PharmaFocus Today – Page 7 – media

Latest Developments in New Drugs for Kidney Disease

In the vast and complex field of chronic kidney disease, IgA nephropathy (IgAN) has long been considered a “silent corner.” However, with a deeper understanding of its pathogenesis and breakthroughs in treatment, this once-neglected disease area is now showing renewed vitality. 01 Changes in the Times The unique aspect of IgA nephropathy lies in its complex pathogenesis. Traditionally, it was considered an autoimmune disease, but recent studies have found that its pathogenesis involves multiple steps, including mucosal immune abnormalities, the production of galactose-deficient IgA1, the formation of autoantibodies, and the deposition of immune complexes, ultimately leading to kidney tissue damage through complement activation. The elucidation of this mechanism provides a clear direction for the development of targeted drugs. Current treatment strategies mainly focus on four pathways: (1) Mucosal immune regulation: targeting the initial stage of the pathogen immune response; (2) Inhibition of the endothelin-1 (ET-1) pathway: improving glomerular hemodynamics and ...
- Source: drugdu
- 54
- November 25, 2025
PD-1 + ADC, securing a major indication

Recently, Pfizer’s Padcev and Merck’s Keytruda (including the intravenous infusion version of Keytruda and the subcutaneous injection version of Keytruda Qlex) received early approval from the U.S. FDA for the perioperative treatment of adult patients with muscle invasive bladder cancer (MIBC). This regimen is suitable for MIBC patients who are ineligible for cisplatin-based chemotherapy, specifically consisting of neoadjuvant therapy (3 cycles) followed by adjuvant therapy (14 or 7 cycles). This is the first and only approved complete perioperative treatment regimen for MIBC patients who are ineligible for cisplatin. This approval is based on the results of the pivotal Keynote-905/EV-303 study. This study enrolled adult MIBC patients who were unsuitable for or actively refused cisplatin therapy and aimed to compare the efficacy of PD-1 inhibitor/ADC combination therapy plus surgery versus surgery alone. Merck presented the results of this study at this year’s ESCO annual meeting. After a median follow-up of 25.6 ...
- Source: drugdu
- 50
- November 25, 2025
CSPC Pharmaceutical Group Limited ‘s chemical 1-class new drug, a double-stranded small interfering RNA drug, has received approval for clinical trials from the FDA

On November 24th, CSPC (01093) released an announcement stating that the group’s independently developed chemical Class 1 new drug, the double-stranded small interfering RNA drug (SYH2061 injection), has been approved by the US Food and Drug Administration (FDA) and can now conduct clinical trials in the United States. Additionally, this product was approved by the China National Medical Products Administration in October 2025 to conduct clinical trials in China. SYH2061 injection is a siRNA drug that achieves liver-targeted delivery through the conjugation of acetylated galactosamine (GalNAc). It aims to target the complement protein C5 (C5) and effectively reduce its level. Preclinical studies have shown that this product outperforms other similar siRNA products in terms of drug activity and drug efficacy persistence, and has high clinical development value. It is suitable for the treatment of IgA nephropathy and other complement-mediated related diseases. https://finance.eastmoney.com/a/202511243573136076.html
- Source: drugdu
- 66
- November 25, 2025
Hinova Pharmaceuticals Inc.：The combination of HP518 tablets and anti-tumor drugs for the treatment of advanced prostate cancer has received the approval notice for clinical drug trials

People Finance News, November 24th: Hinova Pharmaceuticals Inc. (688302) announced on November 24th that recently, they received the “Drug Clinical Trial Approval Notice” issued by the Drug Evaluation Center of the National Medical Products Administration of China, approving the use of HP518 tablets in combination with anti-tumor drugs for the Phase IIB/II clinical trial for the treatment of advanced prostate cancer. As of now, HP518 tablets have been approved for clinical trials for advanced prostate cancer in China, Australia, and the United States respectively. Currently, there are no similar products approved for market launch domestically or internationally. HP518 is an oral PROTAC drug independently developed by the company based on its core technology platform for protein degradation targeting complexes. It is designed to target and degrade the androgen receptor and is intended to be used in combination with anti-tumor drugs for the treatment of advanced prostate cancer. https://finance.eastmoney.com/a/202511243573069661.html
- Source: drugdu
- 49
- November 25, 2025
Walvax Biotechnology announces that the clinical trial application for its Varicella Attenuated Live Vaccine has been accepted

On November 21, Walvax Biotechnology (300142) announced that the clinical trial application for its Varicella Attenuated Live Vaccine has been accepted by the National Medical Products Administration, with the acceptance number CXSL2500991. The application was jointly developed by the company and its subsidiary. The product is named Varicella Attenuated Live Vaccine and is classified as a preventive biological product under Category 3.3. The vaccine is produced using an attenuated strain of the varicella-zoster virus and aims to stimulate the body’s immune response against the virus to prevent varicella. The announcement noted that although the clinical trial application for this vaccine has been accepted, it must still be approved by the Center for Drug Evaluation of the National Medical Products Administration after technical review before clinical trials can proceed. The outcome of the review and approval process remains uncertain. This acceptance is not expected to have a significant impact on the ...
- Source: drugdu
- 79
- November 24, 2025
Iza-bren New Drug Application Accepted for Review

