Core Viewpoint - The announcement highlights that New Horizon (300765.SZ) has received approval from the National Medical Products Administration for the clinical trial of its biosimilar drug, Lecanemab injection, which is intended for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease [1] Group 1 - The product is a recombinant anti-human beta-amyloid monoclonal antibody and is classified as a biosimilar to Lecanemab [1] - This marks the first biosimilar Lecanemab injection in China to receive clinical trial approval [1] - The development of the product adheres to the relevant research guidelines for biosimilars, indicating a structured approach to its clinical research [1] Group 2 - Pharmaceutical and non-clinical research results demonstrate that the product is highly similar to the reference drug in terms of quality, safety, and efficacy, supporting the initiation of subsequent clinical studies [1]

Investment Rating - The investment rating for the company is "Buy" (maintained) [7] Core Insights - The company reported a 2025 H1 revenue of 101 million yuan, a year-on-year decrease of 12.43%, with a net profit attributable to the parent company of -551 million yuan. However, drug sales revenue reached 100 million yuan, showing a significant year-on-year growth of 53.50%, which is the main growth driver [5][13] - The long-acting G-CSF drug, Mai Li Sheng®, was approved for market release, and a new drug technology license agreement worth 500 million yuan was signed with Qilu Pharmaceutical. Additionally, the company granted CALICO exclusive rights to develop, produce, and commercialize IL-11 targeted therapy products outside Greater China, receiving an upfront payment of 25 million USD, with potential milestone payments up to 571 million USD [5][14] Summary by Sections Financial Performance - In 2025 H1, the company achieved a revenue of 101 million yuan, a decrease of 12.43% year-on-year, while the drug sales revenue was 100 million yuan, increasing by 53.50% [5][13] - The company is expected to see revenues of 677 million, 1.484 billion, and 3.260 billion yuan for the years 2025, 2026, and 2027, respectively, with year-on-year growth rates of 238.86%, 119.25%, and 119.65% [15][16] Research and Development - The company has increased its R&D expenditure by 21.72% year-on-year, focusing on advancing clinical trials and key registration clinical research phases. As of 2025 H1, the company has 10 innovative drugs and 4 biosimilars in its pipeline, including ADCs and monoclonal antibodies [14] Market Position and Future Outlook - The company is positioned to benefit from the approval of innovative drugs and the gradual market release of biosimilars. The expected net profit attributable to the parent company is projected to improve from -859 million yuan in 2025 to -40 million yuan in 2027 [15][16]

Core Viewpoint - The European Commission has approved two biosimilars of denosumab, BILDYOS and BILPREVDA, developed by Fuhong Hanlin and Organon, marking a significant milestone in expanding treatment options for osteoporosis and related conditions in Europe [1] Group 1: Product Approval - The approval includes BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7 mL), which are biosimilars to PROLIA and XGEVA, respectively, covering all indications approved for the original products in the EU [1] - With this approval, Fuhong Hanlin now has a total of four products approved in the EU [1] Group 2: Market Impact - The approval is expected to enhance accessibility to critical bone health treatments for millions of European patients, particularly women who are more affected by osteoporosis [1] - The launch of these biosimilars supports the sustainability of the European healthcare system by providing more treatment options for conditions related to bone loss [1] Group 3: Strategic Partnership - The approval is a result of the collaboration between Fuhong Hanlin and Organon, which signed a licensing and supply agreement in 2022, granting Organon exclusive commercialization rights for these biosimilars outside of China [2]

