BIO-THERA Bio-Pharmaceutical Co., Ltd (Stock Code: 688177) has recently received a Notice of Approval of Drug Clinical Trial approved by the State Drug Administration for the Company’s investigational product BAT7205 for injection. BAT7205 is a PD-L1/IL-15 bifunctional antibody fusion protein developed by BIO-THERA and is intended to be developed for the treatment of locally advanced or metastatic solid tumors.IL-15 is a pleiotropic cytokine that is essential for the regulation of many immune functions, particularly the development, proliferation and activation of CD8+ memory T cells and NK cells, and promotes PD-1 inhibitor-naïve CD8 + activation and proliferation of tumor-infiltrating T cells, which is expected to significantly improve the clinical efficacy of PD-1/PD-L1 analogs. BAT7205 consists of recombinant humanized anti-PD-L1 antibody and IL-15/IL-15Rαsushi fusion protein, which can both block the PD-1/PD-L1 immunosuppressive pathway and activate the immune cells through IL-15, thus achieving the synergistic effect of deregulation of immunosuppression and activation of ...
Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies. By FRANK VINLUAN A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products. The Amgen antibody, denosumab, is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients as well as those whose solid tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis indication will be marketed under the name Jubbonti. For cancer, the Sandoz product will be called Wyost. The Amgen and Sandoz drugs work by binding to a ...
March 4), according to the CDE official website, Lundbeck’s clinical trial application for Class 1 chemical drug Lu AF28996 capsules has been accepted. Currently, the drug is undergoing Phase I clinical trials overseas. Parkinson’s disease is a neurological dysfunction disease with complex symptoms and difficult early diagnosis. It is common in middle-aged and elderly people. At present, the main treatment for Parkinson’s disease is drug therapy, with the purpose of reducing symptoms, delaying the progression, and improving the patient’s quality of life. Lu AF28996 is a dopamine D1/D2 receptor agonist developed by Lundbeck Pharmaceuticals. It is a relatively new anti-Parkinson therapy and is currently undergoing Phase I clinical trials overseas. Among them, a study to evaluate the safety, tolerability, etc. of Lu AF28996 in Parkinson’s patients is expected to be completed in 2025. This time, the approval of Lu AF28996’s clinical trial application in China is expected to bring a ...
Shanghai, China, 29th February 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications (sNDAs) of its adalimumab biosimilar HANDAYUAN for the treatment of polyarticular juvenile idiopathic arthritis,pediatric plaque psoriasis and other indications have been accepted by the National Medical Products Administration (NMPA),bringing new hope to pediatric patients and their families. As of now, HANDAYUAN has been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. Autoimmune diseases are a group of diseases caused by the body’s immune system attacking its own organs or tissues[1]. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases[2]. Currently, autoimmune diseases are difficult to cure, and once it occurs, most patients need long-term to lifelong medication. Some autoimmune diseases are particularly dangerous and severely affect the quality of life of patients, posing a threat to their lives and ...
Orthohantaviruses, known for their ability to cause hemorrhagic fever with renal syndrome (HFRS) in Eurasia and hantavirus cardiopulmonary syndrome in the Americas, are significant public health concerns due to their high transmission rates and impact on health. These zoonotic pathogens have been the focus of extensive research, particularly for controlling outbreaks and devising intervention strategies. In South Korea’s Gyeonggi Province, a notable number of HFRS cases have been reported, highlighting the need for diligent epidemiological surveillance and a deeper understanding of orthohantaviruses’ genomic diversity. Now, new research has unveiled the potential of cost-efficient Flongle sequencing for rapid hantavirus genome-based diagnostics and phylogeographical surveillance. A research team from Korea University College of Medicine (Seoul, South Korea) undertook a study in the Gyeonggi Province to investigate the prevalence, viral loads, and genetic variations of Hantaan orthohantavirus (HTNV). They utilized Flongle sequencing, an innovative and budget-friendly approach, for detecting HTNV genomes, emphasizing the ...
