Onabotulinumtoxin A

近期，石药集团通过国方先导基金完成对君合盟生物的数千万元战略注资。据基金方透露，将来有机会与君合盟生物重组肉毒素在严肃医学领域的探索形成协同效应。这并非石药集团首次加码合成生物学赛道，早在2023年，石药集团全资子公司石药圣雪便与恒鲁生物达成合作，共同出资6000万元设立石家庄恒鲁生物科技有限公司。1.为何是君合盟？君合盟生物是一家聚焦合成生物学技术与产品的创新型企业，致力于将创新重组蛋白药物应用于内分泌治疗、神经治疗、皮肤抗衰及新一代生物医用材料等领域。公开信息显示，自成立以来，君合盟已累计完成6轮融资，总额超6.5亿元，吸引了包括“胰岛素一哥”通化东宝、新氧集团、国投旗下国投创合等在内的知名机构和企业参与投资，充分体现了市场对其技术价值与发展潜力的高度认可。数据来源：天眼查君合盟构建了重组人胶原蛋白、重组人生长激素、重组A型肉毒毒素等具有显著技术优势与市场竞争力的核心产品管线。重组人胶原蛋白系列：君合盟生物在大分子表达、翻译后修饰及规模化生产等关键技术上实现突破，成功研发出与天然人胶原蛋白高度同源的重组I型和III型人胶原蛋白。该系列产品具备更高的生物活性和更强的体内稳定性，能够满足化妆品、医用敷料等多元场景的应用需求。目前，已获得重组人胶原蛋白修复液的医疗器械注册证（II类）。根据弗若斯特沙利文的分析，中国重组胶原蛋白市场在2022年至2027年期间将以50%的年复合增长率高速扩容，预计2027年市场规模将突破547亿元人民币，君合盟的技术突破使其在该领域占据先发优势。生长激素系列：君合盟布局了两款采用基因工程技术制备的在研生长激素产品，分别为重组人生长激素和长效生长激素。其中，长效生长激素作为国家一类创新药，其蛋白质结构设计与制备工艺均为国际首创，拥有完全自主知识产权。通过原核表达Fc融合蛋白技术，该产品实现了活性提升与用药安全性优化，且有望实现双周给药，显著改善患者用药依从性，目前处于临床前研究阶段。重组人生长激素注射液针对儿童生长激素缺乏症的III期临床试验正在推进中。数据显示，2022年中国生长激素缺乏症的治疗率为4.8%，预计2030年将提升至10.5%，对应市场规模将增长至358亿元（2018年至2030年复合年增长率19.8%），而辅助生殖、抗衰老等新适应症的拓展将进一步扩大市场空间。重组A型肉毒毒素：该产品在医美和严肃医疗领域展现出双轨发展潜力。在医美场景中，其作为除皱、瘦脸等美容项目的常用成分；在严肃医疗领域，针对脑卒中患者术后常见的肌肉痉挛问题，具有显著的症状缓解价值。目前正开展改善中、重度眉间纹适应症的临床III期研究，以及成人脑卒中后上肢痉挛的临床II期试验。全球肉毒毒素市场规模庞大且增长势头强劲，2023年Botox全球销售额达56.73亿美元（其中医美用途占26.82亿美元，严肃医疗用途占29.91亿美元），跻身全球畅销药物前列。中国市场方面，预计2030年肉毒毒素市场规模将达390亿元人民币。值得关注的是，当前中国获批上市的6款肉毒毒素产品均源自肉毒杆菌提取，而君合盟作为全球重组A型肉毒毒素研发的领先企业，其产品凭借技术创新性与安全性优势，有望重新定义市场格局。2.拓宽新边界石药集团2024年全年营收为290.09亿元，较2023年下降7.7%，主要因成药业务收入下滑；毛利率同步降至70%，核心原因是药品集中采购政策下产品价格下调，叠加成本上升压力。具体来看，其成药业务全年收入237.36亿元（含授权费1783万元），同比减少7.4%。其中舒安灵、欧来宁受市场影响销售收入大幅下跌。抗肿瘤领域压力尤为突出：津优力（聚乙二醇化重组人粒细胞刺激因子注射液）和多美素（盐酸多柔比星脂质体注射液）在京津冀3+N联盟集采中分别降价约58%和23%。在多美素入选第十批国家集采目录后，中标价格进一步下降低至98元/支。随着2024年3月集采结果在相关省份落地执行，两款产品收入出现下滑。面对集采带来的业绩承压，石药集团选择以加大研发投入作为破局点，持续推进创新药物研发与临床开发，开拓业务新边界。2022至2024年研发投入分别为39.87亿元（+16%）、48.30亿元（+21%）、51.91亿元（+7.5%），2024年石药的研发费用占成药业务比重提升至21.9%。2025年5月，石药集团通过独家注资君合盟生物再次踏足合成生物领域。君合盟在重组蛋白创新药物及合成生物学领域拥有技术优势与研发管线，基金方表示，将来有机会与君合盟生物重组肉毒素在严肃医学领域的探索形成协同效应。早在2023年，石药集团全资子公司石药圣雪便与恒鲁生物共同出资6000万元成立合资公司石家庄恒鲁生物科技有限公司，聚焦母乳低聚糖（HMO）及其他生物合成产品的生产。恒鲁生物在HMO领域突破“卡脖子”技术，其第三代酵母发酵法以乳糖为唯一碳源合成人乳寡糖，区别于欧美细菌合成的二代技术。2025年5月6日，恒鲁生物HMO管线重磅新品LNTrⅡ（乳糖-N-三糖）获FDA GRAS（一般认为安全）认证，这不仅是该产品全球首次获得国际食品安全权威认证，也是第三代酵母发酵法合成HMO的首次认证。目前，该产品已实现结晶量产，纯度高达99%。石药集团已搭建起mRNA药物开发平台、细胞治疗等技术体系，其中小核酸药物研发位居国内第一梯队，mRNA疫苗正从预防性领域向治疗性领域拓展，VZV、HPV等多个疫苗产品临床研究稳步推进。通过借助合成生物学这一前沿技术与现有抗体、疫苗等管线的协同效应，石药集团持续丰富产品线、提升创新能力，在生物制药领域筑牢更稳固的竞争壁垒。3.纷纷入局合成生物学正以“生物铸造厂”的颠覆性姿态重构全球产业格局，其技术革新与市场扩张正在重塑制药、医美、材料等多个领域的底层逻辑。从Amyris通过微生物发酵以甘蔗为原料合成法尼烯、替代石油化工路径，到Ginkgo Bioworks搭建生物设计自动化平台，全球合成生物学市场规模呈现爆发式增长。根据Deep Tech数据，2016年到2021年合成生物学市场规模从35.3亿美元增长至73.7亿美元，CAGR高达83.6%，其中医疗健康领域增速最快，2021年全球医疗健康领域合成生物学市场规模达68.7亿美元。图片来源：中信证券政策层面，2022年5月国家发改委发布的《“十四五”生物经济发展规划》作为我国首部生物经济五年规划，明确将加快发展合成生物学等前沿技术列为重点任务。在临床应用层面，合成生物学通过融合基因疗法与细胞疗法，将携带人工合成治疗性基因回路的工程化细胞精准植入体内，以实现治疗疾病的目的，这种突破传统药物递送机制的创新手段，为癌症、遗传疾病等难治性病症提供了精准干预的新路径。近两年来，面对医药行业仿制药利润下滑、原料药海外订单转移的压力，合成生物技术已成为企业突破行业寒冬、构建新增长极的战略选择。普洛药业：2024年成立医美原料事业部，依托合成生物学技术布局医美及化妆品产业链上游，并与百葵锐生物合作推动合成生物学在原料药、医药中间体的应用医药应用。四环医药：随着仿制药利润的下降，四环医药开始代理海外医美产品。2022年，四环医药与蓝晶微生物合资成立晶颜生物，聚焦PHA生物材料研发，其首款产品填充用PHA微球即将进入临床。国药集团：2023年与微元合成成立合资公司国药微元，落地阿洛酮糖生产项目。华东医药：2021年与安琪集团成立合资公司“湖北美琪健康科技有限公司”。意在共同发展合成生物学，推进营养健康食品原料和个人护理功能原料等产品研发、生产和销售。2022年投资成立了全资子公司珲益生物，专注于生物催化与生物酶制剂领域。2022年，其全资子公司中美华东与杭州市拱墅区政府、浙江工业大学联合成立华东合成生物学产业技术研究院，以合成生物学技术为基础，聚焦营养与医药化学品、医美生物、生物材料及健康代糖品四大领域。#石药 #合成生物学参考资料：[1] 各公司官网、官媒[2] 《最新!合成生物学行业深度报告!》合成生物产业网[3] 《焦虑的药企们，卷向合成生物》智药局来源：药智网作者：小铃铛点击 阅读原文 了解更多

