On August 30, 2024, Shanghai Iris Pharmaceutical Technology Co., Ltd. (Iris) (688578. SH) signed a strategic cooperation agreement with Carcos Pharmaceutical (1167. HK). Iris obtained the exclusive license to research, develop, produce, register and commercialize the KRAS G12C inhibitor Golarese and SHP2 inhibitor JAB-3312 in China (including Chinese Mainland, Hong Kong, Macao and Taiwan). According to the terms of the agreement, Elys will pay 150 million yuan in head of state payments, up to 700 million yuan in development and sales milestone payments, and double-digit sales commissions to Gakos for this authorization, including value-added tax. Established in 2004, Elise is an innovative pharmaceutical company dedicated to providing unmet clinical needs for patients worldwide. It was listed on the Shanghai Stock Exchange’s Science and Technology Innovation Board in 2020. Since its establishment, the company has adhered to independent innovation and established a complete new drug research and development system, covering various ...
Before this, furiquintinib was regarded as another effective treatment option for gastric cancer patients. After all, gastric cancer is the fifth most common cancer in the world, and my country is a country with a high incidence of gastric cancer, with a large number of patients. With the continuous development of precision medicine, PD-1 combined with chemotherapy has become a new standard for first-line treatment of advanced gastric cancer. However, both in China and around the world, there is still a lack of treatment options available for second-line and above patients. Global pharmaceutical companies have deployed a large number of research in this field to promote clinical trials including PD-1, ADC, and VEGFR inhibitors. Among them, VEGFR inhibitors play a vital role in inhibiting tumor angiogenesis, and studies have shown that gastric cancer tissues often express high levels of VEGF, which is associated with more advanced disease and poor prognosis. ...
Recently, according to the Financial Times, Siemens Healthineers plans to acquire the diagnostic business of Advanced Accelerator Applications (AAA), a subsidiary of Novartis, for 200 million euros (approximately 1.593 billion yuan). AAA specializes in producing radioactive nuclide drugs, also known as nuclear drugs, for molecular imaging equipment PET (positron emission tomography). The transaction is expected to be completed in the fourth quarter. Expand business territory AAA was spun off from the European Organization for Nuclear Research (CERN) in 2002 and is an innovative radiopharmaceutical company focused on targeted radioligand therapy, precise radioligand imaging, and molecular imaging product development. Its main focus is on the development, production, and commercial application of Molecular Nuclear Medicine (MNM) products. On October 30, 2017, Novartis acquired the company for $3.9 billion to strengthen its radiopharmaceutical business capabilities, making AAA a subsidiary of Novartis. After years of development, AAA has built a pipeline covering various diagnostic ...
Bayer has teamed up with startup biotech NextRNA Therapeutics to develop small molecules targeting long non-coding RNAs (lncRNAs) in oncology. Under the terms of the deal, NextRNA can get up to $547m if all the milestones are reached, and the deal also included an undisclosed upfront payment. The companies will collaborate on two oncology programmes, the first involving a lncRNA-targeting small molecule in early preclinical development at NextRNA. For the second, NextRNA will pursue lncRNA targets identified by its platform, with Bayer having the option to choose one target for joint development. In 2022, Dana-Farber spinout NextRNA came out of stealth with $9.3m from a seed financing round and $46.8m from a Series A. This is the first high-profile pharma deal for the startup, which focuses on lncRNA-driven diseases. lncRNAs are RNA molecules over 200 nucleotides long that regulate gene expression without coding for proteins. They play key roles in ...
Johnson & Johnson’s (J&J) Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) has secured US Food and Drug Administration (FDA) approval as a first-line treatment for patients with some types of non-small cell lung cancer (NSCLC). The indication covers patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. The approval is based on data from the Phase III MARIPOSA study (NCT04487080), which compared the Rybrevant/Lazcluze combination to AstraZeneca’s Tagrisso (osimertinib). Data showed that Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30% compared to Tagrisso alone. Additionally, the median duration of response was nine months longer with the combination therapy compared to Tagrisso. The study met its primary endpoint of progression-free survival (PFS) and additional secondary endpoints, including participant race, type of EGFR mutation, and history of brain metastasis. These ...
