SAN DIEGO, Calif. & PARMA, Italy--(BUSINESS WIRE)--Gossamer Bio, Inc. (“Gossamer”) (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension, and Chiesi Farmaceutici S.p.A (“Chiesi Group”), an international, research-focused biopharmaceutical group, today announced that they have entered into a global collaboration and license agreement to develop and commercialize seralutinib..

加利福尼亚州圣地亚哥和意大利帕尔马——（商业新闻短讯）——Gossamer Bio，Inc.（“Gossamer”）（纳斯达克：GOSS），一家临床阶段的生物制药公司，专注于开发和商业化用于治疗肺动脉高压的seralutinib，以及Chiesi Farmaceutici S.p.a（“Chiesi Group”），一家以研究为重点的国际生物制药集团，今天宣布，他们已经签署了一项全球合作和许可协议，以开发和商业化seralutinib。。

This global collaboration combines the strengths of both Chiesi and Gossamer to support ongoing work in pulmonary arterial hypertension (PAH) and to accelerate development in pulmonary hypertension associated with interstitial lung disease (PH-ILD), enabling the expansion of the seralutinib franchise to reach more patients with pulmonary hypertension world-wide.

这项全球合作结合了Chiesi和Gossamer的优势，以支持正在进行的肺动脉高压（PAH）工作，并加速与间质性肺病（PH-ILD）相关的肺动脉高压的发展，从而扩大了seralutinib的特许经营权，以覆盖全世界更多的肺动脉高压患者。

Patients will benefit from both Chiesi’s expertise in global respiratory, rare disease, and inhaled drug development and commercialization and Gossamer’s world-class PAH and PH-ILD development and commercialization teams..

患者将受益于Chiesi在全球呼吸、罕见疾病和吸入药物开发和商业化方面的专业知识，以及Gossamer的世界级PAH和PH-ILD开发和商业化团队。。

“This partnership with Chiesi allows us to meaningfully deepen and rapidly accelerate our investment in seralutinib as a potential treatment for PAH, PH-ILD, and other indications of high unmet medical need,” said Faheem Hasnain, Co-Founder, Chairman and CEO of Gossamer. “We are particularly thrilled that this collaboration enables seralutinib to move directly into a Phase 3 trial in PH-ILD, an indication with a paucity of available treatments, and a disease which we believe seralutinib is specifically designed to address.”.

Gossamer联合创始人、董事长兼首席执行官法希姆·哈斯奈（Faheem Hasnain）表示：“与Chiesi的这种合作关系使我们能够有意义地深化并迅速加速我们对seralutinib的投资，将其作为PAH、PH-ILD和其他未满足医疗需求的潜在治疗手段。”。“我们特别高兴的是，这项合作使seralutinib能够直接进入PH-ILD的3期临床试验，这是一种缺乏可用治疗的迹象，我们认为seralutinib是专门针对这种疾病设计的。”。

“Seralutinib is a potential paradigm shifting therapy in PAH and PH-ILD, and we could not be more excited to partner with Gossamer to develop and bring this therapy to patients world-wide,” said Giuseppe Accogli, Group CEO of Chiesi. “Gossamer shares Chiesi’s commitment to using innovation to promote the health and well-being of people around the world and we are proud to add this collaboration as a key pillar to our next phase of growth.”.

Chiesi集团首席执行官朱塞佩·阿科利（GiuseppeAccogli）表示：“Seralutinib是PAH和PH-ILD的一种潜在的范式转换疗法，我们非常高兴与Gossamer合作开发并将这种疗法带给全球患者。”。“戈萨默与基耶西一样致力于利用创新促进世界各地人民的健康和福祉，我们很自豪地将这种合作作为我们下一阶段发展的关键支柱。”。

Prevalence estimates vary widely, but PAH is believed to affect approximately 30,000 to 50,000 people in the US, with a similar prevalence in Europe. While many approved PAH treatments are available, most are primarily vasodilators and do not impact the progressive course of the disease. Median 5-year overall survival rate for patients with PAH is approximately 57%.

