YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 351 drug applications between 27 July 2024 and 2 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 70 drug names.

2024/07/27 – 2024/08/02

Period
2024/07/27 to 2024/08/02, 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
351
Drugs with new generic filings (by drug name, de-duplicated)
70
Accepted this week, now under review
13

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

351filings, 96 of them generic

By application type

Application typeFilings
Supplement162
Generic96
New drug72
Import11
Unspecified7
Import re-registration3

By drug type

Drug typeFilings
Chemical drug238
Therapeutic biologic54
TCM51
Prophylactic biologic6
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

70 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Isavuconazonium Sulfate for Injection4415
2Trazodone Hydrochloride Tablets325
3Bromhexine Hydrochloride Oral Solution3222
4Neostigmine Methylsulfate Injection314
5Magnesium Sulfate Injection317
6Diquafosol Sodium Eye Drops225
7Pediatric Faropenem Sodium Granules222
8维生素B6注射液 · No verified English name2210
9Procaterol Hydrochloride Solution for Inhalation212
10复方电解质醋酸钠葡萄糖注射液 · No verified English name2122

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

220 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ha Yao Group Pharmaceutical Factory romanized1120
2Hunan San Xue Pharma Co., Ltd. romanized970
3Shandong Lv Ye Pharmaceutical Co., Ltd. romanized610
4Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized610
5Shen Wei Pharma Group Co., Ltd. romanized550
6AstraZeneca AB530
7Guangdong Ke Hong Pharma Co., Ltd. romanized510
8Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized510
9Qinghai Lu Kang Da Di Pharma Co., Ltd. romanized440
10Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized423

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

120 this week

AcceptedDrugApplicants
2024/08/02Import · Class 3.1 elranatamab · No verified English nameJXSL2400140 Pfizer Inc.; Pfizer Investment Co. Ltd.
2024/08/02Import · Class 3.1 注射用sotatercept · No verified English nameJXSL2400139 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/08/02Import · Class 3.1 注射用sotatercept · No verified English nameJXSL2400138 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/08/02Generic · Class 3 Foscarnet Sodium InjectionCYHS2402461 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2024/08/02Generic · Class 3 Amisulpride Oral SolutionCYHS2402458 Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized
2024/08/02Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2402451 Beijing SL Pharmaceutical Co., Ltd.
2024/08/02Generic · Class 3 布美他尼片 · No verified English nameCYHS2402450 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2024/08/02New drug · Class 1.2 冻干带状疱疹mRNA疫苗 · No verified English nameCXSL2400514 Wuhan Rui Ji Bio Technology Co., Ltd. romanized; Shenzhen Rui Ji Bio Technology Co., Ltd. romanized
2024/08/02New drug · Class 1 IHS002赋能人脐带间充质干细胞注射液 · No verified English nameCXSL2400513 Wuxi Hua Tai Innovation Yao Technology Research Institute Co., Ltd. romanized
2024/08/02New drug · Class 1.2 LVRNA007 · No verified English nameCXSL2400512 Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized
2024/08/02New drug · Class 1 SYS6020注射液 · No verified English nameCXSL2400511 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2024/08/02New drug · Class 1 LM-108 注射液 · No verified English nameCXSL2400510 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/08/02New drug · Class 1 注射用肿瘤特异性重组IL-12 Fc融合蛋白 · No verified English nameCXSL2400509 Beijing Kang Kang Bio Technology Co., Ltd. romanized; Shanghai Kang Kang Bio Technology Co., Ltd. romanized
2024/08/02New drug · Class 1 SON-DP注射液 · No verified English nameCXSL2400508 Suzhou Fu En Te Pharma Co., Ltd. romanized
2024/08/02New drug · Class 2.2 贝莫苏拜单抗注射液 · No verified English nameCXSL2400507 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/08/02New drug · Class 1 注射用CIGB-814 · No verified English nameCXHL2400775 Shandong Lukang Pharmaceutical Co.,Ltd.
2024/08/02New drug · Class 1 ISM6331胶囊 · No verified English nameCXHL2400774 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2024/08/02New drug · Class 1 HW211026软膏 · No verified English nameCXHL2400773 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized
2024/08/02New drug · Class 1 ISM6331胶囊 · No verified English nameCXHL2400772 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2024/08/02New drug · Class 1 HW211026软膏 · No verified English nameCXHL2400771 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized
2024/08/02New drug · Class 1 ISM6331胶囊 · No verified English nameCXHL2400770 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
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

90 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.