CS1003-305研究是一项国际多中心、双盲、随机对照的III期注册研究，在全球范围内设有74家研究中 心，旨在评估PD-1单抗nofazinlimab(CS1003)联合仑伐替尼对比安慰剂联合仑伐替尼一綫治疗不可切除 或转移性肝细胞癌(HCC)患者的有效性和安全性。该研究的主要终点为总生存期(OS)。关键次要终点包 括盲态独立中心审閲(BICR)评估的无进展生存期(PFS)和客观缓解率(ORR)。 最终分析结果显示nofazinlimab联合仑伐替尼对比安慰剂联合仑伐替尼，OS呈现出明显的临床获益趋 势，尽管未达到统计学显著性，但仍显示出切实的患者获益。此外，该联合疗法在PFS和ORR方面也取 得有临床意义的改善，其数据与目前标准疗法治疗数据可比。并且，nofazinlimab安全性良好，与既往 研究结果以及已上市的抗PD-(L)1抗体安全性特征一致，未观察到新的安全性信号。公司将与监管机构 沟通，寻求该联合疗法的注册路径。 Nofazinlimab是一种靶向人程序性细胞死亡蛋白1(PD-1)的人源化重组IgG4单克隆抗体，正在开发用于肿 瘤的免疫治疗。Nofazinlimab与人类、食蟹猴和小鼠PD-1 ...

九龙仓置业(01997)涨7.32%，香港5月零售总销货价值止跌回升，小摩上调公司评级。 环球新材国际(06616)再涨超5%，收购默克表面解决方案业务交易事项即将落地。 巨星传奇(06683)涨超3%，近日附属斥资800万美元认购星光新经济产业基金权益。 信达生物(01801)涨超6%，玛仕度肽近日获批上市，后续商业化在即。 基石药业-B(02616)涨超11%，首次披露CS2013与CS2015两款双特异性抗体药物靶点。 先声药业(02096)涨4.43%，新一代抗VEGF单抗"苏维西塔单抗"获批上市。 博彩股继续上扬，澳门6月博彩收入超预期，花旗料增长势头将于下半年持续。美高梅中国(02282)涨 2.6%；新濠国际发展(00200)涨1.75%。 智通财经APP获悉，港股恒生指数跌0.96%，跌232点，报23989点；恒生科技指数跌1.20%。港股早盘成 交1306亿港元。 国家医保局与国家卫生健康委员会于7月1日联合发布了《支持创新药高质量发展若干措施》，机构称创 新药仍为重要投资主线之一。恒生生物科技指数大涨2.79%。亚盛医药-B(06855)涨8%；科伦博泰生物- B(06990)涨7%；再 ...

Core Insights - Company disclosed two proprietary bispecific antibody drug candidates targeting autoimmune/inflammatory diseases: CS2013 and CS2015, both showing potential as best-in-class or first-in-class therapies [1][2] - CS2013 targets BAFF and APRIL to block B cell and plasma cell development, with preclinical data indicating a synergistic effect and superior pharmacokinetic properties compared to fusion protein drugs [1] - CS2015 targets OX40L and TSLP, providing a new treatment strategy for type 2 inflammatory diseases such as atopic dermatitis and asthma, also showing long half-life and potential for subcutaneous administration [2] Company Strategy - The CEO emphasized the significant unmet needs in the autoimmune/inflammatory disease market, which is becoming the second-largest disease market after oncology, due to the variety of diseases and large patient base requiring lifelong treatment [2] - The development of CS2013 and CS2015 reflects the company's strategic expansion beyond oncology and its commitment to innovation aimed at improving global patient health [2] - The company plans to initiate IND preparation for new drug clinical trials in the second half of 2025 [1]

港股医药股走强 宜明昂科涨超8% 智通财经5月20日电，截至发稿，宜明昂科-B(01541.HK)涨8.38%、基石药业-B(02616.HK)涨7.82%、百 济神州(06160.HK)涨3.25%、加科思-B(01167.HK)涨2.80%、映恩生物-B(09606.HK)涨2.68%。 ...

