Aflibercept Biosimilar(Shandong Boan Biological Technology Co., Ltd.)

博安生物（6955.HK）今日发布2024年全年业绩情况及最近业务进展。报告期内，公司实现营业收入7.3亿元（人民币，下同），同比增长17.5%；毛利5.4亿元，同比增长32.7%，毛利率大幅提升8.6个百分点至74.7%；EBITDA转正为1.8亿元，同比大幅增加2.0亿元；净利润转正为7319万元，同比大幅增加1.9亿元并首度实现自然年的全年盈利。  强大的商业化能力，助力博安率先盈利博安生物的产品组合以兼顾“创新质量”和“风险均衡”为特点，通过生物类似药率先进入商业化阶段，迅速实现自我“造血”的同时也为创新药的开发提供资金支持。当下，首批研发成果的收获期已至，公司凭借强大的商业化能力加速推动这些产品的市场价值转化，成为当下国内为数不多已实现年度盈利的生物科技公司。博优诺®（左）、博优倍®（中）、博洛加®（右）报告期内，3款已上市产品合计实现销售收入6.9亿元，占当期总收入的95%。其中：2款产品博优诺®（BA1101，贝伐珠单抗）和博优倍®（BA6101，地舒单抗60mg）合计覆盖全国约3000家医疗机构和商业终端。公司与合作伙伴青岛国信制药强强联合，推动博优倍®的销售额较2023年增长近3倍。第3款产品博洛加®（BA1102，地舒单抗120mg）于2024年5月在中国获批上市用于治疗骨巨细胞瘤，商业化矩阵持续扩容。以创新力构筑中长期高速增长“护城河”“立足创新、服务全球患者”是博安生物的核心发展战略。公司基于3大技术平台——抗体药物偶联（ADC）技术平台、双特异T-cell Engager技术平台、全人抗体转基因小鼠及噬菌体展示技术平台，开发具有First-in-Class（同类首创）、Best-in-Class（同类最优）潜质的创新生物药，为公司的中长期高速发展构筑竞争优势。当前，公司已有2款ADC、1款双抗、2款单抗在研药物处于1/2期临床阶段。重点品种包括：●BA1302（抗CD228 ADC）：是全球唯一处于临床阶段的靶向CD228的创新型ADC药物，中国处于1期临床阶段；在美获得治疗肺鳞癌和胰腺癌孤儿药资格●BA1301（抗Claudin18.2 ADC）：在中国处于1期临床阶段，在美国获得治疗胃癌和胰腺癌的孤儿药资格；●BA1106（非IL-2阻断型抗CD25抗体）：是国内首个进入临床的、用于治疗实体瘤的抗CD25创新抗体，处于1期临床阶段；相关数据将于近期亮相美国癌症研究协会年会（AACR）；博安生物通过“肿瘤免疫+抗体偶联药物”（“IO+ADC”）开发策略，联合公司自有的PD-1抑制剂和VEGF抑制剂，积极探索联用机会，以提升现有标准疗法的疗效、增强管线价值、提高创新药的临床开发成功率。多元化BD合作，为业务发展按下“加速键”博安生物秉持“自主研发与对外合作双轮驱动”的业务模式，积极把握各项合作机遇，协同国内外优秀合作伙伴，推动业务高速发展。随着公司的产品开发和商业化渐入佳境，其创新能力与市场价值获得业界颇多关注与认可。在中国，博安生物授权健康元开发和商业化BA2101（长效抗IL-4Rα单抗）呼吸系统疾病适应症的独家权利；授权科兴制药在中国香港和澳门地区独家推广博优倍®（BA6101，地舒单抗60mg）和博洛加®（BA1102，地舒单抗120mg）；授权臻格生物在中国大陆非独家使用本公司自主知识产权的BA-HIEXcell®稳定细胞株开发平台；授权青岛国信制药独家在中国大陆商业化博优倍®（地舒单抗60mg）的独家权利；与欧康维视共同推进博优景®（BA9101，阿柏西普）在中国的3期临床试验，并授权欧康维视在中国大陆独家商业化该产品；在海外，博安生物已与全球业务伙伴达成博优诺®（BA1101，贝伐珠单抗）、博优倍®（BA6101，地舒单抗60mg）和博洛加®（BA1102，地舒单抗120mg）等产品在部分国际市场的战略合作，持续拓展全球商业版图。公司另有多个项目正在洽谈合作，涉及从临床前到上市后的多款产品，包括创新生物药和生物类似药，覆盖国内及海外市场。智能制造，助推生产力持续升级随着生物医药技术的快速发展，药品质量与可及性要求不断提升。博安生物以智能制造为重要支撑，持续推进生产体系的数字化升级。公司从产线设计之初即融入智能化理念，通过工艺优化、设备更新、管理改进及生产智能化，不断提升制造水平。2024年，博安生物的数字化车间获评山东省级数字化车间。在质量管理方面，公司已建立一整套符合中国、美国、欧盟、日本相关标准的质量管理体系，并成功通过ISO9001、ISO14001、ISO45001、ISO50001四大国际标准认证，此外，生产车间“零缺陷”获得巴西GMP认证并顺利完成欧盟QP审计。高度整合的运营体系，驱动效能全面提升博安生物是少数具有“研-产-销”一体化运营体系的本土生物制药公司。高度整合的自主运营体系不仅利于其在研产品向商业化阶段的高效率转化，亦为公司的精细化管理和中长期高质量发展奠定坚实基础。报告期内，公司实现毛利同比增长32.7%，远超同期的营收增速；毛利率74.7%，较2023年大幅增加8.6个百分点。这一改善主要归因于主营产品博优诺®（贝伐珠单抗）的生产工艺升级、生产成本降低。接下来，公司还将持续推动已上市产品和在研产品的生产成本优化工作。研发方面：尽管研发开支有所减少，但公司集中资源投入优势项目，于报告期内高效推进1个项目获批上市、3个项目的BLA审评、3个项目的3期临床试验和5个项目的1/2期临床试验顺利进行。销售与管理方面：公司通过组织结构优化、提升人员效能、并探索AI赋能具体业务，提高运营效率，推动报告期内销售费用率和管理费用率持续下降，尤其管理费用同比大幅下降10.1%，盈利能力和市场竞争力得到进一步提升。2025-2027年进入产品上市密集期博安生物预计自2025年至2027年，多款新产品有望在国内和海外市场批量上市，其中包括：●博优平®（BA5101，度拉糖肽）：在中国处于BLA审评阶段，有望于今年获批。该产品也在美国获准开展临床试验，研发进度在国内和海外均处于领先水平；●博优景®（BA9101，阿柏西普）在中国处于BLA审评阶段，有望于今年获批；●博洛加®（BA1102，地舒单抗120mg）用于治疗实体肿瘤骨转移和多发性骨髓瘤适应症的上市申请工作在中国推进中，有望于今年获批；●博优诺®（BA1101，贝伐珠单抗）在巴西处于BLA审评阶段，有望于今年获批；●博洛加®（BA1102，地舒单抗120mg）和博优倍®（BA6101，地舒单抗60mg）预计将于今年完成欧美日国际多中心3期临床试验，并陆续开始在各大国际市场递交BLA；●BA1104（纳武利尤单抗）在国内处于3期临床阶段，当前研发进度领先；该产品也已获得美国食品药品监督管理局（FDA）同意，以“简化”的临床策略即可提交BLA，即：仅需开展一项PK相似性试验（1期试验），无需开展3期临床试验。博安生物首席执行官兼董事会主席姜华表示：“博安生物始终坚定不移地朝着既定战略目标全速前进，现已成功上市3款产品，2024年的营收达到2021年的四倍以上，并首次迈入年度盈利的关键拐点，对此我感到非常自豪。展望2025年，我们的工作重点将聚焦4款新产品（含新适应症）的卓越上市，加快2款产品在海外市场的临床和报产进度，挖潜多款创新生物药的临床价值，以及积极布局重点项目的战略合作。我坚信，在全体博安人的共同努力下，公司未来三年将保持高速增长，以更优质的产品回馈社会，以更高的业绩回报股东的支持。”关于博安生物博安生物（6955.HK）是一家全面综合性生物制药公司，专业从事生物药开发、生产和商业化，专注于肿瘤、自身免疫、眼科和代谢疾病。公司的新药发现活动围绕多个平台展开，包括全人抗体转基因小鼠及噬菌体展示技术平台、双特异T-cell Engager技术平台、抗体药物偶联（ADC）技术平台及细胞治疗平台。博安生物拥有完整的涵盖抗体发现、细胞株开发、上游及下游工艺开发、分析及生物分析方法开发、技术转移、非临床研究、临床研究、法规与注册及商业化规模生产的全整合型产业链。在细胞治疗领域，博安生物聚焦新一代增强型及可调控T细胞治疗技术，研发更安全、有效、可负担的细胞治疗产品。目前，博安生物已有三款产品获批上市，两款产品正处于上市许可申请的审评阶段，另有多个具有国际知识产权保护的创新型生物药和生物类似药的在研产品组合。公司荣获“国家高新技术企业”和国家级专精特新“小巨人”企业认定，并拥有“山东省省级新型研发机构”、“山东省工程研究中心”及 “山东省企业技术中心” 等省级技术平台。除了在中国，博安生物也在包括美国、欧洲和日本在内的海外市场从事生物药产品开发。基于差异化的产品组合以及不断成熟的商业化能力，博安生物已构建起覆盖“研发-生产-商业化”的全产业价值链运营体系，为其长期的高质量发展奠定坚实基础。

