荃信生物-B(02509)再涨超3%，截至发稿，涨3.26%，报20.9港元，成交额306.19万港元。 消息面上，荃信生物宣布，12月8日，公司收到合作伙伴Caldera Therapeutics, Inc支付的500万美元里程 碑付款，此付款是基于QX030N/CLD-423获得人类研究伦理委员会I期临床试验伦理许可而触发的。 据悉，公司自主研发的双抗QX030N/CLD-423于澳大利亚通过HREC审批，计划于2026年初启动临床试 验。本次许可标志着公司的双抗矩阵布局在海外正式迈入临床阶段，将进一步强化公司在自免及过敏疾 病领域的领先地位。公司及Caldera也将加快项目开发进度，早日取得更多临床进展。 ...

荃信生物-B(02509)再涨超3%，截至发稿，涨3.26%，报20.9港元，成交额306.19万港元。 据悉，公司自主研发的双抗QX030N/CLD-423于澳大利亚通过HREC审批，计划于2026年初启动临床试 验。本次许可标志着公司的双抗矩阵布局在海外正式迈入临床阶段，将进一步强化公司在自免及过敏疾 病领域的领先地位。公司及Caldera也将加快项目开发进度，早日取得更多临床进展。 消息面上，荃信生物宣布，12月8日，公司收到合作伙伴Caldera Therapeutics,Inc支付的500万美元里程 碑付款，此付款是基于QX030N/CLD-423获得人类研究伦理委员会I期临床试验伦理许可而触发的。 ...

荃信生物-B(02509)公布，于2025年12月8日，公司收到合作伙伴Caldera Therapeutics,Inc.(Caldera)支付的 500万美元里程碑付款，该付款乃基于QX030N/CLD-423*获得人类研究伦理委员会(Human Research Ethics Committee，HREC)I期临床试验伦理许可而触发。 近日，公司自主研发的双抗QX030N/CLD-423于澳大利亚通过HREC审批，计划于2026年初启动临床试 验。该试验是一项随机、双盲、安慰剂对照、剂量递增的I期临床试验，其主要研究目的为评估 QX030N/CLD-423针对健康成人单次和多次静脉(IV)╱皮下(SC)给药的安全性、耐受性、药代动力学 (PK)和药效学(PD)特徵。 本次许可标志着公司的双抗矩阵布局在海外正式迈入临床阶段，将进一步强化公司在自免及过敏疾病领 域的领先地位。公司及Caldera也将加快项目开发进度，早日取得更多临床进展。 据悉，公司与Caldera于2025年4月23日签署对外授权协议，Caldera获得QX030N/CLD-423的全球独家开 发和商业化权利。截至2025年12月8日，公司 ...

近日，公司自主研发的双抗QX030N/CLD-423于澳大利亚通过HREC审批，计划于2026年初启动临床试 验。该试验是一项随机、双盲、安慰剂对照、剂量递增的I期临床试验，其主要研究目的为评估 QX030N/CLD-423针对健康成人单次和多次静脉(IV)╱皮下(SC)给药的安全性、耐受性、药代动力学 (PK)和药效学(PD)特徵。 本次许可标志着公司的双抗矩阵布局在海外正式迈入临床阶段，将进一步强化公司在自免及过敏疾病领 域的领先地位。公司及Caldera也将加快项目开发进度，早日取得更多临床进展。 据悉，公司与Caldera于2025年4月23日签署对外授权协议，Caldera获得QX030N/CLD-423的全球独家开 发和商业化权利。截至2025年12月8日，公司已获得预付款及里程碑款共计1500万美元，以及Caldera一 定比例的股权。未来，在达成特定临床开发、监管及商业里程碑的前提下，公司亦可获得最高5.4亿美 元的额外付款，及根据QX030N/CLD-423销售净额收取分级特许权使用费。 智通财经APP讯，荃信生物-B(02509)公布，于2025年12月8日，公司收到合作伙伴Caldera ...

本次许可标志着公司的双抗矩阵布局在海外正式迈入临床阶段，将进一步强化公司在自免及过敏疾病领 域的领先地位。公司及Caldera也将加快项目开发进度，早日取得更多临床进展。 近日，公司自主研发的双抗QX030N/CLD-423于澳大利亚通过HREC审批，计划于2026年初启动临床试 验。该试验是一项随机、双盲、安慰剂对照、剂量递增的I期临床试验，其主要研究目的为评估 QX030N/CLD-423针对健康成人单次和多次静脉(IV)╱皮下(SC)给药的安全性、耐受性、药代动力学 (PK)和药效学(PD)特徵。 格隆汇12月9日丨荃信生物-B(02509.HK)宣布，于2025年12月8日，公司收到合作夥伴Caldera Therapeutics, Inc.(「Caldera」)支付的5百万美元里程碑付款，该付款乃基于QX030N/CLD-423*获得人类 研究伦理委员会(Human Research Ethics Committee，HREC)I期临床试验伦理许可而触发。 ...

