格隆汇1月14日丨维立志博-B(09887.HK)宣布，于2026年1月14日，PD-L1/4-1BB双特异性抗体维利信 TM(奥帕替苏米单抗，LBL-024)获美国食品药品监督管理局(「FDA」)授予快速通道资格认定，用于治 疗肺外神经内分泌癌。 快速通道资格认定是FDA批准加速审查治疗严重或危及生命病情或解决未满足医疗需求的药物以助加快 药物开发的方法。其提供若干重要程序性激励措施，包括获得FDA更频繁的监管互动与指导，以及有权 滚动提交新药申请以获得监管批准。 维利信™是一种同时靶向PD-L1与4-1BB的双特异性抗体，为针对肺外神经内分泌癌的全球首款达到注 册临床阶段的靶向4-1BB受体的疗法。于非小细胞肺癌、小细胞肺癌及肺外神经内分泌癌这3种适应症 的II期或注册临床试验中，维利信™展现出同类第一或同类最佳临床活性潜力。维利信TM亦有望成为 治疗晚期肺外神经内分泌癌的首款获批药物。凭藉我们自主研发并具有知识产权的X-body®平台，维利 信™采用最佳的2:2结构设计，可解除PD-1/L1免疫抑制并强化4-1BB调节的T细胞激活，实现协同消灭 肿瘤的效果，具有较PD-1/L1抑制剂更强的广谱癌症治疗潜 ...

截至本公告日期，公司QX030N/CLD-423的合作伙伴Caldera Therapeutics,Inc.(Caldera Therapeutics)累计 完成融资1.125亿美元。于2025年4月，Caldera Therapeutics从Atlas Venture、LAV及venBio获得7500万美 元的A轮融资，近期则完成由Omega Funds领投的3750万美元A-1轮融资，参与的新投资者包括 Wellington Management及Janus Henderson Investors。 荃信生物-B(02509)公布，靶向经临床验证的IL-23p19及TL1A通路的双特异性抗体QX030N/CLD-423的I 期健康志愿者试验已完成首批受试者给药。 ...

Core Viewpoint - WuXi Biologics (02269.HK) is set to participate in the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2024, where it will present updates on its business operations and financial performance [1] Group 1: Business Performance - The company reported a strong business and financial performance, with 209 new projects expected in 2025, bringing the total to 945 projects, including 74 in Phase III clinical trials and 25 CMO (Contract Manufacturing Organization) projects [1] - The research platform continues to show robust momentum, with record upfront and total payments in 2025, and new research contracts with potential milestone payments exceeding $4 billion [1] Group 2: Market Opportunities - Two-thirds of the new projects are focused on bispecific antibodies, multispecific antibodies, and ADCs (Antibody-Drug Conjugates), which are expected to drive innovation and open exciting market opportunities for the company [1] - The company completed 28 PPQ (Process Performance Qualification) projects in 2025, with 34 PPQ projects confirmed as of the announcement date in 2024, indicating a continuous increase in project activity [1] Group 3: Future Outlook - The company expresses confidence in maintaining growth momentum into 2026 and remains optimistic about its future prospects [1]

Core Viewpoint - Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. has announced that its self-developed innovative drug GR1803 injection has received acceptance for conditional marketing authorization from the National Medical Products Administration, focusing on the urgent clinical need in the treatment of relapsed refractory multiple myeloma [1][2] Group 1: Product Development - GR1803 injection is a dual-target bispecific antibody targeting BCMA and CD3, designed to enhance safety by reducing non-specific T cell activation while effectively recruiting and activating T cells to kill tumor cells [2] - The drug's affinity for BCMA is significantly higher than for CD3, with a two-order magnitude difference, which contributes to its therapeutic efficacy [2] - GR1803 injection was previously included in the National Medical Products Administration's list of breakthrough therapies in August 2024 [2] Group 2: Market Context - Multiple myeloma is the second most common hematological malignancy, with increasing incidence rates, particularly among the aging population in China [1] - The targeted patient population for GR1803 includes adults with relapsed or refractory multiple myeloma who have undergone at least three lines of treatment, indicating a significant unmet medical need [1]

