Core Viewpoint - The approval of BILDYOS and BILPREVDA by the European Commission marks a significant milestone for the company, enhancing its international presence and product influence in the market [1][2] Group 1: Product Approval - BILDYOS and BILPREVDA have received centralized marketing authorization in all EU member states and EEA countries, which includes Iceland, Liechtenstein, and Norway [1] - 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 skeletal-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] Group 2: Regulatory and Clinical Background - The approval was based on a comprehensive review of comparative studies demonstrating the high similarity of HLX14 (the active ingredient in BILDYOS and BILPREVDA) to its reference drug, Prolia, in terms of quality, safety, and efficacy [2] - The company received two GMP certificates from the Belgian Federal Agency for Medicines and Health Products in June 2025, confirming compliance with EU GMP standards for the production line of HLX14 [2] - In July 2025, HLX14 received a positive opinion from the EMA's Committee for Medicinal Products for Human Use, recommending the approval of the marketing authorization applications for BILDYOS and BILPREVDA [2]

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].

签约仪式上，澳斯康生物集团董事长兼总裁罗顺对与科兴制药的合作充满期待，他表示，科兴制药近几 年在国际化道路上进展迅速，澳斯康生物将发挥自身优势，以全球视野和前沿技术，加快双方合作项目 的研发进程。 科兴制药董事长邓学勤也表示，澳斯康生物团队在单抗、多抗、ADC等大分子领域拥有CMC（化学、 制造和控制）开发与商业化生产及申报的丰富经验，未来双方将紧密合作，研发符合中、美、欧监管标 准的高品质生物类似药，丰富公司欧美产品线，抢占市场先机。 科兴制药启动针对欧美市场的生物类似药合作开发项目，正是基于对生物类似药临床价值支撑商业端持 续高增长的坚定判断。依托公司在国际市场的前瞻性拓展、欧美市场的精准布局及新兴市场的深度耕 耘，科兴制药有望实现"弯道超车"，为未来全球化竞争与突破奠定坚实基础。 中证报中证网讯（王珞）近日，科兴制药（688136.SH）宣布与上海澳斯康生物制药有限公司（澳斯康 生物全资子公司）达成战略合作关系，合作研发KXBS001生物类似药，双方在深圳举办签约仪式。这 一合作标志着科兴制药向欧美生物类似药市场进发。 IQVIA（艾昆纬）研究报告显示，欧盟目前仍是全球生物类似药的主流市场，其市场价值占 ...

上证报中国证券网讯（赵彬彬 记者 杨烨）近日，科兴制药与上海澳斯康生物制药有限公司（简称"澳斯康生物"）达成战略合作，共同研发KXBS001生物类似药，正式进军欧美生物类似药市场 欧洲药品管理局(EMA)近期公布的生物仿制药开发草案计划简化审评流程，有望为国内药企打开欧盟市场"快速通道"。据IQVIA研究报告，欧盟作为全球生物类似药主流市场（价值占比约40%） 科兴制药坚持"创新+国际化"战略，已形成抗体技术平台全链条创新能力，布局抗病毒、肿瘤、自免等领域十余款新药。 科兴制药董事长邓学勤表示，澳斯康生物团队拥有单抗、多抗、ADC等大分子领域CMC开发与商业化生产及申报的丰富经验，未来双方将紧密合作，研发符合中、美、欧监管标准的高品质生物类 来源：上海证券报·中国证券网 签约仪式上，澳斯康生物董事长罗顺表示："科兴制药近几年在国际化的道路上进展迅速，澳斯康生物将发挥自身优势，以全球视野和前沿技术，加快合作项目研发进程。" ...

Core Viewpoint - The company Baiotai (688177.SH) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its biosimilar drug Qletli® (BAT1406, Adalimumab injection) [1] Group 1: Product Approval - Qletli® is a biosimilar of Adalimumab developed by the company, expressed in CHO cells as a recombinant fully human monoclonal antibody [1] - The drug works by specifically binding to TNF-α, neutralizing its biological function, and blocking its interaction with cell surface TNF-α receptors, thereby inhibiting the inflammatory effects of TNF-α [1] - The approval allows the company to expand its product offerings in the UK market, enhancing its international influence and potentially positively impacting long-term operational performance [1] Group 2: Indications - Adult indications for Qletli® include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, spondyloarthritis related to enthesitis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, and uveitis [1] - Pediatric indications include polyarticular juvenile idiopathic arthritis, spondyloarthritis related to enthesitis, pediatric plaque psoriasis, pediatric Crohn's disease, pediatric ulcerative colitis, and pediatric uveitis [1]

BAT1406是百奥泰自主研发的阿达木单抗生物类似药，是由CHO细胞表达的重组全人源单克隆抗体，通 过与TNF-α特异性结合并中和其生物学功能，阻断其与细胞表面TNF-α受体的相互作用，从而阻断TNF- α的致炎作用。Qletli获得英国MHRA上市批准后可在英国进行销售，公司海外销售产品品类得到进一步 扩充，将进一步提升公司产品的国际影响力，有望对公司长期经营业绩产生积极影响。 百奥泰(688177.SH)发布公告，公司于近日收到了英国药品和健康产品管理局(简称"英国MHRA")签发的 关于Qletli(BAT1406，阿达木单抗注射液)上市批准通知。 ...