– Continue to conduct analytical studies to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 – – Pursuing a 351(k) regulatory pathway for ABP-450, which offers potential access to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic indications – – Appointed Rob Bancroft as the Company’s President and Chief Executive Officer; Mr. Bancroft also joined AEON’s Board of Directors – IRVINE, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced its financial results for the first quarter ended March 31, 2025, and provided a business update. “I am excited to report that our team is quickly advancing the biosimilar development program for ABP-450 under the 351(k) regulatory pathway utilizing BOTOX as the reference product. By utilizing this pathway, we plan to bring ABP-450 to the U.S. market under a single FDA approval that could cover all of BOTOX’s currently approved and future therapeutic indications,” commented Rob Bancroft, AEON’s President and Chief Executive Officer. “We are making progress in conducting the primary analytical studies. Once the initial analytical studies are completed, we will be able to conduct the primary comparative analytical assessment, which the FDA will evaluate at our Biosimilar BPD Type 2a meeting and determine the next steps for the program.” “Once we successfully complete the FDA's rigorous approval process for ABP-450 as a biosimilar to Botox, we believe our therapeutic neurotoxin has the potential to offer a more economically viable solution that would enhance patient access and optimize cost-efficiency for payers and healthcare providers. These changes would likely be widely welcomed by these stakeholders, given the current dynamics of the therapeutic toxin market, which is estimated to be at least $3.3 billion worldwide and predominantly controlled by a single toxin,” concluded Mr. Bancroft. Recent Clinical and Corporate Highlights Advancing its development plan for ABP-450 utilizing 351(k) regulatory pathway for biosimilars – The Company is pursuing a 351(k) biosimilar regulatory pathway for ABP-450 (prabotulinumtoxinA) injection, using BOTOX® (onabotulinumtoxinA) as a proposed reference product for all of the therapeutic indications for which BOTOX is approved. The Company believes it is aligned with the FDA on the initial key requirements to proceed with the 351(k) regulatory pathway. The Company continues to conduct the primary analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA). Extensive preclinical toxicology and other data have been previously generated by the Company’s licensing partner. The Company plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development. Management Changes – The