Investment Rating - The investment rating for the company is "Outperform the Market" (maintained) [1][4][22]. Core Viewpoints - The HARMONi clinical trial has achieved its primary endpoint of progression-free survival (PFS), demonstrating statistically significant efficacy in both Asian and non-Asian populations [3][5]. - The company’s partner, Summit, announced that the HARMONi trial reached its primary clinical endpoint, indicating strong potential for the drug Ivonescimab in treating EGFRm NSCLC [2][5]. - The clinical data from HARMONi shows that Ivonescimab combined with chemotherapy has a significant PFS benefit (HR=0.52) and a positive trend in overall survival (OS) (HR=0.79) [3][5][6]. - The company has initiated multiple phase 3 clinical trials across various cancer types, including NSCLC, TNBC, BTC, CRC, and SCLC, indicating a robust pipeline [3][19]. Summary by Sections Clinical Trial Results - The HARMONi trial included approximately 38% of patients from Europe and the US, aligning with other recent international trials for EGFRm NSCLC [5][6]. - The trial results showed a median PFS of 7.06 months for the experimental group compared to 4.80 months for the control group, with a hazard ratio (HR) of 0.46 [11][18]. - The trial also reported an overall response rate (ORR) of 50.6% in the experimental group versus 35.4% in the control group [11][18]. Financial Projections - The company is expected to generate revenues of 33.0 billion, 52.0 billion, and 79.0 billion yuan for the years 2025, 2026, and 2027, respectively, with net profits of 0.29 billion, 7.30 billion, and 17.93 billion yuan [4][22][26]. Competitive Landscape - Ivonescimab has shown superior efficacy compared to PD-1 monoclonal antibodies in head-to-head trials, positioning it as a potential cornerstone in immunotherapy [19][20]. - The clinical data indicates that Ivonescimab has a favorable safety profile compared to other treatments, with a lower incidence of grade 3 or higher adverse events [16][18].

Core Viewpoint - The company has presented preliminary data for IBI363 at the ASCO conference, demonstrating breakthrough efficacy in both hot tumors (NSCLC) and cold tumors (MSS CRC/mucosal melanoma) [1][2]. Group 1: Efficacy Data - In NSCLC, patients treated with IBI363 at a dose of 3 mg/kg showed a median progression-free survival (mPFS) of 7.3 months, indicating excellent performance [1][2]. - For MSS CRC, the median overall survival (mOS) reached 16.1 months in a mixed-dose single-agent treatment, approaching the benefits seen in first-line patients [1][3]. - In squamous NSCLC, the clinical objective response rate (cORR) was 36.7% with a disease control rate (DCR) of 90.0% [2]. - In cold tumors, IBI363 demonstrated an mOS of 16.1 months in MSS CRC, significantly exceeding the current treatment standard of 9-10 months [3][4]. Group 2: Safety Profile - The incidence of treatment-emergent adverse events (TEAEs) was reported at 99.3%, with 42.6% being grade 3 or higher [2]. - Only 6.6% of patients discontinued treatment due to TEAEs, and the mortality rate attributed to TEAEs was very low at 2.9% [2]. Group 3: Future Developments - The company plans to communicate with regulatory authorities regarding key registration clinical trials for squamous NSCLC, with expectations to initiate Phase III trials within the year [3][6]. - IBI363 is anticipated to reshape the immune environment for IO-resistant lung cancer patients, potentially replacing docetaxel as the new standard of care [2][4]. Group 4: Pipeline and Financial Outlook - The company is advancing its core pipeline, with expectations for multiple catalysts in 2025, including new indications for existing products [5][6]. - Revenue projections for the company are estimated at 11.856 billion, 15.613 billion, and 21.479 billion yuan for 2025-2027, with a target market valuation of 131.9 billion HKD [6].

Core Viewpoint - China Biologic Products (01177) announced positive results from a Phase III clinical trial comparing Bemesumab injection combined with chemotherapy and Anlotinib hydrochloride capsules against Tislelizumab injection combined with chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) [1][2] Group 1: Clinical Trial Results - The trial involved 565 patients randomly assigned to treatment and control groups, showing a median progression-free survival (mPFS) of 10.12 months for the trial group compared to 7.79 months for the control group, resulting in a 36% reduction in disease progression risk [2] - The objective response rates (ORR) were 71.9% for the trial group and 65.1% for the control group, with a median duration of response (DoR) of 9.69 months versus 8.34 months, indicating a significant improvement in the trial group [2] - Subgroup analysis revealed benefits across nearly all subgroups, particularly in the PD-L1 expression 1-49% population, with a hazard ratio (HR) of 0.47 [2] Group 2: Clinical Significance - The study addresses unmet clinical needs, as lung cancer has the highest incidence and mortality rates globally, with sq-NSCLC accounting for approximately 30% of all NSCLC cases [3] - The innovative treatment regimen may change existing treatment paradigms for advanced sq-NSCLC patients, who have limited options due to low mutation rates for targeted therapies [3] - The company aims to leverage its innovation and commercialization capabilities to accelerate the global market entry of this product, benefiting more patients [3]

