1月13日，博安生物发布公告，其自主研发的地舒单抗注射液(60mg)(代号BA6101)已获玻利维亚国家药 品和卫生技术局(AGEMED)批准上市。BA6101为原研参照药Prolia®的生物类似药，在全球范围内 Prolia®广泛应用于骨质疏松症的治疗。 智通财经APP获悉，香港联交所最新资料显示，1月13日，博安生物(06955)股东将股票由中国证券登记 结算香港转入中信证券经纪香港，转仓市值5.12亿港元，占比8.76%。 ...

客户端 博安生物（06955）早盘股价上涨6.07%，现报9.96港元，成交额5480.87万港元。 客户端 热点栏目 自选股 数据中心 行情中心 资金流向 模拟交易 博安生物（06955）早盘股价上涨6.07%，现报9.96港元，成交额5480.87万港元。 1月11日，博安生物发布公告，公司董事会欣然宣布，其自主研发的地舒单抗注射液（60mg）（代号 BA6101）已获玻利维亚国家药品和卫生技术局（AGEMED）批准上市。BA6101为原研参照药Prolia® 的生物类似药，在全球范围内Prolia®广泛应用于骨质疏松症的治疗。BA6101的适应症与原研参照药相 同。BA6101基于本公司全球研发策略开发，并计划在全球多个国家及地区开展商业化。当前，BA6101 在英国的上市许可申请正处于审批阶段，本公司计划在欧洲、美国、日本等国家和地区提交上市许可申 请。 责任编辑：卢昱君 1月11日，博安生物发布公告，公司董事会欣然宣布，其自主研发的地舒单抗注射液（60mg）（代号 BA6101）已获玻利维亚国家药品和卫生技术局（AGEMED）批准上市。BA6101为原研参照药Prolia® 的生物类似药，在全球范围 ...

Core Viewpoint - The company, Luye Pharma Group, has announced an increase in trading volume of its H-shares and confirmed that it is unaware of any reasons for this change, aside from disclosed information regarding the issuance of exchangeable preferred shares [1][2]. Group 1: Share Issuance and Trading - Luye Pharma Group's wholly-owned subsidiary, Luye Geneora Holding Limited, issued exchangeable preferred shares on December 12, 2025, which allow holders to exchange these shares for existing H-shares held by Luye Pharma Group [1][2]. - Following the issuance of the exchangeable preferred shares, an agreement was made to transfer 100.5 million H-shares to a designated custody account to fulfill the exchange rights associated with these shares [2]. - On January 9, 2026, Luye Pharma Group arranged for its subsidiary, Shandong Luye Pharmaceutical Co., Ltd., to transfer 50 million H-shares to the issuer in the market [2]. Group 2: Product Development and Approval - The company's self-developed drug, BA6101 (60mg), has been approved for market launch by Bolivia's National Medicines and Health Technologies Authority (AGEMED) [2][3]. - BA6101 is a biosimilar to the reference drug Prolia®, widely used for the treatment of osteoporosis, and has the same indications as the reference drug [3]. - The development of BA6101 adheres to international guidelines and has demonstrated high similarity in quality, safety, and efficacy compared to the reference drug, with no clinically significant differences [3]. Group 3: Commercialization Strategy - The company plans to commercialize BA6101 in Bolivia and enhance the accessibility of the drug for patients, providing more treatment options [4]. - Strategic partnerships have been established for the commercialization of BA6101 in other Latin American markets, the United States, Southeast Asia, Hong Kong, and Macau [4]. - The company aims to accelerate its international strategy by offering high-quality domestic biopharmaceuticals, including BA6101, to meet global patient treatment needs [4].

Group 1 - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) is recognized as one of the best performing pharmaceutical stocks in 2025, with a price target raised to $15 from $14 by Truist while maintaining a Buy rating [1] - The U.S. Food and Drug Administration approved Amneal Pharmaceuticals' Biologics Licensing Applications for two biosimilars, Boncresa™ and Oziltus™, which reference Prolia® and XGEVA® respectively [2] - The addition of these two denosumab biosimilars expands Amneal's portfolio to five commercial biosimilars, enhancing its position in the biosimilars market [3] Group 2 - Amneal Pharmaceuticals operates in various segments including Generics, Specialty, and AvKARE, and offers a diverse product portfolio that includes biosciences, specialty drugs, and generics [4]

Approvals expand Amneal’s biosimilars portfolioCompany expects to commercialize six biosimilars across eight presentations by 2027 BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz), a biosi ...

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has had its drug registration application for the biosimilar HLX14 accepted by the National Medical Products Administration of China, targeting all indications approved for the reference drug Prolia in mainland China [1] Group 1 - The drug HLX14 is a biosimilar to Prolia, which has already been approved for marketing in the US, EU, and UK [1] - The application for HLX14 covers all indications that Prolia has been approved for in China, excluding Hong Kong, Macau, and Taiwan [1] - Two products under HLX14, BILDYOS and BILPREVDA, have received approval in the aforementioned regions, aligning with the indications of their reference products Prolia and XGEVA [1]

