Burosumab-TWZA

2024年9月30日，香港维健医药集团（以下简称“维健医药”）正式宣布，已成功完成对日本协和麒麟（以下简称“协和麒麟”）株式会社全资子公司——协和麒麟（中国）制药有限公司（以下简称“协和麒麟中国”）股权收购的交割。 On September 30, 2024, Hong Kong Winhealth Pharma Group (hereinafter referred to as "Winhealth Pharma") officially announced the successful completion of the equity acquisition of Kyowa Kirin (China) Pharmaceutical Co., Ltd. (hereinafter referred to as "Kyowa Kirin China"), a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd. (hereinafter referred to as "Kyowa Kirin"). 交割之后，维健医药将持有协和麒麟中国100%股权，并获得协和麒麟在中国上市商业化的五个原研品牌药品的永久商业化及生产权益以及未来在肾科和血液科管线的优先商业化权益。此外，维健医药还与协和麒麟签订了全球重磅产品麟平®和惠尔金®的商业化许可协议，获得其在中国的长期商业化权益。 Following the closing, Winhealth Pharma will hold 100% equity of Kyowa Kirin China and obtain the permanent commercialization and production rights of five original brand drugs commercialized in China by Kyowa Kirin, as well as the priority commercialization rights of future pipeline products in the nephrology and hematology fields. Additionally, Winhealth Pharma has also signed a commercial license agreement with Kyowa Kirin for the global blockbuster products Crysvita® and Poteligeo®, securing their long-term commercialization rights in China. 此次交易，自2024年8月1日宣布签约以来，历时两个月。在此期间内，项目得到了各方的高度重视与支持，双方团队能够在短短61天的时间里，完成项目所涉交割程序和附属协议的签署，使得项目高效、顺利、平稳的交割，得益于双方高度专业化的项目团队，以及内、外部团队、合作伙伴多方的积极努力和高效协同。 This transaction has spanned two months since the signing was announced on August 1, 2024. During this period, the project has received high-level attention and support from all parties. The project teams of both sides were able to complete the closing procedures and the signing of ancillary agreements involved in the project in just 61 days. The efficient, smooth, and stable closing of the project is attributable to the highly professional project teams of both sides and the active efforts and efficient collaboration of internal and external teams and multiple partners. 维健医药董事长/创始人兼CEO王威先生表示： Mr. Wang Wei, Chairman/Founder and CEO of Winhealth Pharma, said: “我们对股权收购的成功完成感到非常高兴，它将显著增强我们在创新药物研发和商业化领域的综合竞争力；意味着维健医药从一家医药商业化推广企业成为一家大型创新型生物制药企业的战略转型的顺利完成；更是维健医药真正迈向维健2.0时代的重大里程碑事件。未来，我们将始终秉持‘患者为先’的初心，致力于为全球患者提供更多更好的治疗方案。此交割的圆满落幕，维健医药将会继承和发扬协和麒麟中国的业务、持续扩大中国市场，满足更多未被满足的患者需求。” “We are extremely delighted with the successful completion of the equity acquisition. It will significantly enhance our comprehensive competitiveness in the fields of innovative drug research and development and commercialization. It means the smooth completion of Winhealth Pharma's strategic transformation from a pharmaceutical commercial promotion enterprise to a large innovative biopharmaceutical enterprise. It is also a significant milestone event as Winhealth Pharma truly steps into the Winhealth 2.0 era. In the future, we will always adhere to the original intention of ‘patient comes first’ and be committed to providing more and better treatment options for patients around the world. With the successful conclusion of this transaction, Winhealth Pharma will inherit and carry forward the business of Kyowa Kirin China, continuously expand the Chinese market, and meet more unmet patient needs.” 维健医药集团执行董事、联席CEO郝景辉先生表示： Mr. Hao Jinghui, Executive Director and Co-CEO of Winhealth Pharma, remarked,  “从8月1日签约到今天的高效交割，历时不到两个月，这一成就离不开双方管理层和交易团队的专业互信、一丝不苟与精诚合作。作为长期战略合作伙伴，维健医药与协和麒麟始终保持着紧密且良好的合作关系，共同构建了基于互惠互信共赢原则的共生关系。今天的成功交割，标志着双方合作迈入了全新的发展阶段。未来，维健医药将持续秉承对患者、合作伙伴和员工的承诺，携手协和麒麟及众多全球优秀战略合作伙伴，将更多领先的原研创新药品带给中国患者，共创更加辉煌的未来。” "From the signing on August 1 to today's efficient closing, it took less than two months. This achievement is inseparable from the professional mutual trust, meticulousness, and sincere cooperation of the management and transaction teams of both sides. As a long-term strategic partner, Winhealth Pharma and Kyowa Kirin have always maintained a close and excellent cooperative relationship and jointly established a symbiotic relationship based on the principles of mutual benefit, mutual trust, and win-win. Today's successful closing signals that the cooperation between the two sides has entered a new stage of development. In the future, Winhealth Pharma will continue to uphold its commitments to patients, partners, and employees. Together with Kyowa Kirin and many outstanding global strategic partners, we will bring more leading original innovative drugs to Chinese patients and create a more glorious future." 