ScinoPharm Taiwan Announces Approval of Bortezomib Injection for Multiple Myeloma Treatment in Taiwan, Strengthening Domestic Pharmaceutical Supply Chain Resilience

ScinoPharm Taiwan announced that it has successfully obtained marketing approval from the Taiwan Food and Drug Administration (TFDA) for Bortezomib, a treatment for Multiple Myeloma. Following the U.S. FDA approval secured in 2023, the newly granted Taiwan approval marks another significant milestone for the company. This achievement not only highlights ScinoPharm Taiwan's decades-long expertise in oncology drug development, but also demonstrates its concrete response to the government's policy to strengthen pharmaceutical supply chain resilience. ScinoPharm Taiwan is currently actively pursuing National Health Insurance reimbursement approval, with the goal of benefiting more patients in Taiwan and firmly anchoring internationally recognized critical manufacturing technologies and high-quality medicines within the local healthcare system.

Multiple Myeloma: The Second Most Common Hematologic Malignancy

Multiple myeloma is a malignant plasma cell disorder characterized by abnormal plasma cell proliferation and a high risk of relapse, and it remains a disease that is difficult to cure definitively. It ranks as the second most common hematologic malignancy in many countries. The disease is marked by excessive plasma cell growth in the bone marrow, which crowds out normal blood-forming cells and leads to complications such as hypercalcemia, anemia, and bone disease, including fractures. In addition, abnormal monoclonal immunoglobulin fragments are produced, resulting in kidney damage and compromised immune function. According to statistics from Taiwan's Health Promotion Administration, approximately 700 to 800 new cases of multiple myeloma are diagnosed annually in Taiwan, predominantly among patients around 70 years of age, with a slightly higher incidence in men than in women. Once diagnosed, treatment with the proteasome inhibitor Bortezomib represents a critical component of multiple myeloma therapy, as it inhibits proteasome activity and induces apoptosis in cancer cells.

According to the latest treatment guidelines issued by the U.S. National Comprehensive Cancer Network (NCCN), combination regimens containing Bortezomib have been designated as Category 1, indicating the highest level of clinical evidence and broad consensus among oncology experts. These regimens are widely recognized as standard-of-care treatments for multiple myeloma. In Taiwan, Bortezomib has also been included in the TFDA's list of essential targeted therapies, underscoring its necessity and importance in the treatment of multiple myeloma.

ScinoPharm General Manager Li-An Lu, stated: "ScinoPharm Taiwan has long been dedicated to oncology drug development, with multiple products successfully approved by the U.S. FDA. We are committed to bringing internationally recognized, high-quality medicines to the Taiwan market. Accordingly, we initiated the Taiwan regulatory submission process in 2025, and receiving TFDA approval for Bortezomib today is a tremendous encouragement for our team. Bortezomib is the first anticancer injectable product fully manufactured in-house by ScinoPharm Taiwan to receive U.S. FDA approval. With the additional TFDA approval, it has become the only domestically manufactured multiple myeloma injectable in Taiwan holding both U.S. FDA and TFDA approvals. This achievement demonstrates that ScinoPharm Taiwan's R&D and manufacturing capabilities are recognized both internationally and domestically.

Looking ahead, ScinoPharm Taiwan plans to pursue additional product approvals in Taiwan as part of its proactive support for the National Health Insurance Administration's policy to strengthen the resilience of the domestic pharmaceutical supply. By leveraging its technical expertise, the company aims to expand its own finished dosage form portfolio and deepen its long-term commitment to the Taiwan market."

For many years, ScinoPharm Taiwan has supported global pharmaceutical partners through the stable supply of high-quality APIs and strong R&D and manufacturing capabilities, particularly in the oncology field, where it has built an extensive track record and established a solid international reputation. The company's world-class R&D expertise and product quality form the foundation for the expansion of its own finished dosage form business, through which it has already secured four drug approvals in the United States.

With the approval of its first product in Taiwan, ScinoPharm Taiwan is now extending its long-standing international experience to the domestic market, delivering medicines that meet the same rigorous quality standards to ensure safety, efficacy, and high quality. The company also looks forward to collaborating with local pharmaceutical partners, combining complementary strengths to improve access to medicines and create meaningful value for patients in Taiwan. At the same time, ScinoPharm Taiwan will continue advancing strategic partnerships across Europe, Asia, and emerging markets to further expand its global footprint.