Core Viewpoint - Company regained global rights for IMM2510 and IMM27M, enhancing its control over overseas clinical development and accelerating global development pace. The company is a global innovator in CD47 fusion proteins with significant potential in oncology, autoimmune diseases, and cardiovascular applications. The current market capitalization is only HKD 2.7 billion, indicating a severe undervaluation, and it is recommended to pay active attention to the company [1]. Group 1: Event and Rights Recovery - The company terminated the agreement with Axion, reclaiming global development and commercialization rights while allowing Axion to gradually conclude its clinical development activities. This termination does not affect the USD 35 million upfront and milestone payments already received from Axion [2]. - Due to significant delays and challenges faced by Axion in development progress, the company regained global rights for IMM2510 and IMM27M, allowing it to take the lead in overseas clinical research and accelerate the global development pace [3]. Group 2: Clinical Data and Efficacy - At the 2025 World Conference on Lung Cancer (WCLC), data for the PD-L1xVEGF bispecific antibody (IMM2510) showed an objective response rate (ORR) of 35.3% (6/17) among 17 evaluable patients with sq-NSCLC, with a disease control rate (DCR) of 76.5% (13/17). The median duration of response (DoR) was 7.59 months (95% CI: 4.07–NA), and the median progression-free survival (PFS) was 9.4 months (95% CI: 1.87–NA). The ORR of 35.3% outperformed similar VEGF/PD-(L)1 bispecific antibodies, which had ORRs of 33% and 19%, respectively, while the PFS of 9.4 months ranks among the best in its class [4]. - The company's PD-L1xVEGF bispecific antibody has clear differentiation advantages, with IgG1 Fc capable of activating ADCC, aiming to induce direct killing of PD-L1+ tumor cells. Compared to other PD-(L)1xVEGF bispecific antibodies, its VEGF blocking mechanism is broader, potentially leading to superior efficacy. With regained overseas R&D rights, the company is expected to significantly accelerate overseas clinical studies and simplify future business development negotiations, leveraging its differentiation advantages to attract multinational corporations [5]. Group 3: Safety and Pipeline - Among 23 enrolled patients, common ≥3 grade treatment-related adverse events (TRAEs) included thrombocytopenia (8.7%), lymphopenia (8.7%), and infusion-related reactions (8.7%). The safety profile of IMM2510 as a monotherapy is manageable. The company is also actively advancing clinical trials for IMM2510 in combination with chemotherapy, IMM27M, IMM01, and ADC for various solid tumor indications. An IND application for refractory solid tumors has been approved in the U.S. [6]. - The company has a rich pipeline with significant product potential and broad business development opportunities. The CD47CD20 bispecific antibody (IMM0306) is in Phase Ib clinical trials, showing an 85.7% (6/7) response rate in the 0.8 mg/kg group and 87.5% (7/8) in the 1.2 mg/kg group for SLE patients. IMM01 (CD47 fusion protein) is progressing well in a Phase III trial for CMML, with mid-term data analysis expected in the second half of next year. The clinical trial for IMM72 targeting pulmonary arterial hypertension (PAH) commenced patient recruitment in August 2025, with all enrollments completed, indicating high R&D efficiency [7].

Aclaris Therapeutics Conference Call Summary Company Overview - **Company**: Aclaris Therapeutics (NasdaqGS: ACRS) - **Focus**: Development of therapies for inflammatory and immune disorders (I&I) Key Points from the Conference Call Clinical Trial Update - **Trial**: Positive interim results from the ATI-052 phase 1a single and multiple ascending dose trial were discussed [2][4] - **Date of Results**: Interim results as of December 31, 2025 [3] ATI-052 Overview - **Mechanism**: ATI-052 is a bispecific antibody that binds both TSLP (Thymic Stromal Lymphopoietin) and IL-4R (Interleukin-4 Receptor) to block signaling pathways associated with I&I disorders [4][5] - **Efficacy**: The compound shows strong safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles, indicating potential best-in-class efficacy [4][5][11] Safety and Tolerability - **Adverse Events**: Low rate of adverse events (AEs) observed, predominantly grade 1, with no serious AEs reported [15][16] - **Injection Site Reactions**: Most common AE was mild injection site redness, self-resolving [15][16] Pharmacokinetics (PK) and Pharmacodynamics (PD) - **PK Profile**: Effective half-life of at least 26 days, significantly longer than Dupilumab [18] - **PD Results**: ATI-052 showed complete inhibition of CCL17 production at low doses, indicating strong efficacy in modulating immune responses [21][23] Future Development Plans - **Upcoming Trials**: - Phase 1b proof-of-concept trial in atopic dermatitis to start imminently [23] - Second phase 1b trial in asthma expected to follow shortly [23] - Phase 2b trial planned for the second half of 2026 to assess extended dosing schedules [6][24] Competitive Landscape - **Market Positioning**: Aclaris aims to position ATI-052 as a best-in-class therapy for both dermatological and respiratory indications, competing with existing therapies like Dupilumab [33][34] - **Dosing Schedule**: Potential for extended dosing intervals of up to three months, which could enhance patient compliance and market appeal [23][34] Additional Insights - **Biomarker Analysis**: CCL17 (TARC) is highlighted as a robust biomarker for assessing the drug's efficacy [42] - **Patient Enrollment Strategy**: Ongoing discussions regarding the mix of biologically naive and experienced patients for upcoming trials [60][64] Conclusion - Aclaris Therapeutics is optimistic about the potential of ATI-052 based on the interim results, with plans for accelerated clinical development and a focus on both dermatological and respiratory indications. The company is building a strong pipeline and aims to deliver innovative therapies to the market [67]