Core Viewpoint - The European Commission has approved the marketing authorization for two biosimilars of denosumab, BILDYOS® and BILPREVDA®, developed by Fuhong Hanlin in collaboration with Organon, marking a significant milestone in expanding treatment options for osteoporosis and related conditions in Europe [1][2]. Group 1: Product Approval - The approval includes BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), which are biosimilars to PROLIA® and XGEVA®, respectively, covering all indications approved for the original products in the EU [1]. - With this approval, Fuhong Hanlin now has a total of four products approved in the EU [1]. Group 2: Market Impact - The approval of BILDYOS and BILPREVDA is expected to enhance accessibility to critical bone health treatments for millions of European patients, particularly women who are more affected by osteoporosis [1]. - The launch of these biosimilars supports the sustainability of the European healthcare system by providing more treatment options for conditions related to bone loss [1]. Group 3: Strategic Partnership - The collaboration between Fuhong Hanlin and Organon, established through a licensing and supply agreement in 2022, grants Organon exclusive commercialization rights for these biosimilars outside of China [2]. - This partnership is seen as a significant achievement in meeting the needs of European patients and healthcare systems [1].

复宏汉霖(2696.HK)与Organon(OGN.US)今日联合宣布，欧盟委员会已批准地舒单抗注射液(60 复宏汉霖首席商务发展官兼高级副总裁曹平表示："此次获批是复宏汉霖与Organon强强联合、共同满足 欧洲患者和医疗系统需求的又一重要成果。凭借对科学卓越与产品质量的始终坚守，我们在美国获批的 基础上不断前行，将这些生物类似药治疗方案带给全球更多有需要的患者。" BILDYOS和BILPREVDA的获批是基于一整套全面数据的审查，其中包括结构与功能分析数据、临床药 代动力学数据，以及一项临床对比研究。研究表明，BILDYOS和BILPREVDA在结构、生物活性以及疗 效、安全性和免疫原性特征(蛋白和其他生物药物诱发免疫应答或免疫相关事件的能力)方面与欧盟已批 准的另一种生物药(即"原研产品")高度相似。 mg/mL)BILDYOS®(denosumab)和地舒单抗注射液(120mg/1.7mL)BILPREVDA®(denosumab)的上市许 可，两款产品分别为PROLIA®(地舒单抗)和XGEVA®(地舒单抗)的生物类似药，覆盖原研产品在欧盟已 获批的所有适应症。 ...

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the European Commission marks a significant milestone for the company, enhancing its international presence and product influence in the market [1][2] Group 1: Product Approval - BILDYOS and BILPREVDA have received centralized marketing authorization in all EU member states and EEA countries, which includes Iceland, Liechtenstein, and Norway [1] - BILDYOS is indicated for the treatment of osteoporosis in high-risk postmenopausal women and men, as well as for bone loss related to prostate cancer and long-term systemic glucocorticoid therapy [1] - BILPREVDA is indicated for the prevention of skeletal-related events in adults with advanced bone malignancies and for the treatment of giant cell tumors of bone in adults and skeletally mature adolescents [1] Group 2: Regulatory and Clinical Background - The approval was based on a comprehensive review of comparative studies demonstrating the high similarity of HLX14 (the active ingredient in BILDYOS and BILPREVDA) to its reference drug, Prolia, in terms of quality, safety, and efficacy [2] - The company received two GMP certificates from the Belgian Federal Agency for Medicines and Health Products in June 2025, confirming compliance with EU GMP standards for the production line of HLX14 [2] - In July 2025, HLX14 received a positive opinion from the EMA's Committee for Medicinal Products for Human Use, recommending the approval of the marketing authorization applications for BILDYOS and BILPREVDA [2]

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the European Commission marks a significant milestone for the company, enhancing its international market presence and product influence [1][2]. Product Approval - BILDYOS (60 mg/mL) is approved for treating osteoporosis in high-risk postmenopausal women and men, bone loss in prostate cancer patients undergoing hormone ablation, and bone loss related to long-term systemic glucocorticoid treatment in high-risk adult patients [1]. - BILPREVDA (120 mg/1.7 mL) is approved for preventing bone-related events in adults with advanced bone malignancies and treating patients with giant cell tumors of bone that cannot be surgically removed or may lead to severe functional impairment [1]. Regulatory Basis - The approval is based on comprehensive reviews of comparative studies between HLX14 (the biosimilar) and its reference drug Prolia, demonstrating high similarity in quality, safety, and efficacy [2]. - The European Medicines Agency's guidelines allow extrapolation of clinical safety and efficacy data to other approved indications of the reference drug [2]. International Recognition - Following the approval in the United States, the EU approval of BILDYOS and BILPREVDA represents further recognition of the company's products in major international markets, supporting its globalization strategy [2].

