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 - Watson Bio's subsidiary has applied for clinical trials of a freeze-dried mRNA vaccine for herpes zoster, which has been accepted by the National Medical Products Administration [1] Company Summary - The mRNA vaccine is developed in collaboration with Blue Magpie Bio and Fudan University, utilizing an independently developed mRNA vaccine technology platform [1] - Currently, there are no mRNA-based herpes zoster vaccines available on the market, with existing options being live attenuated and recombinant vaccines [1] - The acceptance of the clinical trial application will not have a significant impact on the company's operating performance for the current year [1] Industry Summary - The development of mRNA vaccines represents a new technological approach in the vaccine industry, particularly for diseases like herpes zoster [1] - The absence of mRNA-based herpes zoster vaccines in the global market indicates a potential opportunity for innovation and market entry [1]

Core Viewpoint - The company, Xinlitai (002294.SZ), has announced that its subsidiary, Xinlitai (Suzhou) Pharmaceutical Co., Ltd., has received acceptance for the market application of its self-developed Class 1 biological drug, "Taikasi Monoclonal Antibody Injection," from the National Medical Products Administration. The intended indications for this drug are hypercholesterolemia and mixed dyslipidemia [1]. Summary by Categories Company Developments - Xinlitai has successfully submitted a market application for its new biological drug, indicating progress in its research and development efforts [1]. Product Information - The drug "Taikasi Monoclonal Antibody Injection" targets high cholesterol levels and mixed lipid disorders, which are significant health concerns [1].

Core Insights - The company, Fuhong Hanlin (复宏汉霖), has received approval from the European Commission for the marketing authorization applications (MAAs) of two products, BILDYOS and BILPREVDA, which are now authorized for sale in all EU member states and EEA countries [1][2] - 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 bone-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] Product Details - BILDYOS (60mg/mL) is approved for three specific indications: 1. Treatment of osteoporosis in high-risk postmenopausal women and men 2. Treatment of bone loss in high-risk prostate cancer men related to hormone ablation 3. Treatment of bone loss in high-risk adult patients associated with long-term systemic glucocorticoid therapy [1] - BILPREVDA (120mg/1.7mL) is approved for two specific indications: 1. Prevention of bone-related events in adults with advanced bone malignancies 2. Treatment of giant cell tumors of bone in adults and skeletally mature adolescents [1] Market Context - The company’s biosimilar HLX14, a denosumab product, has also received approval in the U.S. for specific osteoporosis indications, covering all indications of the original product [2] - The global sales of denosumab are projected to be approximately $7.463 billion in 2024, indicating a significant market opportunity for the company’s products [2] - The approval of BILDYOS and BILPREVDA in the EU represents a further step in the company's international expansion and enhances the global influence of its product portfolio [2]

Group 1: Financial Performance and Dividend Policy - The company has not distributed dividends for 7 consecutive years due to negative distributable profits, which complies with relevant regulations [3][18] - The management is focused on improving operational efficiency and resource allocation to meet future dividend conditions [7][18] - The company emphasizes the importance of shareholder returns and plans to develop a cautious dividend policy based on actual profit distribution conditions [3][18] Group 2: Core Business Areas - The company focuses on three main business segments: materials, pharmaceuticals, and cell therapy [3][11] - Key products in the materials segment include biological dura mater patches and sterile biological dressings, applicable in various medical fields [3][11] - The pharmaceutical segment features products like Bimekizumab, which treats inflammatory and autoimmune diseases [3][11] Group 3: Research and Development Progress - The company is actively advancing research in stem cell therapy and has ongoing projects in various medical fields, including liver disease and skin conditions [5][9] - The biological artificial liver project is currently in the preclinical research stage [9][18] - The company collaborates with several hospitals for clinical studies in areas such as cartilage repair and severe psoriasis treatment [5][9] Group 4: Market and Investor Relations - The company acknowledges the need for improved communication with investors regarding clinical results and project updates [6][9] - There are no current plans for share buybacks, but the company will adhere to regulations if such plans arise in the future [9][18] - The management is committed to maintaining transparency and fulfilling information disclosure obligations as required by regulations [6][9]

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].

