HaemaLogiX Pty Ltd.

SYDNEY, May 20, 2024 /PRNewswire/ -- HaemaLogiX Ltd, a clinical stage biotech developing novel immunotherapies for patients with blood cancers and B-cell diseases, is pleased to announce the appointment of Professor the Hon Greg Hunt, former Australian Federal Minister for Health, to the HaemaLogiX Board as a Non-Executive Director. This appointment marks the first corporate directorship that Prof Hunt has accepted since completing his period as Minister for Health. As the Federal Minister for Health from 2017 to 2022, Prof Hunt oversaw Australia's response to the global COVID-19 pandemic. He established telehealth as a permanent and universal centrepiece of Medicare, Australia's publicly funded universal healthcare scheme. In addition, Prof Hunt reformed private health and established long-term plans for mental health, aged care, medical research and primary care and listed over 2,000 new and amended medicines for public access. As Minister for Industry, Innovation & Science, Prof Hunt laid the foundation for the Australian Space Agency. As Minister for the Environment, he established the Emissions Reduction Fund, the Green Army, the $1 billion Reef Trust and helped lead Australia's negotiations for the Montreal Protocol update and Paris Climate Change Accord. For his work as Environment Minister, Prof Hunt was named Best Minister in the World at the World Government Summit in 2016. Outside of his political career, Prof Hunt holds academic appointments with world-class institutions including the University of Melbourne and University College, London. Prof Hunt is also the Chair of the CARDIO4Cities Accelerator Steering Committee under Novartis Foundation, and Chair of the Turner Institute for Mental Health at Monash University. On his decision to join the Board, Professor Hunt said, "HaemaLogiX tackles an unmet treatment need through innovative science which is recognised by world-leading scientific voices. Through my career, I have seen first-hand the invaluable benefits that immunotherapy and other emerging therapies can bring to patients. As we continue to advance our clinical trials (and subject to those trials) there is great hope for safer and more effective treatments which may be made available for patients with multiple myeloma and other conditions," said Prof Hunt. "Working with this well-respected team was also a very exciting prospect. HaemaLogiX is led by an impressive senior executive and board. The Scientific Advisory Board is notable for its internationally-renowned researchers, medical professionals, and academics," said Prof Hunt. Established in 2014, HaemaLogiX is an Australian biotech company specialising in developing immune-based treatments to improve outcomes for patients battling blood cancers such as multiple myeloma, and B-Cell diseases. The company has identified unique therapeutic targets and developed antibody-based treatment strategies to change the course of related diseases. Damian Clarke-Bruce, CEO and Managing Director of HaemaLogiX, said that the synergy between the company's research focus and Prof Hunt's passion for enhanced patient outcomes and innovation in science, makes him a strong addition