Breaking Boundaries: Everest Medicines Celebrates Nefecon® Milestone with Macao’s Drug Application Approval for Primary IgA Nephropathy Treatment

SHANGHAI, Aug. 24, 2023 /PRNewswire/ — Embarking on a Pioneering Journey: Everest Medicines (HKEX 1952.HK, “Everest” or the “Company”), a trailblazing biopharmaceutical powerhouse, has unveiled a momentous chapter in its saga. With a steadfast focus on crafting innovative medicines and transformative vaccines, Everest proudly announces a monumental achievement – the nod from the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China, which warmly embraces Everest’s New Drug Application (NDA) for Nefecon®. This breakthrough therapy promises new hope for adults at risk of disease progression due to primary immunoglobulin A nephropathy (IgAN).

Anticipation thrives in the air as Everest sets its sights on 2023, envisioning the approval of its NDA for Nefecon® in the vibrant realm of Macao. This triumphant stride marks the third milestone in Everest’s journey, following Mainland China in November 2022 and Singapore in April 2023. Each acceptance echoes the resounding success of Nefecon® as a pioneering treatment therapy, defying disease norms.

Rogers Yongqing Luo, the visionary Chief Executive Officer of Everest Medicines, underscores the company’s unwavering commitment. With heartfelt determination, Luo shares, “Everest remains dedicated to reaching out to as many patients as possible across Asia. The battle against primary IgA nephropathy holds immense significance, particularly in a region where its prevalence surpasses global averages. Our mission extends to cover the Greater Bay area, and beyond, encompassing the rich tapestry of patients who await a ray of hope.”

Nefecon®’s acclaim has already extended to the United States, the European Union, and the UK. But Everest’s vision doesn’t stop there. The NDA journey in mainland China is accompanied by a Priority Review, with the much-anticipated approval slated for the second half of this year. It stands as a trailblazer, the first non-oncology medicine to seize the coveted Breakthrough Therapy Designation in China, a testament to its transformative potential. Amid this backdrop of anticipation, Nefecon® has already commenced its transformative journey in Shanghai Ruijin Hospital’s Hainan subsidiary, touching lives through an early-access program since April.

The narrative of Everest’s Nefecon® is a symphony of innovation, resilience, and hope. As the chapters unfold, patients find solace in a treatment crafted with care, a beacon of progress in the relentless battle against primary IgA nephropathy. Everest’s legacy is one of transformation, where science meets compassion, weaving a tapestry of possibilities for a better tomorrow.

About Nefecon® 

“Unveiling the Science Behind Nefecon®: A Glimpse into Its Innovative Design and Far-Reaching Impact”

Nefecon® emerges as a trailblazing creation, a patented oral wonder that carries the promise of transformation. At its core lies budesonide, a corticosteroid that wields potent glucocorticoid power intertwined with a gentle mineralocorticoid touch. But what truly sets Nefecon® apart is its intricate dance with metabolism – a dance of delayed release, carefully choreographed to unveil its magic precisely where it matters.

Imagine a capsule, enteric coated to withhold its secrets until it reaches the heart of the action – the Peyer’s patch region of the lower small intestine. Within each capsule, coated beads of budesonide lie in wait, each one a messenger of hope. These beads are on a mission, a journey that ends where the battle begins – the ileum, where mucosal B-cells hold the key to igniting change.

The tale of Nefecon® is also one of partnerships and alliances, exemplified by Everest Medicines’ exclusive, royalty-bearing license agreement with Calliditas. This agreement has woven a tapestry of exclusive rights, a roadmap that guides Nefecon®’s journey of development and commercialization across a vivid landscape – Mainland China, Hong Kong, Macau, Taiwan, Singapore, and now, South Korea.

Through innovation, precision, and a commitment to pioneering solutions, Nefecon® beckons a new era, inviting us to witness science in action. It’s more than a capsule; it’s a testament to the transformative potential of human ingenuity.”

About Everest Medicines

“Pioneering Change: Everest Medicines, a Trailblazer in Asia’s Healthcare Landscape”

Amidst the dynamic canvas of Asian healthcare, Everest Medicines stands tall as a biopharmaceutical force with an unswerving focus on revolutionizing treatments. Their mission is clear: crafting pharmaceutical products and vaccines that bridge the chasm of unmet medical needs for patients across the region.

Guided by a stellar management team, Everest Medicines weaves together expertise and experience gathered from the global and local fronts of pharmaceutical prowess. Their collective journey reads like a symphony of discovery, clinical mastery, regulatory finesse, business acumen, and operational excellence. This isn’t just a company; it’s a convergence of visionary minds, each contributing their unique brilliance to the tapestry of transformation.

The heart of Everest Medicines’ endeavor is an impressive portfolio, a treasury of molecules that hold the promise of being global trailblazers. With many of these heroes stepping into the final stages of clinical development, Everest Medicines isn’t just creating treatments; they’re crafting solutions that redefine possibilities.

Renal diseases, infectious battles, autoimmune enigmas – these are the battlegrounds where Everest Medicines chooses to make a difference. Their therapeutic realms echo with dedication, compassion, and an unwavering commitment to addressing challenges that have lingered far too long. As Everest Medicines journeys forward, it carries with it the aspirations of countless individuals awaiting a brighter and healthier tomorrow.

Forward-Looking Statements:

“Embarking on the Future: Navigating Forward-Looking Statements with Everest Medicines”

In the realm of possibility, Everest Medicines paints a canvas of intent, belief, and ambition through its forward-looking statements. The future unfolds with promises that resonate with words like “will,” “expects,” “anticipates,” and “confident.” Yet, within this tapestry of aspiration lies the acknowledgment that the journey forward is laced with uncertainty.

Forward-looking statements, like constellations in the night sky, guide the way but do not guarantee the destination. As Everest Medicines charts its course, it does so with the understanding that risks, uncertainties, and unforeseeable factors are woven into the very fabric of progress.

Realism tempers optimism, reminding us that the road ahead is subject to twists and turns. The future is a symphony of change, orchestrated by a medley of variables – from business operations and financial landscapes to the broader context of our world. Everest Medicines acknowledges that the script of reality may diverge from the lines penned by intent.

The horizon teems with potential shifts – in our business, in the competitive arena, and within the intricate dance of politics, economics, law, and society. As Everest Medicines propels itself forward, it does so with a commitment to transparency. The company, along with its affiliates and stewards, doesn’t just issue a proclamation; it crafts an agreement with its stakeholders. There’s a recognition that the journey isn’t solitary – it’s a partnership that demands honesty, adaptation, and shared responsibility.

The roadmap is illuminated, but it is also agile, ready to accommodate the unexpected. Everest Medicines acknowledges the rhythm of change and the dynamism of growth. It sets forth, promising not a static journey but a vibrant evolution. And as time marches on, Everest Medicines assures us that it won’t merely state its course and move on; it will remain anchored in its duty to provide updates and insights that light our way forward.

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