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复星医药:控股子公司地舒单抗生物类似药HLX14获国家药监局受理
Hua Er Jie Jian Wen· 2025-12-02 15:17
Core Points - The subsidiary of Fosun Pharma, Fuhong Hanlin, has received acceptance for the drug registration application of the biosimilar HLX14, a drug similar to Dexamethasone, by the National Medical Products Administration [1] - The application is classified as a Class 3.3 therapeutic biological product, with indications based on all approved indications of the reference drug Prolia in China [1] Product Information - HLX14 has been approved for marketing in the United States, European Union, and the United Kingdom, covering all indications of the original product [1] - The application for marketing registration was accepted by Health Canada in September 2024 [1] - Cumulative R&D investment is approximately 320 million yuan (unaudited) as of October 2025 [1] Market Outlook - According to IQVIA data, the global sales of Dexamethasone products are projected to be approximately 7.463 billion USD in 2024 [1]
复星医药子公司地舒单抗生物类似药HLX14药品注册申请获受理
Bei Jing Shang Bao· 2025-12-02 10:36
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received acceptance for its drug registration application for HLX14, a biosimilar to Prolia, from the National Medical Products Administration of China [1] Group 1 - The drug HLX14 is a recombinant anti-RANKL fully human monoclonal antibody injection [1] - The application is for all indications that Prolia has been approved for in China [1]
集采冲击商业化逻辑,博安生物(06955)股价2个月跌超30%后能否脱离下行通道?
智通财经网· 2025-10-17 02:51
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]