to the board. "We're thrilled to welcome Greg to our company. He brings a wealth of advisory experience and knowledge to HaemaLogiX, with an equal commitment to seeing new treatments reach patients and the market." HaemaLogiX is the first and only company, of which we are aware, developing antibody therapy focused on the novel targets kappa myeloma antigen (KMA) and lambda myeloma antigen (LMA). KMA and LMA are found on the surface of cancer cells and not on normal cells in patients with multiple myeloma and AL amyloidosis, two diseases with limited treatment success and no effective cure. The company's antibody clinical trial programs targeting KMA and LMA are conducted in partnership with global leaders in haematology at Alfred Health and the Peter MacCallum Cancer Centre (Peter Mac). Validated and guided by these pioneering research institutions, HaemaLogiX runs first-in-class clinical programs. Led by Professor Andrew Spencer from the Alfred, a published Phase 2b efficacy study for the KappaMab program demonstrated an 83% overall response rate in multiple myeloma patients, combined with a 46% reduction in risk of death compared to the matched case control group, without delivering any increased adverse effects for the patients. Two patients from this study have remained on therapy for more than 4 years following their initial treatment. Haemalogix and Peter Mac are actively progressing the manufacturing stage of their collaborative CAR-T development program. The team plans to initiate the first CAR-T Phase 1 clinical trial targeting KMA on malignant plasma cells. This trial is in relapsed/refractory myeloma patients with KMA-positive bone marrow plasma cells and whose disease is progressing in spite of prior standard of care treatments. "Science is always evolving. Through our identification of unique novel antigens, HaemaLogiX technology and multiple therapeutic vehicles provide new options for patients. Greg further links us internationally with key industry stakeholders. As we move to expand our presence into the US, we are excited by this and ready for the next step of our company's growth," said Clark-Bruce. Non-Executive Chairman, Dr John Cullity said: "Greg represents a significant addition to our Board. As we further our clinical achievements, we look forward to working closely with Greg to amplify our presence within the Australian life science sector in addition to accessing global audiences as we scale up HaemaLogiX." Media Contact Jane Lowe +61 411 117 774 [email protected] Evelyn Yang +61 432 871 726 [email protected] About HaemaLogiX Ltd Formed in 2014, HaemaLogiX is a public unlisted biotech company researching antibody therapies for multiple myeloma. Multiple myeloma is a haematological (blood) cancer of plasma cells (B cells) that can cause focused damage to a patient's bone marrow. Multiple myeloma is considered treatable but generally incurable. The HaemaLogiX team has a wide range and depth of experience in antibody research, nonclinical & clinical development, manufacturing and commercialisation. The Scientific Advisory Board (SAB) members are internationally recognised experts in monoclonal antibody therapies and haematology. Our