内容来源:复宏汉霖
2023年9月12日,复宏汉霖(2696.HK)扩大与印度尼西亚制药公司PT Kalbe Farma Tbk.(以下简称“Kalbe”)旗下控股子公司PT Kalbe Genexine Biologics(以下简称“KGbio”)的独家许可与商业化合作,授予其在沙特阿拉伯、阿联酋、埃及、卡塔尔、约旦、摩洛哥等12个中东和北非地区(MENA)国家对复宏汉霖自主开发的抗PD-1单抗 H药 汉斯状 ® (斯鲁利单抗)包括广泛期小细胞肺癌(ES-SCLC)在内的两项适应症进行独家开发和商业化的权益。复宏汉霖与KGbio已于2019年达成协议,授予其H药在东盟十国的部分适应症及疗法的独家开发和商业化权利。
根据协议,复宏汉霖将负责H药在MENA区域上市后的产品生产和供应,并将从此次交易中获得700万美元的首付款、至多800万美元的监管里程碑付款和H药在上述合作区域净销售额从百分之十五到百分之二十的特许权使用费。此外,复宏汉霖还将基于H药在东南亚、中东和北非合作区域内的累计净销售额获得至多6.5亿美元的销售里程碑付款。
复宏汉霖首席执行官、总裁兼首席财务官
朱俊先生
H药是全球首个且目前唯一获批一线治疗小细胞肺癌的抗PD-1单抗,凭借其优异的疗效迄今已惠及逾3万名中国患者。乐虎lehu唯一官网非常高兴继东南亚授权之后,再度与KGbio在中东和北非地区携手,以期持续支持和改善当地患者的治疗效果和生存质量。通过KGbio在新兴市场强大的商业化网络和运营能力,乐虎lehu唯一官网深信,H药将为东南亚、中东和北非地区的患者带去新的希望与健康。
复宏汉霖首席商务发展官、商务拓展副总裁
曹平女士
复宏汉霖和KGbio于2019年达成合作,双方秉持共同的愿景和使命,加速推动了汉斯状在东南亚地区的上市进程。在过去的4年中,乐虎游戏官方网站不仅建立了深厚的合作基础,还在共同目标的驱动下,展现出高度的协同效应。展望未来,在中东北非地区,复宏汉霖和KGbio将进一步加强协作,深入挖掘市场潜力,为汉斯状开启新的篇章。
Kalbe董事、KGbio董事长
Sie Djohan先生
lehu66乐虎官网平台热忱欢迎复宏汉霖再次与KGbio携手合作。凭借KGbio在中东和北非地区的布局和运营能力,两家公司将共同推动创新药的开发。
H药 汉斯状®为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液,自2022年3月获批上市以来,H药已在中国获批用于治疗微卫星高度不稳定(MSI-H)实体瘤、鳞状非小细胞肺癌和广泛期小细胞肺癌。凭借突破性疗效和差异化优势,H药展现出了强大的市场竞争力,获得了业内广泛认可,其多项关键性临床研究结果发表于《美国医学会杂志》(JAMA)等国际知名期刊。复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合,在全球同步开展十余项肿瘤免疫联合疗法临床试验,广泛覆盖肺癌、食管癌和胃癌等适应症,全面覆盖肺癌一线治疗。H药全球累计入组患者超3600人,其中2项国际多中心临床试验入组白人的比例超过30%,充分的国际临床试验数据有望支持海外市场的申报,也为全球性临床应用奠定基础。
此次双方再度携手,将充分利用各自的资源和优势,积极推动H药在东南亚、中东和北非地区的商业化进程,提高H药在新兴市场的可及性,为更多患者带来可负担的高品质创新生物药。
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Henlius Expands Collaboration with KGbio to Develop, Commercialize and Supply Henlius' novel anti-PD-1 mAb HANSIZHUANG in MENA
Shanghai, China, September 12, 2023 - Shanghai Henlius Biotech, Inc. (2696.HK) has entered into an exclusive license agreement with PT Kalbe Genexine Biologics ("KGbio"), an Indonesian pharmaceutical company and a holding subsidiary to PT Kalbe Farma, Tbk ("Kalbe"), for the development and commercialisation of HANSIZHUANG (serplulimab injection) as a treatment for two indications including ES-SCLC, Henlius’ novel anti-PD-1 mAb, in 12 Middle East and North African (MENA) countries including Saudi Arabia, the United Arab Emirates, Egypt, Qatar, Jordan, Morocco, etc. In 2019, Henlius reached a collaboration agreement with KGbio, upon which KGbio is granted exclusive rights to develop and commercialize HANSIZHUANG in certain therapies in 10 ASEAN member countries.
Under the terms of the agreement, Henlius will be responsible for manufacturing and supply and will receive a US$7 million upfront payment, up to US$8 million in regulatory milestones, and royalties from KGbio ranging from 15% to 20% of net sales of HANSIZHUANG in the licensed MENA territory. Henlius will also be eligible to receive up to US$650 million upon the achievement of sales milestones in the licensed 22 countries in Southeast Asia and MENA.
“HANSIZHUANG is the first and only anti-PD-1 therapy approved for first-line treatment of small cell lung cancer. More than 30,000 Chinese patients have benefited from its excellent efficacy. We are excited to join forces with KGbio in MENA after the license granted in Southeast Asia,” said Jason Zhu, Chief Executive Officer, President, and Chief Financial Officer of Henlius. “Our aim is to continue supporting and improving the treatment outcomes and quality of life for local patients. Through KGbio's commercial network and operational capabilities in MENA, we firmly believe that HANSIZHUANG will bring new hope and health to patients in Southeast Asia and MENA.”
Ms. Ping Cao, Chief Business Officer, and VP of Business Development of Henlius, said, “The collaboration between Henlius and KGbio since 2019 was driven by a shared vision and mission and has opened a vast potential market for HANSIZHUANG in Southeast Asia. In the past 4 years, both parties have demonstrated a high level of synergistic effect driven by shared objectives. It has laid a strong foundation for our continued collaboration and I'm confident that together, we will continue to achieve more success in MENA.”
“We welcome the collaboration between KGbio and Henlius. With KGbio's network and operational capabilities in the Middle East and North Africa, this collaboration is an effort for the two companies to develop the products, especially for innovative biological products,” said Sie Djohan, President Director of KGbio, who is also the Director of Kalbe, KGbio's holding company.
The company's first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022. At present, HANSIZHUANG has been approved for 3 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC). With its breakthrough efficacy and differentiation advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognitions and its pivotal clinical research results have been published in leading medical journals such as the Journal of the American Medical Association (JAMA). Its synergy with in-house products of the company and innovative therapies are being actively promoted and over 10 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications, such as lung cancer, esophageal carcinoma, gastric cancer, etc., covering full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,600 subjects globally, and the proportion of White is over 30% in two multi-regional clinical trials (MRCTs). Its global clinical trial data will further support marketing applications in global markets and lay a foundation for clinical application all over the world in the future.
In the future, the two companies will fully leverage their respective resources and advantages to promote the commercialisation of HANSIZHUANG in Southeast Asia and MENA. It is anticipated that this will enhance HANSIZHUANG's accessibility in emerging markets and bring high-quality, affordable, and innovative medicines to more patients.
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