Genentech, Inc.

“中国版的罗氏收购基因泰克”，这几天来自中国生物医药行业一个重磅并购，甚至吸引了全球的关注。港股医药龙头中国生物制药宣布将以约10亿美元的估值收购来自上海的生物科技公司礼新医药100%股权。这起中国大型制药企业（Big Pharma）对生物科技公司（Biotech）的并购案，迅速吸引了彭博社、路透社、Fierce Biotech等多家海外权威财经与医药行业媒体的关注。在海外，大型并购是MNC的常规武器，其市值增量往往由交易与合作驱动；而国内药企受制于发展阶段，过去在并购上的投入与魄力都相对有限。如今，中国生物制药用一次教科书般的收购告诉市场：属于中国Pharma的并购时代正式启幕，市场躁动。这预示了，中国医药产业的“并购之王”可能已经在路上，新一轮价值重估与行业洗牌在所难免。01中国pharma开启并购新时代中国生物制药此次并购的一个焦点是：国内制药产业并购时代的开启。并购是海外大药厂创造价值的核心途径之一。最被市场熟知的，莫过于超级巨头罗氏。Biotech鼻祖基因泰克，就是被罗氏并购，加速pharma、biotech合作生态的成熟。而目前，并购逻辑越来越受到MNC认可。默沙东的顶流K药就是并购而来；随着K药的专利悬崖逼近，其在加速并购节奏，日前刚刚宣布以百亿美元价格并购Verona。过去5年，默沙东贡献了3起百亿美元级别的并购。甚至，管线一项侧重于自主研发的礼来，近年来也是按捺不住野心，在并购市场动作连连。在减肥药市场，其已经接连出手并购下一代疗法。更多领域，也在通过并购补强，日前就有消息透露，其或以最高13亿美元的价格收购基因编辑公司Verve Therapeutics。核心逻辑在于，大药厂本质上是利用“临床开发实力、制造能力和商业影响力”来创造价值，而并购可以加快在相应领域建立优势的速度。这对于中国pharma也适用。类似中国生物制药这类大pharma，“临床开发实力、制造能力和商业影响力”均属于业界公认的顶流。实际上，中国生物制药在过去几年也均有并购行为。从这个角度来说，中国生物制药收购礼新医药并非心血来潮，而是战略的延续。只是，因为发展阶段问题，中国药企过去在并购层面的力度和魄力，并没有跟上MNC节奏，以至于中国biotech主要是被MNC并购。眼下，中国生物制药的强力出击，无疑是中国pharma开始角逐并购市场的积极信号。这让市场值得期待。虽然国内资本市场行情火热，但biotech卖身pharma的产业分工趋势并不会改变，未来会有更多优质biotech寻求进入pharma体系。在中国生物制药带动下，更多中国pharma必然会加入并购队伍。属于中国phrama的并购大时代，已经拉开大幕。02“并购之王”呼之欲出新时代开启，属于中国制药产业的“并购之王”呼之欲出。此次并购，中国生物制药所展现的“战略眼光和定价能力”超过市场认知。战略眼光的体现在，中国生物制药是礼新医药第一个看得懂的买方。双方之间早有合作，去年11月前者就参与礼新医药的C轮融资，且是该轮融资中唯一参与的制药企业。换句话说，在此之前，中国生物制药就已经注意到礼新医药的价值。如今的并购，看起来更是此前“认可”的延续。定价能力则在于，中国生物制药并购礼新，并不是市场捡漏或者压价的生意，而是协同逻辑下的结果。礼新技术研发实力突出不假，BD能力也很出色，但作为biotech，在国内创新药竞争程度再上台阶的情况下，存在去主动寻求强力产业方合作加速管线推进的强烈需求，以聚焦研发+授权优势，抓住外部市场窗口良机。这并不是礼新医药一家的选择，去年年末选择卖身BioNTech的普米斯等也是如此。正如上文提及，研发能力、效率，以及商业化能力，不只是MNC的专属，也是old money中国生物制药的强项。此前，在入股礼新医药的之前，双方已经基于管线研发展开合作，去年10月，其LM-108注射液联合贝莫苏拜单抗/派安普利单抗的IND已获得NMPA批准。相信礼新医药对于中国生物制药的实力已经有所感触。也正因此，此次并购并不突兀，属于“双向奔赴”的结果，强强联合水到渠成。从这个角度来看，中国生物制药若后续其推动更多并购落地，且继续展现独树一帜的战略眼光和定价能力，其必然蜕变为中国制药产业的并购之王，与海外MNC一样拥有“创新桥梁”属性，加速价值落地，助力推动中国创新造福全球患者。而在成为中国医药并购之王的同时，公司本身也会成为高确定性资产。03下一个安罗替尼浮上水面事实上，随着并购公告的宣布，市场已经开始对中国生物制药的未来，充满新期待。价值增厚是明牌。礼新医药属于“研发+BD”双在线的优质企业，是中国创新药此次资产重估的驱动者之一。2023年，其GPRC5D ADC药物在临床前，即被阿斯利康以6亿美元总额锁定。目前该药物被阿斯利康标注为血液肿瘤领域的核心资产之一，优先级较高。2024年，礼新医药刚获批1期临床的管线PD-1/VEGF双抗，又获默沙东8.8亿美金首付款，总规模超30亿美元，再次震惊市场。从ADC到双抗，均引领中国创新药对外授权的巅峰，并且不是终点。礼新生物目前公开的临床管线还有20余条，未来两三年有望持续通过临床、BD兑现价值。现阶段的礼新医药，如果登陆港股市场，大概率具备千亿市值的潜力。如今，这部分价值必然会体现在中国生物制药的体系内。更大的看点，则是两者强强联手创造的更高价值——下一个安罗替尼持续浮出水面的“暗线”。安罗替尼是中生目前的王牌产品，已经获批9个适应症，有“国药之光”之称。礼新医药诸多管线中，CCR8单抗LM-108被寄予厚望，被视为消化道肿瘤的安罗替尼。