复星医药控股子公司药品注册申请获受理公告要点 产品情况 HLX14已在美国、欧盟、英国获批上市，覆盖原研产品所有适应症 2024年9月获加拿大卫生部受理上市注册申请 截至2025年10月累计研发投入约3.20亿元（未经审计） 核心事项 控股子公司复宏汉霖自主研发的地舒单抗生物类似药HLX14获国家药监局受理 申请注册分类：治疗用生物制品3.3类 申报适应症为参照药普罗力在中国境内已获批的所有适应症 市场前景 根据IQVIA数据，2024年地舒单抗产品全球销售额约74.63亿美元 风险提示 上市后销售存在不确定性 仅为受理阶段，对现阶段业绩无重大影响 商业化生产前需通过GMP检查、获得注册批准等 ...

北京商报讯（记者 丁宁）12月2日晚间，复星医药（600196）发布公告称，公司控股子公司上海复宏汉 霖生物技术股份有限公司及其控股子公司自主研发的地舒单抗生物类似药HLX14（即重组抗RANKL全 人单克隆抗体注射液）的药品注册申请获国家药品监督管理局受理。本次申报适应症为其参照药普罗力 （英文商品名：Prolia）于中国境内1已获批上市的所有适应症。 ...

Core Viewpoint - The stock price of Bohan Biotech (06955) has declined over 30% since reaching a peak of 19.90 HKD on August 8, 2023, and is now facing pressure to maintain its status in the Hong Kong Stock Connect due to a decrease in average market capitalization [1][2] Group 1: Stock Performance - Bohan Biotech's average market capitalization has fallen to 6.651 billion HKD, approaching the Hong Kong Stock Connect exit threshold of 5.745 billion HKD [1] - The stock has been in a downward trend characterized by "price drop and volume shrinkage" since August, with significant trading volume declines observed [2][3] - On October 14, the stock price reached a low of 11.22 HKD, but there are signs of stabilization in the following trading days [1][5] Group 2: Market Dynamics - The company has faced challenges due to the introduction of centralized procurement for biosimilars, which could impact its valuation and market position [1][6] - Bohan Biotech's strategy of developing biosimilars has been crucial for its commercial success, but the centralized procurement poses a risk to its business model [6][7] - The centralized procurement initiated on August 1, 2023, includes several key monoclonal antibodies, directly affecting Bohan Biotech's products [7][8] Group 3: Competitive Landscape - Bohan Biotech's core product, Bevacizumab (博优诺®), faces intense competition with 11 approved biosimilars in the market, leading to price pressures [8][9] - The company has partnered with AstraZeneca for the exclusive promotion of Bevacizumab, but its market share remains low compared to competitors [8] - The pricing strategy post-procurement will be critical, as Bohan Biotech's pricing is competitive but may still struggle against established players [9]