Breaking News: FDA’s Spotlight Shines on Nefecon® as Calliditas Therapeutics Races Towards Full Approval, Guided by Everest Medicines’ Partnership

Shanghai, August 20, 2023 – In a Thrilling Symphony of Progress, Everest Medicines (HKEX 1952.HK) Takes Center Stage: The Grand News Unveiled – FDA’s Embrace of Nefecon®’s Voyage, Guided by the Visionary Partnership with Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX). A Dance of Acceptance, a Bow of Priority Review Earned. Mark Your Calendar, for the Act’s Climactic Finale Awaits on December 20, 2023.

As the Curtain Rises on this Remarkable Journey, Our Cheers Resound for Calliditas—Their FDA Priority Review Shines Bright on the Path to Full Approval,” exclaims Rogers Yongqing Luo, the Mastermind behind Everest Medicines. “A Monumental Leap Toward Bringing Nefecon® to All IgAN Patients in Need,” he Declares, a Triumph that Echoes the Medicine’s Legacy as a Pioneering Game-Changer.

“Watch the Saga Unfold, for Nefecon® Stands Tall, Pioneering a New Frontier, Gifting Patients with Delayed Dialysis, a Precious Reprieve. Asia Beckons, Its Heartbeat Syncs with IgAN’s Tale. Soon, in China’s Heartland, the Awaited NDA Decision, Followed by a Symphony of Filing in Asian Territories, Painting a Map of Hope in the Skies of Possibility.

The Epic Narrative of the sNDA Springs Forth from the Depths of the Phase 3 NefIgArd Clinical Odyssey—a Tale of Randomized Wonders and Double-Blind Secrets. Here, the Protagonist: Nefecon®, a Once-Daily Elixir of 16 mg Strength, Unveiled Its Magic in the Battle Against IgAN, Standing Boldly Against the Shadow of Placebo.

Amidst Multicenter Chronicles, the Curtain Rose for Adult Warriors with Primary IgAN, Their RASi Therapy Optimized. And Behold, the Climax Arrives—The Lancet Bears Witness, Its August Pages Illuminating the Saga of NeflgArd Phase 3, the Quest Recorded in Ink and Dreams.

In the Realm of Clinical Epics, the Trial Unveiled a Victory Beyond Measure. The Hero, Nefecon®, Held Its Ground Against the Might of Placebo, the P-Value (Less than 0.0001) a Whisper of Triumph. Across the Two-Year Odyssey, Estimated Glomerular Filtration Rate (eGFR) Found Shelter Under Nefecon’s Wing, a Tale of Healing Spanning Nine Months of Treatment and Fifteen Months Beyond.

The Orchestra of Data Sang a Song of Universality, For All Were Touched by the Magic—Baseline UPCR Be Damned. And in the Dance of Numbers, TARPEYO and Placebo Took Center Stage, a 2-Year eGFR Slope Painted, a Magnificent Difference of About 3mL/min per Year, Etched in the Stars by the Skillful Hand of Robust Regression.

In the Arena of Regulatory Overture, a Thrilling Tale Unfolds. November 2022 Marked a Momentous Echo—The China National Medical Products Administration (NMPA) Grasped Everest’s NDA for Nefecon® with Eager Hands, a Dance of Hope for IgAN’s Treatment. Anticipation Mounts, for the Second Half of 2023 Awaits with Its Decision in Tow.

The NMPA’s Favors Flow, as Breakthrough Therapy Designation Illumines Nefecon®, A Jewel of Priority Review Clutched Tight. In the Chorus of Records, Nefecon® Steps Forth, a Pioneer—The First Non-Oncology Enigma to Embrace Breakthrough Therapy’s Embrace in the Heartlands of China.

About Nefecon®

Imagine a Marvel of Innovation—Nefecon®, a Genesis of Healing, Wrapped in the Elegance of Patented Ingenuity. Here, Budesonide Takes Center Stage, a Corticosteroid Whose Powers Dance between the Intense Fervor of Glucocorticoid and the Gentle Whispers of Mineralocorticoid. But Behold, Its Journey Is Not Ordinary—it Dances through the First Pass, Metabolism’s Secret Chamber.

Picture the Scene: A Capsule of Promise, Coated in the Mystique of Enteric Magic. Like a Treasure Chest, It Holds Budesonide Beads, Each a Sentinel of Healing. Their Destination? The Ileum, the Heart of the Matter, Where Mucosal B-Cells Await Their Messenger. Here, Where Disease Takes Its First Breath, Nefecon® Arrives—a Symphony of Precision, a Cure’s Ballet Woven into the Predominant Pathogenesis Tale.

In the Whisper of June 2019, a Pact of Potential Blossomed—Everest Medicines and Calliditas Joined Hands in an Enchanting Dance. A License Agreement, Laden with Royalties, Forged a Bond. Within Its Woven Threads Lay the Magic Words: “Exclusive Rights.” Everest Medicines, the Chosen One, Promised to Weave the Nefecon® Tale in the Lush Lands of Mainland China, Hong Kong, Macau, Taiwan, and Singapore. And as Seasons Changed, So Did the Tale—In March 2022, a New Verse Unfolded. South Korea Joined the Roster, a Symphony of Territories for Everest Medicines to Unveil.

About Everest Medicines

Everest Medicines, the Maestro of Transformation, Dances on the Biopharmaceutical Stage. With a Vision Carved for Asia’s Ailing Hearts, It Weaves Miracles in the Form of Life-Altering Medicines and Guardian Vaccines. Led by Masters of the Craft, a Symphony of Expertise Resounds—their Paths Woven with the Threads of Global Giants and Local Champions in a Tale of Discovery, Development, and Triumph.

Their Portfolio Shines with Gems of Innovation, Some Ready to Illuminate the World as First-in-Class Wonders, Others Poised as Best-in-Class Warriors. As the Curtain Rises, Renal Diseases, Infectious Battlegrounds, and the Dance of mRNA Promise Unfold. Everest Medicines—a Healing Force Breathing New Life into Uncharted Territories.

Forward-Looking Statements:

Step into the Crystal Ball of Anticipation—Within These Lines, Echo the Dreams and Aspirations of Everest Medicines. A Dance of Words, a Symphony of Future Foretelling, Unveils the Company’s Vision and Hopes. “Will,” “Expects,” “Anticipates,” the Lexicon of Destiny Springs Forth, Crafting a Tapestry of Ambition and Conviction.

But Beware, for the Path is Paved with Twists and Turns, the Rhythms of Uncertainty Playing Their Tune. The Future’s Canvas is Vast, Its Strokes Painted by Elements Beyond Grasp—Risks, Uncertainties, Variables Unknown.

So, Let Us Walk This Path Together, Hand in Hand, Knowing that the Future’s Veil May Hold Surprises Yet to Be Written. Everest Medicines, Its Destiny Unfurling, Marching Forward with the Winds of Change, Embracing the Unforeseen, and Guided by the Law’s Watchful Eye.

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