BOSTON--(BUSINESS WIRE)--Manifold Bio, a platform therapeutics company pioneering AI-guided drug discovery coupled with direct-to-vivo measurement, today announced a strategic research collaboration and license agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY). The partnership will apply Manifold's proprietary tissue-targeting shuttle portfolio and mDesign AI-driven in vivo discovery engine to create multiple next-generation BBB shuttles for the treatment of neurological and neurodegenerative d. ...

消息面上，10月28日，荃信生物宣布与罗氏就其自主研发的长效自免双抗QX031N达成全球独家合作与 许可协议。根据协议，罗氏将被授予研究、开发、注册、生产及商业化QX031N的全球独家权益。荃信 生物将获得7500万美元的首付款，以及至多9.95亿美元里程碑付款、潜在未来产品销售的梯度特许权使 用费。 据悉，QX031N注射液是一款同时靶向TSLP和IL-33的长效双抗。中邮证券指出，QX031N属于临床前管 线，尚未进入临床阶段即与MNC达成了高首付的协议，我们认为一方面系对公司创新早研能力的背 书，另一方面亦系对自免领域呼吸赛道市场潜力与靶点选择的认可。从BD金额和合作方来看，本次交 易具备一定稀缺性，QX031N临床价值并不逊色于IBD领域的TL1A双抗，同时亦意味着该靶点组合在全 球中具备领先身位和市场潜力。 荃信生物-B(02509)盘中涨超11%，截至发稿，涨4.78%，报22.82港元，成交额1229.38万港元。 ...

荃信生物-B(02509)盘中涨超11%，截至发稿，涨4.78%，报22.82港元，成交额1229.38万港元。 据悉，QX031N注射液是一款同时靶向TSLP和IL-33的长效双抗。中邮证券指出，QX031N属于临床前管 线，尚未进入临床阶段即与MNC达成了高首付的协议，我们认为一方面系对公司创新早研能力的背 书，另一方面亦系对自免领域呼吸赛道市场潜力与靶点选择的认可。从BD金额和合作方来看，本次交 易具备一定稀缺性，QX031N临床价值并不逊色于IBD领域的TL1A双抗，同时亦意味着该靶点组合在全 球中具备领先身位和市场潜力。 消息面上，10月28日，荃信生物宣布与罗氏就其自主研发的长效自免双抗QX031N达成全球独家合作与 许可协议。根据协议，罗氏将被授予研究、开发、注册、生产及商业化QX031N的全球独家权益。荃信 生物将获得7500万美元的首付款，以及至多9.95亿美元里程碑付款、潜在未来产品销售的梯度特许权使 用费。 ...

Core Insights - Genentech, a member of the Roche Group, announced significant results from the Phase III ALLEGORY study of Gazyva (obinutuzumab) for adults with systemic lupus erythematosus (SLE) [1] Study Results - The study met its primary endpoint, demonstrating a higher percentage of patients achieving a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at one year (52 weeks) with Gazyva [1]

Core Insights - Roche announced statistically significant and clinically meaningful results from the phase III ALLEGORY study of Gazyva®/Gazyvaro® (obinutuzumab) for adults with systemic lupus erythematosus (SLE), demonstrating a higher percentage of patients achieving a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at one year compared to standard therapy [1][2] Group 1: Study Results - The ALLEGORY study met its primary endpoint, showing that Gazyva/Gazyvaro led to a higher percentage of patients achieving SRI-4 at 52 weeks [1] - All key secondary endpoints were also met, including statistically significant improvements in BICLA response, sustained corticosteroid control, sustained SRI-4, a six-point improvement in SLE disease activity score (SRI-6), and time to first flare [2][4] - The study involved approximately 300 participants, randomized to receive Gazyva/Gazyvaro or placebo for up to one year, followed by an open-label period [6] Group 2: Disease Context - Systemic lupus erythematosus (SLE) affects over three million people globally, primarily women aged 15 to 45, with a significant impact on women of color [2][7] - Around 50% of SLE patients progress to lupus nephritis within five years of diagnosis, which can lead to life-threatening kidney complications [2][7] Group 3: Future Implications - If approved, Gazyva/Gazyvaro would be the first anti-CD20 therapy for SLE targeting B cells, addressing a key driver of inflammation and disease activity [4][5] - Roche aims to share the data with global health authorities, including the US FDA and the European Medicines Agency, to expedite the potential new standard of care [2][5] - The ALLEGORY study is the third positive phase III study for Gazyva/Gazyvaro in immune-mediated diseases, indicating its potential across a spectrum of autoimmune conditions [2][4]

