"Biotech sector in Taiwan moves fast, making it easier to pivot and innovate"

Caliway Biopharmaceuticals has recently announced the completion of its initial public offering (IPO) and up-listing from the Emerging Stock Market to the Taipei Exchange (TWSE-6919). The round raised approximately $206 million (NT$6.4 billion), marking it the largest IPO in Taiwan's biotech industry history and valuing the company at nearly $3 billion. The company is poised for a transformation in 2025, advancing its groundbreaking clinical programmes and strengthening its global market presence. Following its recent record-breaking IPO, BioSpectrum Asia took an opportunity to speak with Vivian Ling, Chief Executive Officer & Chief R&D Officer, Caliway Biopharmaceuticals to explore their innovative contributions in biopharmaceuticals. Edited excerpts:

- Vivian Ling

Which products are currently under development?

2025 will be a defining year for Caliway as we push ahead with key clinical advancements and corporate milestones, bringing CBL-514 closer to market. CBL-514, a first-in-class small-molecule drug designed to selectively induce adipocyte apoptosis, provides a non-invasive alternative to liposuction for non-surgical fat reduction in medical aesthetics. We are preparing to secure IND approvals for two pivotal Phase 3 studies from the US FDA and Health Canada, a critical step in advancing CBL-514 as the world's first investigational drug for large-area localised fat reduction. Beyond fat reduction, we're also submitting a Phase 2 IND application for a new indication focused on improving body weight rebound, expanding CBL-514's potential applications.

In Q1, Caliway announced positive Phase 2b study results for CBL-514 (0205 Study), the second and final Phase 2b before moving into Phase 3. In Q2, we are preparing for regulatory discussions with the FDA (EOP2) and EMA to align on the next steps for CBL-514's late-stage development.

A key focus in Q4 will be completing patient enrollment for the Phase 2b study of CBL-514 in Dercum's Disease (CBL-514 0202DD). CBL-0202DD is being developed as a potential first-in-class therapy for Dercum's Disease, a rare and painful condition, and has already been granted Fast Track Designation by the FDA and Orphan Drug Designation by both the FDA and EMA. In the early-stage pipeline, CBA-539 offers a novel approach to hyperpigmentation and skin ageing by inhibiting melanin production and transmission, reducing dark spots and evening skin tone, while also stimulating collagen production to improve skin elasticity and firmness for natural, long-lasting results. Expanding into therapeutic applications, CBL-0201OB targets post-weight loss fat accumulation in combination with GLP-1, with a Phase 2 IND submission planned for Q4 2025.