According to the Hong Kong Stock Exchange, on February 26, Jiangsu Qyuns Therapeutics-B passed the IPO hearing on the main board of the Hong Kong Stock Exchange and will be listed soon. It is reported that Qyuns Therapeutics was established in 2015. It is a clinical-stage biotechnology company completely focused on biotherapeutics of autoimmune and allergic diseases, covering four major disease areas: skin, rheumatism, respiratory and digestive tract diseases. According to its official website, based on its complete independent innovation capabilities, Qyuns Therapeutics has formed two core products, QX002N and QX005N, as well as a product pipeline of seven other drug candidates. One variety has been accepted by BLA, one is in clinical phase 3, and four varieties are in clinical phase 2 and 1 respectively. The indications cover silver eyebrow disease, atopic dermatitis, ankylosing spondylitis, systemic lupus erythematosus, It covers four major disease areas including asthma, inflammatory bowel disease, ...
Recently, SHR-A1912, an innovative CD79b antibody-drug-conjugate (ADC) drug for injection independently developed by Hengrui, was granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA). ), for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) that has received at least two lines of therapy in the past. This will help accelerate the advancement of clinical trials and marketing registration. This is also the company’s second product to obtain fast tracks designation from the US FDA. In January this year, the company announced that its independently developed HER3 ADC innovative drug SHR-A2009 for injection has been granted fast track designation by the FDA for the treatment of third-generation EGFR-positive tumors, EGFR-mutated metastatic non-small cell lung cancer (NSCLC) with disease progression after amino acid kinase inhibitors and platinum-containing chemotherapy. Previously, the clinical trial application of SHR-A1912 for the treatment of B-cell non-Hodgkin lymphoma has been implicitly approved ...
Recently, Hengrui Pharmaceuticals’s self-developed CD79b antibody-drug-conjugate (ADC) innovation SHR-A1912 for injection has been granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory diffuse large B-cell lymphomas (R/R DLLC) that have received at least 2 lines of therapy in the past. SHR-A1912 was granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) that has previously received at least 2 lines of therapy. This is also the 2nd product of the Company to be granted Fast Track status by the FDA. In January this year, the Company announced that its self-developed HER3 ADC innovative drug SHR-A2009 for injection was granted Fast Track status by the FDA for the treatment of metastatic non-small-cell lung cancer (“NSCLC”) with EGFR mutation that has progressed after third-generation EGFR tyrosine kinase inhibitor and ...
Davy James The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024. Image credit: ibreakstock | stock.adobe.com The FDA has granted Priority Review to Regeneron Pharmaceuticals’ biologics license application (BLA) for linvoseltamab to treat adults with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies. The bispecific antibody was developed to bridge B-cell maturation antigen on multiple myeloma cells that have CD3-expressing T cells, which subsequently activates T cells to prompt the elimination of cancer cells. The FDA assigned the BLA with a Prescription Drug User Fee Act of August 22, 2024. An estimated 35,000 US residents will be diagnosed with multiple myeloma on an annual basis. Although research efforts have achieved significant progress in treating multiple myeloma, the disease is not yet curable. Current treatments have been able ...
Don Tracy, Associate Editor Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer. WuXi Advanced Therapies announced that it has officially received approval from the FDA to begin analytical testing and manufacturing of Amtagvi (lifileucel), Iovance Biotherapeutics’ recently approved treatment for advanced melanoma. According to a company press release, the treatment is a tumor-derived autologous T cell immunotherapy, specifically developed for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody. This also marks the first one-time, individualized T cell therapy to be approved by the FDA for any solid tumor cancer. “We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma. WuXi ATU has partnered with Iovance since 2015, and we are thrilled to help them through each step of the drug development pipeline – from ...
On February 20, the recombinant herpes zoster vaccine, a Class I new drug independently developed by Shanghai Institutes for Biological Products of China, received a notice of approval for clinical trial from the State Drug Administration. Herpes zoster is a common viral infectious disease caused by the reactivation of varicella-zoster virus latent in the human sensory ganglia, with severe nerve pain and skin herpes as the main symptoms. According to relevant data, there are about 1.56 million new cases of herpes zoster in people aged 50 years and above every year in China. Herpes zoster and its complications seriously affect the work and life of patients. Vaccination against herpes zoster is an important measure for the prevention of herpes zoster and postherpetic neuralgia, but at present there are limited varieties of herpes zoster vaccine available in China. Shanghai Institutes for Biological Products (SIBI) has independently developed a recombinant herpes zoster ...
Recently, Hengrui Medical ushered in a new breakthrough in the field of medical nuclide preparation, and its subsidiary Tianjin Hengrui Medical Co., Ltd. has realized the independent mass production of copper chloride [64Cu] solution with stable and controllable quality through independent projects and technological research, and the PET imaging of the labeled drug is good for small animals. This breakthrough of Hengrui Medicine lays the foundation for the development of 64Cu-labeled diagnostic drugs, and can also provide the industry with the nuclide for the R&D and production of such drugs. In 2021, eight national ministries and commissions jointly issued the Medium- and Long-term Development Plan for Medical Isotopes (2021-2035), which explicitly pointed out that 64Cu is an isotope with broad application prospects, and the key technology of gas pedal preparation of 64Cu is the key task of the plan. Radiopharmaceuticals refer to a special class of drugs containing radionuclides for ...
Davy James Amtagvi (lifileucel) becomes the first and only one-time, individualized T cell therapy to gain FDA approval for a solid tumor cancer. Image credit: Christoph Burgstedt | stock.adobe.com The FDA has granted accelerated approval to Iovance’s Amtagvi (lifileucel) for adults with unresectable or metastatic melanoma who received prior treatment with a PD-1 antibody, and in patients who are BRAF V600-positive, a BRAF inhibitor with or without a MEK inhibitor. The regulatory action makes Amtagvi the first and only one-time, individualized T cell therapy to gain FDA approval for a solid tumor cancer. “Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited ...
Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor). “Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.” Melanoma is a form of skin cancer that is often caused by exposure to ultraviolet light, which can come from sunlight ...
MABWELL (SHANGHAI) BIOSCIENCE CO. LTD. (688062.SH), an innovative biopharmaceutical company with a full industrial chain layout, announced that the U.S. FDA has granted orphan drug to the iron homeostasis macromolecule regulatory drug 9MW3011 (R&D code in the U.S.: MWTX-003/DISC-3405) (Orphan Drug Designation, ODD). 9MW3011 is indicated for the treatment of polycythemia vera (PV). Orphan drug designation from the FDA applies to drugs for rare diseases that affect fewer than 200,000 patients in the United States. Orphan drug designation can bring policy benefits to drug developers, including assistance during the drug development, clinical fee reductions, and seven years of market exclusivity after approval. 9MW3011 has been undergoing clinical trial in China and the United States and received FDA fast track designation in September last year. About 9MW3011 9MW3011 is an anti-TMPRSS6 monoclonal antibody independently developed by MABWELL’s San Diego Innovation R&D Center in the United States. It can upregulate the level ...
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