（接上文） 有海量的市场规模，有政策的大力扶持，医药上市公司特别是创新药公司走出一批长春高新那样的牛股并非天方夜谭。 香港创新药个股里面，已经走出了一批涨了几倍的股票。科济药业从2.48元涨到了19.78元，加科思聪1.2元涨到了4.3元，康宁杰瑞从2元涨到了8.73元，基石 药业从0.8元涨到3.89元，康方生物从26.45元涨到105.5元。而香港创新药的走牛其实也只是开了个头，后面的行情还有很远的路，因为这是一个50年的大周 期。 内地创新药会不会跟随港股？我们先不做判断，看看05年到07年的地产股走势就知道了。 05年到07年的地产股行情，港股帅先启动。中国海外发展05年7月启动行情，一直涨到07年12月底，从2.29元涨到了21.95元。合富辉煌05年1月启动，涨到07 年7月，从1.38元涨到7.79元。万科海外04年11月就开始启动，一直到07年的7月，从6.76元涨到了33.82元。永泰地产04年11月启动，涨到07年底，从1.40元 涨到6.88元。 香港创新药指数自年初以来，从859点涨到1284点，涨了50%。内地创新药指数从年初最低948，涨到最高1156，涨幅22%，严重滞后。 而A ...

Core Viewpoint - The company, Basestone Pharmaceuticals, has announced significant advancements in its clinical pipeline, particularly focusing on the dual-targeting antibody CS2011, which shows promise in treating various cancers by effectively blocking key signaling pathways associated with tumor growth [1][22]. Group 1: CS2011 Development - CS2011 is a dual-specific antibody targeting EGFR and HER3, capable of blocking nearly all HER family-related signaling pathways except for HER2 homodimers, thus overcoming tumor heterogeneity [2][5]. - The binding affinity of CS2011 to EGFR is 2.04 nM and to HER3 is 5.04 nM, with a combined affinity of less than 1 pM for both targets [8]. - CS2011 effectively binds to tumor cells expressing either EGFR or HER3 alone, as well as those expressing both [9]. Group 2: Comparative Efficacy - In both in vitro and in vivo studies, CS2011 demonstrated superior anti-tumor activity compared to potential major competitors, including EGFR monoclonal antibodies and HER3 monoclonal antibodies [11][12]. - CS2011's ability to inhibit downstream EGFR signaling is comparable to that of EGFR monoclonal antibodies, while its inhibition of HER3 signaling surpasses that of competing dual-target antibodies [12][14]. - In animal models, CS2011 exhibited tumor suppression effects superior to those of EGFR and HER3 monoclonal antibodies, with efficacy comparable to combination therapies involving both [16]. Group 3: Other Pipeline Products - CS5007, an ADC targeting EGFR and HER3, is designed using the CS2011 antibody framework, aiming to be a leading candidate in precision oncology [21]. - CS5005 is a first-in-class ADC targeting SSTR2, showing strong anti-tumor activity in preclinical studies and good tolerability in initial toxicity studies [22]. - CS5006 is another first-in-class ADC targeting ITGB4, which has shown significant upregulation in various cancers while maintaining low expression in normal tissues, indicating its therapeutic potential [23].

