Summary of Sichuan Kelun-Biotech Biopharmaceutical FY Conference Company Overview - **Company Name**: Sichuan Kelun-Biotech Biopharmaceutical (SEHK:06990) - **Industry**: Biopharmaceuticals - **Focus Areas**: Research, development, manufacturing, and commercialization of novel drugs in oncology, immunology, metabolism, and other therapeutic areas [2][3] Key Points Pipeline and Product Development - **Pipeline Programs**: Over 30 pipeline programs, including four approved products with seven indications, two products at NDA stage, and over 10 in clinical development [3] - **Employee Count**: Approximately 2,000 employees, with 900 in R&D, 500 in manufacturing and quality control, and 500 in sales and marketing [3] - **Approved Products**: - TROP2 ADC (SAC-TMT) approved for three indications in China, including lung cancer [4] - HER2-ADC (trastuzumab botidotecan) approved for HER2-positive breast cancer [4] - Cetuximab N01 for RAS wild-type colorectal cancer and PD-L1 for nasopharyngeal carcinoma [4] Clinical Studies and Results - **Clinical Trials**: Five pivotal studies initiated for breast cancer, six for lung cancer, and one for gastrointestinal cancer [5] - **Study Presentations**: Clinical data presented at major conferences, including ESMO and published in journals like the New England Journal of Medicine [6] - **Efficacy Data**: SAC-TMT demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) in various cancer types [10] Strategic Collaborations - **Partnerships**: Collaborations with MSD, Ellipses Pharma, and others to enhance pipeline value and global market reach [7][8] - **Out-License Agreements**: Entered into agreements to develop and commercialize novel oncology therapies [8] Market Position and Future Plans - **Market Access**: Three core products included in the National Reimbursement Drug List (NRDL) effective January 2026 [7] - **Commercialization Strategy**: Full-fledged commercialization team established, focusing on Class III hospitals and key opinion leaders [6] - **Growth Plans**: Focus on advancing differentiated pipeline programs, optimizing ADC platform, and expanding capabilities for drug development and commercialization [15][16] Innovation and Technology - **OptiDC Platform**: A world-class drug-conjugate technology platform aimed at optimizing drug design for better efficacy and safety [2][13] - **Non-Oncology Applications**: Exploring ADCs for autoimmune and metabolic diseases, combining biologicals and small molecules [14][15] Additional Insights - **Market Trends**: The company is positioned to leverage its innovative drug development capabilities in a rapidly evolving biopharmaceutical landscape, particularly in oncology [2][15] - **Regulatory Environment**: The inclusion of products in the NRDL indicates a supportive regulatory environment for biopharmaceuticals in China [7] This summary encapsulates the key aspects of the conference, highlighting the company's strategic direction, product pipeline, and market positioning within the biopharmaceutical industry.

智通财经APP获悉，科伦博泰生物-B(06990)涨超6%，截至发稿，涨5.89%，报427.2港元，成交额1.29亿 港元。 2025年12月，公司与Crescent Biopharma, Inc.就SKB105/CR-003与SKB118(程序性细胞死亡蛋白-1(PD-1)x 血管内皮生长因子(VEGF)双特异性抗体，亦称CR-001)达成战略合作，其中公司授予Crescent在美国、 欧洲及所有其他大中华地区(包括中国内地、香港、澳门及台湾)以外市场研究、开发、生产和商业化 SKB105/CR-003的独家权利，Crescent则授予公司在大中华地区研究、开发、生产和商业化SKB118/CR- 001的独家权利。 公司计划于近期向中国国家药品监督管理局药品审评中心递交SKB118/CR-001的IND申请。 消息面上，1月4日，科伦博泰生物-B发布公告，公司自主研发的靶向整合素β6(ITGB6)抗体偶联药物 (ADC)SKB105(亦称CR-003)的新药临床试验(IND)申请已获中国国家药品监督管理局(NMPA)药品审评中 心(CDE)批准，用于治疗晚期实体瘤。 ...

Core Insights - Heng Rui Medicine's SHR-A1904 has been included in the list of breakthrough therapies by the National Medical Products Administration, marking a significant advancement in the ADC field [1] - The global ADC market is experiencing explosive growth, with the market size surpassing $10 billion in 2023 and projected to reach $66.2 billion by 2030 [4] Group 1: Company Developments - Heng Rui Medicine's SHR-A1904 is a targeted Claudin18.2 antibody-drug conjugate (ADC) with a payload of topoisomerase inhibitor, currently undergoing multiple clinical studies for various solid tumors [1] - The company has invested approximately 174 million yuan in the development of SHR-A1904 [1] - Heng Rui Medicine's SHR-A2102, another ADC targeting Nectin-4, has received clinical trial approval, with a total investment of about 248 million yuan in its development [2] - The company has established a proprietary technology platform for ADCs, with over 10 differentiated ADC molecules successfully approved for clinical trials [2] Group 2: Industry Trends - Other innovative pharmaceutical companies, such as CanSino Biologics, BaiLi TianHeng, and Kelun-Biotech, are also making significant progress in ADC development [3] - The ADC drug market is characterized by rapid innovation and increasing recognition of the value of Chinese ADC assets in international markets [4] - Strategic partnerships, such as the one between Kelun-Biotech and Crescent Biopharma, highlight the growing trend of Chinese ADC companies expanding their reach globally [4]