Core Viewpoint - The recent licensing agreement between Sangfor Biopharma and Pfizer for the PD-1/VEGF bispecific antibody SSGJ-707 has sparked significant trading activity in the biopharmaceutical sector, highlighting the growing interest in innovative cancer therapies [2][3]. Group 1: Licensing Agreement Details - Sangfor Biopharma and its affiliates granted Pfizer exclusive global rights (excluding mainland China) for the development, production, and commercialization of SSGJ-707, with Pfizer making an upfront payment of $1.25 billion and potential milestone payments up to $4.8 billion [2]. - The agreement sets a new record for upfront payments for domestic innovative drug licensing, surpassing the previous record of $800 million held by Baitai Tianheng for its bispecific ADC drug [2]. - The asset ownership distribution in the agreement is 30% for Sangfor Biopharma and 70% for Shenyang Sangfor [2]. Group 2: Clinical Development Status - SSGJ-707 has received breakthrough therapy designation from the National Medical Products Administration for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression [3]. - The drug is currently in Phase III clinical trials for monotherapy in NSCLC and Phase II trials for combination therapy with chemotherapy, as well as for metastatic colorectal cancer and advanced gynecological tumors [3]. - The PD-1/VEGF bispecific antibody is seen as a potential game-changer in the competitive PD-1/L1 treatment landscape, with clinical data suggesting it may outperform existing therapies [3]. Group 3: Market Impact and Future Prospects - The transaction is expected to accelerate the global development and commercialization of SSGJ-707, enhancing its market accessibility and recognition [4]. - The acquisition of other PD-1/VEGF bispecific antibodies by multinational companies, such as BioNTech's acquisition of Pumice Biotech for up to $950 million, indicates a growing trend in the market [4]. - The licensing of LM-299 by Lixin Pharma to Merck for an upfront payment of $588 million and potential milestone payments of $2.7 billion further illustrates the increasing interest and investment in PD-1/VEGF bispecific antibodies [4].

Core Viewpoint - The article discusses the development of CAR-M (Chimeric Antigen Receptor Macrophages) therapy targeting inflammation, highlighting its potential in treating various inflammatory diseases by converting immune responses into anti-inflammatory effects [7][10]. Group 1: Inflammation and Macrophages - Inflammation plays a critical role in many diseases, and unresolved inflammation can lead to severe outcomes such as organ failure [2]. - Macrophages are strategically located throughout the body and are essential for maintaining homeostasis by clearing pathogens and harmful substances [2]. - M2 macrophages have shown promise in reducing damage in various disease models, but their effectiveness is limited by their phenotypic plasticity, which can lead to pathogenic transformation in inflammatory environments [2][8]. Group 2: CAR-M Therapy Development - Recent research from the University of Sydney introduced CAR-M therapy, which uniquely transforms immune responses into immunosuppressive responses when triggered by inflammatory cytokines [7]. - The CAR-M design includes an extracellular domain that binds to tumor necrosis factor (TNF) and an intracellular domain that activates anti-inflammatory responses, programming macrophages to exhibit M2-like functions [7][10]. Group 3: Efficacy in Animal Models - CAR-M therapy demonstrated efficacy in both acute and chronic inflammatory disease models in mice, showing a transition to an anti-inflammatory phenotype in inflamed kidneys and improving kidney function and structure [8][10]. - In models of kidney ischemia-reperfusion injury, CAR-M cells effectively reduced tissue damage and maintained their anti-inflammatory phenotype in the presence of high TNF levels [8][10].

景红梅教授表示，"一站式"免疫细胞治疗专病门诊的成立，旨在建立标准化、规范化的免疫细胞治疗全 流程管理体系，为符合条件的患者提供精准评估及长期随访服务，并推动临床研究及成果转化，以提升 学科区域影响力。"以往患者挂号，选择医生时会比较困难，很难了解哪些医生更擅长免疫治疗。免疫 细胞治疗专病门诊成立后，会安排在免疫治疗方面更专业的医生出诊，精准评估患者的免疫状态，量身 定制个体化MDT（多学科联合会诊）诊疗方案，提升诊疗规范，加强学科建设，并将在线上线下开展 疾病科普、患者关爱系列活动。" 北方血液病联盟的成立，则是北医三院血液科在诊疗网络建设上做出的进一步探索。景红梅教授介绍， 联盟将开通外地患者挂号绿色通道，并进一步加深北医三院与地方医院血液科之间的合作。具体而言， 联盟医院血液科医生可以通过北医三院血液科医生为患者加号。患者在北医三院诊断并明确治疗方案， 展开第一个疗程的治疗后，便可回到当地医院按方案进行治疗。等需要对治疗效果进行评估时，再回到 北医三院，看是否要调整诊疗方案。"这样既可以节省我们医院的很多床位资源，照顾到更多患者，地 方医院的床位资源也能被充分利用起来。在这个过程中，地方医院血液科的诊断 ...