* Strong growth of RMB 190 million in net profit * Time to reap the benefits of R&D Boan Biotech (6955.HK) today announced its annual results for fiscal year 2024 and latest developments. In the reporting period, the company's total revenue was RMB 726.3 million, up 17.5% YoY; its gross profit was RMB 542.6 million, up 32.7% YoY, and its gross margin was increased significantly by 8.6% to 74.7%; its EBITDA was increased by RMB 201 million YoY to turn around from a negative figure last year to a positive figure of RMB 179 million; and its net profit turned around from a negative figure last year to a positive figure of RMB 73.19 million, up RMB 193 million YoY, marking the first time for the company to become profitable in a whole calendar year.  One of the first Chinese biotech companies turning profitable thanks to its strong commercial capabilities The portfolio of Boan Biotech is characterized by innovation plus a balanced risk profile. By commercializing biosimilars first, the company is able to generate cash quickly while funding new drug development. Now it’s time for the company to reap the benefits of its first R&D investments. By leveraging its strong commercial capabilities to cash on those products, Boan Biotech has become one of a few biotech companies in China to deliver a profitable year. Boyounuo®（Left）、Boyoubei®（Middle）、Boluojia®（Right） The company has launched three products. In the reporting period, their combined sales were RMB 690 million, accounting for 95% of its total revenue in the period. Two of them, Boyounuo® (BA1101, bevacizumab injection) and Boyoubei® (BA6101, denosumab injection 60mg), have been sold to approximately 3,000 hospitals and institutions across China. The company partnered with Qingdao Conson Pharmaceutical to commercialize Boyoubei®, resulting in a three-fold sales increase from 2023. The third product, Boluojia® (BA1102, denosumab injection 120mg) for the treatment of giant cell tumor of bone, was approved for marketing in China in May 2024, an addition to the company’s portfolio.  Fueling long-term, high-speed growth through innovation At its core, Boan Biotech pursues a strategy to serve patients around the world through innovation. The company develops innovative biologics with the potential to become first-in-class or best-in-class drugs on three platforms: the Antibody-drug Conjugate (ADC) Technology Platform, the Bispecific T-cell Engager Technology Platform, and the Human Antibody Transgenic Mouse and Phage Display Technology Platform. They will help to build a competitive edge for the company to achieve long-term, high-speed growth.  