Financial Performance - Total revenue for the year ended December 31, 2024, was RMB 407.2 million, a decrease of RMB 56.6 million or 12.2% year-over-year[11]. - Revenue from licensing fees increased by RMB 108.3 million or 113.1% year-over-year, significantly offsetting the decline in drug sales revenue[11]. - R&D expenses decreased from RMB 527.8 million in 2023 to RMB 134.7 million in 2024, a reduction of RMB 393.1 million[11]. - Administrative expenses decreased from RMB 182.7 million in 2023 to RMB 77.8 million in 2024, a reduction of RMB 104.9 million[11]. - Sales and marketing expenses decreased from RMB 199.3 million in 2023 to RMB 133.8 million in 2024, a reduction of RMB 65.5 million[11]. - Net loss for the year decreased by RMB 276.0 million or 75.2% to RMB 91.2 million in 2024, primarily due to a significant reduction in operating expenses[11]. - Cash and cash equivalents and time deposits as of December 31, 2024, amounted to RMB 672.9 million[11]. - Total assets as of December 31, 2024, were RMB 1,393.5 million, down from RMB 1,661.0 million in 2023[12]. - Total liabilities as of December 31, 2024, were RMB 1,029.6 million, compared to RMB 1,205.2 million in 2023[12]. Drug Development and Regulatory Approvals - The company achieved significant milestones in regulatory approvals, clinical progress, and strategic partnerships, reinforcing its leadership in innovative therapies[13]. - Three new drug applications (NDA) are expected to be approved in 2024, including a fifth indication for the drug Zhejie Mei® in China for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC)[14]. - Shugli monoclonal antibody has been approved in the EU and the UK for first-line treatment of stage IV non-small cell lung cancer (NSCLC), marking its entry into major international markets[14]. - The drug Taji Hua® (Avapritinib) has been included in the National Reimbursement Drug List (NRDL) in China, effective January 1, 2024, improving affordability for eligible patients[18]. - CS5001 (ROR1 ADC) has shown promising clinical data, with an objective response rate (ORR) of 70% for non-Hodgkin lymphoma (NHL) and 100% for Hodgkin lymphoma (HL) at the recommended phase II dose[24]. - The GEMSTONE-304 study results for first-line esophageal squamous cell carcinoma (ESCC) are expected to be published in Nature Medicine in February 2024[16]. - CS5001 (ROR1 ADC) and CS2009 (PD-1/VEGF/CTLA-4 tri-specific antibody) are advancing to critical trials, with plans to seek global partnerships to accelerate development[29]. Strategic Partnerships and Collaborations - The company has established strategic alliances to enhance global commercialization, including partnerships with Ewopharma AG and Pharmalink Store for market access in Central and Eastern Europe, MENA, and Latin America[16]. - A strategic commercialization partnership was established with Ewopharma, granting them commercialization rights for Sugli monoclonal antibody in Switzerland and 18 Central and Eastern European countries, with potential upfront payments of up to $51.3 million[43]. - The company has entered a commercialization strategic partnership with Pharmalink for Sugliant (舒格利单抗) in the Middle East, North Africa, and South Africa, receiving upfront and milestone payments based on net sales[45]. - The company plans to establish more partnerships in Western Europe, Southeast Asia, and Canada by 2025[16]. Clinical Trials and Pipeline Development - The company is advancing its pipeline with over nine potential candidates in preclinical stages, focusing on first-in-class and best-in-class characteristics across various therapeutic areas[27]. - A global Phase I trial for CS2009 (PD-1/VEGF/CTLA-4 tri-antibody) has been initiated in Australia, with plans to expand to China and the US[25]. - CS5001 is currently ranked among the top two candidates globally in clinical progress, showing promising Ia phase data for aggressive and indolent lymphomas[33]. - The company’s product pipeline has made significant progress, with CS5001 (ROR1 ADC) entering phase 1b, showing promising efficacy and safety in clinical trials[49]. Management and Governance - The board of directors includes a mix of executive and independent non-executive members, with some set to retire at the upcoming annual general meeting[129]. - The company has received annual independence confirmations from all independent non-executive directors, affirming their independence during the reporting period[132]. - The compensation committee has been established according to Listing Rule 3.25 and Appendix C1 of the Corporate Governance Code to determine the remuneration policy for directors and senior management[134]. - The leadership team has a strong background in business development and strategic management, which is expected to drive future growth and market expansion[110][116]. Stock Options and Incentive Plans - The company has adopted three share incentive plans[153]. - The total number of stock options granted is 73,147,494, with 17,482,900 options currently unexercised and 8,083,239 options exercised[164]. - The stock options program is designed to incentivize long-term performance and retention of key personnel[167]. - The company aims to align employee incentives with long-term performance through its stock option and restricted share unit plans[175]. Market Presence and Future Outlook - The company aims to maximize the global commercial potential of its approved drugs through strategic collaborations and localized production[28]. - The company is focused on expanding its market presence and developing new products, as evidenced by ongoing clinical trials and strategic partnerships[51]. - The company aims to enhance the accessibility and affordability of Tai Ji Hua® (Apatinib) through its inclusion in the national insurance list[50]. - The company is committed to maintaining its competitive edge in the market through innovative product development and strategic collaborations[40].