Core Viewpoint - The approval of the new indication for Ivosidenib (依沃西单抗) by Kangfang Biopharma (康方生物) did not positively impact the company's stock price, which fell by 11.83% on April 28 due to concerns over the overall survival (OS) data, which showed clinical benefits compared to Keytruda (K药) but lacked statistical significance [1][4][6]. Summary by Sections Drug Approval and Clinical Data - Ivosidenib received approval for a second indication as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 positivity (TPS≥1%) and negative for EGFR and ALK mutations [4]. - The approval was based on positive results from the AK112-303/HARMONi-2 clinical trial, which demonstrated a median progression-free survival (PFS) of 11.14 months for Ivosidenib compared to 5.82 months for Keytruda, with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [4][5]. Overall Survival Analysis - A mid-term analysis at 39% maturity showed that Ivosidenib reduced the risk of death by 22.3% compared to Keytruda, although this result did not achieve statistical significance [6][8]. - The total survival data is considered the gold standard for evaluating the efficacy of cancer therapies, and there are differing opinions on the interpretation of these results [6][9]. Market Reaction and Future Prospects - The market's reaction to the OS data has been viewed as misaligned with the essence of the clinical findings, according to Kangfang's chairman, Xia Yu [6][8]. - The ongoing competition with Keytruda is significant, as lung cancer remains the most prevalent and deadly cancer type in China, with Ivosidenib's performance in clinical trials being closely monitored [9][10]. Upcoming Research - The HARMONi-7 study, conducted by Summit, will further evaluate Ivosidenib against Keytruda in patients with high PD-L1 expression, with a focus on achieving statistically significant benefits in overall survival [10]. - This study is crucial for determining whether Ivosidenib can genuinely challenge Keytruda's dominant position in the market [10].

Core Viewpoint - The article highlights the importance of cancer prevention and control, particularly focusing on lung cancer, and promotes a series of educational initiatives aimed at improving public awareness and understanding of cancer treatment advancements, specifically in precision medicine and immunotherapy [1]. Group 1: Cancer Prevention and Awareness - The 31st National Cancer Prevention Week is scheduled from April 15 to 21, 2025, aimed at expanding cancer prevention education and encouraging individuals to take responsibility for their health [1]. - The "People's Good Doctor · Camellia Plan" series will feature experts discussing cancer prevention and treatment, fostering a supportive social atmosphere for cancer control [1]. Group 2: Advances in Lung Cancer Treatment - Lung cancer remains the most prevalent and deadly malignancy globally, with significant changes in treatment paradigms due to breakthroughs in precision medicine and immunotherapy [1]. - A live session on April 29 will feature experts sharing insights on how precision medicine and immunotherapy are transforming the survival rates of lung cancer patients [1]. Group 3: Expert Profiles - Liu Anwen, Director of the Lung Cancer Specialty Center at Nanchang University Second Affiliated Hospital, holds multiple leadership roles in oncology associations [2]. - Liu Siyang, a physician at Guangdong Provincial People's Hospital, is involved in clinical research and holds significant positions in clinical trial committees [2]. Group 4: Viewing Instructions - The live broadcast can be accessed through the People's Good Doctor App, specifically in the "Famous Doctor Live" section [3]. - Users can download the app from app stores or follow the instructions provided via the People's Health public WeChat account [4].

康方生物的依沃西持续对PD-1单抗发起头对头挑战，也关乎着免疫治疗中PD-1的大盘子能否被撬动。 4月23日，康方生物（09926.HK）港股盘中股价一度达到100港元/股，创出历史新高。 早间，康方生物宣布，公司双抗药物依沃西单抗又一次在头对头试验中战胜了PD-1，这次挑战的对象 是百济神州（ONC.NS、06160.HK、688235.SH）的替雷利珠单抗。 4月23日，百济神州A股股价下跌1.42%。 根据康方生物公布的消息，依沃西单抗（PD-1/VEGF双抗）联合化疗对比替雷利珠单抗联合化疗一线治 疗晚期鳞状非小细胞肺癌（sq-NSCLC）的注册性III期临床研究（AK112-306/HARMONi-6），经独立 数据监察委员会评估的预先设定的期中分析显示强阳性结果：达到无进展生存期（PFS）的主要研究终 点，研究结果具有统计学显著获益和重大临床获益。 该研究数据表明，在意向治疗人群中，依沃西联合化疗组的患者无进展生存期相较对照组，获得了决定 性胜出的阳性结果；相较对照组，依沃西组在PD-L1阳性及PD-L1阴性人群中，均显示出具有临床意义 的无进展生存期显著获益。 肺癌根据癌细胞的形态，可初步分为非 ...