Taikang Biotech (6589), Mitsubishi Gas Chemical Co., Ltd. (MGC), and the Taiwan Sugar Association (4168) have entered into a strategic tripartite agreement to promote the Denosumab biosimilar drug SPD8 for osteoporosis treatment.

Signed on December 16, the agreement includes commissioned production, pre-launch planning, and collaborative strategies for expanding SPD8’s presence in Japanese and international markets.

The Taiwan Sugar Alliance announced on December 17 that SPD8, developed in collaboration with MGC, has successfully passed its initial acceptance of Phase III clinical trials. The drug is expected to reach unblinding in Q2 2026, marking a significant milestone in its development journey.

A Biosimilar Breakthrough in Osteoporosis Treatment

SPD8 is a Denosumab biosimilar co-developed by the Taiwan Sugar Alliance and MGC to address the growing global burden of osteoporosis. The drug has completed Phase I clinical trials and received approval from Japan’s PMDA regulatory body to advance to Phase III trials. Following successful testing, Taikang Biotech plans to apply for regulatory approvals, including marketing authorizations from PMDA and other international authorities, and will oversee commercial-scale production of the raw materials.

This collaboration aligns with Taiwan’s National Health Insurance Administration’s recent policy reforms, which incentivize locally manufactured biosimilar drugs with a 30% price premium. These changes strengthen SPD8’s market competitiveness, providing a cost-effective alternative that meets the quality standards of original drugs.

Addressing a Global Health Crisis

Osteoporosis, identified by the World Health Organization as the second most prevalent epidemic after coronary heart disease, poses significant health and economic challenges worldwide. With over 50% of hip fractures projected to occur in Asia by 2050 due to an aging population, biosimilars like SPD8 represent a vital step in improving drug accessibility and affordability.

Dr. Yang Meijun, General Manager of the Taiwan Sugar Alliance, emphasized that the development of SPD8 could dramatically lower treatment costs and increase patient access. With global Denosumab drug sales totaling $6.1 billion in 2023, SPD8 is poised to capture a substantial share of the growing market.

Expanding Horizons

Beyond SPD8, Taikang Biotech is advancing its portfolio with innovative developments like the anti-cancer drug GNX102. This drug, which has secured patents across multiple regions, is set to enter Phase I clinical trials, supported by a manufacturing agreement with Sterling Pharma Solutions. These developments underscore Taikang Biotech’s dual focus on biosimilar and novel drug development, leveraging expertise in antibody-based therapies.

A Leader in Biopharma Manufacturing

Taikang Biotech, Taiwan’s sole GMP-certified biologics API manufacturer by the US FDA, Japan PMDA, EU EMA, and other global regulators, operates 12 state-of-the-art production lines. With capabilities spanning ADCs, recombinant proteins, and complex biologics, Taikang has successfully supported over 50 drug development projects and amassed extensive global regulatory submission experience.

The SPD8 partnership further highlights Taikang Biotech’s strength in CDMO services and exemplifies Taiwan's growing biopharmaceutical prowess. By collaborating with Japanese and Taiwanese partners, Taikang ensures SPD8 meets global production standards and accelerates its path to market.

A Global Vision for Biosimilars

This tripartite collaboration sets a benchmark for Japan-Taiwan cooperation in biopharmaceutical innovation. It strengthens Taiwan’s position in the global biotech ecosystem while enhancing patient access to high-quality biosimilar drugs. Taikang Biotech’s growing footprint in Japan and the US underscores its commitment to expanding the reach of Taiwanese biopharma excellence, benefiting patients worldwide.