Currently, Boan Biotech has two investigational ADCs, one bispecific antibody, and two monoclonal antibodies undergoing Phase 1/2 clinical trials. Among them: ● BA1302 (an anti-CD228 ADC): the world's only innovative anti-CD228 ADC under clinical development, currently undergoing a Phase 1 clinical trial. ● BA1301 (an anti-Claudin18.2 ADC): currently undergoing a Phase 1 clinical trial in China, and granted the Orphan Drug Designation (ODD) in the U.S. for the treatment of gastric cancer and pancreatic cancer. ● BA1106 (a non-IL-2 blocking anti-CD25 antibody): the first innovative anti-CD25 antibody in China undergoing a Phase 1 clinical trial for the treatment of solid tumors, with the data of the trial to be presented at this year’s annual meeting of the American Association for Cancer Research (AACR) soon. Boan Biotech pursues an “IO+ADC” development strategy. The company is also exploring opportunities for combination therapies based on its own PD-1 and VEGF inhibitors in an effort to improve the efficacy of current standard of cares, to enhance the value of its pipeline, and to increase the success rate of new drug development. Accelerating growth through diverse partnerships Boan Biotech adopts a business model driven by in-house development and partnership building. The company is actively seeking various partnership opportunities, working together with leading partners in China and abroad to drive high-speed growth. With its product development and commercialization activities gaining momentum, the company is catching attention and winning recognition in the industry for its commercial value and innovation capability.  In China, the company has granted Joincare the exclusive rights to develop and commercialize BA2101 (a long-acting anti-IL-4Rα monoclonal antibody) for the treatment of respiratory diseases, has granted Kexing Biopharm the exclusive right to commercialize Boyoubei® (BA6101, denosumab injection 60 mg) and Boluojia® (BA1102, denosumab injection 120 mg) in Hong Kong and Macao, has granted Zencore Biologics the non-exclusive right to use the company's proprietary BA-HIEXcell® platform to develop stable cell lines in the Chinese mainland, has granted Qingdao Conson Pharmaceutical the exclusive right to commercialize Boyoubei® (BA6101, denosumab injection 60 mg) in the Chinese mainland, and has conducted a Phase 3 clinical trial of Boyoujing® (BA9101, aflibercept intravitreous injection) with Ocumension and granted them the exclusive commercialization right for the product in the Chinese mainland. Internationally, the company has entered into strategic partnerships on Boyuno® (BA1101, bevacizumab injection), Boyoubei® (BA6101,  denosumab injection 60 mg), and Boluojia® (BA1102, denosumab injection 120 mg) in several countries, to keep expanding its global footprint. The company is also in talks with potential partners both in China and abroad on multiple projects ranging from preclinical candidates to post-market products, including both innovative biologics and biosimilars. Increasing productivity through smart manufacturing With the rapid development of biopharmaceutical technologies, the requirements for drug quality and accessibility are growing. Boan Biotech is upgrading its production system using digital tools with a focus on smart manufacturing. The company’s production lines are designed to be intelligent from the very