摩根士丹利发布研报，将复星医药A股和H股评级双双上调至"增持"，A股目标价上调至42元，H股目标 价上调至33港元。其中，大摩给予复星医药旗下复宏汉霖720亿元的估值(当前市值约为440亿元)，折算 相当于每股143-145港元，其中73%的估值来自核心候选药物——HLX43(PD-L1 ADC)、HLX22(HER2 mAb)和serplulimab(PD-1)的全球潜力。 复星医药持有复宏汉霖63.4%的股份，后者已经建立起由抗体和抗体偶联受体激动剂(ADC)组成的多元 化产品组合，并正在向双特异性/三特异性抗体领域拓展。复宏汉霖的销售额主要来自生物类似药和PD- 1，但今年的反弹主要得益于其创新产品线，这些产品线在临床试验中显示出良好的数据，看好其对外 授权的前景，以及在国际市场的价值。 ...

Core Viewpoint - The company reported a decline in revenue and net profit for the first half of 2025, but showed significant improvement in the second quarter, driven by its biopharmaceutical business and export growth in formulations [1][2]. Financial Performance - In 1H25, the company's revenue, net profit attributable to shareholders, and net profit excluding non-recurring items were 1.98 billion, 286 million, and 260 million yuan, respectively, representing year-on-year declines of 7.60%, 29.32%, and 29.46% [1]. - For Q2 2025, the revenue, net profit attributable to shareholders, and net profit excluding non-recurring items were 1.095 billion, 202 million, and 185 million yuan, showing year-on-year declines of 3.84%, 11.53%, and 6.36%, but a quarter-on-quarter improvement of 24%, 138%, and 145% respectively [1][2]. Business Segments - The raw material drug business faced challenges, with revenue declining by 45% year-on-year to 291 million yuan in 1H25, reducing its revenue contribution to 15% from 25% in 1H24 [2]. - The formulation segment showed stable growth, with revenue of 1.659 billion yuan in 1H25, up 7% year-on-year, driven by strong export performance, particularly in the U.S. market, which generated 1.137 billion yuan, a 20% increase year-on-year [3]. - The company has received over 100 overseas approvals and is expanding its pipeline in the European market, aiming to replicate U.S. growth [3]. Biologics Development - The company is building a product matrix in biosimilars, with approvals for adalimumab, liraglutide, and paclitaxel biosimilars, and expects to introduce more potential products [3]. - The collaboration with Tonghua Dongbao on insulin products is anticipated to yield approvals starting in 2026 [3]. Profit Forecast and Valuation - The company forecasts net profits attributable to shareholders of 1.024 billion, 1.327 billion, and 1.650 billion yuan for 2025-2027, representing year-on-year growth of 24%, 30%, and 24% respectively [4]. - The estimated EPS for the same period is 0.63, 0.82, and 1.02 yuan [4]. - A target price of 17.34 yuan is set, based on a 2025 PE of 27.37x, reflecting a 20% discount to the average PE of comparable companies [4].

Core Viewpoint - The stock of Fuhong Hanlin (02696) has seen a significant increase, with a rise of over 6% in early trading, attributed to recent developments including a stake increase by Point72 and FDA approvals for its biosimilar products [1] Group 1: Stock Performance - Fuhong Hanlin's stock rose by 5.09%, reaching HKD 79.45, with a trading volume of HKD 32.3344 million [1] - Point72, a hedge fund managed by Steve Cohen, increased its holdings in Fuhong Hanlin by 243,800 shares at an average price of HKD 83.5703 per share, investing approximately HKD 20.3744 million [1] - Following the purchase, Point72's total shareholding increased to 8.2379 million shares, raising its ownership percentage from 4.89% to 5.04% [1] Group 2: Product Approvals - Fuhong Hanlin announced that the U.S. FDA has approved the market applications for two biosimilar products: BILDYOS (denosumab-nxxp) and BILPREVDA (denosumab-nxxp) [1] - These products are biosimilars to PROLIA (denosumab) and XGEVA (denosumab) [1] - In 2022, Fuhong Hanlin entered into a licensing and supply agreement with Organon, granting Organon exclusive commercialization rights for several biosimilars, including BILDYOS and BILPREVDA, outside of China [1]

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the FDA marks a significant advancement in improving accessibility to critical bone care treatments for millions of Americans, particularly the aging population [1][2] Company Summary - Fuhong Hanlin has successfully developed and produced biosimilars BILDYOS and BILPREVDA, which have received FDA approval, demonstrating the company's commitment to scientific excellence and product quality [1] - The collaboration with Organon aims to expand the accessibility of high-quality biologics, providing patients with treatment options that are equivalent in efficacy and safety to the original drugs [1] Industry Summary - The approval of BILDYOS and BILPREVDA is based on a comprehensive review of data, including structural and functional analyses, pharmacokinetic data, and a clinical comparative study, showing high similarity in safety, purity, and efficacy to the original drugs PROLIA and XGEVA [2] - The approval enhances Organon's portfolio of biosimilars in the U.S., which has been developed over eight years and covers five major therapeutic areas [2]