Davy James Trogarzo (ibalizumab-uiyk) is currently approved in combination with other antiretroviral therapy for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen. The FDA has issued a refusal to file letter (RTF) to a supplemental Biologics License Application (sBLA) filed by Theratechnologies Inc. for an intramuscular (IM) method of administration for maintenance dosing of Trogarzo (ibalizumab-uiyk).1 The CD4-directed post-attachment HIV-1 inhibitor is approved in combination with other antiretroviral therapy (ART) for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current ART regimen.2 The RTF followed a preliminary review of the sBLA by the FDA, which found that the application did not include data the agency required to establish a pharmacokinetic bridge between IM administration and intravenous (IV) administration of Trogarzo. “While we are disappointed to receive this letter from the FDA, we were aware that the approval of this ...
Shanghai, China, 29th February 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications (sNDAs) of its adalimumab biosimilar HANDAYUAN for the treatment of polyarticular juvenile idiopathic arthritis,pediatric plaque psoriasis and other indications have been accepted by the National Medical Products Administration (NMPA),bringing new hope to pediatric patients and their families. As of now, HANDAYUAN has been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. Autoimmune diseases are a group of diseases caused by the body’s immune system attacking its own organs or tissues. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases. Currently, autoimmune diseases are difficult to cure, and once it occurs, most patients need long-term to lifelong medication. Some autoimmune diseases are particularly dangerous and severely affect the quality of life of patients, posing a threat to their lives and ...
Recently, Anrotinib Hydrochloride Capsules and anti-PD-L1 “Behmosubaisumab (TQB2450 Injection)” developed by Zhengda Tianqing have submitted a new indication application to the Center for Drug Evaluation of the State Drug Administration (CDE), which has been accepted, with the indications of non-microsatellite patients who have previously failed to receive or cannot tolerate the first- or second-line chemotherapy regimens. Recurrent or metastatic endometrial cancer that is not microsatellite highly unstable (non-MSI-H) or non-DNA mismatch repair defective (non-dMMR), or intolerant. Bemosumab is an innovative, fully humanized anti-PD-L1 monoclonal antibody with a new sequence developed by AstraZeneca.In April 2022, Bemosumab in combination with amrutinib hydrochloride capsules for the treatment of recurrent or metastatic endometrial cancer was included in the Breakthrough Therapeutic Classification by the CDE.In January 2023, Bemosumab’s application for marketing in the first-line treatment of recurrent or metastatic endometrial cancer in combination with amrutinib hydrochloride capsules was formally accepted by the CDE.The application was ...
Recently, Hengrui Pharmaceuticals’ subsidiaries, Shanghai Shengdi Pharmaceuticals Co., Ltd. and Suzhou Shengdia Biopharmaceuticals Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved by the State Drug Administration, which authorizes the company to carry out the clinical trial of adelberizumab in combination with SHR-A1811 for the treatment of breast cancer. According to the data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, breast cancer has become the world’s number one malignant tumor and is the most common malignant tumor in women. Statistics show that in 2020, there were about 2.26 million newly diagnosed cases of female breast cancer and 685,000 deaths worldwide, ranking first in female malignant tumor morbidity and mortality. The incidence and mortality rates of breast cancer worldwide vary according to regional distribution. In China, the 2020 China Cancer data show that the incidence rate of breast ...
The white paper outlines three strategic recommendations to support further research Researchers from King’s College London and Erasmus MC in the Netherlands have called for further funding support in a recently published white paper to investigate the use of radioactive cancer-targeted drugs to improve cancer treatments. The white paper, Unlocking the Full Potential of Cancer Treatments Using Targeted Radionuclide Therapy through Netherlands-UK Partnerships, outlined three strategic recommendations to achieve this. Most radioactive drugs are used to specifically deliver a radiation dose to cancer cells to produce a therapeutic effect. They are used to treat the disease areas identified on medical scans but can also specifically target the microscopic tumour deposits, which are involved in the progression of the disease. More specifically, targeted radionuclide therapy, a type of radiation therapy, is effective to treat prostate cancer and some other types of cancer where radionuclide, a radioactive chemical, is linked to cell-targeting ...
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