Core Viewpoint - The company is leveraging technological innovation as a driving force for its drug development, with key products in advanced clinical stages and expected market submissions in the near future [1][2]. Group 1: Product Development and Clinical Trials - The company has two main products, KN026 (HER2 bispecific antibody) and JSKN003 (HER2 bispecific antibody ADC), both in Phase 3 clinical trials, with KN026 expected to submit for market approval for 2L+ HER2-positive gastric cancer in 2025 [1]. - KN026 is involved in three Phase 3 clinical trials, including a combination study with chemotherapy for 2L+ HER2-positive gastric cancer, which has met the primary endpoint for progression-free survival (PFS) [1]. - JSKN003 is also in three Phase 3 clinical trials targeting HER2-positive breast cancer and platinum-resistant recurrent epithelial ovarian cancer [1]. Group 2: Financial Performance and Collaborations - In 2024, the company achieved significant licensing revenue from multiple collaborations, including a $700.8 million deal for KN035 and a $308 million deal for JSKN003, leading to a total revenue of 640 million yuan, a year-on-year increase of 192.6% [2]. - The company turned a profit of 166 million yuan in 2024, marking its first profitable year, while maintaining a stable R&D expenditure of 404 million yuan [2]. - Cash reserves at the end of 2024 stood at 1.571 billion yuan, providing a solid financial foundation for ongoing clinical development [2]. Group 3: Future Outlook and Strategic Focus - The company is focusing on the development of JSKN016 (TROP2/HER3 ADC), which is currently in Phase 2 clinical trials, aiming to enhance efficacy through dual-targeting mechanisms [2]. - The clinical strategy for JSKN016 includes targeting unmet needs in triple-negative breast cancer (TNBC) and EGFR-TKI resistant non-small cell lung cancer (NSCLC) [2]. - Revenue projections for 2025-2027 are estimated at 458 million, 490 million, and 398 million yuan respectively, with a recommendation for investment based on the promising pipeline [3].

Investment Rating - The report gives a "Buy" rating for the company, marking its first coverage [1]. Core Views - The company is moving towards a harvest period with multiple licensing collaborations validating its platform value [1]. - The company achieved its first profit in 2024, driven by significant licensing income and a strong focus on R&D [6][22]. - The company has a robust pipeline of HER2-targeted products, with key candidates in late-stage clinical trials [6][25]. Summary by Sections 1. Technical Innovation as a Driver - The company focuses on antibody-drug conjugates (ADC) and bispecific antibodies, leveraging core technologies for differentiated cancer immunotherapy [11]. - The management team has extensive experience in research and development, ensuring innovation and operational efficiency [11][19]. - The company has secured multiple high-value licensing agreements, enhancing its platform and pipeline value [19][20]. 2. HER2-targeted Product Strategy - The company has three HER2-targeted products, including KN026 (HER2 bispecific antibody) and JSKN003 (HER2 bispecific ADC), positioned for various cancer indications [25][30]. - KN026 is expected to submit a domestic application for 2L+ HER2-positive gastric cancer by 2025, with promising clinical data [30][34]. - JSKN003 has a commercial collaboration with a partner, with a total transaction value of 30.8 billion RMB [39]. 3. JSKN016 (TROP2/HER3 ADC) Development - JSKN016 is being explored for both monotherapy and combination treatments, targeting high-expression TROP2 and HER3 in various tumors [7][25]. - The drug is in clinical phase 2, focusing on unmet needs in triple-negative breast cancer and EGFR-TKI resistant non-small cell lung cancer [7][25]. 4. Financial Performance and Projections - The company achieved a revenue of 6.4 billion RMB in 2024, a year-on-year increase of 192.6%, with a profit of 1.66 billion RMB [22][23]. - The R&D expenditure for 2024 was maintained at 4.04 billion RMB, ensuring continued investment in clinical development [22][24]. - Revenue projections for 2025-2027 are estimated at 4.58 billion RMB, 4.90 billion RMB, and 3.98 billion RMB respectively [6][25].

Core Viewpoint - The report maintains a "buy" rating for Kangfang Biopharma (09926), projecting significant revenue growth from 2025 to 2027, driven by strong commercialization and a promising innovation pipeline [1][2]. Group 1: Financial Performance - Kangfang Biopharma reported a revenue of 14.12 billion yuan for H1 2025, representing a year-on-year increase of 37.75% [1][2]. - The sales revenue from product sales reached 14.01 billion yuan, reflecting a 49.20% year-on-year growth [2]. - R&D expenses were 7.31 billion yuan, up 23.06% year-on-year, while sales and management expenses increased by 29.84% and 34.00%, respectively [1]. Group 2: Product Development and Clinical Trials - The commercialization of core dual antibodies, Kadunil and Ivosidenib, is driving revenue growth, with expectations for further performance improvements as new products and indications are approved [2]. - The WCLC 2025 conference showcased updated overall survival (OS) data for Ivosidenib, indicating a significant improvement in survival benefits, particularly in the North American population [2][3]. - Ongoing clinical trials for Ivosidenib include various cancer types, with a focus on expanding its indications, which could enhance its market potential [3].

