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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 370 drug applications between 13 October 2023 and 19 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 59 drug names.

2023/10/13 – 2023/10/19

Period
2023/10/13 to 2023/10/19, 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
370
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
3

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

370filings, 86 of them generic

By application type

Application typeFilings
Supplement196
Generic86
New drug59
Import19
Import re-registration6
Unspecified4

By drug type

Drug typeFilings
Chemical drug233
TCM82
Therapeutic biologic49
Prophylactic biologic5
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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diquafosol Sodium Eye Drops435
2Famotidine Injection328
3小儿复方氨基酸注射液(19AA-I) · No verified English name312
4Ixazomib Citrate Capsules317
5盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
6Oseltamivir Phosphate For Oral Suspension312
7Diprophylline Injection227
8Ezetimibe Tablets224
9Lidocaine and Prilocaine Cream2224
10Compound Ipratropium Bromide Solution For Inhalation224

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

222 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized13120
2Hainan Pu Li Pharmaceutical Co., Ltd. romanized910
3Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized830
4Pfizer Europe MA EEIG640
5Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized636
6Guangxi Hong Ji Pharma Group Co., Ltd. romanized440
7Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized440
8Pfizer Inc.430
9ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.434
10Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized420

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

114 this week

AcceptedDrugApplicants
2023/10/19Import · Class 2.1 Guselkumab Final Vialed Product for Intravenous Infusion (FVP(IV)) · No verified English nameJXSL2300187 Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd.
2023/10/19Import · Class 2.1 Guselkumab Final Vialed Product for Intravenous Infusion (FVP(IV)) · No verified English nameJXSL2300186 Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd.
2023/10/19Import · Class 1 LY3537982胶囊 · No verified English nameJXHL2300258 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/10/19Import · Class 1 LY3537982胶囊 · No verified English nameJXHL2300257 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/10/19Import · Class 1 RZL-012注射液 · No verified English nameJXHL2300256 Raziel Therapeutics (RT) Ltd.; Tianjin Juvestar Biotech Co. Ltd.
2023/10/19Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2302807 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/10/19Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2302806 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/10/19Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2302805 Rui Yang Pharmaceutical Co., Ltd. romanized
2023/10/19Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2302804 Rui Yang Pharmaceutical Co., Ltd. romanized
2023/10/19Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2302803 Shandong Jian Dao Pharmaceutical Co., Ltd. romanized
2023/10/19New drug · Class 1 靶向磷脂酰肌醇蛋白多糖-3嵌合抗原受体修饰的自体T细胞注射液 · No verified English nameCXSL2300716 Ke Ji Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2023/10/19New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300715 Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized
2023/10/19New drug · Class 1 注射用LM-108 · No verified English nameCXSL2300714 Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized
2023/10/19New drug · Class 1 ZHB103注射液 · No verified English nameCXSL2300711 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2023/10/19New drug · Class 2.2 注射用硼[10B]法仑 · No verified English nameCXHL2301125 Zhong Peng (Xiamen) Biopharmaceuticals Co., Ltd. romanized
2023/10/18Import · Class 1 Sisunatovir 片 · No verified English nameJXHL2300255 Pfizer Inc.; Pfizer Investment CO. Ltd
2023/10/18Generic · Class 3 富马酸酮替芬滴眼液 · No verified English nameCYHS2302799 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2023/10/18Generic · Class 3 Aminophylline InjectionCYHS2302798 Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/10/18Generic · Class 3 Calcium Acetate Oral SolutionCYHS2302797 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2023/10/18Generic · Class 3 Acetylcysteine InjectionCYHS2302796 Shaanxi Li Cai Pharma Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/10/18Generic · Class 3 Diprophylline InjectionCYHS2302795 Xizang Hai Jin Pharma Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/10/18New drug · Class 1 BD211自体CD34+造血干细胞注射液 · No verified English nameCXSL2300710 Shanghai Ben Dao Ji Yin Technology Co., Ltd. romanized
2023/10/18New drug · Class 2.2 赛帕利单抗注射液 · No verified English nameCXSL2300709 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/10/18New drug · Class 2.2 赛帕利单抗注射液 · No verified English nameCXSL2300708 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/10/18New drug · Class 1 Domvanalimab注射液 · No verified English nameCXSL2300707 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/10/18New drug · Class 1 Domvanalimab注射液 · No verified English nameCXSL2300706 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/10/18New drug · Class 1 Tinlarebant 片 · No verified English nameCXHL2301124 Bei Liang Sheng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized
2023/10/18New drug · Class 1 TQB3909片 · No verified English nameCXHL2301123 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/10/18New drug · Class 1 TQB3909片 · No verified English nameCXHL2301122 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/10/18New drug · Class 1 TQB3702片 · No verified English nameCXHL2301121 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD

84 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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