NEFECON(R) is the first ever treatment for IgAN to receive full approval from the U.S. Food and Drug Administration (FDA) and the first non-oncology therapeutic to receive breakthrough therapy designation in China by the China National Medical Products Administration (NMPA), underscoring its globally leading position and exceptional clinical value. Recently, at the 2024 American Society of Nephrology (ASN) Annual Meeting, data from the open-label extension (OLE) phase of the NefIgArd Phase 3 trial demonstrated that patients undergoing a second course of NEFECON(R) treatment experienced similar benefits in estimated glomerular filtration rate (eGFR) preservation and proteinuria reduction as observed after the initial treatment, with good tolerance. These findings further validate the feasibility and efficacy of long-term treatment strategies, aligning with recommendations from the "KDIGO 2024 Clinical Practice Guideline for The Management Of Immunoglobulin A Nephropathy (IgAN) And Immunoglobulin A Vasculitis (IgAV)", highlighting NEFECON(R)'s innovation and clinical value in IgAN treatment. NEFECON(R) was also listed as the only treatment proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes.
IgAN is highly prevalent in Asia and is one of the main causes of kidney failure in young adults in China. Statistics show that with approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand. Since NEFECON(R)'s first prescription was issued in Mainland China in May 2024, the product has demonstrated strong market performance. According to Everest Medicines' interim report, NEFECON(R) achieved RMB1.673 billion in sales within its first month, reflecting widespread recognition of its therapeutic benefits and the significant demand for innovative therapies among Chinese patients.
With NEFECON(R)'s successful inclusion in the NRDL, its accessibility and coverage in China are expected to increase significantly, driving sustained and robust commercial revenue growth for Everest Medicines. This milestone not only strengthens the company's leadership in nephrology but also injects new momentum into optimizing resource allocation and promoting synergistic development. As reimbursement coverage leads to expanded market penetration, this development is poised to be a key catalyst in unlocking the full value of the company's core products, further accelerating the reevaluation of its market potential.
NEFECON(R) included in the NRDL is a testament to Everest Medicines' differentiated commercial strategy. Another core product, XERAVA(R) (eravacycline) is the world's first fluorocycline antibiotic for the treatment of complicated intra-abdominal infections, continues to excel in the field of complicated intra-abdominal infections. According to the recently released final report of the "Comprehensive Evaluation Project on the Clinical Application of Eravacycline", the drug demonstrated an impressive overall treatment effectiveness rate of 90.1%, further affirming its clinical value and safety. As of the first half of 2024, XERAVA(R) achieved cumulative sales of RMB2.33 billion, underscoring its strong market acceptance and potential.
In the autoimmune disease portfolio, VELSIPITY(R) continues to make steady progress in its commercialization journey. In October, under the "Hong Kong and Macau Medicine and Equipment Connect" policy, VELSIPITY(R) received approval from the Guangdong Provincial Medical Products Administration and is now available for use in three designated medical institutions within the Greater Bay Area. Earlier this year, VELSIPITY(R) was also approved for use in Macau and Singapore. In addition, Everest Medicines recently submitted a new drug application (NDA) for VELSIPITY(R) in Hong Kong and plans to submit an NDA in Mainland China by the end of the year. As Everest Medicines' third commercialized product, VELSIPITY(R) is poised to become a key growth driver, with significant market potential expected to unfold as its adoption expands further.
Everest Medicines continues to make significant strides in innovative R&D, with its proprietary mRNA development platform now fully localized. The company's first personalized mRNA cancer vaccine, EVM16, has Initiated an Investigator-Initiated Clinical Trial (IIT). Additionally, EVER001, a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor being developed globally for the treatment of renal diseases, marks another important advancement. Everest Medicines will host an investor call on December 4th to discuss the results of the Phase 1b/2a clinical study of EVER001 in primary membranous nephropathy, highlighting its potential to drive future growth.
Driven by the inclusion of NEFECON(R) in the NRDL and the continued progress of its core pipeline, Everest Medicines' business model demonstrates its resilience and strength. The company remains steadfast in fulfilling its commitments to investors while strengthening market confidence in its innovation and long-term growth potential. With a diversified focus on renal, infectious, and autoimmune diseases, Everest Medicines is harnessing its robust commercialization platform to fuel growth, steadily advancing toward its vision of becoming Asia's leading global biopharmaceutical company.
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