ScinoPharm Partners with Handa Pharmaceuticals to Advance 505(b)(2) Drug Development

ScinoPharm Taiwan, Ltd. today announced a strategic investment in Handa Pharmaceuticals, Inc., marking the beginning of a collaboration to share R&D resources and leverage complementary strengths in advancing 505(b)(2) new drug development. This partnership will drive efforts in research, clinical trials, regulatory approvals, and product commercialization.

ScinoPharm highlighted that Handa is a specialty pharmaceutical company focused on developing niche portfolios. With extensive expertise in oral formulations, Handa specializes in 505(b)(2) new drugs and patentable high-barrier generic drugs. Several of its products have already been successfully launched in the U.S. and Canada, with a promising pipeline currently under development. ScinoPharm's strategic investment reflects its confidence in Handa's proven capabilities in product development and commercialization. After multiple in-depth exchanges between the two teams, both sides recognized their aligned expertise in product portfolios and R&D capabilities, as well as a shared corporate culture, making the collaboration a significant step forward for both companies' future growth.

ScinoPharm's Commitment to Excellence and Growth

ScinoPharm, founded on the development of high entry barrier APIs, is internationally recognized for its high-quality services and stringent GMP controls. Over the past eight years, it has achieved a remarkable record of seven consecutive zero-deficiency inspections by the U.S. FDA, setting a role model within the industry. Its API products are marketed globally, benefitting patients worldwide, particularly in critical therapeutic areas such as oncology and Alzheimer's disease, where it supplies first-line treatments essential for medical care.

Since adopting a vertical integration strategy from APIs to finished dosage forms, ScinoPharm has steadily executed its plans with measurable results. In 2024, all production lines at its injectable formulation facility passed U.S. FDA inspections, and in 2023, the company successfully shipped its first commercial batch of albumin-bound paclitaxel injectables for U.S. market. This product, known for its production complexity, is manufactured by only a few selected facilities globally and has been a first-line oncology treatment that faced shortages in the U.S.. In addition, ScinoPharm has initiated the development of 505(b)(2) injectable products. The collaboration with Handa not only extends the value chain of ScinoPharm's APIs but also broadens its formulation portfolio to include oral dosage forms, enriching its product offerings and market presence.

Expanding Into Diabetes and Obesity Markets

In response to the growing global prevalence of diabetes and obesity, ScinoPharm has embarked on the independent development of advanced peptide injections, targeting high-tech, large-scale production capabilities. Leveraging its expertise in commercial-scale process development, the company has successfully submitted three peptide injectable products for U.S. regulatory approval, with launches anticipated within the next three years. These products represent significant milestones in ScinoPharm's evolution.

In recent years, ScinoPharm has actively expanded its manufacturing capabilities for peptide APIs and injectables, integrating advanced sustainable technologies to enhance production efficiency. With its ongoing investments and partnerships, ScinoPharm is poised to redefine innovation in pharmaceutical development, bringing transformative treatments to global health.