Core Viewpoint - The American Association for Cancer Research (AACR) annual meeting will showcase the latest preclinical research results of five innovative drugs developed by the company, highlighting its advancements in cancer treatment [1]. Group 1: Drug Innovations - CS2009 is a trispecific antibody targeting PD-1, VEGFA, and CTLA-4, designed to enhance efficacy while minimizing systemic toxicity, showing superior antitumor efficacy in preclinical studies compared to potential competitors [2]. - CS5006 is a first-in-class ADC targeting ITGB4, demonstrating strong antitumor activity in various animal models, indicating its potential for further clinical development [2]. - CS2011 is a bispecific antibody targeting EGFR and HER3, which effectively blocks downstream signaling and enhances antitumor efficacy while minimizing toxicity to normal tissues [3]. - CS5007 is an ADC that targets EGFR and HER3, showing promising antitumor activity through the release of chemotherapy agents in a target-dependent manner [6]. - CS5005 is an ADC targeting SSTR2, exhibiting robust antitumor activity and maintaining pharmacokinetic characteristics comparable to monoclonal antibodies [8]. Group 2: Research Presentation Details - CS2009 will be presented at the AACR meeting with a focus on its mechanism of action and safety profile, including a maximum non-severe toxicity dose of 100 mg/kg [4]. - CS5006 will be showcased for its potential as a novel integrin β4-targeted ADC with significant antitumor activity [5]. - CS2011 will be highlighted for its promising anti-tumor activity in preclinical evaluations, demonstrating effective inhibition of EGFR/HER3 signaling [5]. - CS5007 will be presented for its potent antitumor activity and favorable pharmacokinetic profile [6]. - CS5005 will be discussed for its potential in targeting SSTR2-positive tumors and its promising development as a dual-targeting ADC [8].

Financial Performance - In 2024, the total revenue of CStone Pharmaceuticals reached RMB 407.2 million, with licensing and royalty income contributing RMB 232.1 million; the net loss for the year decreased by 71.5% year-over-year [1][6]. Product Development and Approvals - The company achieved significant progress with the drug Sugliumab, receiving three approvals for marketing applications, including first-line treatment for gastric adenocarcinoma and stage IV non-small cell lung cancer (NSCLC) in China and the EU; an application for a new indication for stage III NSCLC has also been submitted to the European Medicines Agency (EMA) [1][11][12]. - CStone has established three international strategic collaborations for Sugliumab, covering 40 countries across three major regions, enhancing its global commercialization efforts [1][13]. Local Production and Commercialization - The local production application for the drug Tazemetostat has been approved in China, and CStone has formed a strategic partnership with Hengrui Medicine to enhance the accessibility and affordability of Tazemetostat in the domestic market [1][19]. Clinical Development Progress - The clinical development of CS5001 (ROR1 ADC) is advancing with global multi-center trials ongoing in the US, Australia, and China, showing promising efficacy and safety for treating aggressive and indolent late-stage lymphomas [2][30]. - The first patient has been dosed in the global multi-center phase I trial of CS2009 (a trispecific antibody targeting PD-1, VEGF, and CTLA-4), which has demonstrated superior preclinical anti-tumor activity compared to potential competitors [2][35]. Pipeline and Innovation - CStone is actively promoting its Pipeline 2.0, which includes over nine candidates with global rights and broad indication potential, focusing on next-generation antibody-drug conjugates (ADCs) and bispecific antibodies [2][36]. - The company has developed a proprietary ADC technology platform that supports the expansion of its innovative pipeline [2][44]. Strategic Outlook - CStone aims to enhance its growth trajectory by deepening strategic collaborations, localizing production, and accelerating the clinical development of its key assets, including CS5001 and CS2009 [4][48].

Group 1 - The company reported a revenue of RMB 407 million for the year ending December 31, 2024, representing a year-on-year decrease of 12.21% [1] - The net loss for the year was RMB 91.207 million, a reduction of 75.16% compared to the previous year [1] - Research and development expenses amounted to RMB 134.7 million, down 74.49% year-on-year [1] - The revenue included sales of drugs (Avaratnib and Pralsetinib) totaling RMB 175 million, licensing fee income of RMB 204 million, and royalties from Shuglikizumab of RMB 28.81 million [1] - Licensing fee income increased by RMB 108 million or 113.1%, which significantly offset the decline in drug sales revenue [1] - The company has successfully launched four innovative drugs and received 16 NDA approvals covering nine indications since its establishment [1] - The current research pipeline includes 16 candidate drugs, featuring potential first-in-class or best-in-class ADCs, multi-specific antibodies, immunotherapies, and precision medicines [1] Group 2 - The company aims to enhance its internal development capabilities and continue investing in R&D to advance a strong and distinctive pipeline [2] - The goal is to maximize the global commercial potential of approved drugs through strategic partnerships and localized production [2]