AleBund Pharma Files Updated IPO Prospectus Highlighting Commercialization Partnership with Roche for MIRCERA® in China

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.®MIRCERA®）。

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). A key feature is its 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% of the adult population (130 million people), with more than 50% of patients also suffering from anemia.[1]  。FollowWith the progression of CKD, the prevalence of renal 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 is as high as 91.6% - 98.2%.[2] . The treatment of renal anemia still faces challenges, with gaps remaining between the anemia treatment rate and the hemoglobin (Hb) target achievement rate (Hb≥110g/L). Studies have shown that among patients with stable hemodialysis and peritoneal dialysis, the rates of not reaching Hb targets (Hb<110g/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 cooperate with Roche®In order to commercialize its products, Alebund is building a professional marketing team dedicated to 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 publicly listed firms. He has particular expertise in marketing major products within the renal disease sector and has led two key nephrology products to achieve the top market share ranking. Feng Jun stated, “Meixinluo...®Is the first commercial product of Alebund, the company will demonstrate Mixinluo through professional academic promotion.®"The product characteristics provide doctors with more optimized treatment options, benefiting a large number of chronic kidney disease patients suffering from anemia."

About Alebund

In early 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 and development portfolio 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 and headquartered in Basel, Switzerland, Roche 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 frontier science into diagnostic and therapeutic solutions for diseases, saving lives and improving human quality of 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 appropriate treatment solutions 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 investments of approximately USD 14.8 billion and total sales reaching USD 66.3 billion. Roche has been ranked as one of the global leaders in sustainability in the pharmaceuticals, biotechnology, and life sciences sectors on the Dow Jones Sustainability Index (DJSI) for 13 consecutive years. This is a high recognition of Roche's long-term contributions to improving access to healthcare in collaboration with global partners.

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. For more information about Roche Group, please visit the global Roche website at www.roche.com.

References:

[1] Expert Consensus Group on the Diagnosis and Treatment of Renal Anemia of the Chinese Society 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, Vol. 34, No. 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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