Everest Medicines lands a potential ￥1.24B deal for FIC candidate to broaden kidney pipeline

Everest Medicines (HKEX: 1952.HK) announced that it has entered into a licensing agreement with Micot, securing the exclusive development and commercialization rights for the Secondary Hyperparathyroidism (SHPT) investigational drug MT1013 in China and the Asia-Pacific region (excluding Japan). The transaction structure includes an upfront payment of RMB 200 million and potential milestone payments of up to RMB 1.04 billion.

To enrich its nephrology pipeline and secure high-potential innovative assets in advance, Everest Medicines has acquired the Phase III first-in-class (FIC) investigational drug candidate MT1013 in a transaction valued at up to RMB 1.24 billion. The strategic rationale is clear: by expanding into therapeutic areas characterized by longer treatment cycles and broader patient coverage, Everest Medicines aims to maximize the utilization of its existing commercial resources. As the core product for treating primary IgA nephropathy (IgAN), NEFECON® has been approved for commercialization in China and serves as a key revenue driver for Everest Medicines. However, IgAN—as a niche indication—has a limited patient population, leading to divided market expectations regarding the long-term stability of its revenue. To inject new momentum for sustained growth, Everest Medicines must expand into related therapeutic areas and supplement its pipeline.

The strategic focus on Secondary Hyperparathyroidism (SHPT) creates complementary and synergistic opportunities. As a prevalent complication of chronic kidney disease (CKD), SHPT represents a significant unmet need among patients on maintenance hemodialysis, with treatment often involving long-term concomitant medication use. Importantly, the SHPT patient population substantially overlaps with the target audience for NEFECON®. For Everest Medicines, its existing sales force can simultaneously advance market education and access for MT1013 while promoting NEFECON®, thereby achieving greater commercialization efficiency through marginal cost reduction.

The newly licensed MT1013 is a peptide-based investigational drug that simultaneously targets the Calcium-Sensing Receptor (CaSR) and the Osteogenic Growth Peptide (OGP) pathway. It has already entered a confirmatory Phase III clinical trial using Cinacalcet as the active comparator. While current mainstream therapies for SHPT—such as Cinacalcet and Etelcalcetide—effectively reduce intact Parathyroid Hormone (iPTH) levels, they present notable limitations. These include a high incidence of gastrointestinal side effects, the potential for excessive suppression of bone turnover leading to decreased bone quality with long-term use, a significant risk of hypocalcemia, and limited improvement in bone metabolism.

The dual-target design of MT1013 precisely addresses these challenges: the CaSR target potently controls iPTH, while the OGP target promotes bone formation to counteract the risk of bone quality deterioration. Phase II data indicate that most patients achieved sustained iPTH target levels following treatment, alongside positive trends in bone metabolism improvement and increased bone mineral density, with a manageable safety profile.

However, it is essential to clarify that MT1013's differentiated value still requires validation. Whether it can demonstrate decisive advantages in bone mineral density during Phase III trials—rather than merely serving as a substitute for conventional therapies—will directly determine its post-launch pricing power and market positioning.

Notably, the transaction structure mitigates near-term risks for Everest Medicines: the majority of Phase III development costs are borne by Micot. Effectively, Everest has secured a "near-market-ready" asset with an upfront payment of RMB 200 million, positioning it to rapidly commercialize the product through its established channels upon regulatory approval.

This transaction by Everest Medicines reflects the evolving market characteristics and competitive landscape of the innovative nephrology drug segment. With rising clinical demands and iterative technological innovation, this segment is transitioning from traditional drug dominance to competition based on differentiated innovative assets, accompanied by parallel shifts in market rules and value assessment criteria.

From a market size perspective, the innovative nephrology drug segment exhibits clear growth potential. According to research data from Coherent Market Insights, the global chronic kidney disease (CKD) drug market is estimated at USD 15.92 billion in 2025 and is projected to reach USD 23.02 billion by 2032, representing a compound annual growth rate (CAGR) of 5.4% from 2025 to 2032. As a highly prevalent complication among CKD patients, Secondary Hyperparathyroidism (SHPT) presents persistent unmet clinical needs, as traditional treatment regimens struggle to achieve comprehensive control of calcium, phosphate, and Parathyroid Hormone (PTH) levels. This creates a distinct market opportunity for innovative drugs with differentiated mechanisms of action.

