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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 285 drug applications between 20 July 2023 and 26 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 51 drug names.

2023/07/20 – 2023/07/26

Period
2023/07/20 to 2023/07/26, 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
285
Drugs with new generic filings (by drug name, de-duplicated)
51
Accepted this week, now under review
1

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

285filings, 64 of them generic

By application type

Application typeFilings
Supplement136
Generic64
New drug48
Import25
Unspecified8
Import re-registration4

By drug type

Drug typeFilings
Chemical drug166
TCM63
Therapeutic biologic50
Prophylactic biologic4
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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pravastatin Sodium Tablets422
2Roxatidine Acetate Hydrochloride For Injection225
3Ethyl Iosapentate Capsules2127
4Tacrolimus Sustained-release Capsules216
5Vonoprazan Fumarate Tablets2160
6Carfilzomib For Injection210
7Cefuroxime Sodium for Injection218
8注射用头孢唑肟钠 · No verified English name214
9米诺地尔泡沫剂 · No verified English name212
10Calcium Gluconate in Sodium Chloride Injection215

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

172 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan He Li Xin Jian Pharma Co., Ltd. romanized28270
2Guizhou Tian Di Pharma Co., Ltd. romanized1230
3Takeda Development Center Americas Inc.520
4Shaanxi Feng Wu Chen Da Yao Tang Pharmaceutical Factory Co., Ltd. romanized440
5Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized430
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.433
7Bristol-Myers Squibb Company410
8Novo Nordisk A/S410
9YING KUT LEE MEDICINE FTY. LTD.410
10Guiyang Xin Tian 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

91 this week

AcceptedDrugApplicants
2023/07/26Import · Class 1 Aficamten片 · No verified English nameJXHL2300177 Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2023/07/26Import · Class 1 MK-5684片 · No verified English nameJXHL2300176 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2023/07/26Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2302005 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2023/07/26Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2302004 Guangdong Ke Hong Pharma Co., Ltd. romanized
2023/07/26Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2302003 Guangdong Ke Hong Pharma Co., Ltd. romanized
2023/07/26Generic · Class 3 Polaprezinc GranulesCYHS2301999 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2023/07/26Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2301996 Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2023/07/26Generic · Class 3 米诺地尔泡沫剂(男用) · No verified English nameCYHS2301995 Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized
2023/07/26Generic · Class 3 米诺地尔泡沫剂(女用) · No verified English nameCYHS2301994 Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized
2023/07/26New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSS2300060 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2023/07/26New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSS2300059 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2023/07/26New drug · Class 3.3 贝伐珠单抗注射液 · No verified English nameCXSS2300058 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/07/26New drug · Class 3.3 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSL2300515 Hui Sheng Biopharmaceutical Co., Ltd. romanized
2023/07/26New drug · Class 1 多抗原自体免疫细胞注射液 · No verified English nameCXSL2300514 Heng Rui Yuan Zheng (Shanghai) Bio Technology Co., Ltd. romanized; Heng Rui Yuan Zheng (Shenzhen) Bio Technology Co., Ltd. romanized
2023/07/26New drug · Class 1 TQA3038 注射液 · No verified English nameCXHL2300820 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/07/26New drug · Class 1 APG-2575片 · No verified English nameCXHL2300819 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2023/07/26New drug · Class 1 APG-2575片 · No verified English nameCXHL2300818 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2023/07/26New drug · Class 1 APG-2575片 · No verified English nameCXHL2300817 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2023/07/25Import · Class 3.1 注射用培图罗凝血素α · No verified English nameJXSS2300063 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/07/25Import · Class 3.1 注射用培图罗凝血素α · No verified English nameJXSS2300062 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/07/25Import · Class 3.1 注射用培图罗凝血素α · No verified English nameJXSS2300061 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/07/25Import · Class 3.1 注射用培图罗凝血素α · No verified English nameJXSS2300060 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/07/25Import · Class 3.1 注射用重组人促卵泡黄体激素α · No verified English nameJXSS2300059 Merck Europe B.V.; Merck Serono S.A. Succursale d'Aubonne; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2023/07/25Import · Class 1 HS-20106注射液 · No verified English nameJXSL2300139 Keros Therapeutics Inc.; Shanghai Hansoh Biomedical Co. Ltd
2023/07/25Generic · Class 3 Sodium Bicarbonate InjectionCYHS2301989 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/07/25Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2301988 Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/07/25Generic · Class 3 Cetylpyridinium Chloride Buccal TabletsCYHS2301984 Chengdu Brilliant Pharmaceutical Co., Ltd.
2023/07/25Generic · Class 3 头孢地尼干混悬剂 · No verified English nameCYHS2301983 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2023/07/25Generic · Class 3 无水乙醇注射液 · No verified English nameCYHS2301982 Beijing Tong Ji Da Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2023/07/25Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2301977 Zhengzhou Wei Xian Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized

61 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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