此外，罗氏也将首次展示其在华端到端完整医药价值产业链布局，及最新投资20.4亿元新建的生物制药 生产基地全景。该基地将率先用于眼科创新药罗视佳(法瑞西单抗注射液)的本地化生产，目前已经在紧 锣密鼓建设中，预计将于明年年底取得阶段性进展。 "作为中国高水平对外开放的重要窗口与全球创新成果共享平台，进博会为罗氏这类深耕中国的外资企 业搭建了不可替代的战略舞台。八年间，这里不仅是我们与政府、合作伙伴深化对话的桥梁，更见证了 近15款罗氏全球创新药通过'进博加速度'完成从展品到商品的蜕变，切实惠及中国患者。今年，罗氏带 来十余款即将在华上市及未来管线产品的首秀，覆盖阿尔茨海默病、帕金森病、高血压、代谢性疾病等 重大疾病领域。"罗氏制药中国总裁边欣表示，中国持续优化的营商环境与创新生态，为外资企业提供 了扎根生长的沃土。上海是罗氏全球第二大市场，今年罗氏在上海投资超20亿元打造的全新生物制药生 产基地，是深化本土化战略的关键里程碑。作为跨国药企首个在华实现大分子抗体生物药本地化生产的 基地，它有力印证了罗氏对中国市场的长期信心。 新京报讯(记者王卡拉)第八届中国国际进口博览会(以下简称进博会)进入开幕倒计时，"全勤生" ...

Core Viewpoint - The 2025 National Medical Insurance Directory negotiations are ongoing, focusing on pricing discussions for innovative drugs, particularly in the chronic disease medication sector [1] Group 1: Negotiation Details - The third day of the national negotiations began at approximately 1:40 PM, with participation from companies such as Novartis, Gensai, Roche, and Betta Pharmaceuticals [1] - The morning session emphasized negotiations on chronic disease medications, with Eli Lilly and Sinopharm bringing significant products to the discussions [1]

Basel, 30 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Roche’s wholly owned subsidiary Bluefin Merger Subsidiary, Inc., has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of 89bio, Inc. (“89bio”, NASDAQ: ETNB) at a price of $14.50 per share in cash, plus a non-tradeable contingent value right (CVR) to receive certain milestone payments of up to an aggregate of $6.00 per share in cash ...

文 | 医药研究社 罗氏还在"扫货"，这次轮到了荃信生物。 荃信生物最新发布的公告显示，10月28日，公司与F. Hoffmann-La Roche Ltd（罗氏）达成全球独家合作 与许可协议。 据此，荃信生物授予罗氏开发、生产及商业化QX031N的全球独家权益，并将获得一次性、不可退还且 不可抵扣的首付款7,500万美元，且有资格获得与产品开发、监管批准及商业化相关的至多9.95亿美元里 程碑付款，以及潜在未来产品销售的梯度特许权使用费。交易总额高达10.7亿美元。 不过，今年来多笔巨额BD相继落地，投资市场可能已经习以为常了。但对于荃信生物而言，与罗氏建 立合作的意义无疑是十分重大的。 卖授权，更是卖技术 罗氏此次看中的产品QX031N尚处在临床前阶段，公开信息并不多。 据公告介绍，QX031N是一款长效双特异性抗体，同时靶向人胸腺基质淋巴细胞生成素（TSLP）和人白 细胞介素33（IL-33）。TSLP和IL-33是被称为警报素的蛋白质，机体受到过敏原、病毒、污染、机械刺 激等外界因素诱导时将会释放，其参与慢性阻塞性肺病（COPD）及哮喘等呼吸系统疾病的发生，在炎 症进程中发挥重要作用。 荃信生物认为， ...

智通财经APP获悉，荃信生物-B(02509)高开逾6%，截至发稿，涨6.49%，报26.9港元，成交额240.49万 港元。 消息面上，10月28日，荃信生物宣布与F. Hoffmann-La Roche Ltd（以下简称"罗氏"）就公司自主研发的 长效自免双抗QX031N达成全球独家合作与许可协议。根据协议，罗氏将获授予研究、开发、注册、生 产及商业化QX031N的全球独家权益。作为回报，公司将获得一次性、不可退还且不可抵扣的首付款 7,500万美元，并有资格获得与产品开发、监管批准及商业化相关的至多9.95亿美元里程碑付款，以及潜 在未来产品销售的梯度特许权使用费。 据悉，QX031N注射液是一款同时靶向TSLP和IL-33的长效双抗。QX031N有望被开发成为COPD及哮喘 等呼吸系统疾病的治疗新选择，具备成为First-in-class及Best-in-disease疗法的潜力。荃信生物创始人、 董事会主席兼总经理裘霁宛表示，出海是公司坚定不移的战略目标。与罗氏的重磅合作，是对公司自主 研发平台的充分认可，也有望最大化QX031N的全球价值。 ...