机构:招银国际
研究员:Jill WU/Andy WANG
Significant strides in commercialization. To date, the Company already has three commercialized assets, including Sac-TMT (Trop2 ADC), A140 (cetuximab) and A167 (PD-L1). For Sac-TMT, the drug already received the NMPA’s approval for TNBC (Nov 2024) and 3L EGFRm NSCLC (Mar 2025), and its NDA for 2L EGFRm NSCLC is expected to be approved in 2H25. A166 (HER2 ADC)’s NDAs were accepted for 2L and 3L HER2+ BC, with approvals expected by 2H25. The Company grew its commercial team to 360 employees by end-2024, with plans to expand to 500+ by 2Q25. We believe this year will be a critical year for validating the Company’s commercialization capabilities. Given that the Company will fully leverage Kelun Pharma’s industry experience and resources, combined with the Company’s independently established commercialization network, we are confident in achieving the RMB 800mn to 1.0bn sales target for Sac-TMT this year.
Sac-TMT being the only TROP2 ADC proving OS benefit in TKI-resistant EGFRm NSCLC. We expect overwhelming China pivotal results of Sac-TMT in 3L EGFRm NSCLC to be released at this year’s ASCO meeting. We believe the significant PFS and OS benefits will further confirm Sac-TMT’s best-in-class position in this treatment setting. As of now, MSD has initiated 12 global Phase III clinical trials for Sac-TMT, primarily focusing on breast cancer, lung cancer, gastrointestinal tumors, and gynecologic tumors, demonstrating MSD's strong confidence in this drug.
Second wave of innovation. Kelun-Biotech is advancing a multi-pronged ADC strategy across oncology and non-oncology, leveraging novel payloads, bispecific ADCs, and next-generation conjugation technologies. In oncology, the Company develops differentiated ADCs targeting validated (e.g., SKB315, SKB410) and first-in-class (e.g., SKB571, SKB518, SKB535, SKB445) antigens. SKB571, its first bispecific ADC, mainly targets lung cancer, CRC and other solid tumors. Beyond cytotoxic ADCs, SKB107, a radiopharma drug conjugate (RDC), targets bone metastases by delivering targeted radiation, aiming to treat tumor- induced bone metastases and prevent skeletal-related events.
Maintain BUY. We remain confident about Sac-TMT’s global development and commercialization in China. We raise our DCF-based TP from HK$227.88 to HK$299.93 (WACC: 8.84%, terminal growth rate: 4.0%).