随着本次交割的圆满落幕，维健医药与协和麒麟的合作正式迈入了全新的发展阶段。这不仅是双方合作历程中的一个重要里程碑，更是标志着双方在战略层面的深度融合。维健医药将以此为契机，全面而深入地整合协和麒麟中国在研发、生产及商业化领域的丰富资源。通过资源的优化配置与共享，维健医药将构建起更为专业、完善和高效的全链路商业化体系，夯实公司的竞争优势，为公司的持续发展和转型注入了强大的发展动力。 With the successful closing of this transaction, the cooperation between Winhealth Pharma and Kyowa Kirin has officially entered a new stage of development. This is not only an important milestone in the cooperation process between the two sides but also indicates the deep integration of the two sides at the strategic level. Winhealth Pharma will seize this opportunity to comprehensively and deeply integrate the abundant resources of Kyowa Kirin China in the fields of research and development, production, and commercialization. Through the optimized allocation and sharing of resources, Winhealth Pharma will establish a more professional, complete, and efficient full-link commercialization system, consolidate the company's competitive advantages, and inject strong impetus for the company's continuous development and transformation. 展望未来，维健医药将依托这些优势，不断追求卓越。公司将始终以患者为中心，致力于满足患者日益增长的健康需求，持续扩展我们的自有和合作产品管线。通过不断的创新与突破，维健医药将和我们的优秀产业链伙伴一道共同开创医药产业的新篇章，为健康事业贡献更多的智慧与力量。 Looking ahead, Winhealth Pharma will rely on these advantages and continuously pursue excellence. The company will always center on patients, be committed to meeting the growing health needs of patients, and continuously expand our own and cooperative product pipelines. Through continuous innovation and breakthroughs, Winhealth Pharma will work together with our excellent industrial chain partners to jointly create a new chapter in the pharmaceutical industry and contribute more wisdom and strength to the health cause. 关于香港维健医药集团 About Hong Kong Winhealth Pharma Group 香港维健医药集团是一家总部位于香港的领先生物制药公司，在大中华地区开展商业运营，并在亚洲和欧洲区域不断扩展业务。公司专注于创新药物的商业化，致力于为心肾疾病、血液肿瘤、胃肠疾病、呼吸和抗感染疾病和罕见病以及其他未满足和严重未被满足的医疗需求患者提供突破性疗法。 Hong Kong Winhealth Pharma Group is a leading biopharmaceutical company based in Hong Kong, with commercial operations across the Greater China Area and an expanding regional footprint in Asia and Europe. Specializing in the commercialization of innovative medicines, the company is dedicated to delivering breakthrough therapies for patients with cardio-renal, gastrointestinal, respiratory and anti-infectious and rare diseases, as well as other unmet and severely underserved medical needs. 维健医药与众多世界领先的制药和生物技术公司建立了成功的长期合作伙伴关系，创造了一个独特而有意义的多元化产品组合，包括15种以上的专科产品，覆盖商业和后期临床阶段。维健医药始终以患者为中心，坚守对合作伙伴的承诺，不断扩展其产品组合，寻求通过其全球合作伙伴网络引进更多的变革性疗法。 WinHealth has established successful long-term partnerships with numerous world-leading pharmaceutical and biotechnology companies, creating a uniquely impactful and diversified portfolio that includes over 15 specialty products in both commercial and late clinical stages. Committed to patients and partners, WinHealth continuously expands its portfolio and seeks to bring more transformative therapies from its global network of partners. 欲了解更多信息，请访问www.winhealth.hk。 For more information, please visit www.winhealth.hk. 关于协和麒麟 About Kyowa Kirin 协和麒麟致力于研发具有改变生命价值的创新型药物。作为一家总部位于日本的全球化特药公司，我们在药物研发和生物技术创新等方面持续投入超过70年，目前，我们正致力于研发先进的抗体技术、细胞和基因疗法，以期帮助患有严重疾病或罕见疾病的患者。我们在全球四个地区——日本、亚太、北美和EMEA（欧洲、中东和非洲），因共同的价值观，对可持续发展的承诺以及致力于为人们带来笑容的使命而紧密相联。如需了解更多信息，请访问www.kyowakirin.com。 Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by a severe or rare disease. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions – Japan, Asia Pacific, North America, and EMEA/International. You can learn more about the business of Kyowa Kirin at www.kyowakirin.com.

