[E-Daily Reporter Kim Jinsoo ] The most notable issue in the pharmaceutical and biotech industry this September is HLB INC.(028300)’s second attempt to gain approval in the U.S. HLB is awaiting approval from the U.S. Food and Drug Administration (FDA) through its U.S. subsidiary, HLB Therapeutics. In particular, attention is focused on whether HLB will be able to make up for the delay in the approval of “Riboceranib”—its first attempt at FDA approval—following this approval.

Next, at the World Conference on Lung Cancer to be held in Seoul, companies such as Yuhan(000100) and Voronoi, Inc.(310210) will present research findings on new lung cancer drugs currently in development. Analysts predict that starting in late September, U.S. tariffs will have a slight impact on the domestic pharmaceutical and biotech industry.

Will HLB INC. Regain Trust with FDA Approval?

HLB INC. has a series of major events lined up for this year, starting with the FDA approval of “Lirapugratinib,” a treatment for cholangiocarcinoma, in September. This will be followed by the resubmission of the FDA application for “Riboceranib,” a new liver cancer drug, the announcement of Phase 3 clinical trial results for “RGN-259,” a treatment for ophthalmic diseases, and the release of clinical data for “SynKIR-310,” a next-generation CAR-T therapy.

Among these, the most closely watched development is the outcome of the New Drug Application (NDA) for “Lirapugratinib,” a fibroblast growth factor receptor 2 (FGFR2)-targeted anticancer drug developed by HLB Therapeutics’ U.S. subsidiary, Eleva Therapeutics, scheduled for September. This is in accordance with the final review deadline under the U.S. Prescription Drug User Fee Act (PDUFA), set for September 25 (local time).

PDUFA is a system established to enable the U.S. FDA to collect review fees from companies submitting applications for new drugs or biologics and use those funds to expand its review staff and systems, thereby facilitating expedited approval reviews. Under PDUFA, the FDA sets a target review date (PDUFA date) for each application and uses it to determine whether to grant approval.

Lirapugratinib is a highly selective, oral, small-molecule targeted anticancer drug designed to selectively inhibit FGFR2. It was designated as an Orphan Drug (ODD) by the FDA in 2022 and as a Breakthrough Therapy (BTD) in 2023, and its NDA was selected for Priority Review this year.

According to the results of global Phase 1 and 2 clinical trials, the objective response rate (ORR) was 46.5% among 114 patients. The median duration of response (DOR) was 11.8 months, and the median progression-free survival (PFS) was 11.3 months. The median overall survival (OS) was 22.8 months, and the disease control rate (DCR) was 96.5%.

The approval review for lirapugratinib is in its final stages. Elevate Therapeutics held a Late-Cycle Meeting with the FDA last month. A Late-Cycle Meeting is an official procedure conducted during the final stages of the approval review to address remaining issues while simultaneously coordinating next-step matters—such as labeling and post-marketing compliance plans—with a view toward potential approval.

The outcome of this review for lirapugratinib is also critically important for HLB INC., as it presents an opportunity to restore market confidence in the company, which has been waning.

Last July, HLB PHARMACEUTICAL received its third Complete Response Letter (CRL) from the FDA regarding the approval review for the combination therapy of riboceranib and camrelizumab as a first-line treatment for liver cancer. This combination therapy, administered alongside an immunotherapy drug from China’s Hengrui Pharmaceuticals, has been rejected three times and is currently undergoing its fourth review. As repeated delays in approval have led to skepticism in the market, the approval of lirapugratinib is expected to be HLB INC.’s key to restoring trust.

HLB INC. officials stated, “We have no significant disagreements with the FDA regarding the review process, nor are there any new issues that would affect approval. We will complete the subsequent procedures without a hitch.”

World Conference on Lung Cancer: Yuhan Corporation, Voronoi, Inc., and Others in the Spotlight

The

World

Conference on Lung Cancer (WCLC 2026) is scheduled to take place in Seoul from September 12 to 15. This marks the first time in 20 years that the event will be held in South Korea; over 7,000 global lung cancer experts are expected to attend, and approximately 2,300 abstracts will be presented.

Numerous domestic companies will also participate to provide updates on their new drug pipeline research. In particular, Yuhan, Voronoi, Inc., and STCUBE are drawing attention as they plan to present data confirming early-stage clinical efficacy.