Core Viewpoint - Alvotech has received approval from the European Commission for AVT03 as a biosimilar to Prolia® and Xgeva®, which is expected to enhance access to treatments for osteoporosis and cancer-related skeletal issues in Europe [1][2][4]. Company Summary - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar market by providing high-quality, cost-effective products [11]. - The approval of AVT03 reflects the company's strong capabilities in delivering biosimilars at scale and its commitment to affordable healthcare solutions [4][5]. Product Details - AVT03 is approved in two forms: as a 60 mg/mL single-use pre-filled syringe for osteoporosis treatment and as a 70 mg/mL single-use vial for preventing skeletal-related events in cancer patients [3][9]. - The European denosumab market is valued at approximately US$1.2 billion, indicating significant commercial potential for AVT03 [2]. Clinical Evidence - The approval was based on comprehensive evidence, including pharmacokinetic and pharmacodynamic data, as well as results from clinical studies demonstrating equivalent efficacy and safety compared to the reference products [8]. Market Strategy - AVT03 will be marketed in Europe through partnerships with STADA and Dr. Reddy's, with each partner holding semi-exclusive rights in various regions [7]. - STADA will market AVT03 under the names Kefdensis® and Zvogra®, while Dr. Reddy's will use the names Acvybra® and Xbonzy® [7]. Economic Impact - Osteoporosis-related disabilities in Europe present a significant economic burden, with estimated costs of €57 billion in 2019 due to fragility fractures [6]. - The introduction of biosimilars like AVT03 is expected to support sustainable healthcare budgets by providing cost-effective treatment options [7].

Q3 2025 Financial Performance - Revenues increased by 12% year-over-year, reaching $9557 million in Q3 2025, compared to $8503 million in Q3 2024[12] - Product sales also increased by 12% year-over-year, totaling $9137 million in Q3 2025, up from $8151 million in Q3 2024[12] - The company invested $1900 million in Research and Development (R&D) in Q3 2025, which is a 31% increase compared to $1440 million in Q3 2024[12] - Non-GAAP EPS increased by 1% to $564 in Q3 2025 from $558 in Q3 2024[12] - Free cash flow increased to $42 billion in Q3 2025, compared to $33 billion in Q3 2024[14] Product Performance - Repatha sales increased by 40% year-over-year to $794 million in Q3 2025[20] - EVENITY sales increased by 36% year-over-year to $541 million in Q3 2025[20] - TEZSPIRE sales increased by 40% year-over-year to $377 million in Q3 2025[20] - UPLIZNA sales increased by 46% year-over-year to $155 million in Q3 2025[20] 2025 Guidance - The company revised its revenue guidance for 2025 to $358 billion - $366 billion, up from the previous guidance of $350 billion - $360 billion[16]

Financial Performance - Revenues increased by 9% YoY in Q2 2025, reaching $9.179 billion, with product sales contributing $8.771 billion[9, 105] - Non-GAAP EPS grew by 21% YoY in Q2 2025, reaching $6.02[9, 105] - The company invested $1.7 billion in research and development in Q2 2025, an increase of 18% YoY[9] - Free cash flow was $1.9 billion in Q2 2025, compared to $2.2 billion in Q2 2024[107] Product Sales Highlights - Fifteen products achieved double-digit sales growth, including Repatha, EVENITY, IMDELLTRA, BLINCYTO, TEZSPIRE, UPLIZNA, and TAVNEOS[9, 17] - Repatha sales increased by 31% YoY to $696 million, driven by a 36% increase in volume[12, 23] - EVENITY sales increased by 32% YoY to $518 million, primarily driven by volume growth[12, 23] - UPLIZNA sales increased by 91% YoY to $176 million, driven by 79% volume growth[12, 27] - TEZSPIRE sales increased by 46% YoY to $342 million, driven by volume growth[12, 32] - IMDELLTRA generated $134 million in sales, with a 65% quarter-over-quarter increase[12, 37] Pipeline Development - MariTide: Phase 3 studies are enrolling for obesity and overweight, with or without Type 2 diabetes mellitus, and for adults living with heart failure with preserved or mildly reduced ejection fraction and obesity[42] - UPLIZNA: FDA review of Phase 3 data in generalized myasthenia gravis is ongoing, with a PDUFA date of December 14, 2025[46] - TEZSPIRE: FDA review of Phase 3 data in chronic rhinosinusitis with nasal polyps is ongoing, with a PDUFA date of October 19, 2025[59] - IMDELLTRA: Reduced the risk of death by 40% and significantly extended median OS by more than five months compared to SOC chemotherapy in patients with SCLC who progressed on or after one line of platinum-based chemotherapy[71]

Q1 2025 Financial Performance - Total revenue increased by 9% year-over-year, reaching $8.149 billion[97] - Product sales increased by 11% year-over-year, totaling $7.873 billion[97] - Non-GAAP EPS increased by 24% year-over-year, reaching $4.90[97] - Research and development investment increased by 12% year-over-year, reaching $1.5 billion[9] - Free cash flow was $980 million in Q1 2025, compared to $459 million in Q1 2024[117] Product Performance Highlights - Repatha sales increased by 27% year-over-year, reaching $656 million, driven by 41% volume growth[12, 22] - EVENITY sales increased by 29% year-over-year, reaching $442 million, driven by volume growth[12, 22] - Prolia sales increased by 10% year-over-year, reaching $1.099 billion, driven by 13% volume growth[12, 22] - TEZSPIRE sales increased by 65% year-over-year, reaching $285 million, driven by volume growth[12, 32] - BLINCYTO sales increased by 52% year-over-year, reaching $370 million, primarily driven by volume growth[12, 37] - IMDELLTRA generated $81 million in sales in Q1 2025[12, 17, 37] Pipeline and Regulatory Updates - FDA approved UPLIZNA for the treatment of IgG4-RD in adult patients[9, 51] - Positive Phase 3 data from IMDELLTRA, UPLIZNA, and rocatinlimab[9] - Initiated multiple Phase 3 trials of MariTide and TEZSPIRE[9] - The company expects 2025 revenue to be in the range of $34.3 billion to $35.7 billion[101]