YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 307 drug applications between 2 September 2022 and 8 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 59, covering 42 drug names.

2022/09/02 – 2022/09/08

Period
2022/09/02 to 2022/09/08, 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)
42
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, 59 of them generic

By application type

Application typeFilings
Supplement165
Generic59
New drug41
Import22
Unspecified17
Import re-registration3

By drug type

Drug typeFilings
Chemical drug215
TCM54
Therapeutic biologic35
Prophylactic biologic2
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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diquafosol Sodium Eye Drops335
2Carfilzomib For Injection310
3Lidocaine Hydrochloride Injection316
4Sitagliptin Phosphate Tablets312
5Rivaroxaban Fine Granules210
6Ipratropium Bromide Inhalation Solution212
7Ozagrel Sodium Injection213
8Olaparib Tablets210
9Ornidazole Injection210
10Tranexamic Acid Injection2111

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

160 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized32290
2Bayer AG14120
3Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized870
4Guo Yao Group Gong Ye Co., Ltd. romanized770
5Eli Lilly and Company720
6Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized610
7Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized550
8AstraZeneca AB530
9Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized530
10Guangxi Sheng He Pharmaceutical Co., Ltd. romanized440

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

76 this week

AcceptedDrugApplicants
2022/09/08Import · Class 1 DS-1062a · No verified English nameJXSL2200156 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2022/09/08Import · Class 1 Tigulixostat片 · No verified English nameJXHL2200281 LG CHEM LTD.; PAREXEL China Co. Ltd.
2022/09/08Import · Class 1 Tigulixostat片 · No verified English nameJXHL2200280 LG CHEM LTD.; PAREXEL China Co. Ltd.
2022/09/08Import · Class 1 NBQ72S · No verified English nameJXHL2200279 NANTONG BENCAO QUADRIGA MEDICAL TECHNOLOGY HK LIMITED; PAREXEL China Co. Ltd.
2022/09/08Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2201488 Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2022/09/08Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201487 Jiangsu Guang Cheng Pharma Co., Ltd. romanized
2022/09/08Generic · Class 3 Rivaroxaban Fine GranulesCYHS2201485 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/09/08Generic · Class 3 Rivaroxaban Fine GranulesCYHS2201484 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/09/08Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2201479 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2022/09/08Generic · Class 3 Tranexamic Acid InjectionCYHS2201478 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2022/09/08Generic · Class 3 Tranexamic Acid InjectionCYHS2201477 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2022/09/08New drug · Class 2.2 舒格利单抗注射液 · No verified English nameCXSS2200077 Hui Rui Investment Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized
2022/09/08New drug · Class 1 ZVS101e 注射液 · No verified English nameCXSL2200448 Beijing Zhong Yin Technology Co., Ltd. romanized
2022/09/08New drug · Class 1 ZVS101e 注射液 · No verified English nameCXSL2200447 Beijing Zhong Yin Technology Co., Ltd. romanized
2022/09/08New drug · Class 1 HR20031片(II) · No verified English nameCXHL2200662 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/09/08New drug · Class 1 HR20031片(I) · No verified English nameCXHL2200661 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/09/08New drug · Class 1 TY-1091胶囊 · No verified English nameCXHL2200660 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2022/09/08New drug · Class 1 TY-1091胶囊 · No verified English nameCXHL2200659 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2022/09/07Generic · Class 3 Pentoxifylline InjectionCYHS2201467 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.
2022/09/07Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2201465 Hainan Sai Li Ke Pharma Co., Ltd. romanized
2022/09/07New drug · Class 1 自体RAK细胞注射液 · No verified English nameCXSL2200446 Pu Hua Sai Er Bio Medical Technology Co., Ltd. romanized
2022/09/07New drug · Class 1 自体RAK细胞注射液 · No verified English nameCXSL2200445 Pu Hua Sai Er Bio Medical Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Zhong Liu Hospital romanized
2022/09/07New drug · Class 1 聚乙二醇重组人促红素注射液 · No verified English nameCXSL2200444 Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized
2022/09/07New drug · Class 2.2 兰索拉唑碳酸氢钠胶囊 · No verified English nameCXHS2200046 Xiamen En Cheng Pharmaceutical Co., Ltd. romanized
2022/09/06Import · Class 1 AZD7789 · No verified English nameJXSL2200155 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/09/06Import · Class 2.4 Inclisiran注射液 · No verified English nameJXHL2200278 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2022/09/06Import · Class 2.4 Inclisiran注射液 · No verified English nameJXHL2200277 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2022/09/06Import · Class 1 MK-0616胶囊 · No verified English nameJXHL2200276 Merck Sharp & Dohme LLC; Name not romanized
2022/09/06Import · Class 1 MK-0616胶囊 · No verified English nameJXHL2200275 Merck Sharp & Dohme LLC; Name not romanized
2022/09/06Generic · Class 3 Levofloxacin InjectionCYHS2201462 Anhui Pioneer Pharmaceutical Co., Ltd

46 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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