流行率估计差异很大，但据信PAH在美国影响约30000至50000人，在欧洲也有类似的流行率。虽然有许多经批准的PAH治疗方法，但大多数主要是血管扩张剂，不会影响疾病的进展过程。PAH患者的中位5年总生存率约为57%。

In the past, PH-ILD has not been as readily diagnosed as PAH, in part due to a lack of approved treatment options for these patients. Based on prevalence figures for various forms of ILD and reported rates of PH in ILD patient cohorts, we estimate that PH-ILD affects approximately 60,000-100,000 patients in the US.

过去，PH-ILD不如PAH容易诊断，部分原因是这些患者缺乏批准的治疗选择。根据各种形式的ILD的患病率数据和ILD患者队列中PH的报告率，我们估计PH-ILD会影响美国约60000-100000名患者。

Patients with PH-ILD in the US have access to only one approved therapy, while no therapies to treat PH-ILD are approved outside of the US. Median 5-year overall survival rate for patients with PH-ILD is approximately 23%..

美国的PH-ILD患者只能接受一种经批准的治疗，而美国以外的国家则没有批准治疗PH-ILD的疗法。PH-ILD患者的中位5年总生存率约为23%。。

Seralutinib is an inhaled PDGFRα/β, CSF1R, and c-KIT inhibitor designed to be delivered via dry powder inhaler for the potential treatment of pulmonary hypertension. Following the positive readout of the Phase 2 TORREY Study in patients with PAH, Gossamer initiated the Phase 3 PROSERA Study in 2023.

Seralutinib是一种吸入PDGFRα/β，CSF1R和c-KIT抑制剂，旨在通过干粉吸入器输送，用于潜在的肺动脉高压治疗。在PAH患者的2期TORREY研究获得阳性结果后，Gossamer于2023年启动了3期PROSERA研究。

Gossamer and Chiesi plan to initiate a global Phase 3 registrational study in PH-ILD in mid-2025 and to evaluate seralutinib in additional indications of high unmet need..

Gossamer和Chiesi计划在2025年年中启动PH-ILD的全球3期注册研究，并在其他未满足需求的迹象中评估seralutinib。。

Under the terms of the agreement, Gossamer will continue to lead global development of seralutinib in PAH and PH-ILD, and the companies will evenly split development costs, except with respect to the PROSERA Study, for which Gossamer will remain financially responsible. In the US, the companies will evenly share commercial profits and losses.

根据协议条款，Gossamer将继续领导seralutinib在PAH和PH-ILD领域的全球开发，两家公司将平均分摊开发成本，但PROSERA研究除外，Gossamer将继续承担财务责任。在美国，这些公司将平均分享商业利润和亏损。

Gossamer will lead commercialization and book sales for PAH and PH-ILD in the US, with both companies contributing 50 percent of commercial efforts. Chiesi will lead US commercialization in additional indications. Chiesi will have the exclusive right to commercialize seralutinib outside of the US and will pay Gossamer an escalating mid-to-high teens royalty on net sales.

Gossamer将在美国领导PAH和PH-ILD的商业化和图书销售，两家公司都贡献了50%的商业努力。Chiesi将在其他适应症方面引领美国商业化。Chiesi将拥有在美国境外将seralutinib商业化的独家权利，并将向Gossamer支付不断上升的中高青少年净销售额版税。

Chiesi will pay Gossamer $160 million as a development reimbursement. Additionally, Gossamer will be eligible to receive up to $146 million in regulatory milestones and $180 million in sales milestones..

Chiesi将向Gossamer支付1.6亿美元的开发费用。此外，Gossamer将有资格获得高达1.46亿美元的监管里程碑和1.8亿美元的销售里程碑。。

Conference Call and Webcast

电话会议和网络广播

Gossamer’s management team will host a conference call and live audio webcast to discuss the partnership today, May 6th, at 8:30 a.m. EDT.

