Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech), a leading Chinese innovator in biopharmaceuticals, delivered a keynote speech at the 44th Annual J.P. Morgan Healthcare Conference (JPMHC) held in San Francisco from January 12 to 15, 2026. Dr. Ge Michael, President and CEO, outlined the company's remarkable progress in drug research and development (R&D), commercialization efforts, and strategic globalization initiatives, positioning Kelun-Biotech as a frontrunner in China's innovative drug landscape.

Since embarking on its innovation trajectory in 2012, Kelun-Biotech has constructed differentiated technology platforms, notably its globally recognized OptiDC™ platform for antibody-drug conjugates (ADCs) and novel drug conjugates (DCs). This platform facilitates the creation of a robust, gradient pipeline targeting diverse tumor types, addressing critical unmet needs in oncology. Currently, the company boasts two ADC products on the market: sacituzumab tirumotecan (sac-TMT, branded as 佳泰莱®) and trastuzumab botidotin (舒泰莱®), approved for breast cancer and lung cancer indications in China. These products exemplify Kelun-Biotech's capability to deliver high-efficacy therapies with optimized safety profiles.

In the clinical pipeline, nine uniquely engineered ADC and novel DC candidates are advancing, including pioneering bispecific ADCs and radiopharmaceutical conjugates (RDCs). For prevalent cancers in China such as breast, lung, and gastrointestinal tumors, nine pivotal clinical studies are underway, complemented by multiple Phase II trials in gynecological oncology. Beyond oncology, Kelun-Biotech is diversifying into non-DC candidates and expanding indications to non-oncology therapeutic areas, broadening its market potential.

Commercialization remains a cornerstone of Kelun-Biotech's strategy. The TROP2-targeted ADC sac-TMT has secured approvals for second-line and beyond triple-negative breast cancer, as well as second- and third-line EGFR-mutated non-small cell lung cancer (NSCLC). Trastuzumab botidotin, the first domestically developed HER2-directed ADC for second-line and above HER2-positive breast cancer, was approved last year. Additional launches include the anti-EGFR monoclonal antibody Cetuximab N01 (达泰莱®) for RAS wild-type colorectal cancer and the anti-PD-L1 antibody tagitanlimab (科泰莱®) for nasopharyngeal carcinoma. An upcoming small-molecule RET inhibitor, A400, is poised for approval this year, elevating the commercial portfolio to five products covering five indications, three of which are included in China's National Reimbursement Drug List (NRDL).

To amplify global reach, Kelun-Biotech has forged key partnerships with industry giants like MSD, Ellipses, Windward Bio, and Crescent Biopharma. Notably, MSD is assessing 16 global Phase III trials for sac-TMT, underscoring the international validation of Kelun-Biotech's assets. These collaborations optimize pipeline value and corporate valuation through out-licensing and co-development.

Underpinning these achievements is sustained R&D investment, with over a decade of expertise in ADCs. The OptiDC™ platform integrates precise targeting with tailored payload-linker technologies for superior efficacy-safety balance. A 'multi-pronged' approach explores novel targets, payloads, and conjugation methods, extending applications to both oncology and beyond.

Looking forward, Kelun-Biotech will execute five core strategies to bolster R&D, technology platforms, and operations. Emphasis on globalization will enhance ex-China capabilities in development, registration, and commercialization, aspiring to world-class status. With over 30 key innovative projects—including four marketed, one in NDA, and more than 10 in clinical stages—Kelun-Biotech, a subsidiary of Kelun Pharmaceutical (002422.SZ), targets solid tumors, autoimmune, and metabolic diseases via a globalized platform.

This presentation not only highlights Kelun-Biotech's maturity in innovative drug manufacturing and outsourcing but also signals strategic shifts in pharmaceutical supply chains and contract research organizations (CROs) within Asia. For pharmaceutical executives, it underscores opportunities in ADC technology transfer, manufacturing partnerships, and regulatory pathways for biologics in China, influencing procurement and R&D decisions across the region.

The event reinforces Asia's rising prominence in global biopharma, with Kelun-Biotech's pipeline poised to impact **pharmaceutical manufacturing equipment**, **biotechnology**, and **contract services** sectors. Investors and partners will closely monitor upcoming milestones, including A400's approval and Phase III readouts, as they shape competitive dynamics in high-value therapeutics.