签约仪式上，澳斯康生物集团董事长兼总裁罗顺对与科兴制药的合作充满期待，他表示，科兴制药近几 年在国际化道路上进展迅速，澳斯康生物将发挥自身优势，以全球视野和前沿技术，加快双方合作项目 的研发进程。 科兴制药董事长邓学勤也表示，澳斯康生物团队在单抗、多抗、ADC等大分子领域拥有CMC（化学、 制造和控制）开发与商业化生产及申报的丰富经验，未来双方将紧密合作，研发符合中、美、欧监管标 准的高品质生物类似药，丰富公司欧美产品线，抢占市场先机。 科兴制药启动针对欧美市场的生物类似药合作开发项目，正是基于对生物类似药临床价值支撑商业端持 续高增长的坚定判断。依托公司在国际市场的前瞻性拓展、欧美市场的精准布局及新兴市场的深度耕 耘，科兴制药有望实现"弯道超车"，为未来全球化竞争与突破奠定坚实基础。 中证报中证网讯（王珞）近日，科兴制药（688136.SH）宣布与上海澳斯康生物制药有限公司（澳斯康 生物全资子公司）达成战略合作关系，合作研发KXBS001生物类似药，双方在深圳举办签约仪式。这 一合作标志着科兴制药向欧美生物类似药市场进发。 IQVIA（艾昆纬）研究报告显示，欧盟目前仍是全球生物类似药的主流市场，其市场价值占 ...

上证报中国证券网讯（赵彬彬 记者 杨烨）近日，科兴制药与上海澳斯康生物制药有限公司（简称"澳斯康生物"）达成战略合作，共同研发KXBS001生物类似药，正式进军欧美生物类似药市场 欧洲药品管理局(EMA)近期公布的生物仿制药开发草案计划简化审评流程，有望为国内药企打开欧盟市场"快速通道"。据IQVIA研究报告，欧盟作为全球生物类似药主流市场（价值占比约40%） 科兴制药坚持"创新+国际化"战略，已形成抗体技术平台全链条创新能力，布局抗病毒、肿瘤、自免等领域十余款新药。 科兴制药董事长邓学勤表示，澳斯康生物团队拥有单抗、多抗、ADC等大分子领域CMC开发与商业化生产及申报的丰富经验，未来双方将紧密合作，研发符合中、美、欧监管标准的高品质生物类 来源：上海证券报·中国证券网 签约仪式上，澳斯康生物董事长罗顺表示："科兴制药近几年在国际化的道路上进展迅速，澳斯康生物将发挥自身优势，以全球视野和前沿技术，加快合作项目研发进程。" ...

Core Viewpoint - The company Baiotai (688177.SH) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its biosimilar drug Qletli® (BAT1406, Adalimumab injection) [1] Group 1: Product Approval - Qletli® is a biosimilar of Adalimumab developed by the company, expressed in CHO cells as a recombinant fully human monoclonal antibody [1] - The drug works by specifically binding to TNF-α, neutralizing its biological function, and blocking its interaction with cell surface TNF-α receptors, thereby inhibiting the inflammatory effects of TNF-α [1] - The approval allows the company to expand its product offerings in the UK market, enhancing its international influence and potentially positively impacting long-term operational performance [1] Group 2: Indications - Adult indications for Qletli® include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, spondyloarthritis related to enthesitis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, and uveitis [1] - Pediatric indications include polyarticular juvenile idiopathic arthritis, spondyloarthritis related to enthesitis, pediatric plaque psoriasis, pediatric Crohn's disease, pediatric ulcerative colitis, and pediatric uveitis [1]