October 19 2023, Shanghai, China — Roche Pharmaceutical (hereinafter referred to as “Roche”) and Alebund Pharmaceuticals (hereinafter referred to as “Alebund”) entered a supply and marketing agreement, under which Alebund will exclusively promote Roche’s MIRCERA® (methoxy polyethylene glycol-epoetin beta) in mainland China.
MIRCERA® is a long-acting erythropoiesis-stimulating agent (ESA) used for the treatment of anemia associated with chronic kidney disease (CKD), and is the first ESA approved for once-monthly administration worldwide. The peak sales of MIRCERA® has reached over USD 1 billion. MIRCERA® stimulates erythropoiesis by interacting with the erythropoietin receptor on progenitor cells in the bone marrow, therefore helps patients reach hemoglobin (Hb) level to the target rate (Hb≥110g/L). The advantages of MIRCERA® include the longer half-life, higher Hb stability and better patients’ adherence and compliance.
CKD is a public health issue in China, and anemia is one of the most common complications for CKD patients. The prevalence of CKD in China is about 10.8% (~130 million people), and more than 50% of the CKD patients have anemia. [1] Along with the progression of CKD, the prevalence of anemia continues to increase. The overall prevalence of anemia in non-dialysis CKD patients is 28.5% – 72.0%, while the prevalence of anemia in dialysis patients reaches 91.6% – 98.2%. [2] The treatment of anemia in CKD patients faces challenges and there is a gap between treatment rate and Hb target achieving rate. It has shown that the percentage of dialysis patients who failed to reach the target rate was as high as 62.3% for hemodialysis patients and 67.5% for peritoneal dialysis patients, respectively, according to the database for China renal dialysis patients’ information registration in 2018. [2]
“We are very excited with this cooperation with Roche, one of the world’s largest pharmaceutical companies and a leading provider of transformative innovative solutions,” said Dr. Gavin Xia, Co-founder, Chairman and CEO of Alebund. “Alebund is dedicated and committed to innovative renal therapeutics, and MIRCERA® is an important addition to the best solutions to renal patients.”
“We are pleased to establish this collaboration with Alebund, through which the two parties can fully leverage our strengths, expertise and capabilities to help Chinese CKD patients with anemia access innovative medicine MIRCERA®,” said Vivian Bian, CEO of Roche Pharma China. “Roche‘s long term commitment in China has never changed. As we strive for bringing more innovative medicines to China in fast pace, we also actively explore all kinds of collaboration opportunities, to further accelerate local innovation and support China healthcare development.”
In preparation for MIRCERA® commercialization, Alebund is building up a capable in-house sales & marketing team. Jun Feng, the newly appointed commercial head of Alebund, has rich industry experience of over 25 years in reputable MNCs and private listing companies, especially in the renal sector that he has a successful track record of leading two key renal drugs to reach the No.1 market share among peers. He commented, “MIRCERA® is the first product for Alebund to launch in the market. My team will make the best efforts to promote MIRCERA®, which would be a better treatment option for doctors as well as bring benefits to the large population of CKD patients with anemia in China.”
Reference:
[1] Experts Group of Chinese Society of Nephrology, Chinese Medical Association (CSN-CMA) for prognosis and treatment of anemia in CKD patients. Consensus on prognosis and treatment of anemia in CKD patients (2018 revision). Chinese Journal of Nephrology 2018; 34: 860-867. DOI: 10.3760/cma.j.issn.1001-7097.2018.11.012
[2] Clinical practice guidelines for prognosis and treatment of anemia in CKD patients by Chinese Nephrologist Association, Chinese Medical Doctor Association (CMDA – CNA). Chinese Medical Journal 2021; 101: 1463-502. DOI: 10.3760/cma.j.cn112137-20210201-00309
About Alebund
Alebund is a startup jointly incubated by a group of industry leaders in the field of nephrology in Shanghai in 2018. As a clinical-stage biopharmaceutical company, Alebund focuses on the discovery and development of novel therapies primarily for kidney diseases and their complications, as well as other chronic conditions. Alebund has built a diversified and balanced pipeline of drug candidates targeting a range of renal diseases, including chronic kidney disease (CKD)/dialysis complications, IgA nephropathy, diabetic kidney disease, and autosomal dominant polycystic kidney disease (ADPKD). Alehund’s pipeline comprises both small-molecule and biological assets, in which the most advanced in-house product AP301 is undergoing phase 3 study. For more information, please visit www.alebund.com.
