Core Viewpoint - The announcement from Kelun Pharmaceutical indicates that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) A166 (also known as Shutailai®) for the treatment of adult patients with HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [2] Group 1 - The approved drug A166 targets the human epidermal growth factor receptor 2 (HER2) [2] - The indication for A166 is for patients with unresectable or metastatic HER2-positive breast cancer [2] - The approval is significant as it addresses a patient population that has limited treatment options after prior therapies [2]

Core Viewpoint - Kolon Biotech Inc. reported a significant decline in revenue for the six months ending June 30, 2025, with a 31.3% year-on-year decrease, leading to a loss attributable to equity shareholders of RMB 145 million [1] Financial Performance - The company achieved revenue of RMB 950 million, down 31.3% year-on-year [1] - Research and development expenses amounted to RMB 612 million, a decrease of 6.3% year-on-year [1] - The loss attributable to equity shareholders was RMB 145 million, with a loss per share of RMB 0.64 [1] Product Development and Commercialization - The company has obtained marketing approvals for sac-TMT (佳泰莱®), Tagolizumab (科泰莱®), and Cetuximab N01 (达泰莱®) and has commenced commercialization [1] - The company anticipates launching Botuzumab (舒泰莱®) in the Chinese market in the second half of 2025, pending regulatory communication and approval [1] - Total commercial sales for the first half of 2025 reached RMB 309.8 million, with 97.6% of sales attributed to 佳泰莱® [1] Accounts Receivable Management - All accounts receivable from drug sales were collected within the payment period, indicating efficient and stable cash flow [1]

Group 1 - The company reported a revenue of RMB 950 million for the six months ending June 30, 2025, representing a year-on-year decrease of 31.3% [1] - Research and development expenses amounted to RMB 612 million, a decrease of 6.3% year-on-year [1] - The company incurred a loss attributable to equity shareholders of RMB 145 million, with a loss per share of RMB 0.64 [1] Group 2 - The company has obtained marketing approvals for sac-TMT (佳泰莱®), Tagolizumab (科泰莱®), and Rituximab N01 (达泰莱®) and has commenced commercialization [1] - The company anticipates launching Botuzumab (舒泰莱®) in the Chinese market in the second half of 2025, pending regulatory communication and approval [1] - The total commercial sales for the first half of 2025 reached RMB 309.8 million, with 97.6% of sales attributed to 佳泰莱® [1] Group 3 - The company has a diverse pipeline supported by proprietary technologies in ADCs, novel conjugated drugs, large molecules (monoclonal and bispecific antibodies), and small molecule drugs [2] - The company is a pioneer in ADC development, with over ten years of experience and is one of the few biopharmaceutical companies globally to establish an internal ADC and novel conjugated drug platform, OptiDCTM [2] - The company possesses end-to-end manufacturing capabilities compliant with cGMP standards and a comprehensive quality management system to support drug development [2]