media – Page 56 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

Shiyao Group’s $1.195 billion overseas expansion, Claudin 18.2 ADC awarded FDA fast track certification

Insight Database On September 23rd, Elevation Oncology announced that the FDA has granted fast track designation to EO-3021 (SYSA1801) for the treatment of advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer patients expressing Claudin 18.2. The drug was developed by Shiyao Group and authorized overseas equity to Elevation for a total of $1.195 billion in 2022. Image source: Enterprise official website EO-3021 is a potentially most differentiated clinical stage ADC drug of its kind, consisting of an IgG1 monoclonal antibody targeting Claudin 18.2 connected to MMAE via a cleavable linker, with a DAR value of 2. In preclinical studies, the product showed specific growth inhibitory activity on Claudin 18.2 expressing cells in vitro, and had a strong anti-tumor effect on mice implanted with gastric cancer, pancreatic cancer or lung cancer models in vivo. The product has also been proven to be safe for rodents and non-human primates. On July ...
- Source: drugdu
- 131
- September 25, 2024
EGFR mutated NSCLC has an ORR of 80%! Zhikang Hongyi CDH3 ADC announces latest clinical results

Insight Database On September 14th, Zhikang Hongyi announced the latest clinical data (NCT05957471) on the safety and efficacy of its globally exclusive antibody conjugated drug BC3195 (CDH3 ADC) in phase I clinical trials for advanced solid tumors at the 2024 ESMO Annual Meeting. The ORR for patients carrying EGFR mutations reaches 80%.Image source: ESMO official website BC3195 uses antibodies with high affinity for CDH3 protein and exhibits good endocytic activity, as well as clinically validated linkers and effective payload vc MMA with bystander effect. The data released this time shows that BC3195 has controllable security and good PK characteristics. BC3195 has shown significant anti-tumor activity in NSCLC patients, with an overall response rate (ORR) of 36.4%, especially for patients carrying EGFR mutations with an ORR of 80%. The data deadline is August 10, 2024. This phase I clinical study enrolled a total of 34 patients, all of whom were late stage ...
- Source: drugdu
- 81
- September 25, 2024
Cardinal Health Acquires ION for $1.115 Billion

Recently, Cardinal Health, the world’s ninth largest medical device company, announced that it has signed a final agreement to acquire Integrated Oncology Network (ION) for $1.115 billion (approximately RMB 7.861 billion) in cash to expand its oncology services business. INO is an independent community cancer center operator with over 50 clinics, more than 100 suppliers, and over 1000 healthcare workers in 10 states across the United States. It provides comprehensive care services for communities in areas such as medical oncology, radiation oncology, urology, and diagnostic testing. After this acquisition, all assets of ION will be integrated into the Navista Cancer Care division of Gardenor, and ION’s clinics will also receive Navista’s artificial intelligence analysis capabilities, as well as PPS Analytics platform support previously acquired by Gardenor through the acquisition of Specialty Networks. Navista is a subsidiary of Gardenor, a cancer diagnosis and treatment department jointly established with oncologists and clinic ...
- Source: drugdu
- 156
- September 25, 2024
【EXPERT Q&A】What is the process of exporting drugs to Mexico?

Drugdu.com expert’s response: The process of exporting pharmaceuticals to Mexico involves multiple stages, which can be outlined in detail as follows: I. Pre-Export Preparation （1）Understanding Regulations and Policies: Conduct thorough research on Mexican laws and regulations pertaining to pharmaceutical imports, including import permit requirements, quality standards, prohibited and restricted medicinal ingredients. Verify the legality of the drugs in Mexico and assess market demand. （2）Selecting Partners: Identify logistics companies with expertise in pharmaceutical exports to Mexico, ensuring they possess the necessary qualifications and capabilities. Communicate with the logistics partner to clarify responsibilities and benefits, finalizing a cooperation agreement. （3）Preparing Necessary Documentation: Assemble essential export documents such as export permits, inspection reports, and certificates of origin. Prepare Mexican-required import documents, including import permits, health certificates, and others. II. Pharmaceutical Preparation and Packaging （1）Pharmaceutical Preparation: Ensure drug quality adheres to Mexican import standards. Prepare related materials like drug formulas, instructions, and production batch ...
- Source: drugdu
- 102
- September 25, 2024
Personnel changes in core positions at Medtronic

Recently, Medtronic, the global leader in medical devices, announced that Jorie Soskin has been appointed as the new Vice President and General Manager of TAVR and Congenital Heart Disease businesses. According to data, Jorie Soskin is a seasoned veteran of Medtronic. Since the beginning of this year, multiple personnel changes have been reported at Medtronic. As a giant in the healthcare industry, every decision made by Medtronic may have a profound impact on the entire industry. The personnel changes in core positions also mean a new leadership style and strategic direction. 15 year veteran, helping the high-quality development of TAVR field As mentioned earlier, Jorie Soskin, the newly appointed Vice President and General Manager of TAVR and Congenital Heart Disease Business, is a seasoned veteran of Medtronic, currently residing in Minneapolis, Minnesota, USA. She holds a Bachelor of Arts degree in International Asian Studies from Boston College and has also ...
- Source: drugdu
- 95
- September 25, 2024
Junshi Biosciences’ PD-1 Approved in the EU, Achieving Market Launch in China, the US, and Europe

