C3

WALTHAM, Mass., April 04, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company approved the grant of equity awards to one new employee with a grant date of April 1, 2024, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment with the company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). The employee received 1,215 restricted stock units (RSUs). Each RSU will vest as to 25% of the shares underlying the RSU award on the first anniversary of the grant date and as to an additional 25% of the shares underlying the RSU award annually thereafter, subject to each such employee's continued employment on each vesting date. About ApellisApellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across serious retinal, rare, and neurological diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn. Apellis Forward-Looking StatementStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the safety profile of SYFOVRE. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the benefit/risk profile of SYFOVRE following these reported events will impact our commercialization efforts; whether SYFOVRE will receive approval from foreign regulatory agencies for GA when expected or at all, including the impact of the reported events of retinal vasculitis on the likelihood and timing of such approvals; and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 21, 2023 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.Media Contact:Lissa Pavlukmedia@apellis.com617.977.6764 Investor Contact:Meredith Kayameredith.kaya@apellis.com617.599.8178

WALTHAM, Mass., April 04, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company approved the grant of equity awards to one new employee with a grant date of April 1, 2024, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment with the company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). The employee received 1,215 restricted stock units (RSUs). Each RSU will vest as to 25% of the shares underlying the RSU award on the first anniversary of the grant date and as to an additional 25% of the shares underlying the RSU award annually thereafter, subject to each such employee's continued employment on each vesting date. About Apellis Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across serious retinal, rare, and neurological diseases. For more information, please visit or follow us on Twitter and LinkedIn. Apellis Forward-Looking Statement Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the safety pro SYFOVRE. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the benefit/risk pro SYFOVRE following these reported events will impact our commercialization efforts; whether SYFOVRE will receive approval from foreign regulatory agencies for GA when expected or at all, including the impact of the reported events of retinal vasculitis on the likelihood and timing of such approvals; and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 21, 2023 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Media Contact: Lissa Pavluk media@apellis.com 617.977.6764 Investor Contact: Meredith Kaya meredith.kaya@apellis.com 617.599.8178

2024年2月6日，国家药品监督管理局（NMPA）通过优先审评审批程序批准Roche Pharma (Schweiz) AG申报的可伐利单抗注射液上市，用于阵发性睡眠性血红蛋白尿症（PNH）。可伐利单抗成为继依库珠单抗后，第二种用于治疗该罕见病的C5抑制剂。补体系统是先天免疫系统中非常重要的一部分，它的主要作用是识别并清除外来病原体,凋亡细胞和细胞碎片。补体系统有三种激活途径：从C1开始的经典激活途径；类似经典途径，由病原体启动的甘露糖结合凝集素（MBL）途径；及越过C1、C2、C4，从C3开始的旁路途径。补体系统通常是被精确调控的，但某一些情况下会导致补体系统的免疫失调。例如，正常细胞膜上存在着抑制补体形成膜进攻复合物的蛋白（如CD59），但在PNH患者的体内，由于造血干细胞的基因突变引起了CD59缺失，进而导致补体系统错误地攻击了血细胞。通常由补体系统失调引起的疾病往往是一些罕见病，如非典型溶血性尿毒症，但其他自身免疫性疾病往往也伴随着补体系统的异常激活，例如IgA肾病、狼疮肾炎等有免疫复合物大量沉积在肾小球的病理性改变中，C3也是可以找到的。而最新的研究也显示，许多疾病也有补体系统过度激活的影子，包括黄斑变性、牙周炎、重症肌无力等，抗补体治疗的发展前景是巨大的。抗补体治疗的现状和开发情况补体系统的三条途径相对独立又相互联系，其中最重要的是C5这个补体分子扮演了整个系统中的重要角色，对于补体抑制剂的开发也常围绕它展开。图1：补体途径示意图● C5抑制剂C5是补体系统的共同通路之一，是目前最热门的补体抑制剂研究靶点。C5抑制剂在国内获批的有依库珠单抗、可伐利单抗两种；此外还有雷夫利珠单抗等药物正处于Ⅲ期临床阶段，这些药物已在其他国家上市，在不久的将来也有望进入我国市场。依库珠单抗在我国获批的适应症为PNH和非典型溶血性尿毒症；可伐利单抗目前只获批了PNH。除了我国获批的适应证外，C5抑制剂也被国外临床应用于重症肌无力、吉兰-巴雷综合征等炎症性神经系统疾病。图2：我国C5抑制剂研发获批情况来源：Pharma ONE智能药物大数据分析平台，中国医药工业信息中心图3：依库珠单抗的全球获批适应证来源：Pharma ONE智能药物大数据分析平台，中国医药工业信息中心● C3抑制剂C3抑制剂的开发相比C5抑制剂较少，目前国际上已经上市的仅有培西考布仑一种。我国正在进行临床试验阶段的药品仅有信达生物的依莫芙普α，而且该药物并非单纯的补体抑制剂，而是一种同时阻断VEGF和补体途径双靶点药物，主要用于治疗湿性年龄相关性黄斑变性。其他C3抑制剂领域目前在我国的临床申报阶段仍处于空白。● 其他补体抑制剂其他在我们处于上市申请阶段的补体抑制剂包括伊普可泮、阿伐可泮。前者为补体因子-B(CFB)抑制剂，主要用于PNH的治疗，同时也正在对IgA肾病、C3肾小球病等补体相关肾病展开研究；后者则是以C5AR1（即补体片段C5a受体）为靶点，主要用于治疗肉芽肿性血管炎等疾病。总结目前补体抑制剂的研究仍集中在罕见病领域，以C5这一靶点最为热门，但随着研究的深入，越来越多的靶点被开发，补体抑制剂的临床应用将不止局限于一两种罕见病，会有更加广泛的临床应用的可能性。这次可伐利单抗在我国的上市，解决了罕见病孤儿药的市场处境，丰富了医患的选择空间，有望进一步扩大补体抑制剂类药物在我国的市场规模。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001