SEOUL — A fierce competition is igniting in the domestic pharmaceutical industry as South Korea’s leading drugmakers—Chong Kun Dang, Hanmi Pharm, Daewoong Pharmaceutical, and HK inno.N—prepare to dismantle the monopoly held by Novartis’ blockbuster heart failure treatment, Entresto.
Following a landmark Supreme Court ruling earlier this year that cleared patent hurdles, these four companies are racing to capture a slice of the Entresto outpatient prescription market, currently valued at approximately 80 billion KRW (approx. $60 million USD) annually.
Strategic Maneuvers by Key Players
The "Big 4" are employing distinct strategies to gain an edge, ranging from clinical expansion to intellectual property victories:
Chong Kun Dang (CKD): The company recently completed Phase 3 clinical trials for its generic version, CKD-202A. Beyond heart failure, CKD is aiming to secure indications for essential hypertension, a rapidly growing market. By matching the original drug’s prescription range, CKD hopes to secure a high market share immediately upon launch.
Hanmi Pharm: Leveraging its proprietary formulation technology, Hanmi has positioned itself as a frontrunner by successfully circumventing four follow-up patents held by Novartis. Having won the final Supreme Court battle in January, Hanmi secured First Generic Exclusivity (Priority Sales Approval). This allows them to block other late-comers for nine months post-launch, providing a critical window to absorb original prescription demand.
Daewoong Pharmaceutical: Daewoong is focusing on dual-track progress: clinical expansion and branding. The company has obtained approval for bioequivalence trials for hypertension and has already filed a trademark for its generic, "Entvitril." This proactive branding is designed to ensure rapid market penetration.
HK inno.N: As a late entrant, HK inno.N is moving at high speed. It recently received approval for bioequivalence trials for its candidate, IN-G00007, with plans to complete data collection by March next year. The company intends to leverage its powerful existing sales networks in digestive and circulatory medicine to make a swift impact.
The Technical Challenge: "Co-Crystal" Formulation
Industry experts note that Entresto is not a typical combination drug. It features a sophisticated "co-crystal" structure where two active ingredients (sacubitril and valsartan) are bonded in a specific crystalline form.
"The final hurdle for domestic commercialization will be the technical ability to accurately replicate this co-crystal structure while meeting the strict approval standards of the Ministry of Food and Drug Safety," said a pharmaceutical industry official.
Market Outlook
With Entresto's core patents set to expire between late 2026 and 2027, the South Korean market is bracing for a tectonic shift. For Novartis, the entry of high-quality domestic alternatives poses a significant threat to its long-standing dominance. For patients and the national healthcare system, this competition is expected to increase accessibility and reduce the financial burden of life-saving heart failure treatments.
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