDrugApplicants
2023/07/12Import · Class 2.4 盐酸替纳帕诺片 · No verified English nameJXHS2300064 Ardelyx Inc.; Patheon Pharmaceuticals Inc.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited
2023/07/12Import · Class 2.4 盐酸替纳帕诺片 · No verified English nameJXHS2300063 Ardelyx Inc.; Patheon Pharmaceuticals Inc.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited
2023/07/12Import · Class 2.4 盐酸替纳帕诺片 · No verified English nameJXHS2300062 Ardelyx Inc.; Patheon Pharmaceuticals Inc.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited
2023/07/12Generic · Class 3 Bumetanide InjectionCYHS2301876 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/07/12Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2301873 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2023/07/12Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2301871 Yangtze River Pharmaceutical Group Co., Ltd
2023/07/12Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2301870 Yangtze River Pharmaceutical Group Co., Ltd
2023/07/12Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2301869 Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized
2023/07/12Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2301868 Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized
2023/07/12Generic · Class 3 艾拉戈利钠片 · No verified English nameCYHL2300084 Li Zhu Group Li Zhu Pharmaceutical Factory romanized
2023/07/12Generic · Class 3 艾拉戈利钠片 · No verified English nameCYHL2300083 Li Zhu Group Li Zhu Pharmaceutical Factory romanized
2023/07/12New drug · Class 1 B1344 注射液 · No verified English nameCXSL2300469 Tian Shi Li Biopharmaceuticals Co., Ltd. romanized
2023/07/12New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2300466 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/07/12New drug · Class 1.1 四价重组诺如病毒疫苗(汉逊酵母) · No verified English nameCXSL2300465 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized
2023/07/12New drug · Class 1.1 四价重组诺如病毒疫苗(汉逊酵母) · No verified English nameCXSL2300464 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized
2023/07/12New drug · Class 1 ZG005粉针剂 · No verified English nameCXSL2300463 Name not romanized
2023/07/12New drug · Class 1 G201-Na胶囊 · No verified English nameCXHL2300771 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2023/07/12New drug · Class 1 G201-Na胶囊 · No verified English nameCXHL2300770 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2023/07/12New drug · Class 1 ZG-001胶囊 · No verified English nameCXHL2300769 Shanghai Zhi Gen Pharmaceuticals Technology Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD; Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized
2023/07/12New drug · Class 1 ZG-001胶囊 · No verified English nameCXHL2300768 Shanghai Zhi Gen Pharmaceuticals Technology Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD; Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized
2023/07/12New drug · Class 1 锝[99mTc]异腈氨基葡萄糖注射液 · No verified English nameCXHL2300767 Beijing Shi Hong Pharma Co., Ltd. romanized
2023/07/12New drug · Class 1 WXFL10203614片 · No verified English nameCXHL2300766 Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized
2023/07/12New drug · Class 1 WXFL10203614片 · No verified English nameCXHL2300765 Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized
2023/07/12New drug · Class 1 注射用YZD-27 · No verified English nameCXHL2300764 Xian Qin Shen Jia He Drug Research Co., Ltd. romanized
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

72 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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