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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 440 drug applications between 24 January 2022 and 30 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 116, covering 74 drug names.

2022/01/24 – 2022/01/30

Period
2022/01/24 to 2022/01/30, 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
440
Drugs with new generic filings (by drug name, de-duplicated)
74
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

440filings, 116 of them generic

By application type

Application typeFilings
Supplement204
Generic116
New drug77
Import28
Unspecified8
Import re-registration7

By drug type

Drug typeFilings
Chemical drug313
Therapeutic biologic74
TCM47
Prophylactic biologic5
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

74 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets7423
2氧 · No verified English name4415
3氧(液态) · No verified English name4413
4Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3223
5Oseltamivir Phosphate For Oral Suspension322
6Oliceridine Fumarate Injection310
7Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation3112
8Lurasidone Hydrochloride Tablets312
9Folic Acid Tablets2212
10Olmesartan Medoxomil and Amlodipine Besylate Tablets222

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

241 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Di Tai Pharmaceutical Co., Ltd. romanized15130
2Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized1360
3Hubei Rui Ze Pharma Co., Ltd. romanized12120
4Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized870
5N.V. Organon810
6CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD751
7Qilu Pharmaceutical Co., Ltd.750
8Octapharma AB710
9Chengdu Brilliant Pharmaceutical Co., Ltd.631
10Qilu Pharmaceutical (Hainan) Co., Ltd636

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

134 this week

AcceptedDrugApplicants
2022/01/30Import · Class 1 JNJ-75348780 注射液 · No verified English nameJXSL2200017 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/01/30Import · Class 1 JNJ-75348780 注射液 · No verified English nameJXSL2200016 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/01/30Generic · Class 3 二氟泼尼酯滴眼液 · No verified English nameCYHS2200260 Tianjin Jin Yao Pharma Co., Ltd. romanized
2022/01/30Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200253 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Beijing Hua Run Gao Ke Tian Ran Drug Co., Ltd. romanized
2022/01/30New drug · Class 1 注射用TQB2930 · No verified English nameCXSL2200067 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/01/30New drug · Class 1.3 冻干人用CpG佐剂狂犬病疫苗(Vero细胞) · No verified English nameCXSL2200066 Changchun Zhuo Yi Bio Co., Ltd. romanized
2022/01/30New drug · Class 1 注射用DB-1303 · No verified English nameCXSL2200065 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/01/30New drug · Class 1 IMS001注射液 · No verified English nameCXSL2200064 Zhuhai Heng Qin Ai Mu Si Tan Bio Technology Co., Ltd. romanized
2022/01/30New drug · Class 1 TST001注射液 · No verified English nameCXSL2200063 Suzhou Chuang Sheng Pharmaceuticals Group Co., Ltd. romanized
2022/01/30New drug · Class 1 GT101注射液 · No verified English nameCXSL2200061 Suzhou Sha Li Bio Technology Co., Ltd. romanized
2022/01/30New drug · Class 1 注射用重组人源化抗CD70单抗-AS269偶联物(ARX305) · No verified English nameCXSL2101498 Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized
2022/01/30New drug · Class 1 LNK01004软膏 · No verified English nameCXHL2200070 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2022/01/30New drug · Class 1 LNK01004软膏 · No verified English nameCXHL2200069 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2022/01/30New drug · Class 1 LNK01004软膏 · No verified English nameCXHL2200068 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2022/01/30New drug · Class 1 LNK01004软膏 · No verified English nameCXHL2200067 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2022/01/29Import · Class 1 Nipocalimab注射液 · No verified English nameJXSL2200015 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/01/29Import · Class 2.4 OQL011 · No verified English nameJXHL2200033 OnQuality Pharmaceuticals(USA)LLC; Suzhou Puhe Biopharma Co. Ltd
2022/01/29Import · Class 2.4 OQL011 · No verified English nameJXHL2200032 OnQuality Pharmaceuticals(USA)LLC; Suzhou Puhe Biopharma Co. Ltd
2022/01/29Import · Class 2.4 OQL011 · No verified English nameJXHL2200031 OnQuality Pharmaceuticals(USA)LLC; Suzhou Puhe Biopharma Co. Ltd
2022/01/29Generic · Class 3 Cefotaxime Sodium For InjectionCYHS2200249 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2022/01/29Generic · Class 3 Cefotaxime Sodium For InjectionCYHS2200248 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2022/01/29Generic · Class 3 Arbidol Hydrochloride TabletsCYHS2200238 Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized
2022/01/29Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200237 Guangdong Wan Fang Pharma Technology Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2022/01/29Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200236 Guangdong Wan Fang Pharma Technology Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2022/01/29Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200234 Haerbin Hua Rui Sheng Hua Pharma Co., Ltd. romanized
2022/01/29New drug · Class 1.1 柴金解郁安神片 · No verified English nameCXZL2200005 Hunan Zhong Pharmaceuticals University romanized
2022/01/29New drug · Class 1 注射用MHB008C · No verified English nameCXSL2200062 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2022/01/29New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2200060 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2022/01/29New drug · Class 1 欧司珀利单抗注射液 · No verified English nameCXSL2200059 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2022/01/29New drug · Class 1 TAEST1901注射液 · No verified English nameCXSL2200058 Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized

104 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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