[Edaily Reporter Minji Son ] As capital flowed into semiconductor and artificial intelligence (AI) companies, domestic pharmaceutical and biotech firms were relatively sidelined in the first half of this year.

Although quite a few companies were on the verge of new drug clinical trials and marketing approval milestones, the market reaction and capital inflows were limited. However, with major events scheduled to unfold one after another in the second half of this year—including the results of U.S. Food and Drug Administration (FDA) approval reviews, the announcement of top-line results from global Phase 3 clinical trials, and expectations following major technology exports—attention is focused on the possibility of a turnaround in market sentiment.

July: HLB INC. U.S. FDA Approval and Kolon TissueGene, Inc. TG-C to ‘Kick Off’ the Month

HLB INC.(028300)is expected to be the first company to capture the market’s attention. HLB INC.’s combination therapy of riboceranib and camrelizumab for first-line treatment of liver cancer is set to undergo a Prescription Drug User Fee Act (PDUFA) review by the U.S. Food and Drug Administration (FDA) on the 23rd of next month. Previously, in January of this year, HLB INC. resubmitted its New Drug Application (NDA) for this first-line liver cancer treatment to the FDA.

This is effectively HLB INC.’s third attempt. HLB received letters of complete response (CRLs) from the FDA in May 2024 and March of last year. HLB explained that the issues at that time were not related to the efficacy of the combination therapy, but rather concerned manufacturing and quality control (CMC) at the production facility for camrelizumab operated by China’s Hengrui Pharmaceuticals.

Recently, the possibility of a Record-Based Inspection (RLI) has also been raised. An RLI refers to a process in which the FDA evaluates a facility based on records, reports, and data submitted by the applicant or the manufacturing site, rather than conducting an on-site visit.

HLB INC. stated, “It is true that the RLI system was officially codified last year and has been widely utilized recently,” but added, “However, there is no guarantee that this regulation will apply to the CMC inspection of Hengrui Pharmaceutical.”

If the combination therapy receives FDA marketing approval, expectations for the global commercialization of this domestically developed anticancer drug could rise. However, if an additional CRL is issued, delays in the commercialization schedule for the combination therapy and increased stock price volatility for stocks of companies related to HLB INC. will be inevitable.

Also this month, Kolon TissueGene, Inc.(950160)is scheduled to release topline results from the first of two studies on the U.S. Phase 3 clinical trial of TG-C (formerly Invossa), a cell- and gene therapy for osteoarthritis. The results of the other study are expected to be announced in October.

TG-C is a cell- and gene-based therapy designed to restore the cartilage structure itself with just a single injection into the knee joint cavity of patients with knee osteoarthritis. If TG-C proves effective in improving joint structure beyond mere pain relief, it could establish itself as the world’s first disease-modifying osteoarthritis drug (DMOAD). This could serve as a significant milestone not only for the revaluation of Kolon TissueGene, Inc.’s corporate value but also for the domestic cell and gene therapy industry as a whole.

Kolon TissueGene, Inc. aims to submit a Biologics License Application (BLA) to the FDA in the first quarter of next year and begin commercial sales in 2028. To this end, the company has signed a contract manufacturing agreement with Lonza, a global Contract Development and Manufacturing Organization (CDMO), and is working together to prepare the CMC package for the BLA application and to lay the groundwork for initial commercial production.

A Kolon TissueGene, Inc. official stated, “We selected Lonza as our partner because it is one of the world’s leading CDMOs capable of producing cell and gene therapies,” adding, “We plan to collaborate through the BLA submission in the first quarter of next year, and thereafter, we intend to diversify our production bases to ensure supply security.”

September: The Second Showdown Between AriBio and HLB INC.

This coming September will feature major events in the fields of dementia and cancer treatment. First, #AriBio, a company specializing in the development of new drugs for brain diseases, is highly likely to announce topline results from the Phase 3 clinical trial of its oral dementia treatment, AR1001, in September. AriBio conducted the clinical trial involving 1,535 patients with early-stage Alzheimer’s disease across 230 institutions in 13 countries, including the U.S., Europe, China, and South Korea. After completing dosing in June of this year, AriBio aims to announce the topline results as early as September.