作为全球研发进度第一的管线，LM-108在PD-（L）1耐药这一蓝海市场展现出了极佳的潜力，已经连续两年入选ASCO口头报告，且是目前唯一获得两项突破性治疗品种认定的CCR8在研药物，战斗力爆表。2期数据显示，在CCR8高表达二线胃癌患者中，mPFS高达13.2个月，超过部分一线疗法1倍以上；在CCR8高表达二线胰腺癌患者中，mPFS高达6.9个月，是现有标准疗法的2-3倍。考虑到CCR8靶点市场规模或超80亿美元，LM-108如果能够顺利突围，接棒成为下一个安罗替尼的路径无疑清晰。除此之外，LM-302、LM-168、LM-364也是潜力候选者。LM-302是超级赛道的有力角逐者。Claundin18.2阳性消化道肿瘤市场空间广阔，每年全球新发病人共计约100万，对应100亿美金市场。LM-302是Claudin 18.2 ADC药物潜在FIC，更有成为Claudin 18.2领域BIC。其在胃癌、胰腺癌和胆道癌患者中均观察到突出临床疗效，且对Claudin 18.2低表达和PD-L1低表达的患者也有临床获益，有望解决Claudin 18.2单抗药物Z药的痛点，从而具备更大的临床潜力。LM-168的潜力同样不容小觑。CTLA-4作为被验证过的免疫检查点抑制剂，潜力毋庸置疑。2024年，全球唯一上市的CTLA-4单抗伊匹木2024年销售额为25.3亿美元，这还是建立在伊匹木单抗毒性大、临床使用场景受限的情况下。LM-168属于下一代CTLA-4TME单抗，只在肿瘤微环境下特异性结合，不仅疗效突出且大幅减毒，因此具备更大的想象空间。LM-364也是百亿美金市场的BIC潜力选手。Nectin-4已被验证为临床相关的肿瘤相关抗原，全球潜在患者接近300万。该领域虽然有ADC药物获批，但临床有效性不足且毒副作用大，仍有极大的改善空间。LM-364分子依赖性结合与细胞毒性机制，有助于减少Nectin-4相关毒性；同时搭载具有旁观者效应的Topo-I抑制剂毒素，进一步提升安全性。临床前数据显示，LM-364增效减毒特点明显，未来看点十足。当然，下一个安罗替尼的候选者不局限于此。正如上文所说，礼新生物临床资产20余条，其中必然还有“潜力股”。而礼新医药作为一家平台型企业，具备极强的延展性，因此还有孕育更多新潜力重磅管线的可能。如下图所示，目前其打造了4大技术平台，契合药物的研发趋势。例如，LM-ADCTM作为新一代ADC平台，在靶点、抗体、毒素和连接子等要素层面都有创新之处，属于能够多样化设计多样化的连接子和载荷工具箱。基于此，在开发双载荷ADC等药物层面，就有显著的优势。不只是LM-ADCTM平台，包括LM-AbsTM在内的其它平台，也都有相应丰富的高价值临床项目储备。因此，双方牵手之后的效率协同，必然能够共同打造出庞大的“高价值”矩阵，批量创造下一个安罗替尼。这，也是支撑中国生物制药价值裂变的基础。04结语今年以来，从惊艳ASCO到出海BD，中国生物制药通过一套“组合拳”不断刷新市场认知，不断对其价值重估。但此前的惊艳还未被市场完全消化，中国生物制药又用新动作刷新了自己。将礼新医药加入其版图，可谓如虎添翼，不仅获得礼新团队及平台，更承接已验证的跨国研发资源，从而具备批量制造下一个安罗替尼的能力。有市场人士认为，现在中国生物制药最大的短板是没有短板。是否过于乐观有待市场验证。但不管怎么说，中国Pharma确实已进入狂飙时刻，一个足以重塑中国乃至全球制药产业格局的新物种，正在猛踩油门。来源 | 氨基观察（药智网获取授权转载）撰稿 | 蔡九责任编辑 | 八角声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。合作、投稿 | 马老师 18323856316（同微信） 阅读原文，是受欢迎的文章哦

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) announced today that the company has entered into a license, development and commercialization agreement (DCA) with Harrow (Nasdaq: HROW), for Samsung Bioepis’ ophthalmology portfolio — BYOOVIZ® (ranibizumab-nuna), a biosimilar referencing LUCENTISi (ranibizumab) and OPUVIZ™ (aflibercept-yszy), a biosimilar referencing EYLEAii (aflibercept) — in the United States. The commercial license will become effective upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis, which is expected to be completed by the end of 2025. We will work closely with both Biogen and Harrow to ensure a seamless transition and the continued delivery of services to our customers and patients in the US market. In October 