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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 267 drug applications between 15 January 2022 and 21 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 40 drug names.

2022/01/15 – 2022/01/21

Period
2022/01/15 to 2022/01/21, 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
267
Drugs with new generic filings (by drug name, de-duplicated)
40
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

267filings, 58 of them generic

By application type

Application typeFilings
Supplement147
Generic58
New drug31
Import17
Import re-registration10
Unspecified4

By drug type

Drug typeFilings
Chemical drug204
TCM29
Therapeutic biologic27
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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Memantine Hydrochloride Sustained-release Capsules412
2Rivaroxaban Tablets313
3Enoxaparin Sodium Injection2116
4Diclofenac Sodium Sustained Release Tablets2110
5Empagliflozin Tablets2118
6Sacubitril Valsartan Sodium Tablets2170
7Parecoxib Sodium for Injection212
8Neostigmine Methylsulfate Injection214
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

149 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Rui Ze Pharma Co., Ltd. romanized14130
2Hubei Tai Zi Pharma Co., Ltd. romanized770
3Bayer Vital GmbH710
4Diao Yu Tai Pharmaceuticals Group Jilin Tian Qiang Pharmaceutical Co., Ltd. romanized660
5Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized640
6Hainan Tong Yong San Yang Pharma Co., Ltd. romanized510
7Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized510
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized430
9Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc420
10AstraZeneca AB410

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

65 this week

AcceptedDrugApplicants
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
2022/01/20Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2200025 Seagen Inc.; MSD R&D (China) Co. Ltd.
2022/01/20Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2200024 Seagen Inc.; MSD R&D (China) Co. Ltd.
2022/01/20Import · Class 1 venglustat · No verified English nameJXHL2200023 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd
2022/01/20Import · Class 1 venglustat · No verified English nameJXHL2200022 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd
2022/01/20Generic · Class 3 Desonide CreamCYHS2200138 Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized
2022/01/20Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2200134 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2022/01/20Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2200133 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2022/01/20Generic · Class 3 Peramivir InjectionCYHS2200121 Qilu Pharmaceutical (Hainan) Co., Ltd
2022/01/20New drug · Class 1 IBI321 · No verified English nameCXSL2200028 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/01/20New drug · Class 3.3 13价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2200027 Chengdu Bio Zhi Pin Research Institute Co., Ltd. romanized
2022/01/20New drug · Class 1 QR056251胶囊 · No verified English nameCXHL2200039 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2022/01/20New drug · Class 1 QR056251胶囊 · No verified English nameCXHL2200038 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2022/01/19Import · Class 3.4 达雷妥尤单抗注射液(皮下注射) · No verified English nameJXSL2200010 Janssen Research & Development LLC; Johnson &Johnson(China)Investment Ltd.
2022/01/19Import · Class 1 MBG453 · No verified English nameJXSL2200009 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/01/19Import · Class 1 NIS793 · No verified English nameJXSL2200008 Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd
2022/01/19Import · Class 1 Pritelivir薄膜包衣片 · No verified English nameJXHL2200021 AiCuris Anti-infective Cures AG; Beijing Medpace Co.Ltd
2022/01/19New drug · Class 1 阿得贝利单抗注射液 · No verified English nameCXSS2200006 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized; Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2022/01/19New drug · Class 1 注射用BC004 · No verified English nameCXSL2200026 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized
2022/01/19New drug · Class 1 注射用KL031322 · No verified English nameCXHL2200033 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2022/01/18Generic · Class 3 泽布替尼胶囊 · No verified English nameCYHS2200112 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/01/18Generic · Class 3 Oxycodone And Acetaminophen TabletsCYHS2200109 Yi Chang Ren Fu Pharma Co., Ltd. romanized

35 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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