As a result, Toripalimab has become the first and only PD-1 approved for the treatment of nasopharyngeal carcinoma in Europe, as well as the only first-line treatment drug for advanced or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression. Prior to this, Toripalimab had already been approved in China and the US. On July 28, Junshi Biosciences announced that Toripalimab’s marketing authorization application received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending its approval for the aforementioned indications. Toripalimab injection (Chinese trade name: Tuoyi®) is the first domestically approved PD-1 monoclonal antibody in China. In December 2018, the National Medical Products Administration conditionally approved Toripalimab for the treatment of unresectable or metastatic melanoma in patients who had failed prior systemic therapy. As of now, Toripalimab has received approval for seven indications in China, covering the treatment of melanoma, nasopharyngeal carcinoma, ...
- Source: drugdu
- 142
- September 25, 2024
Wealth myth” of GLP-1

Recently, the Lasker Award, an important award in the field of biomedicine known as the “vane” of the Nobel Prize, was announced. Among them, the “Clinical Medical Research Award” was awarded to Joel Habener (Massachusetts General Hospital), Lotte Bjerre Knudsen (Novo Nordisk) ) and Svetlana Mojsov (Rockefeller University). The reason for the award is that they discovered and developed GLP-1-based drugs, which revolutionized the treatment of obesity. GLP-1, glucagon-like peptide-1, is a peptide hormone encoded by the human glucagon gene and secreted by intestinal L cells. It can promote the synthesis and secretion of insulin and suppress appetite. Delaying the emptying of gastric contents, etc. Representative products include Novo Nordisk’s semaglutide and Eli Lilly’s tilpotide. It is worth mentioning that the research on GLP-1 has not only received attention from academic awards, but also brought “vast wealth” to companies in the industrial chain due to the huge market demand. The ...
- Source: drugdu
- 105
- September 25, 2024
The audit storm continues! Strictly investigate hospital account loopholes

Recently, the National Audit Office released the audit dynamics “Convening a video conference on audit rectification work, conducting public health construction project audits…” It mentioned that the Audit Bureau of Wuhan City, Hubei Province, conducted an audit of public health construction projects at the municipal level. The Audit Bureau of Wuhan City examines whether the construction projects comply with relevant plans, industrial and industry policies, whether the funds are raised in place, whether the project approval procedures are complete, and whether the projects are advanced on schedule, to promote the implementation of public health projects. Pay attention to the construction of major epidemic treatment bases at the municipal level, review the construction of negative pressure wards and negative pressure operating rooms, whether infectious disease beds, normal beds, and peacetime and wartime beds meet the planning requirements, the reserve of hemodialysis machines in designated hospitals meets the standards, whether the reserves ...
- Source: drugdu
- 83
- September 25, 2024
When will it become the global TOP20? Mindray’s latest response

Recently, Mindray Medical disclosed the record of the investor relations event held on September 14, and answered several questions of concern to investors. Among them, “North American growth is lower than expected”, “future performance guidance targets”, mergers and acquisitions, AI medical layout and other issues have become the focus of this meeting. In this regard, Mindray Medical also answered from relevant perspectives. Among them, when mentioning future performance guidance, Mindray Medical said that based on the current situation, the company still has strong confidence that it can successfully achieve the goal of global medical device TOP20 in 2025 at the latest according to the established plan. Achieve global medical device TOP20 at the end of 2025 at the latest. According to the data, Mindray Medical mainly has three major production lines: life information and support, in vitro diagnosis and medical imaging. In recent years, it has also begun to focus ...
- Source: drugdu
- 86
- September 25, 2024
CHMP recommends H drug for EU market launch

Henlius Biopharmaceutical Editor September 23, 2024 09:21 Shanghai H drug Hans form ® It is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC H drug Hans form ® Expected to become the first and only anti-PD-1 monoclonal antibody marketed in Europe for first-line treatment of ES-SCLC H drug Hans form ® Currently approved for market in countries such as China, Indonesia, Cambodia, and Thailand, benefiting approximately 80000 patients On September 20, 2024, Fosun Pharma (2696. HK) announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the company’s independently developed anti-PD-1 monoclonal antibody H drug, Hansid ® (Sullimumab) has received positive approval for marketing authorization, and it is recommended to approve its indication for first-line treatment of extensive stage small cell lung cancer (ES-SCLC). In 2023, Fosun Pharma partnered with Intas to grant exclusive development and commercialization rights for ...
- Source: drugdu
- 85
- September 24, 2024

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.