ANKE Bio (Group) Co., Ltd. and Hefei Alfana Biotechnology Co., Ltd. jointly developed a Class 1 new drug that received clinical approval from the Drug Administration (Drug Clinical Trial Approval Notification: 2024LP01608), with an indication for the treatment of cervical intraepithelial neoplasia. It is reported that this is the first therapeutic mRNA vaccine approved for clinical use in cervical intraepithelial neoplasia in China. Pre-cancerous lesions and their eventual malignant changes caused by viral infections are a serious threat to people’s lives and health. Globally, approximately 600 million people are infected with human papillomavirus (HPV), in addition to approximately 250 million people infected with hepatitis B virus (HBV), and 71 million people infected with hepatitis C virus (HCV). People infected with each of these viruses face a potential cancer risk. For example, approximately 30 million women are diagnosed each year with cervical intraepithelial neoplasia (CIN), an important precursor to cervical cancer. ...
On July 22, the first batch of SINOPHARM’s first antibody drug Sanglijian® (rituximab injection) was officially shipped, marking the company’s antibody drug formally entered a new journey of commercialization. Patient’s Gospel, First-line Targeted Drugs for Hematologic Tumors Lymphoma is a malignant tumor originated from lymphohematopoietic system, which belongs to immune system diseases. Malignant lymphoma is mostly non-Hodgkin’s lymphoma, accounting for about 80%-90% of all lymphoma cases. According to the data released by the National Cancer Center, the current incidence rate of lymphoma in China is about 6/100,000, with nearly 100,000 new cases every year, causing serious harm to patients’ lives, health and quality of life. Sanglijian® (rituximab injection) is mainly used for the treatment of non-Hodgkin’s lymphoma (follicular non-Hodgkin’s lymphoma, CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma), chronic lymphoma cell leukemia (CLL) indications, and it is the first-line targeted drug of hematological tumors. According to the research, SUNLIFE® combined with CHOP ...
Scientists from the University of Glasgow have developed the first bioengineered bone marrow model that supports human stem cells, which are crucial for bone marrow transplants and in vitro study work. Published in Nature Communications, the new model replicates the key aspects of the human bone marrow microenvironment to support rare long-term haematopoietic stem cells (LT-HSCs). Estimated to cause more than 300,000 deaths worldwide every year, leukaemia is a type of blood cancer that affects the white blood cells in the bone marrow, the spongy tissue found inside some bones, where the body makes blood cells. LT-HSCs are a type of cell that can replenish the blood cells after treatment for blood cancers, such as leukaemia. However, due to culturing challenges, researchers often rely on non-human animal models to test drugs that can have effects on blood cell production and target blood diseases. “Currently used animal models are poor predictors ...
Lupus is the lead autoimmune indication for Artiva Biotherapeutics, which has an early-stage clinical trial underway. Artiva’s allogeneic cell therapies are based on natural killer cells. By Frank VinluanCell therapy first reached patients as treatments for cancer. Artiva Biotherapeutics is part of a growing group of companies working to bring cell therapy to autoimmune disease, and its IPO has raised $167 million for clinical trial plans. Artiva priced the IPO at $12 per share, which was below the $14 to $16 per share price range the biotech set in preliminary terms last week. However, it boosted the deal size by increasing the number of shares in the offering. The 8.7 million shares it initially planned to offer would have raised $130.5 million at the proposed pricing midpoint. The company was able to raise more by selling 13.92 million shares. The shares of San Diego-based Artiva shares debuted on the Nasdaq ...
Novartis has reported a significant 43% increase in net income from continuing operations, reaching $3.24bn in the second quarter (Q2) of 2024, up from $2.27bn in the same period of 2023. This notable growth in net income was attributed primarily to an increase in core operating income. Operating income for Q2 2024 soared to $4.01bn – a substantial year-on-year increase from $2.80bn. The rise in operating income has been chiefly attributed to higher net sales and reduced impairments, although this was partly offset by a rise in research and development investments. Net sales from continuing operations for the company stood at a robust $12.51bn in Q2 2024, an increase on the $11.43bn recorded in Q2 2023. Alongside the growth in net sales, Novartis also experienced a 40% rise in free cash flow from continuing operations, which amounted to $4.61bn compared to $3.29bn in the corresponding period of 2023. For the ...