Investment Rating - The investment rating for the company is "Buy" [4] Core Insights - The company has successfully included three core products in the national medical insurance directory, enhancing accessibility for patients [1][3] - A collaboration with Crescent Biopharma aims to develop and commercialize new cancer treatment methods, focusing on ADC and dual-specific antibodies [2][7] - The company is expected to see significant revenue growth due to the successful inclusion of its products in the national insurance scheme and its strong R&D capabilities [8] Summary by Sections Event 1 - The company's three core products, including ADC Sacituzumab Tirumotecan, have been included in the national medical insurance directory, with two indications for the ADC product [1] - This inclusion is expected to improve patient access and benefit a larger clinical population [3] Event 2 - The partnership with Crescent Biopharma will facilitate the development of SKB105 and CR-001, targeting ITGB6 and PD-1xVEGF respectively [2] - The collaboration includes rights for independent development of combination therapies, enhancing the company's pipeline [2][7] Analyst Commentary - The successful inclusion of the ADC product in the insurance directory showcases its clinical potential and market viability [3] - The company is actively expanding its international clinical collaborations, which is expected to bolster cash flow and explore new treatment combinations [7] Financial Projections - Revenue forecasts for 2025-2027 are adjusted to 21.75 billion, 29.12 billion, and 49.23 billion respectively, with year-on-year growth rates of 12.52%, 33.89%, and 69.06% [8][10] - The company is projected to achieve profitability by 2027, with a net profit of 790.85 million [10][12]

Core Viewpoint - Kolon Biotech and Crescent have entered into a collaboration to jointly develop and commercialize new cancer treatment methods, including a novel combination therapy, involving Kolon Biotech's SKB105 and Crescent's CR-001 [1][2] Group 1: Collaboration Details - The collaboration includes global exclusive cross-licensing and joint development of SKB105 and CR-001, with Kolon Biotech granting Crescent exclusive rights for SKB105 outside the US, Europe, and Greater China, while Crescent grants Kolon Biotech exclusive rights for CR-001 in Greater China [1] - Both companies will independently develop other combination therapies for CR-001, which has shown strong anti-tumor activity in preclinical studies [1] Group 2: Financial Terms - Kolon Biotech will receive an upfront payment of $80 million from Crescent, with potential milestone payments totaling up to $1.25 billion and tiered royalties based on SKB105's net sales [2] - Conversely, Crescent will receive an upfront payment of $20 million from Kolon Biotech, with potential milestone payments of up to $30 million and tiered royalties based on CR-001's net sales [2] Group 3: Product Characteristics - SKB105 targets integrin β6 (ITGB6) and is designed to reduce off-target toxicity, with high expression in various solid tumors but low or no expression in most normal tissues, which may lower systemic toxicity and off-target risks [2] - SKB105 is an antibody-drug conjugate (ADC) that combines a fully human IgG1 monoclonal antibody targeting ITGB6 with a clinically validated cleavable linker, utilizing proprietary Kthiol irreversible conjugation technology to enhance drug stability and tumor-specific payload delivery [2] Group 4: Competitive Landscape - Pfizer's Sigvotatug vedotin, acquired through the purchase of Seagen, is currently the fastest progressing ADC targeting ITGB6, with two pivotal Phase III clinical studies initiated for non-small cell lung cancer (NSCLC) [3] - Sigvotatug vedotin has shown promising early clinical data in NSCLC and head and neck squamous cell carcinoma, with significant overall response rates and clinical outcomes reported [3] Group 5: Revenue Projections - The company expects revenues of 2.084 billion, 2.876 billion, and 4.663 billion yuan for the years 2025 to 2027, with net profits projected at -622 million, -130 million, and 561 million yuan respectively, maintaining a "buy" rating [3]

Investment Rating - The report rates multiple companies in the healthcare sector as "Outperform," including BeiGene, China Resources Pharmaceutical, JD Health, Innovent Biologics, WuXi Biologics, and many others [1]. Core Insights - The Hong Kong healthcare sector has shown resilience, with the Hang Seng Healthcare Index gaining 72.2% year-to-date, outperforming the Hang Seng Index by 41.1 percentage points [4][28]. - The implementation of the "dual catalogs" for basic medical insurance and commercial insurance is expected to support innovation in the pharmaceutical sector, with 114 new drugs added to the basic medical insurance catalog and a success rate of 88% [5][30]. - The report highlights the strong performance of the pharmaceutical distribution and CXO sectors, with respective gains of 2.0% and 1.7% in the past week [15][29]. Summary by Sections Market Performance - The Hang Seng Healthcare Index fell by 0.7% in the week of December 1-5, 2025, underperforming the Hang Seng Index by 1.6 percentage points [4][28]. - The pharmaceutical distribution sector and CXO services performed well, with increases of 2.0% and 1.7%, respectively [15][29]. Drug Catalog Implementation - The "National Basic Medical Insurance Catalog" and the first edition of the "Commercial Insurance Innovative Drug Catalog" were released, with 114 new drugs added to the basic insurance catalog [5][30]. - The commercial insurance catalog includes 19 innovative drugs, emphasizing support for innovation and addressing the needs of the elderly and children [13][30]. Company Highlights - Notable companies that performed well include Jinxin Fertility (+7.5%), Harbour BioMed-B (+5.3%), and WuXi Biologics (+4.7%) [15][29]. - The report suggests increasing focus on companies with strong performance certainty in the CXO sector and those with stable long-term demand in medical services [15][29].