A study led by researchers at the University of Leeds has revealed that a new artificial intelligence (AI) test to determine the risk of recurring bowel cancers could help patients avoid chemotherapy. The findings published in the Journal of Clinical Oncology Production could help doctors when deciding whether a patient needs chemotherapy following bowel cancer surgery. Found anywhere in the large bowel, bowel cancer is one of the most common cancers in the world, with 1.9 million cases diagnosed in 2020. In the UK alone, bowel cancer is the fourth most common cancer, affecting over 250,000 people. Researchers aimed to establish whether the number of CD3 cells within tumours could be used to predict the risk of a tumour coming back after surgery. In previous studies, bowel and rectal tumours with higher numbers of CD3 immune cells, which attack the cancer and help the body tackle the disease, have been ...
Barrett’s esophagus is a precancerous condition where chronic acid reflux damages the esophageal lining, increasing the risk of progressing to esophageal cancer or high-grade dysplasia. Currently, about 90% of patients with Barrett’s esophagus undergo endoscopic surveillance every three to five years. However, this frequency may not be sufficient to catch some cancerous changes early. It’s estimated that up to 25% of patients progress to high-grade dysplasia or esophageal cancer before their next scheduled endoscopy, missing crucial early treatment opportunities. Common treatments include radiofrequency ablation or endoscopic resection to eliminate abnormal cells before they turn cancerous. Now, a novel test could significantly aid gastroenterologists in identifying which patients with Barrett’s esophagus are more likely to develop esophageal cancer, thus optimizing surveillance and management strategies. This innovative test, named Esopredict, is a PCR-based test that evaluates DNA methylation changes in the genes RUNX3, p16, HPP1, and FBN1 from biopsy samples. DNA methylation ...
AstraZeneca’s Imfinzi (durvalumab) plus chemotherapy has secured US Food and Drug Administration (FDA) approval for non-small cell lung cancer (NSCLC) in the perioperative setting, just weeks after the agency called for an overhaul of perioperative lung cancer trials. This approval is for patients with resectable early-stage (IIA-IIIB) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated in the perioperative setting – a term that refers to the time before, during, and after surgery. In a 25 July meeting, the FDA’s Oncologic Drugs Advisory Committee (ODAC) raised concerns about the design of trials done in this setting. The Imfinzi approval is based on positive data from the Phase III AEGEAN study (NCT03800134), which showed that the perioperative use of the treatment reduced the risk of cancer returning, progressing, or causing death by 32% compared to using chemotherapy alone. ...
The first 10 drugs selected for Medicare price negotiations now have new prices set to take effect in 2026. Industry observers note that most of these drugs are older products facing generic competition soon, so greater industry impact will come as the program expands to more drugs in years to come. By Frank VinluanMedicare has unveiled prices for the first 10 drugs selected for its negotiation program, resulting in discounts of as much as 79% off of list prices. Taxpayers will save an estimated $6 billion, the White House said in a Thursday announcement of the new prices. The savings won’t happen right away. New pricing for these products won’t take effect until Jan. 1, 2026 for those with Medicare Part D prescription drug coverage. But these 10 widely used products in therapeutic areas such as diabetes and autoimmune disorders represent the first of many drugs on a path to ...
SHANGHAI, Aug. 12, 2024 /PRNewswire/ — Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The designation as a breakthrough therapy is aimed at expediting the development process of drug candidates for serious diseases, with the drug candidates included having demonstrated significant efficacy or safety advantages compared to existing therapies in early clinical trials. For drug candidates included in the breakthrough therapy list, CDE will prioritize the allocation of resources to facilitate communication and provide guidance to promote drug development, which will benefit the further advancement of the clinical development progress and the speed of market review and approval. ...
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