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<Research> CMBI Raises TP of Kelun-Biotech (06990.HK) to HKD507.11 as Commercialization Begins
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CMBI published a research report stating that 2025 is a pivotal year for Kelun-Biotech (06990.HK) as it transitions into a commercial biopharmaceutical company. Four products are expected to be approved within the year, with product sales revenue reaching RMB543 million. Three core assets, SKB264 (sac-TMT), A167, and A140, will be included in the National Reimbursement Drug List starting January 2026, laying a solid foundation for sales expansion this year. Although the net loss for 2025 is expected to widen to RMB382 million, mainly due to the expansion of commercialization scale and late-stage clinical trial enrollment, the company's financial position remains robust, with cash and financial assets totaling RMB4.6 billion as of the end of last year, providing ample liquidity for domestic commercialization and pipeline development. The firm noted that the Chinese Phase III clinical trial comparing SKB264 combined with Keytruda (pembrolizumab) to Keytruda monotherapy for first-line treatment of PD-L1 positive non-small cell lung cancer was successful, achieving the primary endpoint of progression-free survival, with overall survival also showing a positive trend. Complete data will be presented at the American Society of Clinical Oncology Annual Meeting in June this year. This is the world's first Phase III clinical trial to demonstrate the success of an antibody-drug conjugate (ADC) combined with an immune checkpoint inhibitor in first-line non-small cell lung cancer, potentially changing the treatment landscape. In January this year, SKB264 was granted a "Commissioner Priority Review Voucher" by the US FDA, reducing the regulatory review period from the standard 10 to 12 months to 1 to 2 months. The firm expects partner Merck to submit the first marketing application for SKB264 in second-line and above endometrial cancer by 2026, with approval anticipated by late 2026 or early 2027. To date, Merck has initiated 17 global Phase III clinical trials for SKB264, covering areas such as breast cancer, lung cancer, gynecological cancers, and gastric cancer. Considering the out-licensing of ITGB6 ADC to Crescent by the end of 2025, CMBI revised Kelun-Biotech's earnings forecast, raising the target price from HKD498.55 to HKD507.11, based on a discounted cash flow model valuation with an unchanged weighted average cost of capital of 8.69% and a terminal growth rate of 3.5%, maintaining a "Buy" rating. (ec/da) Auto-translated by third-party software This translation was auto-generated by third-party software. AASTOCKS.com Limited does not guarantee its accuracy or completeness and accepts no liability for any damages or losses arising from the use of this translation. More Details
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