近日，华兰生物工程股份有限公司（简称“华兰生物”）发布公告称，其控股子公司华兰基因工程有限公司（以下简称“华兰基因”）研发的重组抗RANKL人源化单克隆抗体注射液（代号：HL1701）已获得国家药品监督管理局（NMPA）批准，正式进入临床试验阶段。该药物主要用于治疗骨质疏松症等与骨代谢相关的疾病。RANKL（核因子κB受体活化因子配体）是调控破骨细胞生成和骨吸收的关键因子。通过抑制RANKL通路，可有效减少骨质流失，从而改善骨密度。目前，全球已有类似机制的药物（如地舒单抗）获批上市，显示出良好的临床疗效。华兰基因此次获批的HL1701为生物类似药，旨在提供更具成本效益的治疗选择。作为国内领先的血液制品和生物制药企业，华兰生物近年来持续加大在创新药和生物类似药领域的研发投入。此次临床试验获批，标志着公司在抗体药物领域取得重要进展，也为其未来产品管线拓展和商业化布局奠定基础。后续，华兰基因将按照相关法规要求，稳步推进临床I期试验，评估药物的安全性、耐受性和初步有效性。
Recently, Hualan Biological Engineering Co., Ltd. (“Hualan Bio”) announced that its majority-owned subsidiary, Hualan Gene Engineering Co., Ltd. (“Hualan Gene”), has received approval from China’s National Medical Products Administration (NMPA) to initiate clinical trials for its recombinant anti-RANKL humanized monoclonal antibody injection (code: HL1701). The drug is intended for the treatment of osteoporosis and other bone metabolism-related disorders.RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) is a key regulator of osteoclast formation and bone resorption. Inhibiting the RANKL pathway can effectively reduce bone loss and improve bone mineral density. Globally, drugs with similar mechanisms—such as denosumab—have already been approved and demonstrated strong clinical efficacy. HL1701, developed by Hualan Gene, is a biosimilar designed to offer a more cost-effective therapeutic option.As a leading Chinese manufacturer of blood products and biopharmaceuticals, Hualan Bio has significantly increased its R&D investment in innovative and biosimilar drugs in recent years. This clinical trial approval marks a significant milestone in the company’s expansion into monoclonal antibody therapeutics and lays the groundwork for future pipeline diversification and commercial strategy. Hualan Gene will now proceed with Phase I clinical trials in accordance with regulatory requirements to evaluate the drug’s safety, tolerability, and preliminary efficacy.
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