About Roche
Founded in1896 in Basel, Switzerland with a history of over 125 years, Roche has grown into the world’s leading biotechnology company and the global leader in in-vitro diagnostics. As one of the leading industrial manufacturers of branded medicines, Roche pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. Roche is a global pioneer in pharmaceuticals with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the suitable care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
The Roche Group, headquartered in Basel, Switzerland, is active in over 150 countries and in 2022 employed more than 103,613 people worldwide. In 2022, Roche invested CHF 14.1 billion (USD14.8 billion) in R&D and posted sales of CHF 63.3 billion (USD66.3 billion). Moreover, for the 13th consecutive year, Roche has been recognized as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
礼邦医药与罗氏就美信罗®在中国的商业化达成合作
2023 年 10 月 19 日，中国上海——礼邦医药（以下简称“礼邦”）与罗氏制药（以下简称“罗氏”）签订商业化协议。根据该协议，礼邦将在中国大陆地区独家推广甲氧聚二醇重组人促红素注射液（商品名：美信罗®MIRCERA®）。
甲氧聚二醇重组人促红素注射液是一种长效促红细胞生成素（ESA），用于治疗慢性肾脏病（CKD）相关贫血；是全球批准上市的首个仅需每月给药一次的促红细胞生成素。甲氧聚二醇重组人促红素注射液通过与骨髓祖细胞上的促红细胞生成素受体相互作用来刺激红细胞生成，可以有效地在目标范围内维持 CKD 患者的血红蛋白（Hb）水平（Hb≥110g/L）。它的一大特点是半衰期长，血红蛋白波动小，可提高患者的依从性。
CKD 是我国的一个重要公共健康问题，而贫血是 CKD 患者最常见的并发症之一。中国 CKD 患病率约占成年人群的 10.8%（1.3 亿人），其中 50% 以上患者合并贫血。[1] 随着 CKD 的进展，肾性贫血患病率不断增加，非透析 CKD 患者中总体贫血患病率 28.5% – 72.0%，而透析患者中贫血患病率则高达 91.6% – 98.2%。[2] 肾性贫血治疗仍面临挑战，贫血治疗率与血红蛋白（Hb）达标率（Hb≥110g/L）存在差距。有研究表明，稳定血液透析和腹膜透析的患者中，Hb 未达标率（Hb<110g/L）高达 62.3% 和 67.5%。[2]
礼邦医药联合创始人、董事长兼首席执行官夏国尧博士表示，“我们非常高兴能与罗氏达成合作。礼邦医药一直致力于创新肾脏病疗法开发，美信罗®进一步丰富了我们的业务管线，为肾脏病患者提供更优的解决方案。”
罗氏制药中国总裁边欣表示，“我们很高兴与礼邦医药建立此次合作关系，充分利用双方的资源和专业能力，让创新药物早日惠及广大中国慢性肾性贫血的患者。罗氏制药深耕中国，我们在不断将创新药物带入中国的同时，也将积极与各方开展多元合作，加速本土创新，助力中国健康事业。”
为配合美信罗®的商业化，礼邦医药正在打造一支专注肾科领域的专业化营销团队。商业化负责人冯俊拥有超过 25 年的丰富的行业经验，曾任职于多家知名跨国公司和上市公司，尤其在肾脏病领域有大产品的营销经验，曾领导肾科两大产品达到市场份额占有率排名第一。冯俊表示，“美信罗®是礼邦医药首个商业化的产品，公司将通过专业化的学术推广力量，展示美信罗®的产品特性，为医生提供更优化的治疗选择，惠及广大患有贫血的慢性肾脏病患者。”
参考文献：
[1] 中华医学会肾脏病学分会肾性贫血诊断和治疗共识专家组. 肾性贫血诊断与治疗中国专家共识（2018 修订版）. 中华肾脏病杂志 2018 年 11 月第 34 卷第 11 期；
[2] 中国医师协会肾脏内科医师分会肾性贫血指南工作组. 中国肾性贫血诊治临床实践指南 [J]. 中华医学杂志 2021 年 6 月 1 日第 101 卷第 20 期。
关于礼邦医药
2018 年初，礼邦医药由顶尖的肾脏病领域行业领导者孵化于中国上海，目前是一家处于临床阶段的生物制药公司，主要致力于肾脏病以及其他相关慢性疾病的创新药物发现和开发，为慢性肾脏病及相关疾病患者提供更佳临床治疗方案。礼邦医药已经建立起了丰富且均衡的肾脏病新药产品管线，包括针对慢性肾病（CKD）/透析并发症、IgA 肾病、糖尿病肾病（DKD）、常染色体显性多囊肾病（ADPKD）等产品。公司在研产品包括小分子药物和生物制剂，自研产品 AP301 正在进行关键性 Ⅲ 期研究。欲了解更多信息，请访问 www.alebund.com。
关于罗氏
罗氏成立于 1896 年，总部位于瑞士巴塞尔，拥有 125 余年悠久历史，是全球领先的生物技术公司和体外诊断的领导者。作为领先的工业化生产原研药的企业之一，罗氏致力于不断探索从前沿科学到疾病诊断和治疗药物的成果转化，挽救生命、改善人类生活质量，在抗肿瘤、免疫、抗感染、眼科和神经科学领域拥有差异化药物。
作为个体化医疗的领跑者，罗氏不遗余力地推进医疗健康发展，以期创造更大价值。凭借制药和诊断两大领域的独特优势，结合临床实践中的数据洞察，罗氏积极携手合作伙伴，致力于为每位患者提供合适的治疗方案。
罗氏总部位于瑞士巴塞尔，业务遍及全球 150 多个国家。2022 年，罗氏全球拥有员工 103,613 名，研发投入约 148 亿美元，销售总额达 663 亿美元。罗氏连续 13 年位列道琼斯指数（DJSI）制药、生物技术和生命科学领域可持续发展的全球领导者之一。这是对罗氏携手全球合作伙伴，为提升医疗健康可及性长期贡献的高度认可。
美国基因泰克公司（Genentech）是罗氏集团的全资子公司。此外，罗氏也是日本中外制药株式会社（Chugai）的控股方。
更多关于罗氏集团的信息，请登陆罗氏全球网站 www.roche.com。