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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 264 drug applications between 15 March 2023 and 21 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 46 drug names.

2023/03/15 – 2023/03/21

Period
2023/03/15 to 2023/03/21, 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
264
Drugs with new generic filings (by drug name, de-duplicated)
46
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

264filings, 68 of them generic

By application type

Application typeFilings
Supplement111
Generic68
New drug37
Import re-registration31
Import9
Unspecified8

By drug type

Drug typeFilings
Chemical drug197
TCM32
Therapeutic biologic29
Biologic5
Prophylactic 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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Amiodarone Hydrochloride Injection420
2Cefalexin Granules for Oral Suspension310
3Ampicillin Sodium and Sulbactam Sodium for Injection3113
4Acetylcysteine Solution For Inhalation224
5Glucosamine Sulfate Capsules2251
6Norepinephrine Bitartrate Injection229
7Sodium Valproate Concentrated Solution for Injection210
8Tacrolimus Ointment216
9Lansoprazole Enteric Capsules213
10Rivastigmine transdermal system211

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

161 companies with new acceptances; top 10 listed

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

67 this week

AcceptedDrugApplicants
2023/03/21Import · Class 2.2 注射用戈沙妥珠单抗 · No verified English nameJXSL2300056 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2023/03/21Import · Class 1 注射用Abelacimab · No verified English nameJXSL2300055 Anthos Therapeutics Inc.; Labcorp Pharmaceutical Research and Development (Beijing) Co. Ltd.
2023/03/21Generic · Class 3 Acetaminophen InjectionCYHS2300856 Jilin Si Huan Pharmaceutical Co., Ltd. romanized; Jilin Si Zhang Pharmaceutical Co., Ltd. romanized
2023/03/21Generic · Class 3 Acetaminophen InjectionCYHS2300855 Jilin Si Huan Pharmaceutical Co., Ltd. romanized; Jilin Si Zhang Pharmaceutical Co., Ltd. romanized
2023/03/21Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2300854 Topfond Pharmaceutical Co., Ltd.
2023/03/21Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2300853 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/03/21Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2300852 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2023/03/21Generic · Class 3 Minoxidil Topical SolutionCYHS2300850 Ren Xi Pharmaceuticals Technology Hebei Co., Ltd. romanized; Hua Bei Pharmaceutical Hebei Hua Nuo Co., Ltd. romanized
2023/03/21New drug · Class 1.2 Z018B胶囊 · No verified English nameCXZL2300019 Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized
2023/03/21New drug · Class 1.2 Z018B · No verified English nameCXZL2300018 Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized
2023/03/21New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSS2300014 Shandong Bo An Bio Technology Co., Ltd. romanized
2023/03/21New drug · Class 1 注射用IAP0971 · No verified English nameCXSL2300205 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2023/03/21New drug · Class 1 人脂肪间充质干细胞注射液 · No verified English nameCXSL2300204 Beijing Ai Ge Gan Xi Bao Technology Co., Ltd. romanized
2023/03/21New drug · Class 1 注射用金纳单抗 · No verified English nameCXSL2300203 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/03/20Generic · Class 3 Cefalexin Granules for Oral SuspensionCYHS2300841 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2023/03/20Generic · Class 3 Cefalexin Granules for Oral SuspensionCYHS2300840 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2023/03/20Generic · Class 3 Cefalexin Granules for Oral SuspensionCYHS2300839 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2023/03/20Generic · Class 3 Diprophylline InjectionCYHS2300838 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/03/20New drug · Class 1 人骨髓间充质干细胞注射液 · No verified English nameCXSL2300202 Jiu Zhi Tang Mei Ke (Beijing) Xi Bao Technology Co., Ltd. romanized
2023/03/18Generic · Class 3 Fluoxetine Hydrochloride Oral SolutionCYHS2300837 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2023/03/18Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2300830 Hui Yu Kang Cheng (Zhejiang) Pharmaceuticals Technology Co., Ltd. romanized; Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized
2023/03/18Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2300829 Hui Yu Kang Cheng (Zhejiang) Pharmaceuticals Technology Co., Ltd. romanized; Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized
2023/03/18Generic · Class 3 Cetirizine Hydrochloride InjectionCYHS2300827 Shenyang Da Shan Pharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/03/18New drug · Class 1 SDT-T002细胞注射液 · No verified English nameCXSL2300201 Sai De Te (Beijing) Bio Gong Cheng Co., Ltd. romanized
2023/03/18New drug · Class 2.2; 2.4 SHR8028滴眼液 · No verified English nameCXHS2300039 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/03/18New drug · Class 2.4 Abiraterone Acetate TabletsCXHL2300322 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/03/18New drug · Class 1 TQB3823片 · No verified English nameCXHL2300321 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/03/18New drug · Class 1 TQB3823片 · No verified English nameCXHL2300320 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/03/18New drug · Class 2.2; 2.4 SBK011口服溶液 · No verified English nameCXHL2300319 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2023/03/17Generic · Class 3 Famotidine InjectionCYHS2300825 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized

37 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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