Recently, Hengrui Pharmaceuticals’ subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. has received the Certificate of Drug Registration approved by the State Drug Administration, which authorizes the company’s self-developed Abiraterone Acetate Tablets (II) (Trademark: Eragon®) to be listed on the market. This is the first Abiraterone Acetate nanocrystalline preparation approved for marketing in China, and also the second new chemical drug of Class 2 approved for marketing by Hengrui Pharmaceuticals. Abiraterone Acetate Tablets (II) innovatively introduces nanocrystal technology, which can significantly improve drug bioavailability and reduce the degree of food influence, thus improving patients’ drug adherence, and will bring new and better therapeutic choices for metastatic prostate cancer patients in China. Prostate cancer is the most common malignant tumor of the urinary male reproductive system. In China, the incidence rate and mortality rate of prostate cancer account for the sixth and tenth of male malignant tumors, respectively. The 5-year survival rate of ...
Recently, the Chinese Breast Cancer Society Breast Cancer Diagnosis and Treatment Guidelines (2024 Edition) (hereinafter referred to as the CBCS Guidelines) has been updated and released. As one of the most important and authoritative Chinese diagnosis and treatment norms in the field of breast cancer, the CBCS Guidelines follow the international pace and cutting-edge progress, and comprehensively summarize and elaborate on breast cancer screening, examination, diagnosis and treatment, and reporting. In this guideline recommendation, two new indications for Hengrui Pharmaceuticals’ innovative drugs have been added, which are the first-line treatment regimen of piretinib combination for HER2-positive metastatic breast cancer, and the first- and second-line treatment regimen of dalsirib for HR-positive HER2-negative metastatic breast cancer (MBC). Thus, both innovative drugs have been recommended by the 2024 CBCS guidelines for the marketed breast cancer indications. Breast cancer has become the number one malignant tumor worldwide and is one of the most common ...
Shanghai, China, January 5th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that ASTRUM-004, Henlius’ pivotal phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) plus chemotherapy as first-line treatment for previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), was published in Cancer Cell, a highly regarded oncology journal with an impact factor of 50.3. This publication serves as further evidence of the exceptional performance of HANSIZHUANG in the field of lung cancer. The study was led by Professor Caicun Zhou from Shanghai Pulmonary Hospital. Results of the overall population ASTRUM-004 were initially presented at the IASLC 2023 World Conference on Lung Cancer (WCLC 2023) in the form of oral presentation. Additionally, the data from its Asian subgroup were showcased in a poster session at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2023. Previously in 2022, the new drug application (NDA) of serplulimab for ...
The calculation of Percent Necrosis (PN) — the proportion of a tumor considered inactive or “dead” following chemotherapy — serves as a vital predictor of survival outcomes in osteosarcoma, a type of bone cancer. For instance, a PN of 99% signifies that 99% that the tumor is dead, indicating the patient’s positive response to chemotherapy and potentially better survival prospects. Pathologists typically assess PN by meticulously examining, interpreting, and marking up whole-slide images (WSIs), which are detailed cross-sections of specimens (like bone tissue) prepared for microscopic examination. Nevertheless, this traditional method is not only time-consuming and demands specialized expertise but also suffers from significant variability among observers. This means two pathologists might report differing PN estimates from the same WSI. Now, a machine learning model created and trained to calculate PN has shown that its calculation was 85% correct when compared to the results of a musculoskeletal pathologist, with the ...
A novel artificial intelligence (AI) tool, designed to interpret medical images with exceptional clarity, is set to revolutionize the way clinicians approach disease diagnosis and image analysis. This advanced tool, named iStar (Inferring Super-Resolution Tissue Architecture), was developed by researchers at the Perelman School of Medicine at the University of Pennsylvania (Philadelphia, PA, USA). It can assist healthcare professionals in diagnosing and treating cancers that might otherwise remain undetected. iStar offers an in-depth view of individual cells and a broader look at the full range of human gene activity, potentially revealing cancer cells that were nearly invisible earlier. This tool could play a crucial role in confirming whether cancer surgeries have fully removed malignancies and provide automatic annotations for microscopic images, marking a significant leap toward molecular-level disease diagnosis. One of the standout capabilities of iStar is its automatic identification of crucial anti-tumor immune formations known as “tertiary lymphoid structures,” ...