current research and clinical trial partners are global leaders in multiple myeloma and AL Amyloidosis therapy. HaemaLogiX is located in Sydney, Australia with clinical trials coordinated in Melbourne, Victoria and an evolving presence in the USA. About Professor Greg Hunt Greg is a highly experienced former Cabinet Minister in the Australian Government, having served as Australia's Minister for the Environment, Innovation and Health across three major portfolios over almost nine years. He advises a wide range of businesses and not for profits in the areas of innovation, leadership, strategic planning, health and the environment. As Minister for Health from 2017 to 2022, Professor Hunt oversaw an annual budget of $132 billion, 17 portfolio agencies and 7,000 staff. Prior to that, Prof Hunt was Minister for Industry, Innovation & Science (2016-2017) and Minister for the Environment, Australian Government (2013-2016). He was first elected to the Parliament in 2001, serving as the Federal Member for Flinders, a seat that he went on holding for the subsequent two decades until his retirement in 2022. Professor Hunt was appointed Honorary Enterprise Professor in the Faculty of Medicine, Dentistry and Health Services and the Faculty of Business and Economics at the University of Melbourne in December 2022 and Honorary Professor at University College, London in February 2024. Greg is also the inaugural Chair of the Advisory Council for the Turner Institute for Brain and Mental Health at Monash University and Chair of the Novartis Foundation's CARDIO4Cities Accelerator Steering Committee. SOURCE HaemaLogiX Limited

▲5月30-31日 第八届广州生物医药创新者峰会 扫码立即报名 注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。根据Nova One Adviso的最新报告，2023年全球医药CDMO市场规模为1462.9亿美元，到2033年将增至2959.5亿美元左右，2024-2033年的复合年增长率为 7.3%。CDMO为扩大新药开发而不断增加的投资；对新型疗法日益增长的需求；生物仿制药、生物制剂、个性化医疗、孤儿药、辅助诊断和适应性试验设计等市场的增长；癌症和老年相关疾病的流行均是推动CDMO市场增长的关键因素。随着企业开拓新领域，对遵守法规的要求不断提高，也推动了对精通合同开发和生产事务的专业服务供应商的需求增加。此外，企业在这一领域采取的关键举措预计也将促进市场增长。2022年1月，Lonza 与单克隆抗体开发商HaemaLogiX 合作生产骨髓瘤候选药 KappaMab单抗。2023 年12月，Innovent Biologics公司延长了与Synaffix B.V.公司的许可协议，Synaffix B.V. 公司隶属于龙沙集团，致力于推动其临床阶段平台技术的发展，以创造具有一流治疗指数的ADC。这些生物制药举措有望加速医药合同开发、生产和服务市场的增长。制药公司谋求创新和进入临床速度的因素也至关重要。小型公司和专业制药企业越来越依赖第三方服务供应商来满足关键的行业要求。许多CRO和CDMO都是采用一站式服务模式的综合解决方案提供商。在这种模式下，CRO负责管理从原料药开发到剂型开发的所有工作，涵盖从早期开发阶段到商业化的各个阶段。为了有效地提供此类服务，CDMO 需要具备各种使能技术和专门处理能力，以应对特定的挑战。虽然这些服务可以解决众多问题，但不同的 CDMO 企业在产品设计能力方面存在着相当大的差异，而这种差异可能是扩大产品概念并将其推向市场的关键。此外，CDMO在各种技术类型方面的广泛技能和熟练程度使其有能力满足不同客户的要求。越来越多的客户愿意在一流的、始终可靠的CDMO服务上投入更多。特别是，大型制药企业热衷于减少与供应商的互动，以无缝整合整个价值链中的多个流程。这促使CDMO提供全面的解决方案，使客户能够协调一致、毫不费力地管理运营。医药CDMO市场报告要点根据产品划分，2023 年，活性药物成分 (API) 市场以81.11%的最大收入份额领跑市场。该细分市场的增长主要受到竞争激烈的药物开发和对端到端CDMO服务日益增长的需求的推动。此外，原料药制造技术的进步、生物制药行业的增长以及老年人口的增加也是推动该细分市场增长的一些关键因素。由于生物仿制药、非专利药和再生疗法等医药产品需求旺盛，2023年商业领域将以 87.99%的最大收入份额领跑市场。在这方面，商业CDMO可以提供知识、节省时间并具有成本效益。根据应用，肿瘤细分市场占据主导地位，2023年的收入份额最大，达到 21.92%。全球癌症病例数量的增加推动了该细分市场的发展。此外，不断增加的医药研发投资、专利到期以及对肿瘤药物和生物创新的需求也是推动肿瘤市场发展的因素。2023 年，亚太地区以37.85%的收入份额占据市场主导地位。各种因素的存在，如完善的社会保险计划和不断改善的经济条件，使患者能够自付医药费用，预计将极大地推动市场的发展。医药CDMO市场最新趋势外包增加：出于成本效益和专业化的考虑，制药公司继续将药物开发和生产的各个环节外包给CDMO，对灵活性、效率和获得先进技术的需求推动了这一趋势。生物制剂和生物仿制药：随着对生物药和生物仿制药需求的增加，CDMO正在扩大其在生物制药开发和生产方面的能力，包括细胞系开发、生物工艺优化和生物制剂的大规模生产。