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安科生物（300009）3月2日发布投资者关系活动记录表，公司于2026年2月28日接受13家机构调研，机构类型为其他、基金公司、证券公司、阳光私募机构。 投资者关系活动主要内容介绍： 公司与投资者就相关问题进行了沟通，整理如下：　　问：2026年预计会为公司的营收带来增量的板块有哪些？　　答：首先是曲妥珠单抗“安赛汀”，2024该品种销售收入超过1亿，2025年也同比大幅增长。待2026年相关政策落地，若2026年该产品未纳入国家集采，公司将更加积极的推进该产品市场布局；若该产品作为国产替代纳入国家集采，公司作为市场后入者将显著受益。其次是公司独家代理宝济药业的长效促卵泡素，公司将会积极开展学术活动，从产品推广、用药观念，处方理念和习惯等多维度进行学术推广，培养新的用药理念。该产品全国潜在市场规模为40多亿，目前市场上仅有两家企业拥有促卵泡素的长效品种，行业竞争环境较好，且该产品属于刚需性品种。当前国家大力支持生育相关产业发展，在此行业大环境下，该产品有望成为公司的核心产品之一，为公司提供可观的销售收入和利润。上述两款产品将为公司未来3至5年的业绩基本面提供强有力的支撑，保障业绩稳定发展。　　问：公司目前的研发思路以及在研品种的进展情况？　　答：公司立足生物制药领域，坚持创新引领公司发展的策略，内部挖掘研发潜力，外部对接先进技术，积极与国内外知名学者、专家合作，推动产学研联动和技术合作等工作，形成“自主创新+外部引进”的研发模式。目前公司在研产品的临床试验正在积极推进中，其中“HuA21注射液”是公司自主研发的HER2靶点的一款新药，与曲妥珠单抗联用可协同增加肿瘤抑制效果，前期探索性研究阶段性数据呈现出较好的安全性和疗效，已顺利完成Ib/II期临床研究的受试者入组，将根据中期分析结果计划开展III期临床研究，目前III期临床试验方案讨论会已经召开；“AK2024注射液”是公司开发的针对HER2靶点的创新药物，目前正在开展I期临床试验，临床前研究表明，“AK2024注射液”可抑制HER2阳性肿瘤细胞的增殖，在增强曲妥珠单抗对肿瘤生长的抑制作用方面，其协同效应明显优于帕妥珠单抗；“HK010注射液”是公司开发的“PD-L1/4-1BB”双抗药物，目前完成II期临床试验的首例受试者入组用药；用于治疗呼吸道合胞病毒引起的儿童下呼吸道感染的“AK1012项目”（人干扰素α2b吸入用溶液）已经完成I期临床试验，目前正在开展II/III期临床试验。此外公司还布局了HER2 ADC药物，即将申请PRE-IND，布局了双表位的HER2抗体，并结合在研的HER2 ADC产品，利用自主建立的linker-payload技术平台，将其打造成一个全新的双抗ADC产品；布局了免疫细胞因子类的双抗、小核酸药物、创新型多肽药物等多款前沿技术的品种。　　问：公司长效生长激素的研发进展情况，以及与维昇药业合作的隆培生长激素的市场定位和销售策略？　　答：公司自主研发的“AK2017注射液”（重组人生长激素-Fc融合蛋白注射液）临床试验进展顺利，目前正在开展III期临床试验，临床推进顺利，患者入组较快，该产品I期和II期临床试验展现出良好的安全性和疗效。与维昇药业合作的进口长效生长激素维臻高?（注射用隆培生长激素）已经获批上市，维昇药业的隆培生长激素先以高品质进口产品推向市场，后续以进口和地产两条线推进。隆培生长激素是全球唯一经临床试验证实，优效于日制剂的长效生长激素，活性成分与人体分泌的生长激素相同。进口阶段以“最优疗效”定位，针对目前市场价格格局的变化、参考进口品牌的价格，综合考虑各方面的因素，在维持高端定位的情况下，制定最合理有利的价格，将产品推向市场。与药明生物合作在中国本地生产隆培生长激素的工作，目前正在进行技术转移，预计2028年实现本地化商业生产。　　问：公司参股公司博生吉公司的研发布局情况？　　答：第一、博生吉安科PA3-17注射液已被纳入突破性疗法品种，目前处于关键临床试验II期，计划1年之内完成全部患者入组，若研发进展顺利，有望在2026年底递交pre-NDA的沟通交流申请，有望成为国内该领域首款上市产品。第二、博生吉安科创新体内慢病毒转染技术制备的in vivo CAR-T产品，临床前研究显示，该产品可高效转染非活化T细胞，能够减轻甚至避免T细胞部分活化带来的临床风险。目前已经进入到研究者发起的临床研究（IIT）阶段，博生吉安科计划通过规范的IIT研究获取数据，支持后续全球IND申报及商务合作拓展。此外，博生吉公司布局了针对自免适应症的全球首创双特异性NK细胞衔接器（NKCE）以及全球领先的UCAR-Vδ1T产品开发平台，该类产品具有优异的肿瘤组织归巢能力，可有效克服肿瘤抗原异质性，是治疗实体肿瘤的理想选择。　　问：公司参股公司阿法纳公司的研发布局情况？　　答：阿法纳公司是由中国科学技术大学多位国家级领军人才联合创立，业务覆盖自身免疫性疾病治疗、肿瘤精准治疗与癌前病变治疗、传染病预防等领域。从产品批件数量及临床进展来看，公司在mRNA药物领域处于国内领先地位，目前重点布局RSV呼吸道病毒、HPV16/18等相关产品。核酸药物方向，特别是肿瘤的主动免疫治疗领域，临床进展最快的是公司与阿法纳合作研发的AFN0328注射液（用于治疗HPV16/18癌前病变），目前已完成I期临床关键阶段研究，临床数据表现良好，为first-in-class产品。预防性疫苗方向，阿法纳自主研发的呼吸道合胞病毒（RSV）mRNA疫苗，是国内首个完成II期临床入组的mRNARSV疫苗，安全性和有效性数据表现优异。归纳来说，阿法纳的核心技术在于mRNA序列设计、组件与软件筛选，以及翻译启动子相关序列设计等方面。公司以递送为基础，以人工智能的手段实现免疫调控，以突破关键核心技术、打造具有全球竞争力的核酸药物创新平台为使命，全力推动该领域的“中国突破”;　　调研参与机构详情如下：参与单位名称参与单位类别参与人员姓名中庚基金基金公司--华安基金基金公司--嘉实基金基金公司--国联安基金基金公司--摩根基金基金公司--永赢基金基金公司--中信建投证券证券公司--中信证券证券公司--兴业证券证券公司--西部证券证券公司--重阳投资阳光私募机构--东证资管其他--明泓投资其他--　　点击进入交易所官方公告平台下载原文>>>

Ascendis Pharma of Denmark has gained its third FDA new drug approval in the last six years as the U.S. regulator has signed off on Yuviwel as a treatment for achondroplasia. Ascendis Pharma is spiraling upward by way of its TransCon platform. For the third time in six years, the Copenhagen-based biopharma has scored an FDA approval for a rare disease medicine that was developed with its “transient conjugation” drug delivery technology. The U.S. regulator has signed off on Yuviwel, a once-weekly injection to treat children with achondroplasia, a rare genetic disorder that causes dwarfism. The accelerated approval covers children age 2 and older who have open growth plates, which are areas where cartilage develops at the end of bones, allowing them to lengthen.By providing continuous exposure to C-type natriuretic peptide (CNP) receptors, Yuviwel can counter the effects of the fibroblast growth factor receptor 3 (FGFR3) gene, which causes the protein to become overactive and restrict growth. This continuous systemic exposure to CNP over the weekly dosing interval sets Yuviwel apart in the achondroplasia treatment landscape, according to Ascendis.