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Henlius Receives Approval in Japan for Phase 3 MRCT of Anti-PD-1 mAb Serplulimab Combo on First-Line mCRC

Shanghai, China, July 2, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the clinical trial notification (CTN) for phase 3 international multicenter clinical study (ASTRUM-015) of Henlius’ self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) in combination with bevacizumab and chemotherapy in patients with metastatic colorectal cancer (mCRC) has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency. The study has previously completed dosing of the first subject in China, and the regulatory registration and clinical development is advancing efficiently in more countries and regions around the world. Colorectal cancer (CRC) is one of the most common malignant cancers globally. Over 1.9 million newly diagnosed cases and more than 900,000 deaths were estimated in 2022, and the incidence rates were highest in Europe and Oceania [1]. It is estimated that, by 2040, the burden of CRC will increase to 3.2 million new cases per year (an increase of 63%) and ...
- Source: drugdu
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- July 4, 2024
Hengrui Pharmaceuticals Bupivacaine Liposome Injection Approved for Marketing in the United States

Today, Hengrui Pharmaceuticals Bupivacaine Liposome Injection was successfully approved for listing in the United States. This product is the first generic drug of this species approved for marketing in the world, and its listing in the U.S. is an important milestone in the international development of the company’s high-end preparations. Bupivacaine liposome injection was first approved in the United States in 2011, and the original product is currently sold only in the United States and Europe, and has not been imported domestically. Because of its high technical barriers, no generic product has been successfully listed for more than 10 years. Hengrui Pharmaceuticals Bupivacaine Liposome Injection has been approved to be listed in China at the end of 2022, which is the exclusive global first generic of Hengrui Pharmaceuticals’ Class 3 new drug, deemed to have passed the consistency evaluation, and is also the first ultra-long-acting local anesthesia drug in China, ...
- Source: drugdu
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- July 4, 2024
First-Of-Its-Kind Integrated Heart Mapping to Prevent Damage Caused By Heart Attack

During and after a heart attack, the heart’s muscles suffer damage leading to the formation of scar tissue known as cardiac fibrosis. This scar tissue lacks the flexibility and contractility of healthy heart muscle, and its permanent presence can impair the heart’s pumping ability, potentially resulting in heart failure. Cardiac fibrosis is associated with all forms of heart disease, including those resulting from the overloading of the heart due to high blood pressure. Despite substantial investment in research seeking treatments to manage cardiac fibrosis, these efforts have largely been unsuccessful. There is a pressing need for innovative treatments that could halt or even reverse cardiac fibrosis, offering hope to millions affected. Scientists have now developed a first-of-its-kind integrated map of heart cells that sheds light on the process of cardiac fibrosis and could aid in preventing damage following a heart attack. This breakthrough achieved by researchers at the Victor Chang ...
- Source: drugdu
- 102
- July 3, 2024
Nanotech to Further Enhance Sensitivity and Accuracy of ELISA Testing for Cancer Screening

The early detection of serious diseases such as cancer or dementia is crucial for effective treatment and improving survival rates. One of the leading methods used for this purpose is the enzyme-linked immunosorbent assay (ELISA), a popular technology in disease screenings. Building upon previous advancements in nanoparticle research, scientists are now working on further enhancing the sensitivity and accuracy of ELISA tests for detecting cancers and other diseases. The promising nanoparticle research being conducted by Associate Professor Xiaohu Xia at the University of Central Florida’s (UCF, Orlando, FL, USA) Department of Chemistry has the potential to increase the accuracy of disease detection by over 300 times compared to current market standards. Supported by a USD 1.3 million grant from the National Institutes of Health, Xia’s four-year project aims to boost the diagnostic performance of ELISA tests by utilizing custom-designed nickel-platinum nanoparticles that attach to specific disease markers like proteins and ...
- Source: drugdu
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- July 3, 2024
ICL granted £150,000 to explore link between breast cancer and breastfeeding

Breast cancer is the most common cancer in the UK, accounting for 15% of all cancersImperial College London (ICL) researchers have been awarded £150,715 by Breast Cancer Now to investigate the links between breast cancer and breastfeeding in women.Currently the most common cancer in the UK, breast cancer affects around 55,000 women every year and accounts for 15% of all cancer cases in the UK. The disease occurs when abnormal breast cells grow out of control and form tumours. Previous research has already shown that breastfeeding is linked to a lower risk of developing breast cancer. Data analysis has shown that the risk of developing the disease decreases by 4% for every 12 months of breastfeeding. Researchers have estimated that this is due to breastfeeding altering the balance of hormones in the body, protecting breast cells and making them less vulnerable to changes that cause cancer. In addition, ICL researchers ...
- Source: drugdu
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- July 3, 2024
University of Liverpool launches new biotech spin-out company Galytx