Core Insights - The strategic collaboration between Kelun-Biotech and Crescent Biopharma is valued at over $1.3 billion, involving a $80 million upfront payment and up to $1.25 billion in milestone payments for the global rights to SKB105 outside Greater China, while Kelun-Biotech acquires exclusive rights to CR-001 in Greater China for a $20 million upfront payment [1][2] Strategic Supplementation - The partnership reflects a deep understanding of the competitive landscape in 2025, with a focus on securing foundational assets for the next decade in the evolving field of tumor immunotherapy [1][2] - The PD-1/VEGF dual antibody space has seen over $7 billion in disclosed licensing and collaboration deals in the past three years, indicating its significance in the post-PD-1 era [2] Differentiated Competition - Crescent's interest in SKB105 is driven by its unique design targeting ITGB6, which is seen as a promising ADC target due to its high expression in difficult-to-treat cancers and low expression in normal tissues [3][4] - SKB105 utilizes a novel Topo-I inhibitor as its payload, which may offer improved therapeutic windows compared to traditional payloads like MMAE used by competitors [3][4] Collaborative Model - Crescent Biopharma exemplifies an efficient development model focused on fast-following validated targets and differentiated innovation, enhancing asset value through rapid clinical advancement [5] - The collaboration allows both companies to leverage their strengths: Crescent gains a core ADC asset, while Kelun-Biotech secures funding and access to a critical immune pipeline [5] Industry Implications - The transaction signifies a maturation of the Chinese biotech outbound model, moving from one-way licensing to a more flexible resource exchange approach [6] - This partnership highlights a pragmatic choice in a complex market, emphasizing the importance of external collaborations to build a competitive product portfolio rather than solely relying on in-house development [7]

Core Viewpoint - The strategic partnership between Sichuan Kelun Biotech Co., Ltd. and Crescent Biopharma aims to develop and commercialize innovative cancer therapies, including new combination treatments [1][2]. Group 1: Partnership Details - The collaboration involves Kelun Biotech's SKB105, an antibody-drug conjugate targeting integrin β6, and Crescent's dual-specific antibody CR-001, which targets PD-1 and VEGF, both intended for solid tumor treatment [2]. - The partnership grants Crescent exclusive rights to research, develop, manufacture, and commercialize SKB105 outside of Greater China, while Kelun Biotech receives exclusive rights for CR-001 within Greater China [2]. Group 2: Financial Aspects - Kelun Biotech will receive an upfront payment of $80 million from Crescent, with potential milestone payments up to $1.25 billion and tiered royalties based on SKB105's net sales [3]. - Crescent will pay Kelun Biotech an upfront fee of $20 million, with milestone payments up to $30 million and tiered royalties based on CR-001's net sales [3]. Group 3: Strategic Implications - This collaboration enhances Kelun Biotech's differentiated oncology pipeline and accelerates the global development of SKB105, increasing its commercial potential and expanding the company's global partnership network [3]. - The partnership leverages both companies' resources to explore new monotherapy and combination therapy strategies in cancer treatment, maximizing the therapeutic potential of both candidates in China and globally [3].

Core Insights - The company, Kelun Pharmaceutical, has established a strategic partnership with Crescent Biopharma to jointly develop and commercialize oncology treatment methods [1] Group 1: Partnership Details - The collaboration involves two candidate drugs: Kelun's SKB105 and Crescent's CR-001 [1] - Kelun grants Crescent exclusive rights to develop SKB105 in markets outside the US, Europe, and Greater China, while Crescent grants Kelun exclusive rights to develop CR-001 in Greater China [1] Group 2: Financial Aspects - Kelun will receive an upfront payment of $80 million from Crescent and has the potential to earn up to $1.25 billion in milestone payments [1] Group 3: Strategic Implications - This partnership allows Kelun to enhance and diversify its oncology research pipeline by incorporating CR-001 [1]

Core Insights - The company announced a strategic partnership with Crescent Biopharma to jointly develop and commercialize oncology treatments [1] - The collaboration involves two candidate drugs: SKB105 from the company and CR-001 from Crescent [1] - The company grants Crescent exclusive rights to develop SKB105 outside the US, Europe, and Greater China, while Crescent grants the company exclusive rights to develop CR-001 in Greater China [1] Financial Aspects - The company will receive an upfront payment of $80 million from Crescent [1] - There is potential for the company to earn up to $1.25 billion in milestone payments [1] Research and Development - The partnership includes the development of both monotherapy and combination therapy for the two candidate drugs [1] - The collaboration enhances the company's differentiated oncology research pipeline by incorporating CR-001 [1]