A key strength of AR1001 is that, unlike existing antibody therapies, it is an oral medication. Given that current market-leading dementia treatments, such as Lecembi and Kisunla, are administered via intravenous (IV) injection, AR1001 is viewed as having significant commercial potential.

Expectations are further heightened by Aribio’s recent signing of an exclusive licensing agreement with China’s Fosun Pharma for the global development, approval, production, and commercialization of AR1001, valued at up to $4.7 billion (approximately 7.1895 trillion won). There is also speculation that, depending on the success of this clinical trial and the global licensing deal, the company could proceed with an initial public offering (IPO).

HLB INC. is also gearing up for another major event: the FDA review results for lirapugratinib, a second-line treatment for cholangiocarcinoma, are expected soon. If HLB achieves success with this cholangiocarcinoma treatment in July, following its recent success with liver cancer, the company will lay the groundwork for its leap toward becoming a global anti-cancer drug company.

October: ESMO and Momentum for Platform Companies

This coming

October,

the European Society for Medical Oncology (ESMO) will be held in Madrid, Spain. ESMO is considered one of the world’s three major cancer conferences, alongside the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AAC). Major global pharmaceutical companies and investment firms will participate in large numbers at this event to identify promising technologies and discuss joint development and technology licensing. Consequently, Korean companies attending the conference are highly likely to achieve related successes. Last year, HanmiPharm, along with △KOLON LIFE SCIENCE Inc.(102940) △Lunit Inc.(328130) △ LigaChem Biosciences △GI Innovation Inc.(358570) △ HLB INC., participated and garnered significant attention.

Among individual companies, Peptron, Inc.(087010)is expected to draw attention in October. This is because Peptron, Inc. is nearing the end of its technology evaluation agreement with global big pharma Eli Lilly. Previously, Peptron, Inc. signed a platform technology evaluation agreement with Eli Lilly for the development of a long-acting injectable obesity treatment. The pharmaceutical and biotech industry believes it is highly likely that a decision on whether to proceed with a full-scale collaboration, such as a formal contract, will be made after the evaluation concludes in the second half of this year.

The fact that Eli Lilly has signed a collaboration agreement with the Swedish company Kamurus regarding a long-acting drug delivery platform is cited as a potential variable. Recently, Eli Lilly exercised an option under that agreement to include an amylin receptor agonist, drawing attention to whether Peptron, Inc.’s technology evaluation results will lead to a formal contract or other forms of collaboration. However, Peptron, Inc. maintains that it is proceeding with its work without any delays in accordance with the agreement.

In addition, expectations for pharmaceutical and biotech companies are expected to become even more diverse in the second half of this year. Inventage Lab Inc.(389470), a developer of drug delivery systems (DDS), is considered a promising candidate for the second half of the year, with speculation swirling about the possibility of an additional joint research agreement with German pharmaceutical company Boehringer Ingelheim. Previously, Inventage Lab Inc. expanded the scope of its collaboration by signing a joint research agreement for long-acting injectables in 2024, followed by an additional research agreement last year. The market views the likelihood of follow-up agreements or a full-scale contract as high if the results of existing projects are positive.

It is particularly noteworthy that the market is placing significant weight on the possibility that the compounds utilizing Inventage Lab Inc.’s platform belong to the obesity and diabetes treatment categories. Given that the global pharmaceutical and biotech industries are actively pursuing the development of long-acting formulations to improve the convenience of obesity treatment administration, the possibility of securing a major contract is being discussed should the project’s results prove positive.

#G2GBIO, Inc. also signed two agreements last year with Boehringer Ingelheim to jointly design and develop long-acting injectable formulations. Although the specific formulation and drug have not yet been disclosed, the company is expected to attract market attention as details are scheduled to be revealed in the second half of the year.

In addition, HanmiPharm signed a large-scale technology transfer agreement with Eli Lilly, raising the possibility of further technology transfer deals in the future. HLB Therapeutics is expected to announce topline results from the Phase 3 clinical trial (SEER-2) of RGN-259, a candidate drug for neurotrophic keratitis (NK), in the second half of the year.

An official in the pharmaceutical and biotech industry stated, “In the first half of this year, the pharmaceutical and biotech sectors received relatively little attention, overshadowed by the semiconductor rally. However, with major events concentrated in the second half of the year, I believe there is ample potential for investor sentiment to reverse depending on the performance of individual companies.”