AleBund Pharma Files Updated Hong Kong IPO Prospectus Highlighting Commercialization of MIRCERA® in China through Roche Partnership

On October 19, Alebund (hereinafter referred to as "Alebund") and Roche (hereinafter referred to as "Roche") signed a commercialization agreement. According to the agreement, Alebund will exclusively promote Methoxy Polyethylene Glycol-Epoetin Beta Injection (brand name: MIRCERA®) in mainland China.

Methoxy Polyethylene Glycol Recombinant Human Erythropoietin Injection is a long-acting erythropoiesis-stimulating agent (ESA) used for the treatment of anemia associated with chronic kidney disease (CKD); it is the world's first approved erythropoiesis-stimulating agent that requires only once-monthly dosing. Methoxy Polyethylene Glycol Recombinant Human Erythropoietin Injection stimulates red blood cell production by interacting with erythropoietin receptors on bone marrow progenitor cells, effectively maintaining hemoglobin (Hb) levels within the target range for CKD patients (Hb≥110g/L). One of its key features is a long half-life, minimal hemoglobin fluctuation, and improved patient compliance.

CKD is an important public health issue in China, and anemia is one of the most common complications in CKD patients. The prevalence of CKD in China accounts for approximately 10.8% (130 million people) of the adult population, with over 50% of these patients also suffering from anemia [1]. As CKD progresses, the prevalence of renal anemia increases significantly. In non-dialysis CKD patients, the overall prevalence of anemia ranges from 28.5% to 72.0%, while in dialysis patients, the prevalence of anemia is as high as 91.6% to 98.2% [2]. Treating renal anemia remains a challenge, with gaps observed between the treatment rate for anemia and the hemoglobin (Hb) target attainment rate (Hb ≥ 110 g/L). Studies have shown that among patients on stable hemodialysis and peritoneal dialysis, the rates of not meeting the Hb target (Hb < 110 g/L) are as high as 62.3% and 67.5%, respectively [2].

Dr. Guoyao Xia, Co-founder, Chairman and CEO of Alebund, stated, "We are very pleased to have reached a collaboration with Roche. Alebund has been committed to innovative therapies for kidney diseases, and Mettinib® further enriches our pipeline, providing better solutions for patients with kidney disease."

Roche China President Bian Xin expressed, "We are very pleased to establish this cooperative relationship with Alebund. By fully utilizing the resources and professional capabilities of both parties, we aim to bring innovative drugs to benefit Chinese patients with chronic kidney disease-related anemia as soon as possible. Roche is deeply rooted in China. While continuously introducing innovative drugs into China, we will also actively engage in diverse collaborations with all parties to accelerate local innovation and contribute to the health care cause in China."

To support the commercialization of Meixinluo®, Alebund is building a professional marketing team focused on the nephrology field. Feng Jun, the head of commercialization, has over 25 years of extensive industry experience, having worked for several well-known multinational companies and listed firms. He particularly has marketing experience with major products in the renal disease area, having led two key nephrology products to achieve the top market share ranking. Feng Jun stated, "Meixinluo® is the first product that Alebund is responsible for commercializing. The company will utilize specialized academic promotion efforts to showcase the product features of Meixinluo®, providing doctors with optimized treatment options and benefiting a large number of chronic kidney disease patients suffering from anemia."

About Alebund

At the beginning of 2018, Alebund was incubated in Shanghai, China by top industry leaders in the field of nephrology. It is currently a clinical-stage biopharmaceutical company primarily dedicated to the discovery and development of innovative drugs for kidney diseases and other related chronic conditions, providing better clinical treatment options for patients with chronic kidney disease (CKD) and related disorders. Alebund has established a rich and balanced pipeline of novel drugs for kidney diseases, including products targeting CKD/dialysis complications, IgA nephropathy, diabetic kidney disease (DKD), autosomal dominant polycystic kidney disease (ADPKD), and more. The company’s research pipeline includes small molecule drugs and biologics, with its self-developed product AP301 currently undergoing pivotal Phase III studies. For more information, please visit www.alebund.com.

About Roche

Founded in 1896, Roche, headquartered in Basel, Switzerland, has over 125 years of history and is a global leader in biotechnology and in vitro diagnostics. As one of the leading companies in the industrial production of original research drugs, Roche is committed to continuously exploring the transformation of cutting-edge scientific achievements into disease diagnosis and therapeutic drugs, saving lives and improving the quality of human life. Roche offers differentiated drugs in the fields of oncology, immunology, anti-infectives, ophthalmology, and neuroscience.

As a leader in personalized healthcare, Roche spares no effort in advancing the development of healthcare to create greater value. Leveraging its unique strengths in both pharmaceuticals and diagnostics, combined with data insights from clinical practice, Roche actively collaborates with partners to provide the most suitable treatment options for each patient.

Roche, headquartered in Basel, Switzerland, operates in more than 150 countries worldwide. In 2022, Roche had 103,613 employees globally, with R&D investment reaching approximately 14.8 billion US dollars and total sales amounting to 66.3 billion US dollars. Roche has been recognized as one of the global leaders in sustainability in the pharmaceuticals, biotechnology, and life sciences sectors by the Dow Jones Sustainability Index (DJSI) for 13 consecutive years. This is a high recognition of Roche's long-term contributions, working with global partners, to improve access to healthcare.

Genentech, a wholly-owned subsidiary of Roche Group, is part of F. Hoffmann-La Roche Ltd. Additionally, Roche is the controlling shareholder of Chugai Pharmaceutical Co., Ltd. in Japan. For more information about Roche Group, please visit Roche's global website at www.roche.com.

References:

[1] Expert Group on the Diagnosis and Treatment of Renal Anemia, Branch of Nephrology, Chinese Medical Association. Chinese Expert Consensus on the Diagnosis and Treatment of Renal Anemia (2018 Revised Edition). Chinese Journal of Nephrology, November 2018, Volume 34, Issue 11;

[2] Renal Anemia Guidelines Working Group of the Nephrology Physicians Branch of the Chinese Medical Doctor Association. Clinical Practice Guidelines for the Diagnosis and Treatment of Renal Anemia in China [J]. Chinese Medical Journal, June 1, 2021, Vol. 101, No. 20.

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