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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 350 drug applications between 26 July 2024 and 1 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 102, covering 78 drug names.

2024/07/26 – 2024/08/01

Period
2024/07/26 to 2024/08/01, 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
350
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
16

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

350filings, 102 of them generic

By application type

Application typeFilings
Supplement170
Generic102
New drug62
Import8
Unspecified5
Import re-registration3

By drug type

Drug typeFilings
Chemical drug247
TCM50
Therapeutic biologic48
Prophylactic biologic5

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

78 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Trazodone Hydrochloride Tablets325
2Bromhexine Hydrochloride Oral Solution3222
3Neostigmine Methylsulfate Injection314
4Magnesium Sulfate Injection317
5Isavuconazonium Sulfate for Injection2215
6维生素B6注射液 · No verified English name2210
7Dapagliflozin Tablets2284
8Procaterol Hydrochloride Solution for Inhalation212
9复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
10Brexpiprazole Tablets2131

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

215 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ha Yao Group Pharmaceutical Factory romanized1120
2Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized910
3Hunan San Xue Pharma Co., Ltd. romanized750
4AstraZeneca AB640
5Shandong Lv Ye Pharmaceutical Co., Ltd. romanized610
6Shen Wei Pharma Group Co., Ltd. romanized550
7Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized510
8Qinghai Lu Kang Da Di Pharma Co., Ltd. romanized440
9Baxter Deutschland GmbH430
10Shandong Yi Jian Pharma Co., Ltd. romanized430

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

114 this week

AcceptedDrugApplicants
2024/08/01Import · Class 1 JNJ-80948543注射液(静脉输注) · No verified English nameJXSL2400137 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/01Import · Class 1 JNJ-80948543注射液(静脉输注) · No verified English nameJXSL2400136 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/01Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402447 Shanxi Hui Da Lin Xi Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/08/01Generic · Class 3 Esketamine Hydrochloride InjectionCYHS2402446 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/08/01Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402443 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized
2024/08/01Generic · Class 3 Chlorphenamine Maleate InjectionCYHS2402442 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/08/01Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2402438 Hong He Pharmaceutical Co., Ltd. romanized
2024/08/01Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2402433 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2024/08/01New drug · Class 2.2 贝莫苏拜单抗注射液 · No verified English nameCXSS2400082 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/08/01New drug · Class 3.3 特立帕肽注射液 · No verified English nameCXSL2400506 Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized
2024/08/01New drug · Class 1 注射用DM001 · No verified English nameCXSL2400505 Si Dao Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2024/08/01New drug · Class 1 玛仕度肽注射液 · No verified English nameCXHS2400072 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/08/01New drug · Class 1 玛仕度肽注射液 · No verified English nameCXHS2400071 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/08/01New drug · Class 1 玛仕度肽注射液 · No verified English nameCXHS2400070 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/08/01New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2400069 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/08/01New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2400068 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/08/01New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2400067 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/08/01New drug · Class 1 H018软膏 · No verified English nameCXHL2400769 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized
2024/08/01New drug · Class 1 H018软膏 · No verified English nameCXHL2400768 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized
2024/08/01New drug · Class 1 H018软膏 · No verified English nameCXHL2400767 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized
2024/07/31Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2402428 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/07/31Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2402427 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/07/31Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2402426 Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/07/31Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2402425 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2024/07/31Generic · Class 3 Potassium Chloride Oral SolutionCYHS2402424 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2024/07/31Generic · Class 3 维生素B?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2402423 Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2024/07/31Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2402420 Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized
2024/07/31New drug · Class 2.3 金花清感颗粒 · No verified English nameCXZL2400044 Ju Xie Chang (Beijing) Pharma Co., Ltd. romanized
2024/07/31New drug · Class 3.4 破伤风人免疫球蛋白 · No verified English nameCXSS2400081 Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized
2024/07/31New drug · Class 1 SYS6010 · No verified English nameCXSL2400504 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized

84 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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