EirGenix, Japan's Mitsubishi Gas Chemical (MGC), and Taiwan's GlycoNex announced on the 16th that they have signed a production agreement for the biosimilar drug SPD8, a denosumab-based treatment for osteoporosis. The agreement involves pre-commercial production to position SPD8 for the Japanese and international markets. On the 17th, GlycoNex further revealed that SPD8, co-developed with MGC, has enrolled its first patient in Phase 3 clinical trials, with results expected in the second quarter of 2026.
EirGenix explained that SPD8 is a denosumab biosimilar for treating osteoporosis, co-developed by GlycoNex and MGC. It has completed Phase 1 clinical trials and received approval from Japan's regulatory authority, the PMDA. Currently in Phase 3 clinical trials, the drug will subsequently undergo regulatory review for marketing authorization in Japan and other countries. EirGenix will be responsible for the commercial production of the active pharmaceutical ingredient (API).
GlycoNex highlighted that this development coincides with recent policy updates by Taiwan’s National Health Insurance Administration (NHIA), which include amendments to drug pricing and reimbursement guidelines. These policies strongly support domestically produced biosimilars, offering up to a 30% pricing premium, which significantly enhances SPD8’s market competitiveness. Furthermore, for biosimilars like SPD8—independently developed by GlycoNex and manufactured by EirGenix—the policy guarantees pricing parity with originator drugs, accelerating market entry and bolstering domestic and international market expansion.
According to GlycoNex, osteoporosis is recognized by the World Health Organization as the second most prevalent disease globally, following coronary artery disease. With the aging global population, more than 50% of hip fracture cases are projected to occur in Asia by 2050. Dr. Mei-Chun Yang, CEO of GlycoNex, emphasized that fractures and complications resulting from osteoporosis pose significant health and economic burdens. The development of biosimilars like SPD8 can lower treatment costs and improve drug accessibility. Currently, denosumab-based drugs, Prolia and Xgeva, have a combined global sales of $6.1 billion in 2023, with market demand continuing to grow as awareness of osteoporosis risks increases.
In addition to SPD8, GlycoNex is advancing its anti-cancer drug GNX102, which has secured patents in the U.S., Japan, South Korea, Russia, and Taiwan. GlycoNex has also partnered with the UK-based Sterling Pharma Solutions for the production of GNX102’s antibody-drug conjugate (ADC), preparing for Phase 1 clinical trials. By leveraging expertise in antibody-drug development, GlycoNex is simultaneously advancing novel drugs and biosimilars, demonstrating its extensive capabilities and professional depth.
EirGenix stands out as Taiwan’s only biologics manufacturing facility certified by the FDA, PMDA, EMA, TGA, and TFDA. Once SPD8 is approved, EirGenix will prioritize the Japanese market while also meeting global demand. The company operates 12 mammalian cell production lines, each with a 2,000-liter capacity, at its Zhubei facility, capable of addressing both internal and external client needs.
EirGenix has successfully completed over 50 complex biologics projects, including ADCs, bispecific/multispecific antibodies, and recombinant proteins. It has also supported more than 30 global IND/BLA filings, solidifying its reputation as one of Taiwan's leading contract development and manufacturing organizations (CDMOs) with international reach.
This collaboration between EirGenix, MGC, and GlycoNex encompasses technology transfer and commercial production for SPD8. EirGenix’s manufacturing of the API ensures sufficient capacity and adherence to international quality standards, aiding clients in securing regulatory approvals for international commercial production.
EirGenix has significantly expanded its presence in the Japanese market, with contracts signed this year accounting for over 45% of its total agreements, including two long-term commercial production contracts and several complex biologics projects. The implementation of the U.S. Biologics Security Act has also driven rapid growth in the American market, which now contributes 20% of EirGenix’s contract value.
This collaboration exemplifies a successful trilateral partnership, linking Taiwan and Japan’s biopharmaceutical upstream and downstream sectors. It not only enhances Taiwan’s soft power in biopharmaceuticals but also deepens market penetration in Japan, benefiting patients in Japan and worldwide. Furthermore, this collaboration underscores Taiwan's strategic biopharma partnerships, fostering growth and innovation in the local industry.
Resource: 台康生技、三菱瓦斯及醣聯簽三方合約 推進 SPD8布局國際市場