beginning. By optimizing processes, updating equipment, improving management, and adopting smart manufacturing, it is able to constantly improve manufacturing. In 2024, the company’s digital facility was recognized as a provincial digital facility in Shandong. Boan Biotech has put into place a quality management system conforming to Chinese, American, European, and Japanese standards. The system has been certified by four major internationally recognized standards: ISO 9001, ISO 14001, ISO 45001, and ISO 50001. In addition, the production facility has passed the GMP inspection by Brazil’s ANVISA resulting in “no observation”, and the QP audit of the European Union. Increasing efficiency through highly integrated operations Boan Biotech is one of a few Chinese biopharmaceutical companies with an integrated operation system allowing it to develop, manufacture and sell products on its own. The highly integrated system helps to drive efficient commercialization and lay a solid foundation for lean management and long-term growth. In the reporting period, the company’s gross profit was increased by 32.7% YoY, far above its revenue growth, and its gross margin was 74.7%, up 8.5% YoY. The increased profitability was mainly attributed to the upgraded production process and reduced production cost of Boyounuo® (bevacizumab injection). Next, the company will continue to drive the cost optimization for its marketed products and its pipeline. On the R&D front, despite the reduced R&D budget, the company is concentrating resources on high-potential candidates. In the reporting period, it obtained one marketing authorization (MA), moved forward the review process of three Biologics License Applications (BLAs), and advanced Phase 3 trials for three investigational drugs and Phase 1/2 trials for five others. On sales and management, by taking multiple measures at the same time such as optimizing its organizational structure, increasing the productivity of its employees, exploring the use of AI, and innovating with its business model, the company was able to constantly reduce its sales and management expenses in the reporting period. Most notably, its management expenses were substantially reduced by 10.1% YoY, whereas its profitability and competitiveness were further increased. Ushering in an expected wave of product approvals during 2025-2027 From 2025 to 2027, Boan Biotech is expected to launch multiple new products both in China and abroad, which will include the following:  ● Boyouping® (BA5101, dulaglutide injection): currently under review for its BLA in China, expected to be approved for marketing this year. It has also been cleared by the U.S. FDA for clinical trials, giving it a leading edge with respect to the development process both in China and abroad. ● Boyoujing® (BA9101, aflibercept injection): also under review for its BLA in China, expected to be approved for marketing this year. ● Boluojia® (BA1102, denosumab injection 120mg): expected to be approved in China this year for the treatment of bone metastases from solid tumors and multiple myeloma as the company works on the BLA. ● Boyuno® (BA1101, bevacizumab injection): under review for its BLA in Brazil, expected to be approved for marketing