AbClon, which had been designated as an issue for administrative action due to sluggish sales, has removed its immediate delisting risk by achieving a sales recovery. The company said its future corporate value will likely hinge on the approval of its chimeric antigen receptor T-cell (CAR-T, "CAR-T") therapy "NespeCell" now in development and the results of its next-generation in vivo CAR-T platform.

Lee Jong-seo, AbClon CEO

According to the Korea Exchange (KRX) on the 17th, AbClon was removed from the administrative issue list after resolving the reason of "sales below 3 billion won." The company's 2025 sales reached 4.714 billion won, nearly doubling from a year earlier. However, as expense for research and development (R&D) grew with the phase 2 trial of the CAR-T therapy candidate "AT101 (NespeCell)," operating loss widened to 17.6 billion won and net loss to 17.9 billion won.

On the day, Chief Executive Lee Jong-seo said in a letter to shareholders, "Under the rules, corporations with a market capitalization of 60 billion won or more are excluded from designation as an administrative issue due to failing the sales requirement," and added, "Our current market cap is stably above that threshold, removing the uncertainty that had hamstrung the company."

Overseas technology transfer contracts played a major role in the sales recovery. AbClon signed a technology transfer contract in Feb. last year with Türkiye corporations TCT Health Technology, and the upfront payment from this contract was reflected in results. TCT has now completed the transfer to aim for local production of NespeCell and is building out production infrastructure. The industry also sees the possibility of additional milestone fees this year.

The financial structure also improved to a degree. The ratio of loss from continuing operations before income taxes—often cited as a key listing risk for biotech companies—also met the listing maintenance requirement. AbClon successfully raised 36 billion won in Oct. last year, issuing 25.2 billion won in perpetual convertible bonds (CB) and 10.8 billion won in convertible preferred shares (CPS) to secure R&D funding.

Buoyed by this optimism, AbClon's market capitalization has swelled quickly. As of the close on the day, market cap stood at about 1.7594 trillion won, far exceeding domestic CAR-T developers Curocell (698.2 billion won), GC Cell (414 billion won), and Vaxcellbio (187.9 billion won).

Looking ahead, some say the company's growth outlook depends on whether NespeCell gains approval. AbClon is aiming to file for conditional approval of NespeCell within this year. The phase 2 trial is underway in patients with relapsed or refractory diffuse large B-cell lymphoma.

According to the phase 2 interim results released in May last year, administering NespeCell to 32 lymphoma patients produced a complete remission rate (CRR)—the state in which cancer cells disappear—of 68%. That level exceeds the complete remission rates (30%–40%) recorded in trials by "Kymriah" from Switzerland's Novartis and "Yescarta" from the United States' Gilead, both currently on the market. Curocell's CAR-T therapy "Lymcato," a domestic competitor, posted a similar 67.1% in its phase 1/2 trial.

Alongside NespeCell, a candidate regarded as a core pipeline is the gastric cancer therapy candidate "AC101 (HLX22)," which was transferred to China partner Henlius. The candidate entered a global phase 3 trial in Jul. last year.

HLX22 is being developed for gastric cancer while also pursuing studies to expand indications. A phase 2 trial in breast cancer combining an antibody-drug conjugate (ADC) with HLX22 is also underway.

AbClon is also positioning the development of a next-generation in vivo CAR-T platform as another growth pillar this year. Unlike the existing approach, which collects and engineers a patient's immune cells ex vivo and then reinfuses them, in vivo CAR-T is a technology that enables therapeutic cells to be generated directly inside the body.

Conventional CAR-T therapies face limits such as a lead time of several weeks to treatment due to complex manufacturing and expenses reaching hundreds of millions of won, but the in vivo approach can skip these steps, sharply cutting time and expense. In fact, global drugmakers including the United Kingdom's AstraZeneca, the United States' Bristol Myers Squibb (BMS), AbbVie, and Gilead are moving to secure related technologies through aggressive mergers and acquisitions (M&A).

Chong Kun Dang pharmaceutical CEO Kim Young-joo and AbClon CEO Lee Jong-seo pose for a commemorative photo after signing a strategic equity investment and joint research and development partnership at the headquarters in Chungjeong-ro, Seoul, on the 9th. /Courtesy of Chong Kun Dang pharmaceutical

Despite the administrative designation, the company succeeded in attracting strategic investment. In May last year, Chong Kun Dang pharmaceutical invested 12.2 billion won to acquire a 7.3% equity stake, becoming the second-largest shareholder. If NespeCell wins approval, Chong Kun Dang pharmaceutical will have domestic first-sale rights.

The two companies' ties date back to the 1990s. AbClon CEO Lee Jong-seo worked for about five years as a researcher at the Chong Kun Dang pharmaceutical laboratory in the early 1990s. Afterward, Lee completed a Ph.D. program at Kyoto University's medical school in Japan with a scholarship from the Chong Kun Dang Kyochon Foundation, then continued research at Harvard Medical School in the United States. Chairman Lee Jang-han of Chong Kun Dang pharmaceutical is said to have maintained ties with Lee by meeting during business trips to Japan or the United States.

Lee Yong-jun, who leads AbClon's CAR-T research, also worked at Chong Kun Dang pharmaceutical from 2013 to 2020. The industry sees this human network as a foundation that will support cooperation between the two companies in the commercialization of CAR-T therapies.

The two companies plan to expand research and development cooperation as well. Chong Kun Dang pharmaceutical will also take part in AbClon's R&D decision-making process, and the two formed a "joint development committee" of experts from both sides. In particular, they plan to participate in the joint development of the switchable CAR-T platform "zCAR-T (AT501)" targeting solid tumors by using AbClon's development platform.

※ This article has been translated by AI. Share your feedback here.