Core Viewpoint - The company has terminated its collaboration agreement with Axion, regaining global rights to certain drug candidates, including IMM2510 and IMM27M, which target PD-L1 and CTLA-4 respectively [1] Group 1: Agreement Details - The company has granted Axion exclusive rights for research, development, and commercialization of several dual-specific antibodies targeting PD-L1 and VEGF, as well as monoclonal antibodies targeting CTLA-4 [1] - A termination agreement has been established, which reverts all previously granted licenses back to the company, while allowing Axion a limited license to gradually conclude its clinical development activities [1] Group 2: Financial Implications - The termination of the agreement will not affect the $35 million in upfront and milestone payments already received from Axion [1] Group 3: Future Outlook - The company expresses confidence in the therapeutic potential of IMM2510 and IMM27M and is committed to accelerating the clinical development of these assets [1]

Core Viewpoint - The company has terminated its licensing and collaboration agreement with Axion Bio, Inc., regaining global rights to its drug candidates IMM2510 and IMM27M, while still receiving a total of $35 million in upfront and milestone payments from Axion [1]. Group 1: Licensing and Collaboration Agreement - The company granted Axion exclusive rights to research, develop, and commercialize several bispecific antibodies targeting PD-L1 and VEGF, including candidate IMM2510, and monoclonal antibodies targeting CTLA-4, including candidate IMM27M [1]. - The termination of the agreement allows the company to reclaim all previously granted licenses, including global development and commercialization rights outside Greater China, while providing Axion with a limited license to wind down its clinical development activities [1]. Group 2: Financial Implications - The termination of the agreement will not affect the $35 million in upfront and milestone payments already received from Axion [1]. Group 3: Future Development Plans - The company expresses confidence in the therapeutic potential of IMM2510 and IMM27M and is committed to accelerating the clinical development of these assets [1].

Core Viewpoint - The company has initiated a Phase 1 clinical trial for HLX37, a dual-specific antibody targeting PD-L1 and VEGF, in patients with advanced/metastatic solid tumors in mainland China, marking a significant step in its development pipeline [1][3]. Group 1: Clinical Trial Details - The Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HLX37 in advanced/metastatic solid tumor subjects, consisting of two parts: 1a (dose escalation) and 1b (dose expansion) [2]. - In the 1a phase, single-agent treatment will explore six dose levels ranging from 1.0 mg/kg to 45.0 mg/kg, administered every three weeks, while combination therapy will assess different dosing regimens of HLX37 with pemetrexed or paclitaxel and carboplatin in advanced non-small cell lung cancer patients [2]. - The primary endpoint of the study is to assess the incidence of dose-limiting toxicities (DLT) to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for both single-agent and combination therapies [2]. Group 2: Mechanism and Potential - HLX37 is a recombinant humanized dual-specific antibody that targets both PD-L1 and VEGF, aiming to treat advanced/metastatic solid tumors by blocking the PD-1/PD-L1 signaling pathway and inhibiting angiogenesis [3]. - The dual-target design may produce a synergistic anti-tumor effect and potentially reduce the risk of resistance, with preclinical studies indicating that HLX37 can inhibit tumor growth while demonstrating good safety profiles [3]. - The drug is expected to achieve regulatory approval from the National Medical Products Administration (NMPA) for its Phase 1 clinical trial in November 2025 [3]. Group 3: Market Potential - According to IQVIA MIDASTM, the global sales of dual-specific antibodies targeting PD-1/PD-L1 and VEGF are projected to reach approximately $920 million in 2024, with the first product in this category expected to be approved in May 2024 [4].

Core Viewpoint - The company has completed the first patient dosing in a Phase 1 clinical trial of HLX37, a dual-specific antibody targeting PD-L1 and VEGF, for advanced/metastatic solid tumors in mainland China [1][2] Group 1: Clinical Trial Details - The Phase 1 study is an open-label trial assessing the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HLX37 in patients with advanced/metastatic solid tumors [1] - The trial consists of two parts: Part 1a involves dose escalation (including monotherapy and combination therapy) with six dose levels ranging from 1.0 mg/kg to 45.0 mg/kg administered every three weeks; Part 1b will expand based on results from Part 1a [1] - The primary endpoint is to evaluate the incidence of dose-limiting toxicities (DLT) to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for both monotherapy and combination therapy [1] Group 2: Mechanism and Potential Benefits - HLX37 is designed to target two different pathways: it blocks the PD-1/PD-L1 signaling pathway to restore T-cell activity against tumors and inhibits VEGF to reduce tumor angiogenesis, potentially leading to synergistic anti-tumor effects and reduced risk of resistance [2] - Preclinical studies indicate that HLX37 can inhibit tumor growth and has a favorable safety profile [2] - The National Medical Products Administration (NMPA) approved the Phase 1 clinical trial application for HLX37 in November 2025 [2]