“The approval of once-weekly Yuviwel is a major step forward in the treatment of children with achondroplasia, giving physicians for the first time the option of prescribing a once-weekly medicine backed by compelling efficacy and excellent tolerability data from three randomized, double-blind, placebo-controlled clinical trials,” Carlos Bacino, M.D., of Baylor University and Texas Children’s Hospital, said in a release.The three trials and up to three years of open-label extension data demonstrated the ability of Yuviwel to provide improvements in annualized growth velocity versus placebo.Achondroplasia is the most common form of short-limbed dwarfism, affecting between 1 in 10,000 and 1 in 30,000 live births and preventing adults from growing taller than four feet,10 inches. The condition can increase the likelihood of spinal cord compression and respiratory blockages early in life along with other muscular and neurological problems.The company said it expects to make Yuviwel available early in the second quarter of this year. In a conference call Monday morning, Ascendis said it will reveal the price in the coming days.The nod comes with a valuable pediatric disease priority review voucher, which can be used to speed the review of a future drug application."Most of the products we're developing are getting priority review, so I'm not sure that we actually need to keep it. I think we'll sell it," Scott Smith, Ascendis' chief financial officer, said in a lighter moment during the conference call.Yuviwel’s approval comes after the FDA delayed its decision on the medicine by three months back in November. Ascendis will compete with BioMarin in the indication. The California company gained approval for its CNP treatment Voxzogo in 2021. The daily injected medicine generated sales of $927 million last year, which were up 26% and accounted for 29% of the company’s revenue in 2025.BioMarin is working on a longer-acting version of Voxzogo, BMN 333, which has shown promise in a phase 1 trial and could be launched by 2030, the company has said. BMN 333 has shown area-under-the-curve (AUC) levels greater than three times those observed in other long-acting CNP studies, BioMarin said in August of last year, referring to Ascendis’ trials for Yuviwel. AUC is a pharmacokinetic measure indicating the total exposure to a drug over time.Ascendis’ current advantage with Yuviwel is its consistent, sustained release over its weekly dosing as opposed to Voxzogo’s daily administration.Last month, BridgeBio revealed the success of a phase 3 trial of its FGFR1-3 selective tyrosine kinase inhibitor infigratinib in children with achondroplasia. BridgeBio and its partner Kyowa Kirin plan to apply for approval of infigratinib in the second half of this year.Ascendis used its TransCon technology to develop Skytrofa, a long-acting growth hormone for children which was approved in the U.S. in 2021, and Yorvipath, a hormone replacement therapy for hypoparathyroidism, which scored an FDA nod in 2024.  Sales for Skytrofa reached 206 million euros ($242 million) last year, which were up 5% year over year. Yorvipath generated sales of 477 million euros ($561 million) last year, with 187 million euros ($220 million) coming in the fourth quarter."We expects Yuviwel revenue to be light this year but don't think that reflects on long-term value," analysts from ISI Evercore wrote in a note to investors. "We continue to believe our $1 billion CNP franchise peak is quite conservative."Evercore sees more sales potential for Yuviwel in Europe than in the U.S., citing sales results for Voxzogo. There are also other potential indications for the treatment. The company also is exploring the potential of Yuviwel in combination with other treatments.