Tag: Everest Medicines Limited

Everest Medicines (HKG: 1952) today announced that the supplemental application for the production expansion of NEFECON® has been officially approved by China’s National Medical Products Administration (NMPA). This approval for production expansion will further boost capacity and increase product supply, enabling a more efficient response to the growing clinical demand in China and across Asia.

NEFECON® is the first and only etiological treatment for IgA nephropathy (IgAN) to receive full approval in China, the United States, and Europe, serving as a foundational first-line therapy for patients with IgAN. Since its initial approval in China in November 2023, NEFECON® was subsequently included in the National Reimbursement Drug List (NRDL) in November 2024, and received full approval from the NMPA in May 2025, irrespective of proteinuria levels, benefiting most individuals living with IgAN.

NEFECON® specifically modulates the mucosal immune system in the gut to reduce the formation of pathogenic galactose-deficient IgA1 (Gd-IgA1) that trigger IgAN. Results from the Phase 3 clinical study NefIgArd demonstrated that NEFECON® reduces the decline in kidney function by 50%. Results from Phase 3 clinical study NefIgArd of the Chinese population shows that NEFECON® reduces kidney function decline by 66%, and delays disease progression to dialysis or kidney transplantation by 12.8 years.

“The expansion of our NEFECON® production capacity will help better meet the growing clinical treatment needs of IgAN patients in China.” Said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “China has one of the highest rates of primary glomerular disease in the world, with more than 5 million patients estimated to be living with IgAN and over 100,000 new cases diagnosed each year. Chinese IgAN patients generally experience faster disease progression and poorer prognosis, highlighting a significant unmet medical need.

As the only etiological treatment for IgAN currently recommended by both international and Chinese guidelines, the expansion of NEFECON® production will further accelerate the uptake of etiological treatment, enabling more patients to access standardized treatment earlier to delay disease progression and protect kidney function. We will continue to enhance the accessibility and affordability of NEFECON®, supporting its advancement from ‘changing the treatment landscape’ to ‘redefining the standard of care’.”

NEFECON®, as the only in-disease IgAN treatment has been included in the KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV) (public review draft), making it the only targeted therapy endorsed by both international and Chinese guidelines. NEFECON® has been approved across all Everest Medicines’ territories, including mainland China, Hong Kong SAR, Macau SAR, Taiwan region, China, as well as Singapore and South Korea, and continues to expand its therapeutic impact across Asia.

As production capacity continues to grow and supply capabilities improve, NEFECON® is well positioned to benefit a broader patient population by accelerating the uptake of etiological treatment, enabling more patients to access standardized care earlier to delay disease progression and preserve kidney function.

Everest Medicines (HKG: 1952) today announced a strategic equity investment in I-Mab (NASDAQ: IMAB), under which Everest will invest US$30.9 million (equivalent to approximately HK$242.6 million) in cash. Upon completion of the subscription and inclusive of shares already held, Everest will own approximately 16.1% of I-Mab’s total outstanding shares.

Under the terms of the agreement of this offering, Everest will subscribe for 15,846,154 newly issued American depositary shares (ADSs) of I-Mab at a price of US$1.95 per ADS, for a total consideration of US$30.9 million. Upon completion, Everest will hold a total of 15,846,154 ADSs and 6,078,571 ordinary shares, representing approximately 16.1% of I-Mab’s total issued share capital, inclusive of 6,078,571 ordinary shares it already owns. In addition to Everest, several leading global institutional investors are participating in this offering, including Janus Henderson Investors, Adage Capital Partners LP, Woodline Partners, and Exome Asset Management.

This strategic investment marks a significant step in Everest’s ongoing efforts to strengthen its position in next-generation cancer immunotherapy. It also reflects the strong clinical and business development complementarity and synergy between the two companies. I-Mab’s Claudin 18.2 x 4-1BB bispecific antibody, givastomig, demonstrated an impressive overall response rate (ORR) of 83% in combination with immunotherapy in a Phase 1b trial for first-line gastric cancer. I-Mab’s differentiated 4-1BB receptor-targeting platform and bispecific antibody pipeline are highly complementary with Everest’s existing mRNA cancer vaccine and in vivo CAR-T platforms.

In addition, I-Mab’s unique clinical translational capabilities, particularly in the U.S., combined with Everest’s clinical capabilities in Asia, could help accelerate the development and global expansion of pipeline products for both companies.

“This strategic equity investment furthers our plan to be an active player in next-generation oncology programs across global markets. Everest and its Board of Directors believe this investment recognizes I-Mab’s unique clinical translational capabilities in the U.S., which are complementary and synergistic with the Company’s strong Asia presence,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “As a biotech pioneer in China, Everest has built internally developed pipeline assets including mRNA therapeutic cancer vaccines and in vivo CAR-T therapies targeting cancer and autoimmune diseases. Our areas of focus meaningfully intersect with I-Mab’s differentiated 4-1BB platform and bispecific antibody pipeline, including oncology candidates Givastomig (Claudin 18.2 x 4-1BB bispecific antibody) and Ragistomig (PD-L1 x 4-1BB bispecific antibody), both promising programs that we are closely watching. Furthermore, both companies may be able to leverage their combined expertise to run clinical programs in both China and the U.S. Everest is proud to develop innovative and valuable therapies that can benefit cancer patients globally.”

The strategic equity investment not only strengthens Everest Medicines’ position in next-generation immuno-oncology, but also extends the global development path of its proprietary AI-powered mRNA platform. As a key pillar of Everest’s “dual-engine” strategy of in-licensing and internal innovation, the company has made solid progress in building and internationalizing its AI+mRNA platform. Multiple pipeline programs are advancing in preclinical research, with a strong focus on oncology and autoimmune diseases. Looking ahead, Everest will accelerate global clinical development and regulatory efforts, while actively exploring collaborations with leading international biopharmaceutical companies to maximize the value of its platform and bring breakthrough therapies to patients worldwide.

Everest Medicines (HKG 1952, Everest, or the Company), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that with the official implementation of the latest update of the National Reimbursement Drug List (NRDL) on January 1, 2025, NEFECON(R) will apply the NRDL pricing, which will benefit more IgA nephropathy (IgAN) patients.

NEFECON(R) was included in the NRDL in November 2024. As the first IgAN etiological treatment drug fully approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), NEFECON(R) received NDA approval from the National Medical Products Administration (NMPA) of China in November 2023 through Priority Review. It is the only approved treatment for primary IgAN in adults at risk of disease progression in China.

Based on policies in various provinces and cities, NEFECON(R) will be eligible for NRDL reimbursement starting in January. Patients will be able to obtain the medication at designated medical institutions or pharmacies and benefit from the reimbursed pricing. The official implementation of the NRDL will expand the accessibility of NEFECON(R), alleviate the financial burden on patients, and enable more IgAN patients in China to benefit from this innovative drug.

Results from the Chinese population of the Phase 3 clinical study NefIgArd study shows that NEFECON(R) reduces kidney function decline by 66%, and delays disease progression to dialysis or kidney transplantation by 12.8 years. With its innovative mechanism of action and clinical advantages, NEFECON(R) has been recommended by several authoritative treatment guidelines. Most recently, it was included in the KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephrophthy (IgAN) and Immunoglobulin A Vasculitis (IgAV) (Public Review Draft), issued by the kidney disease: Improving Global Outcomes (KDIGO) organization.

About NEFECON(R)
NEFECON(R) is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.

In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas Therapeutics, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON(R) in mainland China, Hong Kong, Macau, Taiwan, China and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine’s territories.

About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website atwww.everestmedicines.com.

Forward-Looking Statements:
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