戈萨默的管理团队将于今天（5月6日）美国东部夏令时上午8:30举行电话会议和现场音频网络广播，讨论合作关系。

The live audio webcast may be accessed through the “Events / Presentations” page in the “Investors” section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

现场音频网络广播可以通过公司网站www.gossamerbio.com“投资者”部分的“活动/演示”页面访问。或者，可以通过以下方式访问电话会议：

Date / Time: May 6, 8:30am EDT

日期/时间：美国东部时间5月6日上午8:30

Domestic Dial-in Number: 1-800-285-6670

国内拨入号码：1-800-285-6670

Conference Reference: Gossamer Bio Announcement Presentation

会议参考：Gossamer Bio公告演示

Live Webcast: https://edge.media-server.com/mmc/p/5y35ojfx

网络直播：https://edge.media-server.com/mmc/p/5y35ojfx

A replay of the audio webcast will be available for 30 days on the “Investors” section of the Company’s website, www.gossamerbio.com.

该音频网络广播的重播将在公司网站www.gossamerbio.com的“投资者”部分提供30天。

About Gossamer Bio

关于Gossamer Bio

Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension.

Gossamer Bio是一家临床阶段的生物制药公司，专注于开发和商业化用于治疗肺动脉高压的seralutinib。它的目标是成为肺动脉高压行业的领导者，并改善肺动脉高压患者的生活。

About Chiesi Group

关于Chiesi集团

Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment..

Chiesi是一家以研究为导向的国际生物制药集团，负责开发和销售呼吸系统健康、罕见疾病和专科护理方面的创新治疗解决方案。公司的使命是提高人们的生活质量，对社区和环境负责。。

By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re part of a global community of businesses that meet high standards of social and environmental impact.

通过改变其在意大利、美国和法国的法律地位，使其成为一家福利公司，Chiesi致力于为整个社会创造共享价值，这具有法律约束力，并且是公司决策的核心。自2019年以来，我们一直是经认证的B公司，是全球企业社区的一部分，符合社会和环境影响的高标准。

The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035..

该公司的目标是到2035年实现温室气体（GHG）净零排放。。

With over 85 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,000 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.

Chiesi拥有超过85年的经验，总部位于意大利帕尔马，在全球拥有31家分支机构，拥有7000多名员工。该集团位于帕尔马的研发中心与法国、美国、加拿大、中国、英国和瑞典的其他6个重要研发中心合作。

For further information please visit www.chiesi.com

欲了解更多信息，请访问www.chiesi.com

Forward-Looking Statements

前瞻性声明

Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential reimbursement, regulatory and sales milestones payable to Gossamer pursuant to the collaboration and license agreement; the development and commercialization potential of seralutinib; the worldwide expansion of the seralutinib franchise; the anticipated timing of commencing a Phase 3 registrational study in PH-ILD; the ability to develop seralutinib in additional indications; and each of Gossamer’s and Chiesi’s respective obligations under the collaboration and license agreement to lead commercialization efforts and split development costs.

Gossamer提醒您，本新闻稿中关于非历史事实的声明是前瞻性声明。这些陈述基于公司目前的信念和期望。此类前瞻性声明包括但不限于以下声明：根据合作和许可协议应向Gossamer支付的潜在报销、监管和销售里程碑；seralutinib的开发和商业化潜力；seralutinib特许经营权的全球扩张；PH-ILD开始第三阶段注册研究的预期时间；在其他适应症中开发seralutinib的能力；以及Gossamer和Chiesi在合作和许可协议下各自的义务，以领导商业化工作并分摊开发成本。

The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamer’s business, including, without limitation: the expected benefits of, and opportunities related to, the partnership with Chiesi may not be realized by Gossamer or may take longer to realize than anticipated; potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from pandemics, including clinical trial delays; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of Gossamer’s clinical trials and pre.

包含前瞻性声明不应被视为戈萨默表示其任何计划都将实现。由于Gossamer业务固有的风险和不确定性，实际结果可能与本新闻稿中所述不同，包括但不限于：Gossamer可能无法实现与Chiesi合作的预期收益和机会，或者可能需要比预期更长的时间才能实现；临床试验的开始，注册和完成可能延迟；大流行对我们的运营造成干扰，包括临床试验延迟；公司在产品制造、研究、临床前和临床试验方面对第三方的依赖；临床前研究和早期临床试验的结果不一定能预测未来的结果；Gossamer的临床试验和pre的成功。