强生公司今日宣布，旗下创新治疗药物兆珂速——达雷妥尤单抗注射液(皮下注射)正式获得国家药品监 督管理局批准拓展适应症，与硼替佐米、来那度胺和地塞米松联合用药治疗适合自体干细胞移植的新诊 断多发性骨髓瘤成年患者。 中位随访47.5个月的研究数据显示，主要终点无进展生存期(PFS)获得显著改善。与VRd方案相比， DVRd方案将疾病进展或死亡风险降低了58%(风险比[HR] = 0.42；95%置信区间[CI]：0.30–0.59； p<0.0001)。在缓解深度方面，DVRd方案同样展现出显著优势：获得整体微小残留病(MRD)阴性率(检 测灵敏度10⁻⁵)达75.2%，高于VRd组的47.5%(p < 0.0001)；达到完全缓解及以上的患者占87.9%，高于 VRd组的70.1%(p < 0.0001)；尤为重要的是，获得MRD阴性持续≥12个月的患者比例达64.8%，显著高于 VRd组的29.7%。 这意味着患者在新诊断阶段即有机会接受基于达雷妥尤单抗皮下注射制剂的四药联合方案，获得一项显 著改善预后的全新治疗选择。 此次获批是基于III期PERSEUS研究结果。该研究在适合自体干细胞移植的新诊断多发性骨髓 ...

Core Insights - Morgan Stanley highlights Johnson & Johnson's (JNJ.US) recent clinical data presented at the American Society of Hematology (ASH) annual meeting, particularly the promising results of the Tecvayli and Darzalex combination therapy (Tec-Dara) for relapsed/refractory multiple myeloma (RRMM) in the phase III trial (MajesTEC-3) [1] Group 1: Clinical Trial Results - The MajesTEC-3 trial included 587 patients, showing that the Tec-Dara combination significantly outperformed the control group (DPd/DVd regimen) in key efficacy metrics [1] - The combination therapy also reduced the risk of patient mortality and extended treatment duration, benefiting even those previously treated with anti-CD38 therapy [1] Group 2: Safety Profile - The incidence of grade 3/4 treatment-related adverse events for the Tec-Dara combination was similar to the control group, with low treatment discontinuation rates [2] - Although the combination had a higher infection rate initially, the introduction of an immunoglobulin prophylaxis regimen in February 2023 led to a significant decrease in grade 3 and above infection rates after six months, with only one case of fatal infection reported [2] - The incidence of cytokine release syndrome was 60.1%, while immune effector cell-associated neurotoxicity syndrome occurred in only 1.0% of patients [2] Group 3: Market Potential - Morgan Stanley predicts that Tecvayli's global sales will grow from $1 billion in 2026 to $9.3 billion by 2033, with its efficacy being competitive against Legend Biotech's and Johnson & Johnson's BCMA CAR-T therapy, Carvykti [2] - Darzalex, expected to generate $14 billion in annual sales, has established a strong position in frontline treatment, with approximately 76% of U.S. patients remaining sensitive to it after their first relapse, laying a foundation for Tec-Dara's advancement in treatment lines [2] Group 4: New CAR-T Therapy - Morgan Stanley also mentioned Johnson & Johnson's collaboration with Kelonia on a new CAR-T therapy, KLN-1010, which uses a lentiviral vector for delivery without preconditioning, potentially reducing logistical burdens and production costs [3] - In a preliminary phase I trial involving four patients who had undergone at least three lines of treatment, all achieved minimal residual disease negativity, with one case of complete response and three cases of partial response, demonstrating good safety without neurotoxic side effects [3] - If subsequent trials are successful, KLN-1010 could become a new treatment option for multiple myeloma, further strengthening Johnson & Johnson's leadership in this field and posing long-term competitive pressure on existing BCMA CAR-T therapies [3]

