箕星获得Oyster Point授权在大中华区开发和商业化干眼症新药

干眼症是一种慢性渐进性疾病，在美国有超过3,000万人受其困扰，在中国影响超过1.5亿人。据估计，美国有1,600万成年人被诊断患有干眼症，这是一种由多种因素导致的眼表疾病，以泪膜受损为特征。健康的泪膜可以保护和润滑眼睛、冲走异物，而且含有可减少感染风险的生长因子和抗菌成分，能创造一个光滑的表面以改善屈光力，令视力清晰。干眼症可能导致持续的刺痛、搔痒、烧灼感、对光敏感、视力模糊和眼疲劳，严重影响日常生活。干眼症患者众多，且疾病负担较重，对有效治疗有明显的未满足需求。

OC-01 (varenicline)鼻喷雾剂是多剂量包装、不含防腐剂的高选择性胆碱能激动剂鼻喷雾剂，用以治疗干眼症和神经营养性角膜病变的症状和体征。副交感神经系统主要负责人体的“休息和消化”系统，可部分通过鼻腔内三叉神经对泪膜稳态部分控制。在临床前和临床研究中，OC-01 (varenicline) 以不含防腐剂的水性鼻喷雾剂形式给药，可激活鼻腔内三叉神经副交感神经通路从而激活自然泪膜分泌，这是一种新的作用机制。人类泪膜是由1,500多种不同的蛋白质组成的复杂混合物，包括生长因子、抗体，以及多种脂质和粘蛋白。这种构成复杂的泪膜参与形成眼睛的主要屈光面，同时保护并滋润角膜。2020年12月，Oyster Point Pharma向美国食品和药物管理局(FDA)提交了OC-01 (varenicline)鼻喷雾剂的新药申请(NDA)，用于治疗干眼症的症状和体征。处方药使用费法案(PDUFA)的目标日期是2021年10月17日，如获得FDA批准，OC-01 (varenicline)鼻腔喷雾剂计划于2021年第四季度在美国针对获批适应症上市。OC-01 (varenicline) 鼻喷雾剂是一种试验性药物，尚未在任何国家获批用于任何用途。OC-01 (varenicline)鼻喷雾剂的安全性和有效性尚未得到验证。

OC-02 (simpinicline)鼻喷雾剂是一种高选择性胆碱能激动剂。Simpinicline柠檬酸盐是一种强烟碱乙酰胆碱受体激动剂，对α4β2、α3β4、α3α5β4和α4α6β2受体有活性，对α7受体有微弱的激动活性。OC-02先前已完成两项针对干眼症的2b期临床试验研究。

箕星药业是一家私人控股、总部位于上海的生物制药公司。箕星由RTW Investments投资创立，致力于服务罹患严重危及生命疾病的中国患者，为其提供创新的科学疗法和药物，以解决尚未满足的临床需求。

RTW Investments（以下简称“RTW”）是一家总部位于纽约的全球性全生命周期投资公司，专注于发掘生物制药和医疗技术的变革性和颠覆性创新。作为行业和学术界的领先合作伙伴，RTW将深厚的科学专业知识与以解决方案为导向的投资方法相结合，助力新兴医疗疗法以及研发这些疗法的公司和学者。

欲了解更多有关RTW的信息，请访问www.RTWfunds.com。

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect the current beliefs, expectations and assumptions of Oyster Point Pharma (the “Company” or “our”) regarding the future of the Company’s business, our future plans and strategies, regulatory approvals, preclinical and clinical results, future financial condition and other future conditions. All statements other than statements of historical facts contained in this press release, including express or implied statements regarding plans and objectives of management for future operations, future results of operations and financial position, business strategy, product candidates, regulatory approvals, planned future product commercialization, planned preclinical studies and clinical trials, expected results of preclinical studies or clinical trials, and their timing and likelihood of success, expected research and development and commercialization costs, are forward-looking statements

The words “if approved,” “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the timing or likelihood of regulatory filings and approvals for OC-01, OC-02 and other product candidates in the US and Greater China; the beneficial characteristics, safety, efficacy and therapeutic effects of OC-01, OC-02 and other product candidates; our plans relating to the further development, manufacturing and potential commercialization of our product candidates in the US and in other countries, including potential additional indications or disease areas to be evaluated and pursued; the timing of initiation of our and our collaboration partner’s future clinical trials; the uncertainties inherent in pharmaceutical research and development, including preclinical study and clinical trial results and additional analysis of existing data; the likelihood of clinical trials demonstrating safety and efficacy of our product candidates, and other positive results; our plans and potential for success relating to commercializing OC-01 and OC-02 in the US and in other countries; the prevalence of dry eye disease and Neurotrophic Keratopathy (NK) and the size of the market opportunities for our product candidates in the US and in other countries; our plans and ability to obtain or protect intellectual property rights in the US and in other countries, including extensions of existing patent terms where available; our ability to recruit and retain key personnel needed to develop and commercialize our product candidates, if approved, and to grow our company; the expected potential benefits of strategic collaborations with third parties and our ability to attract collaborators with development, regulatory and commercialization expertise in the US and in other countries; existing regulations and regulatory developments in the United States and in other countries; our continued reliance on third parties to conduct additional preclinical studies and clinical trials of our product candidates, and for the manufacture of our product candidates for potential commercialization and for preclinical studies and clinical trials; the impact of the COVID-19 pandemic on our business, operations, and regulatory and clinical development timelines; the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our financial performance; market conditions; the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements; our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act; and other risks described in the “Risk Factors” section included in our public filings that we have made and will make with the Securities and Exchange Commission (SEC). The Company is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.