Biopsies are important clinical tools used to diagnose various diseases or monitor tissues for abnormal growth or transplant rejection. Typically, this involves removing tissue samples from the body for closer examination, which can be invasive depending on the tissue required. Researchers have developed a new analytical method that could enable the use of “liquid biopsies” as an alternative to traditional biopsies for certain patients or diseases. This new tool, developed by researchers from Vanderbilt University’s School of Medicine Basic Sciences (Nashville, TN, USA), is known as EV Fingerprinting, where EV stands for extracellular vesicles. EVs are membrane-bound particles filled with biologically active materials that play a crucial role in cell-cell communication in both health and disease. Although EVs have been studied since the 1980s, their origins and functions have not been fully defined. Research on EVs has intensified over the last two decades, revealing their involvement in processes such as ...
Revolution Medicine plans to kickstart a Phase III trial following positive data from a first-in-human study of its investigational KRAS inhibitor RMC-6236 in pancreatic cancer patients. In an investor deck released yesterday [15 July], the company outlined updated data from the Phase I trial (NCT05379985) that outlined responses from 127 patients with pancreatic ductal carcinoma (PDAC) who received between a dose of RMC-6236 ranging from 160mg to 300mg. Median progression-free survival was 8.1 months in patients with the KRAS G12X mutation, and 7.6 months in those who broadly have RAS-mutant tumours. Among participants who had at least three prior treatment regimens, the median progression-free survival was 4.2 months. Out of the 127 participants, 96% suffered from side effects. The most common were rashes, diarrhoea, nausea, and mouth sores. Those adverse events were deemed severe or medically significant in 28% of patients. The company had previously presented early Phase I data, ...
On July 11, encouraging news came from the ETER701 study completed by 72 centers nationwide led by Professor Cheng Ying of Jilin Cancer Hospital. The academic paper Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial was published online in the international authoritative medical journal Nature ETER701 was a study of Chiatai Tianqing’s Benmelstobart and anlotinib in combination with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer. The study showed that the median progression-free survival (mPFS) and median overall survival (mOS) of patients included in the current study were the highest in the history of the registry study, and that the combination chemotherapy regimen of Benmelstobart and amlotinib is expected to provide a survival benefit for patients with extensive-stage small cell lung cancer (ES-SCLC). This is another authoritative recognition of Benmelstobart in combination with amlotinib and chemotherapy in the field of extensive-stage small ...
By Don Tracy, Associate Editor The agreement enables SOTIO to license multiple fully human bispecific antibodies from Biocytogen’s RenLite platform. SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, and Biocytogen have agreed to terms on a research collaboration and exclusive option and license agreement. According to the companies, the deal will aim to develop next-generation antibody-drug conjugates (ADCs) for targeting solid tumors, while SOTIO will also have the ability to utilize Biocytogen’s proprietary ADC platform. “SOTIO’s powerful ADC platform brings together multiple technologies, allowing us to tailor our therapeutics to meet the needs of specific cancer types. Specifically, exploiting bispecific targeting in the context of our ADC approaches to improve precision targeting and overcome tumor heterogeneity is particularly appealing,” said Martin Steegmaier, PhD, chief scientific officer SOTIO, in a press release. “This agreement with Biocytogen complements our existing collaborations with Synaffix, LigaChem, and NBE-Therapeutics, providing SOTIO with access ...
By Don Tracy, Associate Editor DSP-5336 targets the menin and mixed-lineage leukemia protein interaction, crucial in various biological processes, including cell growth and genomic stability. Image Credit: Adobe Stock Images/Pichitchai The FDA has granted Fast Track Designation to Sumitomo Pharma America’s DSP-5336, an investigational small molecule inhibitor for the treatment of relapsed or refractory acute myeloid leukemia (AML) with KMT2A rearrangement (MLLr) or nucleophosmin mutation (NPM1m). According to the company, DSP-5336 targets the menin and mixed-lineage leukemia (MLL) protein interaction, which is considered vital in a variety of biological processes, including cell growth and genomic stability.1 “For patients and families facing a diagnosis of relapsed or refractory acute myeloid leukemia, significant unmet medical needs remain—and we share in their urgency to identify and advance new treatment pathways,” said Tsutomu Nakagawa, PhD, president, CEO, SMPA, in a press release. “We are encouraged by FDA’s decision and look forward to working closely ...
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