2024, Biogen notified Samsung Bioepis of its decision to terminate the 2019 Development and Commercialization Agreement within the US and Canada. Samsung Bioepis has been closely working with Biogen on the transfer of commercialization rights for BYOOVIZ and OPUVIZ back to Samsung Bioepis in these regions. Harrow will assume full responsibility for commercialization of BYOOVIZ and OPUVIZ in the US upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis. BYOOVIZ was approved by the U.S. Food and Drug Administration (FDA) in September 2021 as the first ophthalmology biosimilar in the US for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). BYOOVIZ has been commercially available in the US since June 2022. OPUVIZ was approved in May 2024 for the treatment of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). “We are pleased to partner with Harrow, a leading eyecare pharmaceutical company with strong capabilities in commercialization of ophthalmic pharmaceutical products in the North American market. We will work closely with both Biogen and Harrow to ensure a seamless transition and the continued delivery of services to our customers and patients in the US market,” said Josh Sang Hyun Lee, Vice President and Business Development Team Leader at Samsung Bioepis. “Samsung Bioepis remains committed to expanding access and widening treatment options for healthcare systems, healthcare professionals, and patients, by providing affordable and high-quality biologic medicines around the world.” About BYOOVIZ (ranibizumab-nuna) BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use. BYOOVIZ (ranibizumab-nuna) is biosimilar to LUCENTIS (ranibizumab injection). BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection. Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP. Please see Prescribing Information for BYOOVIZ (ranibizumab-nuna) HERE. About OPUVIZ (aflibercept-yszy) OPUVIZ (aflibercept-yszy) injection, for intravitreal use. OPUVIZ (aflibercept-yszy) is biosimilar to EYLEA (aflibercept). OPUVIZ is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. Please see Prescribing Information for OPUVIZ (aflibercept-yszy) HERE. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – LinkedIn, X. i Lucentis is a trademark of Genentech, Inc. ii Eylea is a trademark of Regeneron Pharmaceuticals, Inc.

