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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 296 drug applications between 3 September 2022 and 9 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 41 drug names.

2022/09/03 – 2022/09/09

Period
2022/09/03 to 2022/09/09, 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
296
Drugs with new generic filings (by drug name, de-duplicated)
41
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

296filings, 58 of them generic

By application type

Application typeFilings
Supplement151
Generic58
New drug38
Import29
Unspecified15
Import re-registration5

By drug type

Drug typeFilings
Chemical drug201
TCM46
Therapeutic biologic45
Prophylactic biologic3
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

41 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
9Tranexamic Acid Injection2111
10Parecoxib Sodium for Injection212

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

157 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized32290
2Bayer AG14120
3Eli Lilly and Company930
4Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized870
5Janssen-Cilag International NV650
6Baxalta US Inc.610
7Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized610
8Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized530
9Guo Yao Group Gong Ye Co., Ltd. romanized440
10Novartis Pharma AG420

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

79 this week

AcceptedDrugApplicants
2022/09/09Import · Class 3.1 安纳白介素注射液(预充式) · No verified English nameJXSS2200034 Swedish Orphan Biovitrum AB (publ); Hospira Zagreb d.o.o.; SOBI Pharma (Shanghai) Company Limited
2022/09/09Import · Class 3.1 古塞奇尤单抗注射液 · No verified English nameJXSL2200163 Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd.
2022/09/09Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200162 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200161 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200160 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200159 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200158 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200157 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201498 Hui Yin Bi Group Fu Zhou Pharmaceutical Co., Ltd. romanized; Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized
2022/09/09Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201497 Hui Yin Bi Group Fu Zhou Pharmaceutical Co., Ltd. romanized; Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized
2022/09/09Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2201492 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2022/09/09New drug · Class 3.3 水痘减毒活疫苗 · No verified English nameCXSS2200078 Beijing Min Hai Bio Technology Co., Ltd. romanized
2022/09/09New drug · Class 2.4 ZHB107-108舌下片 · No verified English nameCXSL2200454 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2022/09/09New drug · Class 2.4 ZHB107-108舌下片 · No verified English nameCXSL2200453 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2022/09/09New drug · Class 2.4 ZHB107-108舌下片 · No verified English nameCXSL2200452 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2022/09/09New drug · Class 2.4 ZHB107-108舌下片 · No verified English nameCXSL2200451 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2022/09/09New drug · Class 2.4 ZHB107-108舌下片 · No verified English nameCXSL2200450 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2022/09/09New drug · Class 2.4 ZHB107-108舌下片 · No verified English nameCXSL2200449 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2022/09/09New drug · Class 1 FB-1071 · No verified English nameCXHL2200663 Fu Bei Biopharmaceuticals Technology (Beijing) Co., Ltd. romanized
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

49 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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