The University of Liverpool has announced the launch of a new biotech spin-out company, Galytx, to develop novel therapeutic drugs to treat cancer and fibrotic diseases. The new company will focus on developing small molecular therapeutic drugs against a highly clinically molecular target, galectin-3, a carbohydrate-binding protein that has a close association with the pathogenesis, progression and morbidity of multiple fatal diseases, including cancer, fibrosis and inflammation. Professor Lu-Gang Yu, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, has been leading research at the University of Liverpool and has recently identified several non-carbohydrate, wholly synthetic small molecular compounds as potent galectin-3 inhibitors that have shown huge potential to be developed as galectin-3-targeted novel therapeutic drugs for the treatment of fatal diseases. Yu said: “Galectin-3 is increasingly recognised as a multi-functional, multi-mode promoter in cancer as well as in fibrosis-associated organ failures such as hearts, lungs and kidneys” and ...
- Source: drugdu
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- July 3, 2024
Xu Jianping, Director of Regional Openness Department of National Development and Reform Commission, Investigated Chiatai Tianqing

From June 27 to 28, Xu Jianping, director of the National Development and Reform Commission (NDRC), went to Lianyungang City, Jiangsu Province, to investigate the development of China-Europe (Asia) liner. During the visit, Xu Jianping came to Chiatai Tianqing Pharmaceuticals to investigate the enterprise’s practice of international cooperation and innovation under the promotion of the “Belt and Road” initiative. Vice President of Chiatai Tianqing, Mr. Chen Hui and Mr. Xia Chunguang accompanied him. Xu Jianping and his entourage visited the production workshop of Chiatai Tianqing and learned about the development of the enterprise in detail. Xu Jianping affirmed the achievements made by Chiatai Tianqing in enterprise operation, R&D innovation and internationalization, and encouraged the enterprise to continue to plough into scientific and technological innovation, accelerate the development of new quality productivity of pharmaceuticals, and promote the development of the enterprise to a new level. He emphasized that the enterprise should ...
- Source: drugdu
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- July 3, 2024
Hengrui’s Innovative Drug Henagliflozin Approved for New Indications, Providing New Treatment Options for Type 2 Diabetes Patients

Recently, Henagliflozin Pharmaceuticals received the Certificate of Drug Registration approved by the State Drug Administration, approving the new indication of Henagliflozin (Ruichin®), a Class 1 new drug, sodium-glucose cotransporter protein 2 inhibitor (SGLT2i) proline, which was independently researched and developed by the company: the product, 5mg or 10mg, combined with Regliflozin Phosphate and Metformin is used in patients with type 2 diabetes mellitus whose blood glucose is not yet reached after receiving Metformin monotherapy. adults with type 2 diabetes. This is the second indication for which Henagliflozin has been approved for marketing. Henagliflozin has thus become the only SGLT2i approved for combination therapy with dipeptidyl peptidase-IV inhibitors and metformin in China, which will provide a new therapeutic option for rational drug use in adult patients with type 2 diabetes mellitus. The approval of this indication for marketing is based on a multicenter, randomized, controlled, double-blind phase III clinical study [1]. ...
- Source: drugdu
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- July 3, 2024
FDA Approves New Drug Application for Shorla Oncology’s Tepylute, a Ready-to-Dilute Formulation for the Treatment of Breast and Ovarian Cancer

By Don Tracy, Associate Editor Reportedly, the liquid formulation of Tepylute eliminates the need for complex and time-consuming reconstitution, providing consistent dosing accuracy and allowing for timely preparation. The FDA has approved Shorla Oncology’s Tepylute, a ready-to-dilute formulation designed to treat breast and ovarian cancer. According to the company, the formulation is an easier to prepare injectable product that enables dosing accuracy, addressing the shortcomings and handling complexities associated with the current lyophilized powder formulation. Additionally, Shorla stated that the new formulation eliminates the need for complex and time-consuming reconstitution, enabling consistent dosing accuracy.1 ‘’This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation,” said Sharon Cunningham, CEO, co-founder, Shorla Oncology, in a press release. “We have taken a vital oncology drug and made it easier for oncology clinics and hospitals to use, while also reducing medical personnel exposure to a ...
- Source: drugdu
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- July 3, 2024
CIPM

Organiser：China Association for Pharmaceutical Equipment Time：November 17-19, 2024 Address：No. 198, Huizhan Road, Siming District, Xiamen City Exhibition hall： Xiamen International Convention and Exhibition Center Product range: Raw Material Pharmaceutical Equipment & Machinery: Reaction equipment, tower equipment, crystallization equipment, separation machinery & equipment, extraction equipment, heat exchangers, evaporation equipment, distillation equipment, drying machinery & equipment, storage equipment, sterilization equipment, etc. Pharmaceutical Preparation Machinery: Granule machinery, tablet machinery, capsule machinery, powder injection machinery, small-volume injection machinery & equipment, large-volume injection machinery & equipment, pill machinery, suppository machinery, ointment machinery, oral liquid preparation machinery, aerosol machinery, ophthalmic preparation machinery, pharmaceutical film machinery, etc. Pharmaceutical Packaging Machinery & Materials: Direct packaging machinery for pharmaceuticals, outer packaging machinery for pharmaceutical packaging materials, pharmaceutical packaging material manufacturing machinery, pharmaceutical packaging materials, packaging production lines, packaging software products, integrated packaging solutions, etc. Pharmaceutical Water (Gas) Equipment: Pharmaceutical process gas (steam) equipment, purified water equipment, water for injection equipment, ...
- Source: drugdu
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- July 3, 2024

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