消息面上，康方生物宣布，公司自主研发的全球首创PD-1/VEGF双特异性抗体新药依沃西(商品名：依 达方)联合多西他赛，用于治疗经PD-1/L1抑制剂和含铂化疗治疗失败的局部晚期或转移性非小细胞肺癌 的注册性III期临床研究(AK112-305/HARMONi-8A)，已完成首例患者给药。 值得注意的是，这是依沃西在肺癌领域开展的第7项III期研究(其中3项为国际多中心注册临床)。作为全 球首创的PD-1/VEGF双抗，依沃西已在NSCLC领域实现了核心适应症的全面覆盖，完成多线治疗的布 局，有望重塑全球晚期NSCLC的整体治疗格局。同时，依沃西也作为公司"IO+ADC"2.0战略的核心IO 双抗基石药物，已经针对肿瘤免疫核心适应症一线治疗开展了一系列III期临床和II期临床。 康方生物(09926)早盘涨近5%，高见160.4港元，再创历史新高。截至发稿，涨3.86%，报158.7港元，成 交额9.5亿港元。 ...

Core Insights - On May 20, 2023, 3SBio announced a significant agreement with Pfizer, granting exclusive global rights (excluding mainland China) for the development, production, and commercialization of its innovative PD-1/VEGF bispecific antibody SSGJ-707 [2] - The deal includes an upfront payment of $1.25 billion, setting a record for upfront payments for domestic innovative drugs, and potential milestone payments totaling up to $4.8 billion, bringing the total potential deal value to $6.05 billion (approximately 43 billion RMB) [2] - Following the announcement, 3SBio's stock surged over 35% on May 20 and continued to rise by over 8% the next day [2] Company Developments - SSGJ-707 has shown excellent efficacy in treating non-small cell lung cancer (NSCLC), with promising objective response rates (ORR) and disease control rates (DCR) in clinical trials [3] - The drug has received breakthrough therapy designation from the National Medical Products Administration (NMPA) for first-line treatment of PD-L1 positive locally advanced or metastatic NSCLC, and has also received IND approval from the FDA [3] - Clinical research for SSGJ-707 is also advancing in the treatment of colorectal cancer and gynecological tumors [3] Market Reactions - The capital market reacted strongly to the announcement, with 3SBio's stock price increasing significantly [2] - Other companies in the PD-1/VEGF bispecific antibody space, such as Kangfang Biologics, experienced stock fluctuations following the news, indicating a competitive landscape [5] Strategic Considerations - Pfizer's interest in the PD-1/VEGF bispecific antibody space is part of a broader strategy, as it has previously engaged in collaborations in this area [4] - The oncology segment of Pfizer is facing challenges with its small molecule drugs, prompting a shift towards ADC (antibody-drug conjugate) strategies, which are becoming a research focus [6] - The combination of ADCs with high-quality bispecific antibodies is seen as a potential avenue for enhancing treatment efficacy in oncology [6]

三生制药是一家集研发、生产和销售为一体的生物制药领军企业，致力于以高品质的药品提高患者生存 质量，为人类健康造福。目前，公司拥有100余项国家发明专利授权，40余种上市产品，覆盖肾科、肿 瘤科、自身免疫性疾病、眼科及皮肤科等多种治疗领域。公司拥有抗体药物国家工程研究中心以及生物 药和化药双平台的4大研发中心，共有30种在研产品，4大生产基地及4大CDMO基地。未来，三生制药 将继续秉持"珍爱生命、关注生存、创造生活"的理念，全力打造全球领先的中国生物制药企业。请访问 www.3sbio.com获取更多信息。 此次合作是三生制药国际化征程上一个重要里程碑。其不仅证明SSGJ-707优异的临床效果已获得国际 顶尖认可，也验证了公司自主创新研发体系的国际竞争力，显著提升了公司在肿瘤治疗领域的全球话语 权，有力地推进了公司的国际化步伐。同时，此次合作也将为三生制药带来强劲的财务回报，助力公司 研发体系升级，推动三生制药更好地融入全球生物医药产业价值链。 三生制药董事长兼首席执行官娄竞博士表示："我们非常高兴能与辉瑞这样的全球顶尖药企达成合作。 辉瑞丰富的开发经验及国际化视野将大幅加快SSGJ-707的全球研发及商业化 ...