Co-development

• Co-development partnership model aligns the CDMO’s success with the sponsor’s outcomes.
• By expanding the offering, Mabion enhances its competitiveness and responds with the market shift toward collaborative and value-driven models as traditional CDMO lose attractiveness.
• We will share risks, costs and profits from co-development business model on top of fee for service activities which today is not sufficient anymore to stand out in a competitive CDMO landscape.

Trusted Biologics Partner for Growth-oriented Biotech

Co-development partnership designed to help biotech innovators reach the market faster, with less risk and stronger execution support. For small and medium-sized biotech and biopharma companies, bringing a biologic drug to market is not only a scientific challenge. It is also a capital, CMC, regulatory, manufacturing, and execution challenge.

Mabion’s co-development partnership model is designed to help growth-oriented biotech companies overcome these barriers. Instead of engaging a CDMO only as a fee-for-service contractor, the client gains a biologics partner whose success is directly linked to the product’s success. This creates a more committed, collaborative, and outcome-oriented relationship. Both sides are working toward the same goal: bringing the biologic drug to market and to patients.

Through this model, Mabion supports biotech innovators across both early-stage development projects and commercial projects, helping them develop, scale up, manufacture, and prepare biologic products for clinical and commercial supply.

Mabion Co-development Model

Mabion’s biosimilar co-development program is structured as a transparent partnership model designed to take a biosimilar candidate from early development through clinical evaluation, regulatory submission and commercial readiness. The cooperation is divided into clearly defined work packages, each linked to specific technical, regulatory and manufacturing objectives, budgets and milestones.

Cost-sharing

Building drug development capabilities internally or relying entirely on conventional CDMO services can place substantial pressure on budgets.

Through the Mabion Co-development Model, innovators can access Mabion’s development and manufacturing capabilities at a significantly lower entry cost. Contract costs are focused on the drug development and manufacturing process itself. As a result, the entire project is potentially up to 30% more cost-effective than standard CDMO-based approaches.

This allows biopharma companies to preserve capital for market access preparation, and portfolio expansion. Mabion also offers flexibility in structuring each collaboration. Costs are estimated on a case-by-case basis depending on the product, stage of development, technical scope, and partners’ needs.

For the innovator, this means a more efficient use of resources without the need to build large-scale manufacturing capabilities in-house.

Risk-sharing

Only about 15% of drugs that enter human clinical trials are ultimately approved for marketing by regulatory agencies. Such a high level of risk requires significant actions to be taken to mitigate it.

Mabion supports reduce this risk by contributing proven technology, specialist expertise, manufacturing know-how, and hands-on experience in biologics development. The innovator benefits from working with a partner that understands the challenges of taking biologic products through development and into clinical and commercial production.

Unlike a conventional outsourcing model, the co-development model creates a stronger alignment of interests between Mabion and the innovator. Risk is shared between both companies, giving the innovator more support than in a standard CDMO relationship and reducing the exposure associated with developing the product independently.

Profit-sharing

Mabion’s participation is linked to the future commercial success of the product, creating a partnership structure in which both companies are motivated to achieve market approval, reliable supply, and long-term product performance.

Mabion supports the product through clinical and commercial-scale manufacturing and, in return, participates in profits generated from future sales. Each agreement is assessed individually and tailored to the specific project and its objectives.

Partners may receive exclusive commercial rights in selected territories, while maintaining the option to onboard additional partners within their territory to further optimize cost sharing in exchange for proportional future revenue allocation. The structure is also multi-partner ready, enabling broader market coverage and improved risk distribution.

Co-development for biosimilars

Co-development model allows partners to participate in a biosimilar drug project under a proportional investment structure. Instead of funding the entire development and manufacturing pathway alone, costs are shared according to agreed project participation and future revenue entitlement. This enables more efficient capital allocation and reduces the initial financial burden compared with building internal capabilities.

Mabion brings established biologics development, scale-up, analytical, GMP manufacturing and regulatory-oriented CMC capabilities.

When jointly launching a biosimilar drug development project, Mabion’s activities include:

• Cell Line development
• Process development
• Analytical development
• DS/DP Engineering production
• DS/DP GMP manufacturing
• Stability studies
• PPQ campaign
• Clinical Trails incl. clinical samples analysis
• MAA – CTD submission

A key advantage of the model is the combination of the innovator’s intellectual property and market knowledge with Mabion’s biologics development, manufacturing and regulatory expertise. The program may also create opportunities to access non-dilutive EU funding, reducing total development costs.