MedPath

Handok's Open Innovation Strategy Drives New Drug Development and Global Expansion

8 months ago3 min read

Key Insights

  • Handok Pharmaceutical has embraced open innovation since 2007, collaborating with companies like Genexine and ABL Bio to expedite new drug R&D.

  • The company's strategic investments, including HDB001A for biliary tract cancer, have led to Phase 2/3 trials approved by the FDA, with top-line results expected in early 2025.

  • Handok is also focusing on digital transformation and AI to boost productivity in clinical trials and new drug development, aiming to launch multiple new products.

Handok Pharmaceutical, under the leadership of Chairman Kim Young-jin, has been actively pursuing an "open innovation" strategy since 2007 to accelerate its new drug research and development (R&D) efforts. This approach involves developing products in cooperation with external entities, a strategy deemed necessary as the company transitioned to an independent management system.

Strategic Collaborations and Key Pipelines

One of the notable success stories of Handok's open innovation is its collaboration with Genexine, initiated in 2007 for the joint development of a hemophilia treatment. Handok became Genexine's largest shareholder in 2012 and has since expanded its partnerships to include ABL Bio, SCM Life Sciences, and Spark Biopharma. These collaborations extend to developing in vitro diagnostic medical devices with Envipostec and digital treatment devices with Welt.
Overseas, Handok has partnered with Resolute and Compus Therapeutics in the United States. A significant pipeline product, HDB001A, exemplifies this open innovation approach. HDB001A is a next-generation anticancer drug targeting biliary tract cancer, an area with high unmet medical need. Developed by ABL Bio, Handok holds the domestic license, while Compus Therapeutics, which merged with Trigger Therapeutics, holds the global rights (excluding South Korea and China). Handok's investment in Trigger and subsequent collaboration with Compus underscores its commitment to this project.

Clinical Progress and Regulatory Milestones

Chairman Kim noted that HDB001A has demonstrated positive data in Phase 2 clinical trials conducted in Korea. Based on these results, Compus Therapeutics received FDA approval to proceed with Phase 2/3 clinical trials, with patient registration completed in August. Top-line clinical results are expected in the first quarter of next year, with a potential market release in 2026.

Expanding Therapeutic Areas

In addition to oncology, Handok is collaborating with Resolute on RZ358, a treatment for congenital hyperinsulinemia, and RZ402, an oral treatment for diabetic macular edema. Handok jointly invested in Resolute with Genexine in 2019, aiming to gain experience in biopharmaceutical development in the U.S. and establish a foothold for entering the U.S. market.

Focus on Productivity and Digital Transformation

Handok is also focusing on improving productivity through digital transformation and artificial intelligence (AI). Chairman Kim stated, "We aim to become the most productive company by taking the lead in using digital and artificial intelligence (AI) in both clinical and new drug development." This initiative is part of a broader strategy to enhance efficiency in clinical trials and new drug development processes.
To address the upcoming expiration of product rights for Alexion's Soliris and Ultomiris, Handok plans to launch four to five new products, starting with 'MPAVELI', a treatment for paroxysmal nocturnal hemoglobinuria (PNH).
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