Regeneron Pharmaceuticals Conference Call Summary Company Overview - **Company**: Regeneron Pharmaceuticals (NasdaqGS:REGN) - **Focus**: Linvoseltamab Development Program in multiple myeloma and precursor conditions Key Points Industry and Market Context - The multiple myeloma treatment landscape is complex, with a need for simplified and effective treatment options [6][8] - The estimated market for multiple myeloma is approximately $30 billion, with first-line and second-line settings each representing over $10 billion [27][28] Linvoseltamab Development Program - **Linvoseltamab**: A BCMA x CD3 bispecific antibody aimed at revolutionizing multiple myeloma treatment [4][6] - **Approval**: Accelerated approval received in July 2025 based on LINKER-MM1 study results [12] - **Clinical Data**: - LINKER-MM1 study showed an overall response rate of 71% and a complete response rate of 52% at 20 months of follow-up [11] - In the second-line setting, a combination with Carfilzomib showed an overall response of 90% and a complete response of 76% [16] - In the first-line setting, LINKER-MM4 study reported an overall response rate of 86% and a complete response rate of 43% with only nine months of follow-up [18] Development Strategy - **Late-Line Setting**: Establishing Linvoseltamab in late-line therapy to build market share [8][9] - **Early-Line Therapy**: Plans to advance into early lines with differentiated development strategies [9][14] - **Precursor Conditions**: Aiming to treat high-risk smoldering multiple myeloma and MGUS to potentially eliminate myeloma [24][25] Safety and Efficacy - Linvoseltamab demonstrated a manageable safety profile with the lowest rates of cytokine release syndrome (CRS) compared to other bispecifics [10][11] - Infections decreased over time in patients treated with Linvoseltamab, indicating a potential improvement in immune function [52][53] Commercial Opportunities - Strong early momentum in the launch of Linvoseltamab, with over 300 institutions certified for the REMS program [27] - Positive physician feedback on Linvoseltamab's differentiated clinical profile and patient-centric dosing [27][28] - Potential for significant commercial opportunities in precursor conditions and related diseases [28][29] Future Studies and Trials - Ongoing and upcoming pivotal studies, including LINKER-MM3, LINKER-MM5, LINKER-MM6, LINKER-MM7, LINKER-MM8, and LINKER-SMM2, are expected to provide critical data in the coming years [12][21][25][30] - Anticipated results from LINKER-MM3 in 2027 and LINKER-SMM2 in the first half of 2026 [13][25] Conclusion - Regeneron is positioned to simplify the treatment landscape for multiple myeloma with Linvoseltamab, aiming to establish it as the therapy of choice across various treatment lines and precursor conditions [30][31]

Core Insights - The latest data from the Hong Kong Stock Exchange indicates that on August 18, shareholders of Deking Pharmaceutical-B (06996) deposited shares worth HKD 416 million into Standard Chartered Bank (Hong Kong), representing 9.23% of the total shareholding [1] - On July 28, Deking Pharmaceutical announced that the National Medical Products Administration (NMPA) of China has approved the use of Xivio (Selinexor) in combination with Bortezomib and Dexamethasone (XVd) for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received at least one prior therapy, marking a new indication for Xivio [1]

Core Insights - The increasing prevalence of multiple myeloma (MM) among the aging population in China poses significant health challenges, with a doubling of incidence and a 1.5 times increase in mortality over the past 30 years [1][3] - The five-year survival rate for MM patients in China is only 24.8%, indicating a critical need for improved diagnosis and treatment strategies [1][3] Group 1: Disease Overview - Multiple myeloma is the second most common hematological malignancy, particularly affecting individuals over 60, with 75% of cases occurring in this age group [1][3] - The disease is characterized by high heterogeneity, difficulty in treatment, and a tendency to relapse, with 70% of patients showing bone lesions at diagnosis [4][3] Group 2: Risk Factors - Genetic predisposition plays a significant role in the development of MM, with a higher incidence in individuals with a family history of hematological malignancies [2][3] - Environmental factors such as chemical exposure, radiation, chronic viral infections, and autoimmune diseases also contribute to the risk of developing MM [2][3] Group 3: Treatment Landscape - Recent advancements in treatment options include proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies, although relapse remains a major challenge [4][5] - Less than 10% of patients achieve long-term remission after first-line treatment, and about 25% experience early relapse [4][5] Group 4: Innovative Therapies - BCMA (B-cell maturation antigen) has emerged as a promising target for therapy, with various drug types such as antibody-drug conjugates (ADCs), CAR-T, and bispecific antibodies showing potential [6][7] - Recent studies presented at the EHA 2025 conference indicate that BCMA ADCs provide higher efficacy and longer disease control compared to standard treatments in the Chinese population [7][8] Group 5: Future Directions - The goal is to enhance treatment efficacy for newly diagnosed patients, aiming for clinical cures and improved quality of life [9] - Continuous innovation in drug development is expected to further improve treatment outcomes for MM patients [9]