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ImmuneOncia Therapeutics is gearing up for its Kosdaq debut, a move that could fast-track its flagship PD-L1 checkpoint inhibitor, IMC-001, toward commercialization. The clinical-stage biotech passed its preliminary listing review last Thursday, clearing a key regulatory hurdle five months after submitting its application in October 2024.
With Korea Investment & Securities as its lead underwriter, ImmuneOncia plans to submit its securities registration statement within the month and aims for final approval by mid-May.
Backed by Yuhan and a fast-track strategy, ImmuneOncia’s Kosdaq IPO aims to bring Korea’s first PD-L1 immunotherapy to market before biosimilars flood the space.
Backed by Yuhan and a fast-track strategy, ImmuneOncia’s Kosdaq IPO aims to bring Korea’s first PD-L1 immunotherapy to market before biosimilars flood the space.
The IPO will test investor appetite for Korea’s emerging biotech sector, particularly for immune-oncology companies betting on niche market strategies. Founded in 2016 as a joint venture between Yuhan Corp. and U.S.-based Sorrento Therapeutics, ImmuneOncia is taking a different path from many early-stage biotech IPOs, opting for a structure that limits shareholder dilution while capitalizing on strong backing from its majority owner.
At the core of ImmuneOncia’s IPO pitch is IMC-001, the first domestically developed PD-1/PD-L1 checkpoint inhibitor to secure an investigational new drug (IND) application in Korea. The company completed final patient enrollment for a phase 2 trial early last year, with all patient dosing expected to conclude in 2026. Clinical trials have shown an objective response rate of 79 percent and a complete response rate of 58 percent, positioning it for a biologics license application (BLA) submission in 2027 and potential approval by 2029.
The drug is positioned as a targeted therapy for NK/T-cell lymphoma, a rare cancer with no approved immune checkpoint inhibitors. The company is pursuing conditional approval through fast-track pathways to enter the market ahead of broader label expansions.
As MSD's Keytruda (pembrolizumab) maintains its dominance in the global immune-oncology market, ImmuneOncia is looking to regions where the blockbuster drug has yet to gain a foothold, particularly in Europe, a company spokesperson said. With Keytruda’s patent set to expire in 2028 and biosimilars expected to follow, ImmuneOncia aims to position itself to secure market share before competitors move in, the spokesperson added.
Unlike many biotech IPOs that raise capital through new share issuance, ImmuneOncia is offering 97 percent of its IPO shares from treasury stock to shield existing investors from dilution. The structure, the company spokesperson said, is intended to protect shareholders while ensuring the firm secures the funding needed to advance IMC-001.
As of its latest financial disclosure in December 2024, the company reported 110 million won ($75,742) in annual revenue and 8.86 billion won in net income, though it still holds negative equity of 34.19 billion won.
The structure also helps shield ImmuneOncia from post-IPO selling pressure, as Yuhan, which holds a 67 percent stake, and other key financial investors have committed to retaining their shares. The company has secured voluntary lock-up agreements with major shareholders, reducing the risk of an overhang, the spokesperson said.
While IMC-001 is the company’s most advanced program, ImmuneOncia is also building a broader immuno-oncology pipeline. Its IMC-002 (anti-CD47 monoclonal antibody), licensed to China’s 3D Medicines in a deal worth up to 470.5 billion won in 2021, is in the final stages of its phase 1b trial, with efficacy data expected at ASCO 2025.
The company is also developing next-generation bispecific antibody candidates, including IMC-201 (PD-L1×CD47) and IMC-202 (PD-L1×TIGIT), aiming for long-term sustainability in the immunotherapy market.
ImmuneOncia’s IPO strategy mirrors Yuhan’s playbook with Leclaza (lazertinib), the first FDA-approved Korean lung cancer drug, which secured rapid international expansion.
With Yuhan’s expertise in navigating U.S. and European approvals, ImmuneOncia is positioning itself for a shift from clinical-stage biotech to a commercial-stage player. “The Kosdaq IPO will be a key inflection point as we move closer to bringing our first therapy to market,” the company spokesperson said.
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Kim Ji-hye jkim404@docdocdoc.co.kr
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