先进疗法：人们对细胞和基因疗法等先进疗法的兴趣与日俱增。CDMO正在投资专门的基础设施和专业知识，以支持这些新型疗法的开发和生产。虚拟制药模式：缺乏内部制造能力的小型和虚拟制药公司越来越依赖CDMO将其产品推向市场。创新型初创企业和生物技术公司的崛起推动了这一趋势。综合服务：CDMO正在扩大服务范围，提供从早期开发到商业生产和监管支持的端到端解决方案。这种综合方法简化了药物开发流程，加强了合作伙伴之间的合作。质量与合规性：随着监管标准越来越严格，CDMO 正在优先考虑质量保证和合规性。区域洞察北美的医药CDMO市场预计将以6.6%的复合年增长率增长。美国和加拿大制药业的增长是促进市场增长的关键因素。此外，主要市场参与者的大量存在和临床试验预计将推动市场增长。严格的监管要求（尤其是在美国和加拿大）需要专业知识和合规性专业技能，这使得CDMO成为克服监管障碍的一个有吸引力的选择。亚太地区医药CDMO市场趋势近年来，新加坡、中国和印度等国家因其不断扩大的制造能力而成为制药行业的主要参与者。2023 年，中国的医药CDMO市场份额最大，CDMO与制药公司之间的合作协议不断增加，推动了中国医药CDMO市场的增长。例如，2023年9月，中国 CDMO企业Chime Biologics与韩国Kings Pharm建立了战略合作伙伴关系。由于靶向给药和缓释剂型等给药技术的快速发展推动了药品CDMO市场的增长，预计日本药品CDMO市场在预测期内将以最快的复合年增长率增长。印度制药CDMO市场预计在预测期内将以最快的复合年增长率增长，原因是成本低廉、拥有行业专家和符合WHO-cGMP标准的设施。适应症洞察根据应用，肿瘤细分市场在2023年以21.92%的最大收入份额领跑市场，预计在预测期内将以 8.2% 的最快复合年增长率增长，可归因于癌症发病率的上升、对创新和有效治疗的需求增长以及有利的监管途径。市场细分为肿瘤、传染病、神经系统疾病、心血管疾病、代谢性疾病、自身免疫性疾病、呼吸系统疾病、眼科、胃肠道疾病、激素紊乱、血液病及其他适应症。此外，个性化医疗和靶向治疗的进步也为癌症治疗带来了革命性的变化，疗效更高，不良反应更少等因素将为制药公司与CDMO合作开发针对疾病的创新产品创造新的可能性。此外，对单克隆抗体、ADC 和其他一些生物制药等先进疗法的高研发投入预计将促进该细分市场的收入增长。传染病市场也极具发展前景。肝炎、霍乱、麻疹、水痘和伤寒等严重疾病的发病率不断上升，导致该细分市场的收入大幅增长。此外，医药CDMO专注于发现、研究和开发新药及疗法。尽管如此，一些针对致命疾病（如丙型肝炎、利什曼病、副伤寒、艾滋病、埃博拉病毒、诺如病毒）的分子实体仍处于开发和研究阶段。因此，此类疾病的日益流行产生了对新药的需求，从而推动了市场的增长。产品洞察根据产品划分，2023 年，活性药物成分 (API) 部分以81.11%的最大收入份额领跑市场，该细分市场的增长可归因于对多样化的配方和生产工艺的需求增加、客户偏好以及全球认可度。此外，越来越多的CDMO专注于新药物制剂也是推动该细分市场增长的另一个因素。原料药医药CDMO市场按类型细分为传统原料药、高活性原料药（HP-API）和生物制剂/大分子药物。传统原料药采用复杂的研发和商业生产阶段。由于研发活动不断增加、慢性病病例不断增多、仿制药的采用率不断提高以及小分子等传统活性成分的需求激增，预计传统原料药细分市场在预测期内将以 5.2% 的复合年增长率增长。2023年，药物产品细分市场预计将在预测期内以丰厚的复合年增长率增长。对口服固体制剂、半固体制剂、液体制剂等药物产品的强劲需求预计将推动该细分市场的发展。此外，不断增长的研发管线预计也将对市场产生积极影响。工作流程洞察根据工作流程，2023年，商业部门以87.99%的最大收入份额领跑市场。CDMO市场分为临床和商业两个部分。促进市场增长的一些关键因素包括：CDMO在药物开发和生产方面拥有强大的专业知识、CDMO整合了先进的药物开发和生产技术、创新疗法的研发不断增加以及产品组合不断扩大。此外，商业CDMO还能在较短的时间内提供具有成本效益的服务，这有望促进市场增长。临床领域的增长可归因于在药物开发投资和资金的支持下，研究药物和创新的研发活动不断增加。近期发展2023年2月，药明康德与Cidara Therapeutics扩大合作，共同推进Cidara的肿瘤 DFC项目。该协议扩展了现有合作，包括CMC开发和GMP生产,最初主要针对 Cidara用于流感的CD388药物。2023年4月，Corden Pharma在德国建立了一个卓越的药物产品创新中心，该中心具有提高口服固体制剂 (OSD) 药物产品生物利用度的能力，尤其适用于生物利用度较低的原料药。这一扩张增强了公司在CDMO市场的运营能力。2023年10月，Cambrex公司在北卡罗来纳州高点市的小分子原料药生产厂成功完成了3800万美元的产能扩张。此次扩建使工厂的生产能力提高了两倍。此次扩建包括尖端的分析和化学开发实验室、两个额外的临床生产车间，以及一个拥有三个工作中心和 2,000 升反应器的小规模商业生产基地。总结创新研发的热潮之下，全球CDMO行业处于持续放量发展的趋势，保持较高的市场景气度。无论是研发进程，还是产业化落地，初创药企抑或是大型制药企业均能在CDMO所提供的优质服务中获益，小型制药企业与CDMO公司合作的需求更加强烈，进一步促进了CDMO行业的发展。CDMO也跟随着医药市场日新月异的变化，不断优化服务，满足不同类型客户的实际需求。在内外需求强劲的趋势下，CDMO行业进入稳定发展期，预计未来CDMO市场将有更多巨头涌现出来。参考资料：https://www.biospace.com版权声明：本文转自生物药大时代，如不希望被转载的媒体或个人可与我们联系，我们将立即删除 活动推荐  5月 • 第八届大湾区生物医药创新者峰会  关键词：  小分子，XDC，多肽及GLP-1热点话题，80+行业专家（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

SYDNEY, Nov. 13, 2023 /PRNewswire/ -- HaemaLogiX Ltd, a clinical stage Australian biotech, is pleased to announce the appointment of Damian Clarke-Bruce as Managing Director and CEO, effective 13 November 2023. Outgoing CEO Bryce Carmine will remain active in the company, retaining his role as Chair. "I'm immensely proud to have served as HaemaLogiX's CEO for the past 8 years, during which time we have focused the strategic direction of the company on development of our portfolio from a single immunotherapy asset to potentially seven products, with two now in clinical stages," Mr Carmine said. "I congratulate Damian on his appointment, and