Zzcx.cs.com.cn report – Biokin Pharmaceutical (688506) announced in an evening statement on November 23 that the new drug application for its independently developed, globally innovative, novel-concept, and the only EGFR×HER3 bispecific antibody-drug conjugate (iza-bren) in Phase III clinical trials has been officially accepted by the National Medical Products Administration (NMPA). The acceptance is based on the interim analysis results of the BL-B01D1-303 study. Prior to this, the company had completed pre-NDA meetings and communications with the Center for Drug Evaluation (CDE) of the NMPA. Iza-bren, intended for the treatment of locally advanced or metastatic nasopharyngeal carcinoma, has been included in the list for priority review. According to the announcement, BL-B01D1/iza-bren for injection is indicated for patients with recurrent or metastatic nasopharyngeal carcinoma who have previously undergone PD-1/PD-L1 monoclonal antibody therapy and failed at least two lines of chemotherapy (including at least one platinum-based regimen). The announcement highlights that iza-bren is ...
- Source: drugdu
- 69
- November 24, 2025
The first participant in the Phase III clinical trial of the innovative drug “Angaliduv” by Zhongsheng Pharmaceutical has been successfully enrolled

On November 23rd, Shengli Pharmaceutical (002317) issued a notice stating that its wholly-owned subsidiary, Shengli Ruichuang, has completed the enrollment and administration of the first participant in the Phase III clinical trial of its first-class innovative drug, Angaliduvir Granules, for the treatment of children aged 2 to 11 with uncomplicated influenza A. Angaliduvir Granules were developed to facilitate medication use for children and those with swallowing difficulties. The results of the Phase II clinical trial showed positive efficacy and good safety. The Phase III clinical trial of oneladivir granules has been progressing smoothly under the guidance of Beijing Children’s Hospital, affiliated to Capital Medical University. The announcement states that the completion of this clinical trial will not have a significant impact on the company’s short-term financial situation and operating performance. In the first three quarters of 2025, Sinos Pharmaceutical achieved revenue of 1.889 billion yuan and net profit attributable to ...
- Source: drugdu
- 72
- November 24, 2025
Nine drugs including SHR-9839 (sc) have received approval notices for clinical trials.

South Finance Intelligence News, November 21st: Hengrui Medicine (01276.HK) announced that the company and its subsidiaries, Suzhou Shendiab Pharmaceutical Co., Ltd., Shanghai Hengrui Pharmaceutical Co., Ltd., and Shanghai Shendi Pharmaceutical Co., Ltd., have recently received the approval notices for clinical trials issued by the National Medical Products Administration for Injection SHR-9839(sc), Injection SHR-A2009, Injection SHR-1826, HRS-4642 Injection, Adabeleli Monoclonal Antibody Injection, Injection Rui Kang Trastuzumab, Injection SHR-A2102, HRS-7058 Capsule and HRS-7058 Tablets. These drugs have been approved for clinical trials. Among them, SHR-9839 is a humanized antibody drug independently developed by the company, intended for the treatment of advanced solid tumors, with a cumulative R&D investment of approximately 72.31 million yuan; Injection SHR-A2009 is an antibody-drug conjugate targeting HER3, and there are no similar drugs approved for market worldwide, with a cumulative R&D investment of approximately 227 million yuan; Injection SHR-1826 is an antibody-drug conjugate targeting c-MET, with a cumulative ...
- Source: drugdu
- 79
- November 24, 2025
Announces results from two Phase III trials of its investigational oral PCSK9 inhibitor, Enlicitide Decanoate

November 20 news, MerckMerck ( the trade name of Merck Inc., Rowe, New Jersey, USA) recently presented the results of its pivotal Phase III CORALreef Lipids and Phase III CORALreef HeFH trials for the first time at the American Heart Association (AHA) Scientific Sessions. The CORALreef Lipids trial evaluated the safety and efficacy of the investigational oral PCSK9 inhibitor enlicitide, administered once daily, in adults with a history of severe atherosclerotic cardiovascular disease (ASCVD) events or at risk of ASCVD who were already receiving stable lipid-lowering therapy or were intolerant to statins. https://finance.eastmoney.com/a/202511203570023839.html
- Source: drugdu
- 76
- November 21, 2025
Fosun Pharma subsidiary’s slulimab injection included in Breakthrough Therapy Program

　　Beijing Business Daily (Reporter Ding Ning) – On the evening of November 20, Fosun Pharma (600196) announced that its subsidiary, Shanghai Henlius Biotech Co., Ltd., and its subsidiary’s independently developed slulimab injection (trade name in China: Hanszol) for neoadjuvant/adjuvant chemotherapy in combination with chemotherapy for gastric cancer (GCneo) have been included in the Breakthrough Therapy Program. 　　The announcement indicates that, as of the date of the announcement, no PD-1-targeting monoclonal antibody drugs have been approved globally for neoadjuvant/adjuvant therapy in gastric cancer. Fosun Pharma stated that inclusion in the Breakthrough Therapy designation process is expected to accelerate the review and market launch of the drug for this indication in China. https://finance.eastmoney.com/a/202511203570106585.html
- Source: drugdu
- 83
- November 21, 2025

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.