Investment Rating - The report suggests a positive outlook for the company, indicating that the current market capitalization of HKD 57 billion is significantly undervalued, recommending active attention to the stock [6]. Core Insights - The company presented excellent preliminary efficacy and safety data for IMM2510, a PD-L1xVEGF dual antibody, at the 2025 World Lung Cancer Conference, showing an objective response rate (ORR) of 35.3% and a progression-free survival (PFS) of 9.4 months in patients with advanced squamous non-small cell lung cancer (sq-NSCLC) [2][3]. - The safety profile of IMM2510 is manageable, with common grade ≥3 treatment-related adverse events (TRAEs) reported at 8.7% for thrombocytopenia, lymphopenia, and infusion-related reactions [3]. - The company has a rich pipeline with significant product potential, including the CD47CD20 dual antibody (IMM0306) and other candidates, indicating a broad space for business development [4][5]. Summary by Sections Clinical Data - The ORR for IMM2510 was reported at 35.3% (6 out of 17 patients), with a disease control rate (DCR) of 76.5% (13 out of 17). The median duration of response (DoR) was 7.59 months, and the median PFS was 9.4 months [2]. Safety Profile - Among 23 enrolled patients, the common grade ≥3 TRAEs included thrombocytopenia (8.7%), lymphopenia (8.7%), and infusion-related reactions (8.7%), indicating that the safety of IMM2510 is controllable [3]. Pipeline and Development - The company is advancing multiple clinical trials, including a Phase III registration trial for IMM2510 in sq-NSCLC and various combinations with other therapies [3]. The CD47 fusion protein (IMM01) is progressing well in Phase III trials for CMML and cHL, with mid-term data analysis expected next year [5]. Additionally, the new drug IMM72 for pulmonary arterial hypertension (PAH) has received approval and is currently recruiting healthy volunteers [5].

Summary of Zai Jian Pharmaceutical Conference Call Company Overview - Zai Jian Pharmaceutical focuses on dual-antibody platforms and mature products, with innovative potential in dual-antibody drugs like ZG005 and ZG006, and stable income from mature products such as Donafenib and recombinant human thrombin [2][3] Key Points and Arguments Dual-Antibody Platform - ZG006 shows potential in treating small cell lung cancer (SCLC) with an objective response rate (ORR) close to 60% in third-line and above treatments, outperforming Taletmap's 40% [2][5][9] - ZG005, a PD-1-TIGIT dual-antibody, aims to overcome the limitations of TIGIT monoclonal antibodies and has attracted interest from overseas pharmaceutical companies, indicating potential for international development [2][7] Clinical Progress and Market Potential - Zai Jian Pharmaceutical is a leader in dual-antibody drug development, with significant advancements in cervical cancer treatment, showing progression-free survival (PFS) exceeding 11 months, which is significantly better than competitors [2][9] - The dual-antibody platform has internationalization potential, especially after breakthroughs in lung cancer, which may attract collaborations with foreign pharmaceutical companies [2][10] Product Pipeline Characteristics - The product pipeline includes mature products like Donafenib (for liver cancer), recombinant human thrombin (for hemostasis), and Jikaxitini (for myelofibrosis and autoimmune diseases), providing diversified growth drivers [3][4] Future Development Plans - Zai Jian Pharmaceutical plans to complete a business development (BD) transaction for ZG006 by the end of the year, with expectations to achieve this in the first quarter of the following year [11][16] - Preliminary data for liver cancer and pneumonia treatments are expected to be released by the end of this year or early next year, further validating the internationalization capabilities of their products [11][16] Additional Important Insights - The entry of recombinant human thrombin into medical insurance is expected to enhance revenue growth, while Donafenib is projected to achieve over 10% year-on-year growth [12] - Jikaxitini shows promise in treating autoimmune diseases and may gradually replace other treatments like Ruxolitinib [12][13] - Zai Jian Pharmaceutical is focusing on new fields such as liver cancer, bleeding disorders, and immune inflammation, with a strong emphasis on their innovative dual-antibody platform [14] Recent Data and Significance - Recent data from ZG006 in SCLC treatment indicates a median PFS that could significantly outperform Taletmap, which is crucial for market competitiveness [15] - The ORR for ZG005 in first-line liver cancer treatment is also a key focus, as liver cancer progresses rapidly, making ORR a direct indicator of efficacy [15] This summary encapsulates the critical aspects of Zai Jian Pharmaceutical's conference call, highlighting its strategic focus, product pipeline, clinical advancements, and future growth plans.