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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 265 drug applications between 18 January 2022 and 24 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 50 drug names.

2022/01/18 – 2022/01/24

Period
2022/01/18 to 2022/01/24, 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
265
Drugs with new generic filings (by drug name, de-duplicated)
50
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

265filings, 69 of them generic

By application type

Application typeFilings
Supplement134
Generic69
New drug34
Import14
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug193
TCM36
Therapeutic biologic29
Prophylactic biologic7

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

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Memantine Hydrochloride Sustained-release Capsules412
2Rivaroxaban Tablets313
3Tadalafil Tablets2123
4Enoxaparin Sodium Injection2116
5Diclofenac Sodium Sustained Release Tablets2110
6Empagliflozin Tablets2118
7Sacubitril Valsartan Sodium Tablets2170
8Parecoxib Sodium for Injection212
9Dopamine Hydrochloride Injection213
10Lurasidone Hydrochloride Tablets212

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

150 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Tai Zi Pharma Co., Ltd. romanized880
2Hubei Rui Ze Pharma Co., Ltd. romanized760
3Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized760
4Diao Yu Tai Pharmaceuticals Group Jilin Tian Qiang Pharmaceutical Co., Ltd. romanized660
5Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized640
6PFIZER EUROPE MA EEIG620
7CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD540
8Hainan Tong Yong San Yang Pharma Co., Ltd. romanized510
9Xian Le Xi Medical Technology Co., Ltd. romanized444
10Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc420

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

69 this week

AcceptedDrugApplicants
2022/01/24Import · Class 1 MK-6024注射液 · No verified English nameJXSL2200014 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2022/01/24Import · Class 1 MK-6024注射液 · No verified English nameJXSL2200013 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2022/01/24Import · Class 1 注射用3D-189 · No verified English nameJXHL2200026 3D Medicines Inc.; 3D Medicines(Qingdao)Co. Limited
2022/01/24Generic · Class 3 Fudosteine oral solutionCYHS2200169 Zhejiang Guo Jing Pharma Co., Ltd. romanized
2022/01/24Generic · Class 3 Fudosteine oral solutionCYHS2200168 Zhejiang Guo Jing Pharma Co., Ltd. romanized
2022/01/24Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2200155 Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2022/01/24Generic · Class 3 Aripiprazole Oral SolutionCYHS2200104 Chengdu Easton Biopharmaceuticals Co.,Ltd.; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2022/01/24Generic · Class 3 Aripiprazole Oral SolutionCYHS2200103 Chengdu Easton Biopharmaceuticals Co.,Ltd.; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2022/01/24Generic · Class 3 Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release TabletsCYHS2200102 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2022/01/24Generic · Class 3 Lidocaine CataplasmsCYHL2200009 Nanjing Healthnice Pharmaceutical Technology Co., Ltd
2022/01/24New drug · Class 1 CM313注射液 · No verified English nameCXSL2200042 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2022/01/24New drug · Class 1 注射用YK012 · No verified English nameCXSL2200041 Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized
2022/01/24New drug · Class 1 斯鲁利单抗注射液 · No verified English nameCXSL2200040 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/01/24New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2200039 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/01/24New drug · Class 1 BC008抗体注射液 · No verified English nameCXSL2200037 Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/01/24New drug · Class 1 IBI323 · No verified English nameCXSL2200036 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/01/24New drug · Class 1 TQB2618注射液 · No verified English nameCXSL2200035 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/01/24New drug · Class 2.3 依折麦布匹伐他汀钙片 · No verified English nameCXHL2200044 Le Pu Pharmaceutical Technology Co., Ltd. romanized
2022/01/24New drug · Class 1 DC05F01 · No verified English nameCXHL2200043 Beijing Shuang He Run Chuang Technology Co., Ltd. romanized
2022/01/24New drug · Class 1 ABSK043胶囊 · No verified English nameCXHL2200042 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/01/24New drug · Class 1 ABSK043胶囊 · No verified English nameCXHL2200041 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/01/21Generic · Class 3 Carbocisteine Oral SolutionCYHS2200153 Guangdong Hua Nan Pharma Group Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized
2022/01/21Generic · Class 3 Carbocisteine Oral SolutionCYHS2200152 Guangdong Hua Nan Pharma Group Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized
2022/01/21Generic · Class 3 Efavirenz Lamivudine and tenofovir Disoproxil Fumarate TabletsCYHS2200146 Shanghai Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized
2022/01/21Generic · Class 3 Desmopressin Acetate Oral SolutionCYHS2200141 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2022/01/21New drug · Class 1 注射用重组人源化抗HER2单抗-AS269偶联物(ARX788) · No verified English nameCXSL2200033 Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized
2022/01/21New drug · Class 1 IBI319 · No verified English nameCXSL2200030 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/01/21New drug · Class 2.4 环泊酚注射液 · No verified English nameCXHS2200006 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2022/01/21New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2200035 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2022/01/21New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2200034 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized

39 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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