this year. ● Boluojia® (BA1102, denosumab injection 120mg) and Boyuoubei® (BA6101, denosumab injection 60mg): expected to finish the international multicenter Phase 3 clinical trials in Europe, the U.S., and Japan this year, followed by the submission of a BLA in major international markets. ● BA1104 (nivolumab injection): undergoing a Phase 3 clinical trial in China with a leading edge in the development process. The U.S. FDA has also agreed on a "streamlined" clinical approach for BA1104, meaning that only one pharmacokinetics (PK) similarity study (Phase 1) is sufficient to support the submission of a BLA with no Phase 3 study needed. Jiang Hua, Chairlady and Chief Executive Officer of Boan Biotech, said: “We’re moving full steam ahead towards our strategic goals. We’ve already launched three products, our revenue in 2024 was four times higher than in 2021, and we turned profitable for the first time in a whole calendar year. I’m very proud of these accomplishments.  In 2025, we’ll focus on launching four new products (including new indications for existing products), accelerating the clinical development and BLA submission for two products in overseas markets, tapping the clinical value of multiple innovative biologics, and seeking strategic partnerships on key drugs or drug candidates. I’m confident that, by working as one, our company will be able to maintain high-speed growth in the next three years, to deliver better products for our patients, and to reward our shareholders for their support with better results.”  About Biotech Boan Biotech (6955.HK) is a fully-integrated biopharmaceutical company developing, manufacturing, and marketing biologics, with a focus on oncology, autoimmune diseases, ophthalmology, and metabolic diseases. The company's drug discovery activities revolve around multiple platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform, Bispecific T-cell Engager Technology Platform, ADC Technology Platform and Cell Therapy Platform. Boan Biotech operates across the entire value chain of the industry covering antibody discovery, cell line development, upstream and downstream process development, analytical and bio-analytical method development, technology transfer, non-clinical research, clinical research, regulatory affairs and registration, and commercial production. In the cell therapy field, Boan Biotech focuses on a new generation of enhanced and regulated CAR-T technology, developing safer, more effective, and affordable treatments for patients. Boan Biotech’s portfolio includes three products approved for marketing. Its pipeline includes two investigational drugs under review for their marketing applications, multiple novel biologics as drug candidates protected for their international intellectual property rights, and a number of biosimilar candidates. In addition to China, the company is also developing biopharmaceutical products in overseas markets, including the U.S., the EU, and Japan. With a differentiated portfolio and well-established commercial capabilities, Boan Biotech operates across the industry’s value chain from research and development to manufacturing and commercialization, laying a solid foundation for long-term, high-quality growth in the future.