Historically, this therapeutic area has been dominated by single-target agents such as SGLT2 inhibitors and Angiotensin II Receptor Blockers (ARBs). Although these drugs hold significant market share, intensifying homogeneity and competition have followed patent expirations and the entry of generic alternatives. Against this backdrop, the scarcity of innovative assets with unique mechanisms of action has become prominent. The dual-target design of MT1013 aligns precisely with the industry's demand for "differentiated innovation," which is central to the rationale for its substantial licensing fee.

The dimensions of competition within this segment are shifting from a focus on singular efficacy endpoints toward a comprehensive value assessment. In the past, pharmaceutical R&D often concentrated on improving single metrics, such as merely reducing intact PTH (iPTH) or slowing renal function decline. However, clinical practice has shown that CKD patients' treatment requires addressing multidimensional health needs. The core competitive advantage of MT1013 lies in its ability to deliver multiple benefits simultaneously: potent iPTH control, increased bone mineral density, and reduced cardiovascular risk. This comprehensive value proposition is becoming a critical element in the competition among innovative therapies. When screening assets, investors and pharmaceutical companies are moving beyond a singular focus on core efficacy data to also emphasize a drug's real-world impact on patients' overall health outcomes. This shift is driving the segment toward solutions that are more closely aligned with actual clinical needs.

Concurrently, multi-target synergy is emerging as a significant direction for innovative CKD drug development. Beyond MT1013's CaSR + OGP combination, research is advancing on multiple mechanisms, including the PI3K/AKT/mTOR signaling pathway and fibrosis-related targets. The underlying logic for this trend is the complexity of CKD pathogenesis, where single-target interventions often fail to comprehensively halt disease progression. Multi-target drugs aim to achieve synergistic therapeutic effects by simultaneously acting on multiple pathways involved in the disease. This R&D approach has become an effective path for overcoming current treatment limitations and provides a clear technological direction for innovators and entrepreneurs in the field.

Everest Medicines' licensing of MT1013 serves as a practical case study for all stakeholders in the biopharmaceutical industry, highlighting both opportunities and risks. At its core, it reflects a trend toward resource integration, value enhancement, and a return to genuine innovation, while also demonstrating the strategic dynamics within an increasingly specialized industry landscape.

For innovators and entrepreneurs, a focus on unmet clinical needs and clear differentiation remains essential. The true value of a dual-target design lies in addressing well-defined shortcomings of existing therapies, not in pursuing technological novelty. The most effective path to breaking through therapeutic bottlenecks is to "identify the right target for the disease"—adding complementary mechanisms to validated targets. It is equally critical to anticipate commercial competition early, incorporating head-to-head Phase III trial designs into the development plan to generate robust data that can support product value and pricing.

For investment institutions, a clear three-dimensional framework for evaluating high-value assets should be established. Priority should be given to mid- to late-stage assets—particularly those in Phase III with head-to-head data—which carry lower R&D failure risk. Focus should remain on high-potential, underserved therapeutic areas such as SHPT, characterized by stable patient populations and significant unmet need. Equally important is assessing how well an asset aligns with the commercialization capabilities of potential partners to avoid the trap of "technology without a market."

For corporate executives, Everest's licensing strategy offers a model for low-risk, high-synergy portfolio expansion. In-licensed assets should balance short-term pipeline gaps with long-term strategic fit, leveraging existing commercial infrastructure to lower launch costs and risks. The ability to pursue scaled licensing activities depends on having mature internal capabilities for development and commercialization—not merely on expanding pipeline size. Furthermore, carefully structured deal terms—such as shared development costs and milestone payments tied to key clinical or regulatory achievements—can effectively manage cash flow pressures.

From a broader perspective, this RMB 1.24 billion licensing deal underscores the deepening division of labor within the innovative drug sector. Research-focused entities concentrate on technological breakthroughs, while commercialization partners drive market access, creating complementary strengths. In this evolving landscape, "conceptual innovations" lacking clear, data-backed clinical benefits are gradually being phased out. Assets that address real clinical needs with solid evidence and possess a viable commercial path are establishing the foundation for appropriate valuation and sustainable growth.