Yuhan Corporation will present data from the Phase 1 portion of the global Phase 1/2 clinical trial for “YH42946,” a next-generation tyrosine kinase inhibitor (TKI) targeting HER2 mutations and epidermal growth factor receptor (EGFR) exon 20 insertions. The presentation will focus on safety, pharmacokinetics (PK), and early antitumor activity. Of particular interest are the objective response rate (ORR) and degree of tumor shrinkage in patients with HER2-mutated non-small cell lung cancer (NSCLC), as well as the efficacy in patients with brain metastases. Notably, YH42946 holds significant importance as a successor in the anti-cancer pipeline following Lecraza.

Voronoi, Inc. will present clinical data on its next-generation EGFR TKI, “VRN11.” Key points include safety, PK, and initial antitumor activity, as well as efficacy in patients with the EGFR C797S mutation—a representative resistance mutation that arises following osimertinib treatment. Antitumor activity in the central nervous system (CNS) among patients with brain metastases is also a major point of interest.

STCUBE will unveil preliminary efficacy data for the first time from a Phase 2 clinical trial of its BTN1A1-targeted immuno-oncology drug “Nelmastobat” in combination with docetaxel for NSCLC. It will be crucial to determine whether tangible therapeutic effects, such as objective response rate (ORR) and tumor shrinkage, are confirmed in patients with high BTN1A1 expression. ABION Inc. plans to hold expert meetings and discuss technology transfer during the World Conference on Lung Cancer (WCLC) based on the results of the global Phase 2 clinical trial for “Babamekip (ABN401),” a treatment for MET-mutated NSCLC.

U.S. Drug Tariffs to Take Effect U.S. drug tariffs

will take full

effect

starting September 29. President Trump issued an executive order in April 2026 imposing, in principle, a 100% tariff on patented drugs and related raw materials. However, under the U.S.-Korea trade agreement, the tariff cap for South Korea has been set at 15%. Generics and biosimilars are currently exempt from tariffs, and plasma fractionation products, ADCs, and cell and gene therapies are also subject to a 0% tariff if they meet certain requirements.

Consequently, domestic botulinum toxin manufacturers are expected to face tariff burdens. DAEWOONGPHARMACEUTICAL’s botulinum toxin product, Nabota, is produced in Korea and exported to the U.S., placing it within the scope of the tariffs. Additionally, products such as Hugel, Inc.’s Retivo are also expected to be affected by the tariffs.

On the other hand, SAMSUNG BIOLOGICS, which has a production base in the U.S., is expected to benefit relatively more. SAMSUNG BIOLOGICS acquired a 60,000-liter production facility in Rockville, Maryland, this year, enabling it to meet the growing demand for local production in the U.S.

An official from the Korea Pharmaceutical and Bio-Pharma Association stated, “Since most companies affected by U.S. tariffs have already prepared countermeasures, the impact is not expected to be significant.”

“K-Bio Deal Summit” to Unveil Keys to Success for K-Bio

On September 9, the

“K-Bio Deal

Summit 2026,” hosted by Edaily, will be held at KG Tower in Seoul. Under the theme “K-Bio: Global Success Strategies Through Innovation,” this year’s event will focus on technology exports, global commercialization, and corporate value enhancement strategies for domestic pharmaceutical and biotech companies.

Key speakers at this event include representatives from SK BIOPHARMACEUTICALS, HanmiPharm, D&D Pharmatech Inc., AriBio, GeronCellVein, BreezeBio, and Ingenia Therapeutics.

SK BIOPHARMACEUTICALS will present its global commercialization strategy based on its experience with direct sales of the new epilepsy drug Xcopri in the U.S. and the technology export of Sunosi. HanmiPharm will present development and commercialization strategies for its H.O.P. project targeting obesity and metabolic diseases, including efeglenatide.

D&D Pharmatech Inc. will share its strategy for building a MASH therapy portfolio and technology export strategy, focusing on DD01 and TLY012. AriBio will outline its approval and commercialization plans for the Alzheimer’s treatment AR1001 following global clinical trials. BreezeBio and Ingenia Therapeutics are also scheduled to present their experiences in U.S. business development, global technology transfer, and initial public offerings (IPOs).

Attendees will be able to compare criteria for choosing between direct sales of new drugs and technology exports, global business development (BD) strategies, and post-technology-transfer growth strategies through real-world case studies from each company. The event is drawing significant industry attention as it offers a single venue to hear perspectives not only from companies but also from venture capital (VC) firms, securities firms, and representatives of global pharmaceutical companies.