Bamlanivimab

Isaac Hanson The study plans to enrol up to 500,000 subjects of which at least 5,000 are expected to get bamlanivimab therapy. Credit: Willfried Wende from Pixabay. On 11 August it was announced that the proposed acquisition of home and personal care company Amedisys by healthcare giant UnitedHealth Group would be paused after the Department of Justice (DOJ) requested further information from the companies. The deal, announced in late June, valued Amedisys at $101 a share, a roughly 10% premium on its closing price at the time of the agreement. It is one of a spate of acquisitions by UnitedHealth, which has been making moves into the home health market for some time. Recommended Reports Reports Post-Transplant Lymphoproliferative Disorder Drugs in Development by Stages, Target, MoA, RoA, Mo... GlobalData Reports LOA and PTSR Model - Venetoclax in Rhabdomyosarcoma GlobalData View all Companies Intelligence UnitedHealth Group Inc Amedisys Inc LHC Group Inc Change Healthcare LLC Optum Inc View all In February, the company acquired LHC Group , another player in the field, for $5.4bn. This deal also faced scrutiny from regulators. The Federal Trade Commission (FTC) requested more information last June, extending the timeline of the deal by around six months but ultimately allowing it to happen. The home health market is an increasingly lucrative one. As populations across the US, and the rest of the world, age, the demand for low cost, accessible care will only increase. As such, large insurers and providers are rushing to get a cut of the profits, often through pricey acquisitions. Companies like UnitedHealth are asset rich – with its total current assets sitting at over $89bn – and it is looking at throwing the weight of that cash at smaller firms in order to increase their portfolio. Last year it was finally able to buy healthtech company Change Healthcare for $13bn in a full cash deal, a 41.2% premium on the closing price of Change shares when the deal was announced the year before . These levels of premiums are necessary both to fight off competition – UnitedHealth jumped in with an offer for Amedisys after it had agreed to be bought by Optum just a month before – and because the companies being bought are highly successful in their own right. With giants able to pay over the odds for market share in new sectors of the industry, the only way to prevent their expansion is regulatory oversight. The fear of the DOJ is that the rapid pace of mergers and acquisitions being carried out by the company will create anti-competitive conditions in the home health market, despite LHC and Amedisys having very little geographical overlap. This is indicative of the more active role regulators have taken in the healthcare market since President Biden’s executive order in 2021 ordering more vigorous oversight. Likely encouraged by this, the FTC and DOJ have proposed updated antitrust guidelines that experts argue will make healthcare M&A more difficult, particularly in the case of deals like this where the acquirer isn’t currently a major player in the acquisition space. UnitedHealth reported a 16% year-on-year earnings growth in Q2 of this year, raising revenue to $92.9bn. Our signals coverage is powered by GlobalData’s Disruptor data , which tracks all major deals, patents, company filings, hiring patterns and social media buzz across our sectors. These signals help us to uncover key innovation areas in the sector and the themes that drive them. They tell us about the topics on the minds of business leaders and investors and indicate where leading companies are focusing their investment, deal-making and R&D efforts.

Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application for toripalimab, the company’s anti-PD-1 monoclonal antibody, in combination with etoposide plus platinum for the first-line treatment of patients with extensive-stage small cell lung cancer (“ES-SCLC”), has been accepted for review by the National Medical Products Administration (“NMPA”). According to data released by GLOBOCAN 2020, lung cancer is currently the most prevalent malignant tumor with the highest mortality rate in China. Small cell lung cancer (“SCLC”) is the most aggressive subtype of lung cancer, accounting for approximately 15%-20% of all lung cancer cases with characteristics including rapid progression, early metastasis and a poor prognosis. SCLC is divided into limited-stage small cell lung cancer (“LS-SCLC”) and ES-SCLC. For patients with LS-SCLC, standard chemotherapy and radiotherapy can achieve an objective response rate of approximately 90% and a five-year survival rate of approximately 25%. However, most patients are diagnosed with ES-SCLC by the time they seek medical treatment, with a median survival time of less than one year and a two-year survival rate below 10%. SCLC, and particularly ES-SCLC, pose a significant and unresolved medical challenge. The supplemental new drug application is mainly based on EXTENTORCH (NCT04012606), a randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical study. EXTENTORCH aims to compare the efficacy and safety of toripalimab or placebo in combination with etoposide plus platinum for the first-line treatment of ES-SCLC. The principal investigator for this study is Professor Ying CHENG, who is from Jilin Cancer Hospital and serves as the vice president of the Chinese Society of Clinical Oncology (CSCO). EXTENTORCH was launched in 51 centers nationwide, where patients were randomized in a 1:1 ratio to receive either toripalimab or placebo in combination with etoposide plus platinum. The treatment would be administered for 4-6 cycles, after which patients would receive maintenance treatment with toripalimab or placebo until disease progression, intolerable toxicity or other circumstances requiring termination of treatment as specified in the protocol. In May 2023, the primary endpoints of EXTENTORCH met their pre-defined efficacy boundaries, and toripalimab thus became the first PD-1 inhibitor in the world that met the primary endpoints of both overall survival (“OS”) and progression-free survival (“PFS”) in a Phase 3 study for the first-line treatment of ES-SCLC. The results showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy for the first-line treatment of ES-SCLC could significantly prolong the PFS and OS of patients. The safety profile of toripalimab was similar to previous studies, and no new safety signals were identified. Detailed data will be presented at an upcoming international academic conference. “SCLC presents with less noticeable early symptoms, and due to its rapid tumor proliferation and high malignancy, many patients are already late-stage or have systemic metastasis at the time of their initial diagnosis,” said Professor Ying CHENG of Jilin Cancer Hospital. “For those diagnosed with ES-SCLC, their average survival time is only about a year. However, EXTENTORCH has successfully confirmed that combining toripalimab with chemotherapy as a first-line treatment for ES-SCLC can significantly improve patients’ PFS and OS. These results may offer a broader range of more effective treatment options for ES-SCLC patients.” “It was my great pleasure today to witness the successful sNDA submission for toripalimab’s 10th indication,” said Dr. Jianjun ZOU, the Global Research and Development President of Junshi Biosciences. “Since its clinical approval in late 2015, toripalimab has been addressing the unmet medical needs of patients in China and worldwide. Over 40 registered clinical trials have been conducted to further investigate toripalimab, which has continued to demonstrate stable and powerful anti-tumor activity across various tumor types. In lung cancer alone, toripalimab has been involved in 3 successful large-scale phase 3 clinical trials encompassing diverse subtypes and stages of disease progression. We will work diligently on marketing applications relevant to the indication and strive to help more cancer patients with our innovative therapies!” About Toripalimab Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. In 2021, JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 administered with bamlanivimab, was granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. Meanwhile, VV116 (deuremidevir hydrobromide), a novel oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, has been approved for marketing in China and Uzbekistan. The JS016 and VV116 programs are a part of the company’s continuous efforts towards innovation for disease control and prevention of the global pandemic. 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