The number of people getting tested over the last decade has increased by 133% The NHS has announced a new analysis showing its highest year on record for providing urgent cancer checks over the last year. Almost three million people in the UK received cancer checks between November 2022 and October 2023. In alignment with the health service’s goal of catching cancer earlier, the new analysis has shown a 133% increase in the number of people getting checked for cancer over the last decade. Between November 2022 and October 2023, over 2.9 million people were seen for urgent cancer checks, an increase of 147,960 people between 2021 and 2022. In October alone, the NHS saw the highest month on record for cancer checks, as well as 269,492 urgent referrals and 192,889 people who received an all-clear or definitive cancer diagnosis. In addition to this, the NHS has made major progress ...
Suzhou, China, January 2, 2024 – Suzhou MediLink Therapeutics (“MediLink”) announced today that it has reached a global cooperation and licensing agreement with Roche. The two parties will collaborate to develop a next-generation antibody-drug conjugate product candidate YL211 (“c-MET ADC”) targeting mesenchymal epidermal transforming factor (c-MET) for the treatment of solid tumors. Under the terms of the agreement, Roche will obtain exclusive rights to the global development, manufacturing and commercialization of YL211. MediLink will work with the China Innovation Center of Roche (CICoR) to promote the YL211 project into phase I clinical trials, and Roche will be responsible for further development and commercialization work on a global scale. Roche will pay MediLink an upfront payment and near-term milestone payments of US$50 million, in addition to nearly US$1 billion in potential milestone payments for development, registration and commercialization, as well as future gradient royalties based on global annual net sales. About ...
Millions of people across the world are diagnosed with colorectal cancer and endometrial cancer each year. A significant number of patients with these cancers exhibit mismatch repair deficiency, a genetic anomaly characterized by errors in DNA due to the absence of specific repair proteins. This deficiency hampers DNA repair capabilities, potentially leading to various cancer types. Prior studies have indicated that patients with this condition often show positive responses to immunotherapy, which leverages the body’s immune system to combat cancer. Now, a new study has broadened the scope of patients who might benefit from this treatment approach. A research team from Brigham and Women’s Hospital (Boston, MA, USA) conducted an analysis involving 1,655 patients with either colorectal or endometrial cancer. These patients underwent both immunohistochemistry, the prevailing standard test for this genetic state, and next-generation sequencing tests. Immunohistochemistry detects mutations impacting the antigen, while next-generation sequencing provides a more comprehensive ...
Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod. Lumakras was granted accelerated approval in May 2021 to treat second line KRAS G12C-mutated NSCLC. The company was asked by the FDA to launch a confirmatory trial and a dose optimization study to gain a full approval. The therapy faced an advisory committee meeting in October where a panel was asked to consider whether the primary endpoint for the phase 3 CodeBreak 200 trial could be reliably interpreted in Amgen’s study. The committee voted 10-2 against the measure, suggesting that they were unimpressed with Amgen’s trial design. Despite the negative vote, the agency was not expected to remove Lumakras from the market, but instead request another confirmatory trial. Amgen now says that’s exactly ...
The Radiopharmaceutical Therapy and Dosimetry Lab at Johns Hopkins Medicine, headed by George Sgouros, Ph.D., has been awarded a $15 million grant, to be dispersed over the next five years, from the National Cancer Institute at the National Institutes of Health. They will use these funds to investigate a type of radiation therapy for hard-to-treat cancers. The award will fund several research projects, all of which will investigate a promising cancer treatment known as alpha-particle emitter radiopharmaceutical therapy, or alpha-emitter RPT. This therapy has proved successful in treating widespread, treatment-resistant cancers through directly delivering radiation to cancer cells. Administered into the bloodstream, alpha-emitter RPT treatment delivers highly potent radiation directly to cancer cells. Radioactive atoms that emit alpha-particles (helium nuclei) are attached to special molecules that target, or latch on to, dispersed cancer cells in the body. Alpha-particles delivered to cancer cells cause massive DNA damage that kills the cancer. ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.