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].

此外，复宏汉霖宣布，美国FDA已批准地舒单抗注射液(60mg/mL)BILDYOS(denosumab-nxxp)和地舒单 抗注射液(120mg/1.7mL)BILPREVDA(denosumab-nxxp)的上市申请，两款产品分别为 PROLIA(denosumab)和XGEVA(denosumab)的生物类似药。据悉，2022年，复宏汉霖与Organon签订许可 与供应协议，授予Organon对包括BILDYOS和BILPREVDA在内的多个生物类似药在除中国以外的全球 区域的独家商业化权益。 智通财经APP获悉，复宏汉霖(02696)早盘涨超6%，截至发稿，涨5.09%，报79.45港元，成交额3233.44 万港元。 消息面上，根据香港联交所披露文件，8月26日，Steve Cohen旗下对冲基金Point72增持复宏汉霖24.38万 股股份，每股均价83.5703港元，斥资约2037.44万港元。增持后，Point72最新持股数目为823.79万股股 份，好仓比例由4.89%升至5.04%。 ...

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]

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] Group 1: Product Approval - The FDA has approved two biosimilar products, BILDYOS (denosumab-nxxp) and BILPREVDA (denosumab-nxxp), which are biosimilars to PROLIA and XGEVA, covering all indications previously approved for the original products in the U.S. [1] - The approval is based on a comprehensive review of data, including structural and functional analyses, clinical pharmacokinetics, and a clinical comparative study demonstrating high similarity in safety, purity, and efficacy to the original drugs [2] Group 2: Strategic Partnerships - In 2022, the company entered into a licensing and supply agreement with Organon, granting Organon exclusive commercialization rights for several biosimilars, including BILDYOS and BILPREVDA, outside of China [2] - The approval of these biosimilars enhances Organon's portfolio in the U.S., which has been developed over eight years and covers five major therapeutic areas [2] Group 3: Company Commitment - The approval signifies the company's commitment to scientific excellence and product quality, as stated by the CEO, highlighting the goal of providing affordable treatment options that are equivalent in efficacy and safety to the original drugs [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 partnership 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]

Investment Rating - The investment rating for the company is "Recommended" [1][8] Core Views - The company is experiencing rapid growth in its U.S. formulation segment, while its biosimilars are entering a period of significant market release [1][7] - The company reported a revenue of 1.98 billion yuan for the first half of 2025, a year-on-year decrease of 7.6%, and a net profit of 286 million yuan, down 29.32% year-on-year, which was slightly below previous expectations [3][7] - The company is focusing on expanding its biosimilar pipeline and has received multiple approvals from the U.S. FDA and the National Medical Products Administration of China [7][8] Financial Summary - Revenue projections for the company are as follows: 3.93 billion yuan in 2023, 3.92 billion yuan in 2024, 4.29 billion yuan in 2025, 4.95 billion yuan in 2026, and 5.64 billion yuan in 2027, with a year-on-year growth of 9.3% expected in 2025 [6][10] - The net profit is projected to be 826 million yuan in 2024, 753 million yuan in 2025, 866 million yuan in 2026, and 1.08 billion yuan in 2027, with a year-on-year growth of 15% expected in 2026 [6][10] - The gross margin is expected to be 43.2% in 2024, 41.3% in 2025, 43.1% in 2026, and 44.6% in 2027 [6][10] Segment Performance - The company's heparin raw material revenue was 291 million yuan in the first half of 2025, down 45% year-on-year, while the formulation revenue was 1.66 billion yuan, up 7% year-on-year, with the U.S. formulation platform Meitheal generating 1.14 billion yuan, a 20% increase [7][8] - The company has increased its R&D investment to 433 million yuan in the first half of 2025, accounting for 21.85% of revenue, which is a 126.55% increase year-on-year [7][8] Strategic Focus - The company is concentrating on overseas formulation sales and expects biosimilars to provide a new growth curve, maintaining its "Recommended" rating despite slight underperformance in the first half of 2025 [7][8]

Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its biosimilar drug HLX14, which is a formulation of denosumab [1][3]. Product Information - HLX14 is developed as a biosimilar to treat osteoporosis in postmenopausal women at high risk of fractures and other indications consistent with the reference drug [3]. - The approved products include: - BILDYOS (60 mg/mL) for increasing bone mass in men with non-metastatic prostate cancer and women with breast cancer at high risk of fractures [2]. - BILPREVDA (120 mg/1.7mL) for treating patients with giant cell tumors and refractory hypercalcemia due to malignancy [2]. Market Impact - The approval of BILDYOS and BILPREVDA will enhance the product line of the group and strengthen its international market presence [3]. - As of September 1, 2025, Fuhong Hanlin has three products approved for the U.S. market, indicating a growing portfolio [3]. Financial Insights - The cumulative R&D investment for HLX14 is approximately RMB 323 million (unaudited) as of July 2025 [3]. - The global sales of denosumab injection products are projected to be around $7.462 billion in 2024 [3]. Licensing Agreement - The commercialization rights for HLX14 outside of China and Hong Kong were granted to Organon LLC in June 2022, allowing Fuhong Hanlin to earn milestone payments and sales royalties [4].

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received FDA approval for its biosimilar drug HLX14, which is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] Group 1 - The FDA approved the biologics license application (BLA) for HLX14 in two specifications: 60mg/mL and 120mg/1.7mL [1] - HLX14 is a biosimilar of denosumab, developed by the company and its subsidiaries [1] - The drug is aimed at treating osteoporosis and other indications consistent with the reference drug's label [1]