I look forward to working together to further build toward the successful commercialisation of the company and our products." With more than 25 years' experience in drug commercialisation and portfolio strategy in the pharmaceutical and biotechnology sectors, Mr Clarke-Bruce brings deep clinical knowledge across several therapeutic areas pertinent to HaemaLogiX's clinical strategy, including oncology, immunology and neuroscience. He also brings an extensive international clinical and pharmaceutical network, which will be invaluable to HaemaLogiX's commercialisation pathways. Mr Clarke-Bruce most recently held the position of Managing Director and CEO for Race Oncology. Previous positions include US Executive Director of Marketing in Rare Disease and Head of the Global Launch Leadership Team for Pharming Healthcare Inc., where he was recognised with the CEO award for his role in commercialising leniolosib (Joenja). Mr Clarke-Bruce also held local, global and US-based executive director and leadership roles in therapeutics marketing and sales with Novartis, Celegene and Biogen in immunology and neuroscience. Mr Clarke-Bruce holds MSci and BSSci degrees (USyd & UNSW) and post graduate qualifications in business management (MGSM) and finance from Harvard University, and in bespoke areas of clinical interest from Harvard University and MIT. He is also a Graduate of the Australia Corporate Institute of Directors (GAICD) and holds a board position with Adnovate Clinical, a UK based global clinical services company. HaemaLogiX Director Alan Liddle said: "It's a pleasure to welcome Damian to the HaemaLogiX leadership team. Damian's extensive knowledge of global strategic commercialisation, along with his experience in business development and licensing, launch excellence and marketing will be instrumental to the next stage of the HaemaLogiX journey. He brings all the knowledge, skills, and capabilities at this pivotal time to guide the clinical development of our lead assets, KappaMab and KMA.CAR-T as we continue ongoing efforts to expand our investor base and secure the necessary funding to invest in our key assets. "On behalf of the Board, I sincerely thank Bryce for his 8-year tenure as CEO, in which he successfully spearheaded the company's strategic focus during a period of great global uncertainty. He will be invaluable in his continued role on the Board." About HaemaLogiX Ltd - : Formed in 2014, HaemaLogiX is a public unlisted biotech company researching antibody therapies for multiple myeloma. Multiple myeloma is a haematological (blood) cancer of plasma cells (B cells) that can cause focused damage to a patient's bone marrow. Multiple myeloma is considered treatable but generally incurable. The HaemaLogiX team has a wide range and depth of experience in antibody research, nonclinical & clinical development, manufacturing and commercialisation. The Scientific Advisory Board (SAB) members are internationally recognised experts in monoclonal antibody therapies and haematology. Our current research and clinical trial partners are global leaders in Multiple Myeloma and AL Amyloidosis therapy. HaemaLogiX is located in Sydney, Australia. SOURCE HaemaLogiX