Core Viewpoint - The biotechnology sector in the Hong Kong stock market has seen a surge in new listings, with several companies experiencing significant first-day gains, indicating a favorable environment for IPOs in this industry [2][12] Company Overview - Aikobio, established in 2013, focuses on discovering and developing therapies for respiratory and pediatric diseases, with six candidate drugs targeting various stages of these conditions [2][10] - The company has made multiple attempts to go public, with its latest effort being the third attempt to list on the Hong Kong Stock Exchange [2][6] Product Pipeline - Aikobio has developed six candidate drugs, including: - Qiruisuo (AK0529), a novel RSV treatment that has shown positive results in pivotal Phase III trials [7][8] - AK0610, a monoclonal antibody for RSV prevention currently in Phase II [3] - AK3280, targeting idiopathic pulmonary fibrosis, in the post-proof of concept clinical stage [3][9] - AK0901, an ADHD treatment in the NDA stage [3] - Additional candidates include AK0705 for COPD and AK0406 for influenza [4] Financial Backing - Aikobio has secured multiple rounds of financing from notable investors, achieving a post-money valuation of 4.69 billion yuan after its D round in June 2022 [6] Financial Performance - In 2023, Aikobio reported revenue of 6.701 million yuan, but projected zero revenue for 2024 and the first half of 2025 due to a paused collaboration on an HBV candidate drug [10][11] - The company has incurred losses of 270 million yuan in 2023, 197 million yuan in 2024, and 104 million yuan in the first half of 2025, highlighting its reliance on external financing [11] IPO Plans and Fund Utilization - If successful in its IPO, Aikobio plans to allocate funds towards: - R&D for core products Qiruisuo and AK3280 - Clinical research for other candidates including AK0610, AK0901, AK0705, and AK0406 - Milestone payments and potential licensing opportunities - Commercialization efforts in the Chinese market - General operational expenses [11]

Core Viewpoint - The approval of Masitide, a dual receptor agonist for GCG/GLP-1, marks a significant milestone for the company and the diabetes treatment landscape in China [1] Group 1: Product Approval - Masitide has received approval from the National Medical Products Administration for use in blood sugar control in adult patients with type 2 diabetes [1] - This product is the first globally approved GCG/GLP-1 dual receptor agonist, developed in collaboration with Eli Lilly [1] Group 2: Market Potential - Masitide was previously approved in June 2025 for long-term weight management in adult patients in China [1]

Core Viewpoint - The company Sinopharm Biologics announced that its product, Masitide Injection, has received approval from the National Medical Products Administration for a new indication to control blood sugar in adults with type 2 diabetes, making it the world's first dual receptor agonist for GCG/GLP-1 in diabetes treatment [1] Group 1 - The new indication approval follows the previous approval in June for weight loss, marking the second indication for the drug this year [1]

Core Viewpoint - The approval of the new drug application (NDA) for Masitide injection, a dual receptor agonist for glucagon (GCG) and glucagon-like peptide-1 (GLP-1), marks a significant advancement in the treatment of type 2 diabetes in China, addressing the urgent need for effective blood sugar control and weight management among the country's large diabetic population [1][2][5] Industry Overview - China has the highest number of adult diabetes patients globally, with approximately 140 million individuals, accounting for about one-quarter of the world's diabetic population [2] - The management of diabetes is evolving from mere blood sugar control to a more comprehensive approach that includes patient-centered strategies focusing on blood sugar, weight management, and the prevention of cardiovascular and renal complications [2] Product Details - Masitide is the first approved GCG/GLP-1 dual receptor agonist for type 2 diabetes, expected to provide multiple benefits including blood sugar control, weight loss, and improvements in cardiovascular, liver, and kidney health [1][3][5] - The approval is based on two Phase III clinical studies demonstrating that Masitide outperforms placebo and dulaglutide 1.5mg in terms of blood sugar control and weight loss, while also improving various metabolic indicators [3][4] Safety and Efficacy - The safety profile of Masitide is consistent with previous studies of other GLP-1 receptor agonists, with no new safety risks identified [4] - The innovative injection pen for Masitide enhances convenience and safety, featuring a hidden needle design to reduce injection anxiety and a single-use mechanism to minimize contamination risks [4] Future Outlook - The successful launch of Masitide reflects the regulatory authority's recognition of its clinical value and safety, reinforcing the company's strength in metabolic treatment innovation [5] - The company aims to continue its focus on developing high-quality biopharmaceuticals across various therapeutic areas, including oncology, autoimmune diseases, metabolism, cardiovascular health, and ophthalmology, aligning with the goal of achieving "Healthy China 2030" [5]