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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 307 drug applications between 14 September 2022 and 20 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 46 drug names.

2022/09/14 – 2022/09/20

Period
2022/09/14 to 2022/09/20, 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
307
Drugs with new generic filings (by drug name, de-duplicated)
46
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

307filings, 64 of them generic

By application type

Application typeFilings
Supplement170
Generic64
New drug48
Import10
Unspecified8
Import re-registration7

By drug type

Drug typeFilings
Chemical drug231
TCM42
Therapeutic biologic33
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
1Dapagliflozin And Metformin Hydrochloride Extended-Release Tablets510
2Oseltamivir Phosphate For Oral Suspension322
3Minoxidil Liniment3252
4复方聚乙二醇电解质散(Ⅲ) · No verified English name221
5Nintedanib Esilate Soft Capsules216
6Indobufen Tablets216
7Tandospirone Citrate Tablets212
8Tranexamic Acid Injection2111
9Teicoplanin for Injection216
10Hydrocortisone Sodium Succinate for Injection2116

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

177 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Jin Xing Industrial Co., Ltd. romanized1060
2Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized860
3Shandong Kong Sheng Tang Pharmaceutical Co., Ltd. romanized660
4Actelion Pharmaceuticals Ltd620
5Jiangxi Ke Rui Pharma Co., Ltd. romanized550
6Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized550
7Shanghai Yan An Pharma Co., Ltd. romanized540
8Boehringer Ingelheim International GmbH510
9Sanofi -aventis France510
10Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized515

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

92 this week

AcceptedDrugApplicants
2022/09/20Import · Class 2.4 度维利塞胶囊 · No verified English nameJXHL2200287 Secura Bio Inc.; CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SJZ) CO. LTD.
2022/09/20Import · Class 2.4 度维利塞胶囊 · No verified English nameJXHL2200286 Secura Bio Inc.; CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SJZ) CO. LTD.
2022/09/20Generic · Class 3 多潘立酮干混悬剂 · No verified English nameCYHS2201569 Zhejiang Ya Tai Pharma Co., Ltd. romanized
2022/09/20Generic · Class 3 Minoxidil LinimentCYHS2201568 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/09/20Generic · Class 3 Peramivir InjectionCYHS2201567 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2022/09/20Generic · Class 3 Cytarabine InjectionCYHS2201565 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2022/09/20Generic · Class 3 Cytarabine InjectionCYHS2201564 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2022/09/20New drug · Class 1 注射用XNW4107 · No verified English nameCXHL2200710 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/09/20New drug · Class 1 伯瑞替尼肠溶胶囊 · No verified English nameCXHL2200709 Beijing Pu Run Ao Bio Technology Co., Ltd. romanized
2022/09/20New drug · Class 1 伯瑞替尼肠溶胶囊 · No verified English nameCXHL2200708 Beijing Pu Run Ao Bio Technology Co., Ltd. romanized
2022/09/20New drug · Class 1 PLB1004胶囊 · No verified English nameCXHL2200707 Beijing An Shi Bio Technology Co., Ltd. romanized
2022/09/20New drug · Class 1 PLB1004胶囊 · No verified English nameCXHL2200706 Beijing An Shi Bio Technology Co., Ltd. romanized
2022/09/19Import · Class 1 OMTX705注射用浓溶液 · No verified English nameJXSL2200167 InxMed (Hong Kong) Limited; InxMed (Nanjing) Co. Ltd
2022/09/19Generic · Class 3 Digoxin InjectionCYHS2201563 Hebei Kun An Pharma Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2022/09/19Generic · Class 3 Doxorubicin Hydrochloride Liposome InjectionCYHS2201562 Changzhou Wu He Biopharmaceuticals Co., Ltd. romanized; Wuxi Zi Shan Pharma Co., Ltd. romanized
2022/09/19Generic · Class 3 Doxorubicin Hydrochloride Liposome InjectionCYHS2201561 Changzhou Wu He Biopharmaceuticals Co., Ltd. romanized; Wuxi Zi Shan Pharma Co., Ltd. romanized
2022/09/19Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2201560 Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2022/09/19Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2201559 Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2022/09/19Generic · Class 3 Minoxidil Topical SolutionCYHS2201558 Zhejiang Ding Tai Pharma Co., Ltd. romanized
2022/09/19Generic · Class 3 Olanzapine for InjectionCYHL2200080 Qilu Pharmaceutical Co., Ltd.
2022/09/19New drug · Class 1 UB-221 皮下注射剂 · No verified English nameCXSL2200466 Lian Sheng Yao (Yang Zhou) Biopharmaceuticals Co., Ltd. romanized
2022/09/19New drug · Class 1 注射用BG136 · No verified English nameCXHL2200705 Qingdao Hai Yang Biopharmaceuticals Research Institute romanized; Zhongguo Hai Yang University romanized; Zheng Da Pharmaceutical (Qingdao) Co., Ltd. romanized
2022/09/19New drug · Class 1 注射用BG136 · No verified English nameCXHL2200704 Qingdao Hai Yang Biopharmaceuticals Research Institute romanized; Zhongguo Hai Yang University romanized; Zheng Da Pharmaceutical (Qingdao) Co., Ltd. romanized
2022/09/19New drug · Class 1 注射用JK0004 · No verified English nameCXHL2200703 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized
2022/09/19New drug · Class 1 注射用JK0004 · No verified English nameCXHL2200702 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized
2022/09/19New drug · Class 1 XTYW001胶囊 · No verified English nameCXHL2200701 Xian Xin Tong Drug Research Co., Ltd. romanized
2022/09/19New drug · Class 1 XTYW001胶囊 · No verified English nameCXHL2200700 Xian Xin Tong Drug Research Co., Ltd. romanized
2022/09/19New drug · Class 1 注射用WXWH0075 · No verified English nameCXHL2200699 Zhuo He Pharma Group Co., Ltd. romanized
2022/09/19New drug · Class 1 注射用WXWH0075 · No verified English nameCXHL2200698 Zhuo He Pharma Group Co., Ltd. romanized
2022/09/18New drug · Class 1 DZD9008片 · No verified English nameCXHL2200697 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized

62 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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