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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 316 drug applications between 14 October 2023 and 20 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 48 drug names.

2023/10/14 – 2023/10/20

Period
2023/10/14 to 2023/10/20, 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
316
Drugs with new generic filings (by drug name, de-duplicated)
48
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

316filings, 68 of them generic

By application type

Application typeFilings
Supplement175
Generic68
New drug46
Import17
Unspecified6
Import re-registration4

By drug type

Drug typeFilings
Chemical drug200
TCM74
Therapeutic biologic38
Prophylactic biologic3
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

48 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1小儿复方氨基酸注射液(19AA-I) · No verified English name312
2Ixazomib Citrate Capsules317
3Oseltamivir Phosphate For Oral Suspension312
4Ezetimibe Tablets224
5Lidocaine and Prilocaine Cream2224
6Timolol Maleate Eye Drops224
7Ambroxol Hydrochloride Solution For Inhalation2110
8Diquafosol Sodium Eye Drops215
9Candesartan Cilexetil and Hydrochlorothiazide Tablets210
10复方电解质醋酸钠葡萄糖注射液 · No verified English name2122

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

192 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized16150
2Hainan Pu Li Pharmaceutical Co., Ltd. romanized910
3Shang Qiu Shi Xin Ma Bio Technology Co., Ltd. romanized440
4Guangxi Hong Ji Pharma Group Co., Ltd. romanized440
5Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized440
6Pfizer Europe MA EEIG430
7Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized420
8Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized424
9JANSSEN-CILAG NV410
10Changchun Jin Sai Pharma Co., Ltd. romanized410

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

90 this week

AcceptedDrugApplicants
2023/10/20Import · Class 1 TAK-279片 · No verified English nameJXHL2300262 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2023/10/20Import · Class 1 TNO155 胶囊 · No verified English nameJXHL2300261 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/10/20Import · Class 1 TNO155 胶囊 · No verified English nameJXHL2300260 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/10/20Import · Class 2.4 Atogepant Tablets · No verified English nameJXHL2300259 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2023/10/20Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2302818 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.; Hangzhou Minsheng Pharmaceutical Co., Ltd
2023/10/20Generic · Class 3 Magnesium Sulfate InjectionCYHS2302817 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/10/20Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2302816 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/10/20Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2302815 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/10/20Generic · Class 3 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2302812 Chengdu Sai Nuo Lian Chuang Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/10/20Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2302809 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/10/20New drug · Class 1 注射用AMT-707 · No verified English nameCXSL2300719 Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/10/20New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300718 Shanghai Lai Fu Medical Technology Co., Ltd. romanized
2023/10/20New drug · Class 1 注射用FZ-AD005抗体偶联剂 · No verified English nameCXSL2300717 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2023/10/20New drug · Class 2.4 Docetaxel InjectionCXHL2301134 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/20New drug · Class 1 TQB3720片 · No verified English nameCXHL2301133 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/10/20New drug · Class 1 RN0191注射液 · No verified English nameCXHL2301132 Da Rui Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/10/20New drug · Class 1 EG017软膏 · No verified English nameCXHL2301131 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/10/20New drug · Class 1 EG017软膏 · No verified English nameCXHL2301130 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/10/20New drug · Class 1 EG017软膏 · No verified English nameCXHL2301129 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/10/20New drug · Class 1 EG017软膏 · No verified English nameCXHL2301128 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/10/20New drug · Class 1 TRD205片 · No verified English nameCXHL2301127 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2023/10/20New drug · Class 1 TRD205片 · No verified English nameCXHL2301126 Beijing Tai De Pharmaceutical Co., Ltd. romanized
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

60 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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