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]

智通财经APP获悉，国元国际发布研报称，宜明昂科-B(01541)重新获得IMM2510及IMM27M全球权 利，公司重掌海外临床研发的主导权，将加速全球开发节奏。公司研发管线不断丰富，抗风险能力提 升，是CD47融合蛋白全球创新引领者，在肿瘤、自免以及心血管领域应用前景广阔。目前市值仅27亿 港元，价值严重低估，建议积极关注。 国元国际主要观点如下： 公司的PD-L1xVEGF双抗差异化优势明显，IgG1 Fc可以激活ADCC，ADCC增强型抗体旨在诱导免疫抑 制的PD-L1+肿瘤细胞的直接杀伤。与其他PD-(L)1xVEGF双特异性抗体相比，其VEGF阻断机制更为广 泛，可结合多种VEGF受体配体。虽然VEGF/ PD-（L）1双抗竞争较为激烈，但公司的结构设计优势明 显，有望取得更优异的疗效。公司获得海外研发主导权之后，有望大幅加快海外临床研究，而且在未来 的BD谈判中，流程更简化，凭借差异化优势，有望获得MNC的青睐。 IMM2510的安全性良好 23例入组患者中，常见的≥3级治疗相关不良事件(TRAEs)包括血小板减少(8.7%)、淋巴细胞减少(8.7%) 和输注相关反应(8.7%)。IMM2510 ...

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]

格隆汇1月6日丨宜明昂科-B(01541.HK)公告，内容有关与Axion Bio,Inc.("Axion")有关IMM2510及 IMM27M的授权及合作协议。 根据授权及合作协议，公司同意授予Axion在大中华地区以外研究、开发及商业化若干靶向程序性细胞 死亡配体1(PD-L1)及血管内皮生长因子(VEGF)的双特异性抗体(包括候选产品IMM2510)，以及若干靶向 细胞毒性T淋巴细胞相关蛋白4(CTLA-4)的单克隆抗体(包括候选产品IMM27M)的独家授权。 于本公告日期，公司宣布已与Axion订立终止授权及合作协议协议，据此，先前授予Axion的所有许可 (包括在大中华地区以外的全球开发及商业化权利)已重新归属于公司，惟授予Axion一项有限许可以逐 步结束其临床开发活动。是次终止将不影响公司根据授权及合作协议已自Axion收取的首付款及里程碑 付款35百万美元。 宜明昂科欣然重获IMM2510及IMM27M的全球权利。公司对该等药物的治疗潜力充满信心，并继续致 力于加快该等资产的临床开发。 ...

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]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （股份代號：2696） （於中華人民共和國註冊成立的股份有限公司） C. 關於HLX37 HLX37是本公司自主研發的重組人源化抗PD-L1與抗VEGF雙特異性抗體， 擬用於治療晚期/轉移性實體瘤。HLX37可同時作用於兩個不同的靶點，其作 用機制結合了兩種治療路徑：(1)阻斷PD-1/PD-L1信號通路：通過阻斷腫瘤 細胞表面PD-L1與T細胞表面的PD-1結合，解除腫瘤免疫抑制作用，從而恢 復T細胞對腫瘤的殺傷能力；(2)阻斷血管生成通路：通過抑制VEGF與其受 體結合，減少腫瘤血管生成，從而限制腫瘤的生長和轉移。這種雙靶點設計 可能產生協同抗腫瘤效應，並可能降低耐藥性風險。通過特異性結合腫瘤細 胞PD-L1實現腫瘤內部HLX37雙抗分子的富集，實現大於抗PD-L1單抗和抗 VEGF單抗的聯合療效。臨床前研 ...

Core Viewpoint - Johnson & Johnson's innovative treatment drug Evotaz (Avenatuzumab injection) has received approval from China's NMPA for treating advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations, marking a significant advancement in cancer treatment in China [1][2] Group 1: Product Approval and Benefits - The approval of Avenatuzumab injection provides a more convenient administration method, reducing the administration time from several hours to approximately 5 minutes [1] - Compared to intravenous formulations, the incidence of infusion-related adverse reactions is reduced by 80% [1] - The product utilizes Halozyme's ENHANZE® drug delivery technology, which includes recombinant human hyaluronidase (rHuPH20) [1] Group 2: Market Impact and Patient Needs - Approximately 40% of lung cancer patients in China carry EGFR mutations, indicating a significant unmet medical need within this patient population [2] - The approval of Avenatuzumab injection is seen as a milestone, reinforcing its important role in the treatment of EGFR mutation-positive NSCLC [2] - The new subcutaneous formulation offers greater convenience for patients and clinicians, improving tolerability while maintaining efficacy and manageable safety [2]

Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 （於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司） （股 份 代 號：9887） 自願公告 LBL-024於鉑耐藥卵巢癌IB/II期試驗的首例患者用藥 本公告由南京 維 立志博生物科技股份有限公司（「本公司」，連 同 其 附 屬 公 司 統 稱「本集團」）自 願 作 出，以 告 知 本 公 司 股 東 及 潛 在 投 資 者 有 關 本 公 司 的 最 新 業 務 發 展 情 況。 本 公 司 欣 然 宣 布，評 價 奧 帕 替 蘇 米 單 抗（PD-L1/4-1BB雙特異性抗體LBL-024）用 於治療鉑耐藥卵巢癌的Ib/II期 臨 床 研 究 首 例 患 者 已 成 功 用 藥。 關 於LBL-024 LBL-024是一種 ...