media – Page 13 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

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
- 79
- 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
- 100
- 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
- 110
- November 24, 2025
【EXPERT Q&A】What is the development trend of the high-end medical equipment industry?

Drugdu.com expert’s response: I. Continuous Market Expansion Driven by Domestic Production and Globalization Global Market Growth Steady In 2023, the global high-end medical equipment market reached USD 345.4 billion, marking a 6.64% year-on-year increase. By 2030, China’s market size is projected to exceed RMB 300 billion, accounting for 28% of the global share. The United States, Europe, and China are the three core markets, collectively representing over 86% of the total, with China’s growth rate significantly outpacing the global average (CAGR of 27.8% from 2015 to 2023). Accelerated Localization Rate Technological Breakthroughs: Domestic carbon-ion therapy systems, ECMO devices, artificial hearts, and other cutting-edge equipment have achieved localization. Examples include United Imaging Healthcare’s world-first 5T whole-body MRI, Mindray Medical’s clinical-grade photoacoustic imaging system, and MicroPort Robotics’ laparoscopic surgical robot, all breaking foreign monopolies. Policy Support: The National Medical Products Administration (NMPA) has implemented a “proactive intervention, full-cycle guidance” policy for innovative ...
- Source: drugdu
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- 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
- 92
- 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
- 102
- November 21, 2025
H drug receives Breakthrough Therapy Designation from CDE, potentially filling the gap in perioperative immunotherapy for gastric cancer

　　 China.com.cn Finance, November 20th – Henlius Biotech (2696.HK) announced today that its innovative PD-1 inhibitor, Hetronifly (slulimab, European brand name: Hetronifly), has been officially included in the Breakthrough Therapy List by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). It will be used in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer, becoming the first perioperative treatment drug for gastric cancer to receive Breakthrough Therapy designation from the CDE. Previously, H drug’s Phase III clinical trial for this indication met its primary endpoint. As the world’s first treatment regimen to replace postoperative adjuvant chemotherapy with immunotherapy during the perioperative period of gastric cancer, it is expected to bring patients a dual breakthrough in survival benefits and improved quality of life. According to the “Drug Registration Management Measures” and the “Announcement of the National Medical Products Administration on Issuing Three Documents Including the <Breakthrough ...
- Source: drugdu
- 103
- November 21, 2025
Innovent Biologics releases data on GLORY-2 peptide.

(Reporter Zhang Min) On November 20, Innovent Biologics Inc. (hereinafter referred to as ” Innovent Biologics “), a Hong Kong-listed company, announced that its independently developed GCG/GLP-1 dual receptor agonist, Mastodide, the world’s first such drug, has met its primary endpoint and all key secondary endpoints in the Phase III clinical trial GLORY-2 in Chinese patients with moderate to severe obesity (BMI ≥ 30 kg/m²). Currently, obesity prevalence is high in my country, and the “large body weight” group (BMI exceeding 30 kg/m²) often bears a greater burden of cardiovascular and metabolic diseases, making them a patient group that requires special attention in clinical weight management and prevention of metabolic syndrome. Effective drug treatment options are currently lacking for this population. In the GLORY-2 study, the participants’ baseline average BMI exceeded 34 kg/m², which falls into the category of moderate to severe obesity in my country. Professor Ji Linong of ...
- Source: drugdu
- 111
- November 21, 2025
GSK Announces Research Collaborations with LTZ and Fleming Initiative

GSK is once again making headlines. Just a few weeks after the company announced licensing agreements with Empirico and Syndivia, GSK announced a strategic collaboration with LTZ Therapeutics, advancing novel myeloid cell engagers in oncology, along with launching six new research programs in a collaborative research effort with Fleming Initiative. GSK and LTZ Therapeutics GSK announced a strategic research collaboration with LTZ Therapeutics aiming to advance the development of novel myeloid cell engagers (MCEs), addressing a significant unmet need in oncology.1 The research collaboration aims to develop four potential first-in-class MCE therapies targeting both hematologic cancers and solid tumors.1 Per the terms of the agreement, GSK is granted an exclusive option for worldwide licensing development, along with commercial rights for these pre-clinical therapies. GSK is shifting its focus towards MCEs due to their emergence as a class of immuno-oncology treatments designed to use the body’s own immune system to recognize ...
- Source: drugdu
- 82
- November 21, 2025
Whooping Cough Surges Nationwide as Vaccinations Fall

THURSDAY, Nov. 20, 2025 (HealthDay News) — Whooping cough is making a major comeback in the United States, with sharp increases now seen in Texas, Florida, California, Oregon and many other places. Health officials say the latest rise in pertussis cases is being driven by falling vaccination rates, waning immunity and slower public health tracking systems. What’s more, officials say, is that babies remain the most vulnerable. “Pertussis cases increase in a cyclical fashion driven by waning immunity,” Dr. Demetre Daskalakis, former head of the U.S. Centers for Disease Control and Prevention’s (CDC) immunization program, told CBS News. “But the size of the outbreak and the potential for severe outcomes in children who cannot be vaccinated can be mitigated by high coverage and good communication to folks at risk,” he added. Before a vaccine was introduced in the early 1900s, whooping cough was one of the leading causes of childhood ...
- Source: drugdu
- 84
- November 21, 2025

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