NASHVILLE--(BUSINESS WIRE)--Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced that it has entered into a definitive agreement with Samsung Bioepis Co. Ltd. (hereafter “Samsung Bioepis”) to secure the exclusive U.S. commercial rights to the ophthalmology biosimilar portfolio of Samsung Bioepis — BYOOVIZ® (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTISi (ranibizumab), and OPUVIZ™ (aflibercept-yszy), an FDA-approved biosimilar referencing EYLEAii (aflibercept) — two of the most widely used anti-VEGF therapies for retinal diseases. BYOOVIZ has been commercialized by Biogen in the U.S. since its initial launch in June 2022. In October 2024, Biogen notified Samsung Bioepis of their decision to terminate the 2019 Development and Commercialization Agreement within the U.S. and Canada. Samsung Bioepis has been closely working with Biogen on the transfer of commercialization rights for BYOOVIZ and OPUVIZ back to Samsung Bioepis in these regions. Harrow will assume full responsibility for commercialization of BYOOVIZ in the U.S. upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis. The transition is expected to be completed by the end of 2025. This strategic acquisition enhances Harrow’s position as the leading full-spectrum ophthalmic pharmaceuticals provider in the U.S., expands its pipeline with high-value biosimilars for sight‑threatening retinal diseases, and reinforces its commitment to delivering value-oriented innovation to the U.S. eyecare market. “This transformational acquisition marks a pivotal moment for Harrow and reinforces our commitment to delivering innovation, accessibility, and value to the U.S. ophthalmology community,” said Mark L. Baum, Chairman and Chief Executive Officer of Harrow. “We are excited to leverage our growing commercial presence within the retina specialist community, built over the past year, and partner with Samsung Bioepis, globally recognized for its scientific excellence in biologics and biosimilars. These ophthalmic assets are among the most highly regarded in the market, and we are looking forward to bringing these products to U.S. physicians and patients.” Transaction Highlights Acquired Rights : Harrow gains exclusive U.S. commercial rights to Samsung Bioepis’ portfolio of ophthalmic biosimilars, including BYOOVIZ ® (“bio-viss”) and OPUVIZ™ (“op-u-vis”): BYOOVIZ (ranibizumab-nuna) 0.05mL injection, the first FDA-approved LUCENTIS biosimilar indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). OPUVIZ (aflibercept-yszy) 0.05mL injection , an FDA-approved EYLEA biosimilar indicated for the treatment of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). BYOOVIZ (ranibizumab-nuna) 0.05mL injection, the first FDA-approved LUCENTIS biosimilar indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). OPUVIZ (aflibercept-yszy) 0.05mL injection , an FDA-approved EYLEA biosimilar indicated for the treatment of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). Market Opportunity : The retinal disease treatment market represents a $9 billion opportunity iii in the U.S., with biosimilars expected to expand patient access and affordability. Execution-Ready Platform: Harrow will leverage its established commercial infrastructure and national reach to accelerate the market impact of these biosimilars. Harrow is committed to reshaping the Wet AMD treatment landscape by offering an FDA-approved, on-label, and affordable alternative to existing anti-VEGF therapies. The market is dominated by EYLEA, LUCENTIS, VABYSMO, and compounded Avastin, which continues to be used off-label due to its low cost, despite not being formulated or approved for ocular administration. Current anti-VEGF therapies are among the most expensive drug categories covered under Medicare Part B, with annual spending in the U.S. exceeding $4.2 billioniv. Harrow’s acquisition of these products has the potential to substantially lower the financial burden on Medicare and commercial plans, while improving access and affordability for patients. About BYOOVIZ (ranibizumab-nuna) BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use. BYOOVIZ (ranibizumab-nuna) is biosimilar to LUCENTIS (ranibizumab injection). BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection. Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP. Please see Prescribing Information for BYOOVIZ (ranibizumab-nuna) HERE. About OPUVIZ (aflibercept-yszy) OPUVIZ (aflibercept-yszy) injection, for intravitreal use. OPUVIZ (aflibercept-yszy) is biosimilar to EYLEA (aflibercept). OPUVIZ is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. Please see Prescribing Information for OPUVIZ (aflibercept-yszy) HERE. About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the North American market. Harrow helps eyecare professionals preserve the gift of sight by making its portfolio of pharmaceutical products accessible and affordable to millions of patients each year. For more information about Harrow, please visit harrow.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks, including litigation matters, and other uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q, and other filings with the SEC. Such documents may be read free of charge on the SEC’s web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. i Lucentis is a trademark of Genentech, Inc. ii Eylea is a trademark of Regeneron Pharmaceuticals, Inc. iii Company annual reports & Biopharma AVASTIN estimates iv https://www.reviewofoptometry.com/news/article/annual-medicare-expense-for-antivegf-injections-tops-4-billion-study-finds