YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 271 drug applications between 26 January 2024 and 1 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 60 drug names.

2024/01/26 – 2024/02/01

Period
2024/01/26 to 2024/02/01, 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
271
Drugs with new generic filings (by drug name, de-duplicated)
60
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

271filings, 80 of them generic

By application type

Application typeFilings
Supplement128
Generic80
New drug36
Import14
Import re-registration9
Unspecified4

By drug type

Drug typeFilings
Chemical drug177
TCM49
Therapeutic biologic35
Prophylactic biologic8
Biologic2

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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment5152
2Riociguat Tablets314
3Peramivir Injection227
4Nintedanib Esilate Soft Capsules216
5Diquafosol Sodium Eye Drops215
6Obeticholic Acid Tablets210
7Vonoprazan Fumarate Tablets2160
8Tandospirone Citrate Tablets212
9Sildenafil Citrate Tablets2112
10Potassium Chloride Granules214

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

187 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Fu Ren Jin Shen Pharma Co., Ltd. romanized770
2Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized747
3Pfizer Inc.730
4Le Fu Si Health Industry Shareholding Company romanized515
5Novo Nordisk A/S440
6CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD422
7Xizang An Xing Pharmaceuticals Co., Ltd. romanized420
8Jilin Sheng Zhang Yuan Pharma Co., Ltd. romanized330
9Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized330
10Topfond Pharmaceutical Co., Ltd.321

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
2024/02/01Import · Class 1 BRII-179注射液 · No verified English nameJXSL2400029 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2024/02/01Import · Class 1 BRII-835 (VIR-2218) 注射液 · No verified English nameJXHL2400027 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2024/02/01Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2400429 Shandong Da Yin Jin Kong Er Tong Pharmaceutical Co., Ltd. romanized
2024/02/01Generic · Class 3 Memantine Hydrochloride OD TabletsCYHS2400428 Wan Quan Wan Te Pharmaceutical Jiangsu Co., Ltd. romanized
2024/02/01Generic · Class 3 Obeticholic Acid TabletsCYHS2400425 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/02/01Generic · Class 3 Obeticholic Acid TabletsCYHS2400424 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/02/01Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2400423 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2024/02/01Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2400422 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2024/02/01Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2400421 Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized
2024/02/01Generic · Class 3 Gatifloxacin Eye DropsCYHS2400420 Hefei Yuan Feng Shun Pharmaceuticals Technology Co., Ltd. romanized; Hefei Li Min Pharmaceutical Co., Ltd. romanized
2024/02/01Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2400419 Beijing Han Mei Medicines Co., Ltd. romanized
2024/02/01New drug · Class 1 ABO2011注射液 · No verified English nameCXSL2400083 Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized; Suzhou Ai Bo Bio Technology Co., Ltd. romanized
2024/02/01New drug · Class 3.3 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSL2400082 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2024/02/01New drug · Class 1 SHR-3276注射液 · No verified English nameCXSL2400081 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/02/01New drug · Class 1 MH004软膏 · No verified English nameCXHL2400126 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2024/01/31Import · Class 3.1 Elranatamab注射液 · No verified English nameJXSS2400006 Pfizer Inc.; Pharmacia & Upjohn Company LLC; Pfizer Investment Co. Ltd.
2024/01/31Import · Class 3.1 Elranatamab注射液 · No verified English nameJXSS2400005 Pfizer Inc.; Pharmacia & Upjohn Company LLC; Pfizer Investment Co. Ltd.
2024/01/31Import · Class 1 Ulixacaltamide缓释片 · No verified English nameJXHL2400026 Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd
2024/01/31Import · Class 1 Ulixacaltamide缓释片 · No verified English nameJXHL2400025 Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd
2024/01/31Import · Class 1 Ulixacaltamide缓释片 · No verified English nameJXHL2400024 Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd
2024/01/31Generic · Class 3 Sodium Cromoglicate Eye DropsCYHS2400417 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/01/31Generic · Class 3 Sodium Cromoglicate Eye DropsCYHS2400416 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/01/31Generic · Class 3 Minoxidil LinimentCYHS2400414 Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized
2024/01/31Generic · Class 3 Minoxidil LinimentCYHS2400413 Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized
2024/01/31Generic · Class 3 Minoxidil LinimentCYHS2400412 Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized
2024/01/31Generic · Class 3 Minoxidil LinimentCYHS2400411 Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized
2024/01/31Generic · Class 3 Minoxidil LinimentCYHS2400410 Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized
2024/01/31Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2400406 Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/01/31Generic · Class 3 Proparacaine Hydrochloride Eye DropsCYHS2400405 Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized
2024/01/31Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2400404 Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD

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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