One oral presentation and nine posters will shed light on real-world experiences of people living with XLH and the impact of burosumab treatment TOKYO, Sept. 19, 2024 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151) will share new research that enhances understanding about the use of burosumab in real-world clinical practice as well as the burden of those living with X-linked hypophosphatemia (XLH), a rare genetic metabolic bone disease. The findings will be presented at the American Society for Bone and Mineral Research (ASBMR) 2024 annual meeting, which takes place September 27-30 in Toronto. The oral presentation of "Patient reported outcomes (PRO) from a real-world study of burosumab treatment in adults with X-linked hypophosphatemia in the UK" will be made by Judith Bubbear, MD, Royal National Orthopaedic Hospital (UK) on Saturday, September 28, 11:30 am EDT (Presentation #1022). "As we learn more about XLH and how it impacts people's lives, real-world evidence can provide much-needed insight into potential strategies for managing this debilitating disease," said Angela Williams, PhD, Vice President and Global Head of Health Economics and Outcomes Research at Kyowa Kirin. "The breadth of our ASBMR data reflects our continued focus on advancing the science and understanding of XLH and improving the lives of people living with XLH." ASBMR XLH poster presentations: Real-world impact of burosumab treatment in people living with XLH: "Effectiveness of burosumab versus conventional therapy in adults with X-linked hypophosphatemia in a real-world setting from the XLH Disease Monitoring Program" (Poster#SAT-430) Lead author: Pablo Florenzano, MD, Pontificia Universidad Católica de Chile Poster Session I: Saturday, September 28, 2:15 – 3:45 pm EDT "Biochemical measurements according to age group in burosumab-treated patients with X-linked hypophosphatemia (XLH) in a real-world setting: an analysis of the XLH Disease Monitoring Program" (Poster #Fri-424, #Sun-424) Lead author: Leanne M. Ward, MD, Children's Hospital of Eastern Ontario Welcome Reception/Plenary Poster Session: Friday, Sept. 27, 5:30 – 7:30 pm EDT Poster Session II; Sunday, Sept. 29, 2:15 – 3:45 pm EDT "Symptoms experienced by adolescents living with X-linked hypophosphatemia at the end of skeletal growth (EOSG) treated with burosumab—a mixed methods analysis" (Poster #SAT-445) Lead author: Vrinda Saraff, MD, Birmingham Women's and Children's Hospital (UK) Poster Session I: Saturday, Sept. 28, 2:15 – 3:45 pm EDT "Efficacy and safety of burosumab in adult Chinese patients with X-linked hypophosphatemic rickets/osteomalacia (XLH): an open-label, multi-center, single-cohort, post-marketing phase IV study" (Poster#SUN-119) Lead author: Wei Liu, MD, Peking Union Medical College Hospital Poster Session II: Sunday, Sept. 29, 2:15 – 3:45 pm EDT "Efficacy and safety of burosumab in pediatric Chinese patients with X-linked hypophosphatemic rickets/osteomalacia (XLH): an open-label, multi-center, single-cohort, post-marketing phase IV study" (Poster#SAT-121) Lead author: Xiaoping Luo, MD, Tongji Medical College, Huazhong University of Science and Technology Poster Session I: Saturday, Sept. 28, 2:15 – 3:45 pm EDT XLH burden on multiple aspects of patients' lives: "Association between pain medication use and patient-reported outcomes in adults with X-linked hypophosphatemia: an exploratory analysis of a phase 3 study" (Poster #Sat-025) Lead author: Angela Williams, PhD, Kyowa Kirin International Poster Session I: Saturday, Sept. 28, 2:15 – 3:45 pm EDT "Individuals with hereditary hypophosphatemia are not prone to early death despite significant earlier development of co-morbidities: a retrospective Danish register study" (Poster #Sun-024) Lead author: Signe Sparre Beck-Nielsen, MD, PhD, Aarhus University Hospital (Denmark) Poster Session II: Sunday, Sept. 29, 2:15 – 3:45 pm EDT "X-linked Hypophosphatemia Community Impact Survey: psychosocial health, symptoms, and self-care" (Poster #SAT-LB 543) Lead author: Jill Simmons, MD, Vanderbilt University Medical Center Late Breaking Poster Session I: Saturday, Sept. 28, 2:15 – 3:45 pm EDT Bridging evidence gaps to improve clinical decision-making in XLH: "Advancing Patient Evidence in XLH (APEX): rational and design of real-world XLH global data unification program" (Poster #SAT-427) Lead author: Maria Luisa Brandi, MD, PhD, FIRMO Foundation, Florence, Italy and the University Vita-Salute San Raffaele, Milan, Italy Poster Session I: Saturday, Sep 28, 2:15-3:45 pm EDT About X-linked hypophosphatemia X-linked hypophosphatemia is a rare, lifelong, genetic disease that can impact the bones and muscles in both children and adults. In individuals with XLH, the body doesn't hold on to enough phosphorus, which is an