Company appointed Rob Bancroft as President and Chief Executive Officer, effective April 29, 2025. He was also appointed to the Company’s Board of Directors. Mr. Bancroft has over 25 years of leadership experience in the life sciences industry, spanning biopharmaceuticals, medical devices, and healthcare technology. Prior to joining AEON, he served as General Manager of the Therapeutics business at Revance Therapeutics, where he led the launch of Daxxify® in cervical dystonia with a novel strategy that prioritized expert endorsement, payer coverage, and reimbursement infrastructure ahead of broader investment - driving strong early adoption and differentiated positioning in the $3.3 billion botulinum toxin therapeutics market. Former CEO, Marc Forth, to remain as a member of the Company’s Board of Directors, through which he will continue to advise the Company’s management team and provide strategic guidance. Liquidity and Capital Resources – The Company reported cash and cash equivalents of $10.4 million as of March 31, 2025, which is expected to be sufficient to fund the Company’s operating plan through the fourth quarter of 2025 and its planned BPD Type 2a meeting with the FDA targeted in the second half of 2025. NYSE American Listing – AEON recently announced the NYSE American LLC (“NYSE American”) accepted the Company's previously submitted plan to regain compliance with continued listing standards relating to minimum market capitalization and stockholders' equity. The NYSE American granted the Company until August 3, 2026 to regain compliance with the continued listing standards, subject to the Company’s continued monitoring by NYSE American in the interim. The Company continues to conduct the primary analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA). Extensive preclinical toxicology and other data have been previously generated by the Company’s licensing partner. The Company plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development. Former CEO, Marc Forth, to remain as a member of the Company’s Board of Directors, through which he will continue to advise the Company’s management team and provide strategic guidance. About AEON Biopharma AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency. The product is approved as a biosimilar in Mexico and India. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit www.aeonbiopharma.com. Forward-Looking Statements Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding meetings with the FDA, the timing of primary comparative analytical studies, and potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; (vi) the outcomes from any meetings or discussions with regulatory authorities; and (vii) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements. Contacts Investor Contact: Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 cdavis@lifesciadvisors.com Source: AEON Biopharma The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and include the accounts of the Company and its controlled subsidiaries.