essential mineral for bone health. This is due to the production of excess fibroblast growth factor 23 (FGF23), causing the body to release too much phosphorus through the urine. When phosphorus levels are too low (hypophosphatemia), it can cause the softening and weakening of growing bones in children (rickets) and of mature bones in adults (osteomalacia). In children, XLH typically appears as bowed legs or knock knees. Over time, bone weakening can also lead to bone abnormalities in the legs, delayed growth, and short stature. In adults, XLH may cause osteomalacia, fractures and pseudo-fractures, and hypophosphatemia. About CRYSVITA® (burosumab-twza) Injection CRYSVITA is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, which binds to and inhibits the biological activity of FGF23, the underlying cause of hypophosphatemia in XLH. By blocking FGF23, CRYSVITA helps to restore phosphorus reabsorption in the kidneys and increase the production of active vitamin D, which enhances intestinal absorption of phosphate and calcium. U.S. CRYSVITA Indication CRYSVITA is a fibroblast growth factor (FGF23) blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. Important Safety Information CONTRAINDICATIONS CRYSVITA is contraindicated: In concomitant use with oral phosphate and/or active vitamin D analogs (e.g., calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia. When serum phosphorus is within or above the normal range for age. In patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism. WARNINGS AND PRECAUTIONS Hypersensitivity Hypersensitivity reactions (e.g., rash, urticaria) have been reported in patients with CRYSVITA. Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment. Hyperphosphatemia and Risk of Nephrocalcinosis Increases in serum phosphorus to above the upper limit of normal may be associated with an increased risk of nephrocalcinosis. For patients already taking CRYSVITA, dose interruption and/or dose reduction may be required based on a patient's serum phosphorus levels. Injection Site Reactions Administration of CRYSVITA may result in local injection site reactions. Discontinue CRYSVITA if severe injection site reactions occur and administer appropriate medical treatment. ADVERSE REACTIONS Pediatric Patients Adverse reactions reported in 10% or more of CRYSVITA-treated pediatric XLH patients across three studies are: pyrexia (55%, 44%, and 62%), injection site reaction (52%, 67%, and 23%), cough (52%), vomiting (41%, 48%, and 46%), pain in extremity (38%, 46%, and 23%), headache (34% and 73%), tooth abscess (34%, 15%, and 23%), dental caries (31%), diarrhea (24%), vitamin D decreased (24%, 37%, and 15%), toothache (23% and 15%), constipation (17%), myalgia (17%), rash (14% and 27%), dizziness (15%), and nausea (10%). Postmarketing experience reported in CRYSVITA-treated pediatric XLH patients: blood phosphorus increased. Adult Patients Adverse reactions reported in more than 5% of CRYSVITA-treated adult XLH patients and in at least 2 patients more than placebo in one study are: back pain (15%), headache (13%), tooth infection (13%), restless legs syndrome (12%), vitamin D decreased (12%), dizziness (10%), constipation (9%), muscle spasms (7%), and blood phosphorus increased (6%). Spinal stenosis is prevalent in adults with XLH, and spinal cord compression has been reported. It is unknown if CRYSVITA therapy exacerbates spinal stenosis or spinal cord compression. USE IN SPECIFIC POPULATIONS There are no available data on CRYSVITA use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Serum phosphorus levels should be monitored throughout pregnancy. Report pregnancies to the Kyowa Kirin, Inc. Adverse Event reporting line at 1-844-768-3544. There is no information regarding the presence of CRYSVITA in human milk or the effects of CRYSVITA on milk production or the breastfed infant. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CRYSVITA and any potential adverse effects on the breastfed infant from CRYSVITA or from the underlying maternal condition. PATIENT COUNSELING INFORMATION Advise patients not to use any oral phosphate and/or active vitamin D analog products. Instruct patients to contact their physician if hypersensitivity reactions, injection site reactions, and restless legs syndrome induction or worsening of symptoms occur. You may report side effects to the FDA at (800) FDA-1088 or . You may also report side effects to Kyowa Kirin, Inc. at 1-844-768-3544. For important risk and use information, please see the full Prescribing Information for CRYSVITA. About Kyowa Kirin Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe. Learn more about Kyowa Kirin at: kyowakirin.com. COR-US-CRY-0049 September 2024 SOURCE Kyowa Kirin WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED