Core Insights - The company Kolonbo Tai Biotech-B (06990) has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) A166 (also known as Bodo Trastuzumab) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (BC) who have previously received one or more anti-HER2 therapies [1][2] Group 1 - The approval is based on a multicenter, randomized, open-label, controlled Phase 3 study (KL166-III-06) that evaluated the efficacy and safety of Bodo Trastuzumab compared to T-DM1 in HER2-positive patients with unresectable or metastatic BC who had previously received trastuzumab and taxane treatments [1] - In the pre-specified interim analysis, Bodo Trastuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to T-DM1, as assessed by blinded independent central review (BICR) [1] - A trend towards improved overall survival (OS) with Bodo Trastuzumab was also observed, with results set to be presented at the 2025 European Society for Medical Oncology (ESMO) conference in Berlin [1] Group 2 - The company has initiated an open-label, multicenter Phase 2 clinical study of Bodo Trastuzumab for the treatment of HER2-positive unresectable or metastatic BC previously treated with an effective payload of topoisomerase inhibitor ADC [2] - Bodo Trastuzumab is a differentiated HER2 ADC designed for the treatment of advanced HER2-positive solid tumors, featuring a drug-antibody ratio (DAR) of 2 [2] - The drug specifically binds to HER2 on the surface of tumor cells, leading to internalization and release of the cytotoxic molecule Duo-5, which induces cell cycle arrest in the G2/M phase and triggers apoptosis in tumor cells [2]

Core Points - Tonghua Dongbao announced a share repurchase plan approved by the board with a total fund of no less than RMB 20 million and no more than RMB 40 million [1] - The maximum repurchase price is set at RMB 10 per share, which is 150% of the average trading price over the last 30 trading days prior to the board's approval [1] - The implementation period for the repurchase is within six months from the date of board approval [1] Summary by Category Company Actions - The company held its 11th board meeting on October 17, 2025, where the share repurchase proposal was approved with 9 votes in favor and no opposition [1] - The repurchased shares will be used for employee stock ownership plans and/or equity incentives [1] Financial Details - The total amount allocated for the share repurchase is between RMB 20 million and RMB 40 million [1] - The maximum repurchase price is capped at RMB 10 per share [1] Timeline - The share repurchase must be executed within six months from the board's approval date [1]

Core Insights - The article highlights the success of Carvykti (siltuximab), a CAR-T cell therapy developed by Legend Biotech, which has surpassed $1 billion in annual sales, categorizing it as a "blockbuster" drug in the biopharmaceutical industry [1][4]. Company Overview - Legend Biotech's Carvykti achieved third-quarter sales of $524 million, with total sales for the year reaching $1.332 billion, following first and second-quarter sales of $369 million and $439 million, respectively [1]. - The drug was first approved in the U.S. on February 28, 2022, and is the first Chinese-origin CAR-T cell therapy to be commercialized overseas [1][3]. Market Dynamics - Carvykti is marketed in collaboration with Johnson & Johnson, with Legend Biotech handling commercialization in Greater China and J&J managing the rest of the world. Revenue sharing is structured at 70:30 for Greater China and 50:50 for other global regions [1]. - As of now, there are seven CAR-T cell therapies approved in China, but high prices limit accessibility, with Carvykti not yet sold in the Chinese market [4]. Sales Performance - Carvykti's price in the U.S. has increased from $465,000 to $555,300, significantly higher than the domestic CAR-T therapies priced over 1 million yuan, attributed to its efficacy in treating multiple myeloma [4]. - The drug's sales in overseas markets are on a stable growth trajectory, with a notable performance in multiple myeloma indications [4]. Clinical Data - Recent long-term follow-up data from the CARTITUDE-1 study indicated that 33% of patients with relapsed or refractory multiple myeloma remained disease-free for five years or longer after a single infusion of Carvykti, marking a significant advancement in treatment outcomes [5]. - Carvykti is the first CAR-T therapy to demonstrate overall survival benefits compared to standard therapies in multiple myeloma treatment [5]. Financial Outlook - Legend Biotech is on track to turn a profit by 2026, following a net loss of approximately $101 million in the first quarter of 2025, driven by the increasing sales of Carvykti [5].

来源：格隆汇APP 轩竹生物是一家以创新为驱动的中国生物制药公司，凭借对中国医药行业的理解和对其独特临床需求的 洞察，改善患者健康和生活。自四环医药于2008年收购山东轩竹多数权益以来，公司已经建立一个全面 的内部研发平台，支持公司开发多样化且均衡的管线。自成立以来每年平均推进至少一款候选药物进入 临床试验，截至目前已获得共20项IND批准。 目前，轩竹生物有超过十种药物资产在积极开发中，涵盖消化系统疾病、肿瘤和非酒精性脂肪性肝炎 (NASH)，包括三项NDA批准资产，一个药物项目处于NDA注册阶段，一个药物项目处于III期临床试验 阶段，四个药物项目处于I期临床试验阶段，五个已获IND批准。(格隆汇) 格隆汇10月17日｜港股三大指数今日全线下跌，恒科指跌逾4%创逾一个月新低。由四环医药分拆的轩 竹生物-B(2575.HK)逆势走强，一度大涨17.1%至33.96港元，股价创上市新高。该股于本周三(15日)登陆 港交所，迄今仅仅3个交易日，现价较IPO价格11.6港元已累涨192.76%。 | | | 【 】HY199 4 (it : 51 TN 200 716 #K 19 29 39 109 150 30 ...

Core Viewpoint - The stock price of TEBIO has been declining for four consecutive days, with a total drop of 7.44% during this period, indicating potential concerns among investors [1]. Company Overview - TEBIO, officially known as Xiamen TEBIO Engineering Co., Ltd., was established on August 7, 1996, and went public on January 17, 2020. The company specializes in the research, production, and sales of recombinant proteins and long-acting modified drugs [1]. - The main revenue composition of TEBIO includes antiviral drugs (86.85%), blood/cancer drugs (12.87%), and other supplementary products (0.27%) [1]. Fund Holdings - Huatai-PB Fund has a significant holding in TEBIO, with its Huatai-PB Quantitative Chuangying Mixed A Fund (010303) holding 15,400 shares, unchanged from the previous period, accounting for 1.34% of the fund's net value [2]. - The fund has experienced a floating loss of approximately 18,500 yuan today, with a total floating loss of 96,100 yuan during the four-day decline [2]. - The Huatai-PB Quantitative Chuangying Mixed A Fund was established on November 12, 2020, with a current scale of 58.35 million yuan and has achieved a year-to-date return of 43.46% [2].

10月15日，合肥市创业投资引导基金参股子基金先进制造产业投资基金二期（有限合伙）投资企业—— 轩竹生物科技股份有限公司（股票简称"轩竹生物-B"，股票代码"02575.HK")成功登陆香港联合交易所 主板。本次发行价格为11.60港元/股，开盘价29.46港元/股，涨幅达153.97%，轩竹生物拟将本次募集资 金主要用于其治疗消化系统疾病及肿瘤的核心产品、关键产品的临床试验、持续研发以及商业化等方 面。 轩竹生物科技股份有限公司成立于2018年，是一家以创新为驱动、致力于改善患者健康和生活质量的中 国生物制药公司。公司以强大的内部研发平台为基础，聚焦消化系统疾病、肿瘤及非酒精性脂肪性肝炎 （NASH）等重大疾病领域，凭借其对国内医药行业的深入理解和对临床需求的精准洞察能力，已建立 起涵盖多个临床阶段的创新药物研发管线，拥有超过十项在研药物资产，其三款核心产品，即用于治疗 消化系统疾病的创新型质子泵抑制剂KBP-3571、靶向乳腺癌的细胞周期蛋白依赖性激酶4/6 (CDK4/6)抑 制剂XZP-3287、准靶向非小细胞肺癌(NSCLC)的间变性淋巴瘤激酶(ALK)抑制剂XZP-3621均已获NDA 批准。轩竹 ...

Core Viewpoint - Cathay Securities has initiated coverage on Lepu Biopharma-B (02157) with a "Buy" rating, projecting significant revenue growth from 2025 to 2027, driven by a robust product pipeline and imminent approval of MRG003 [1][2] Group 1: Financial Projections - Revenue forecasts for Lepu Biopharma are set at 853 million, 1.204 billion, and 1.665 billion yuan for 2025, 2026, and 2027 respectively [1] - The company is assigned a target price of 9.55 to 10.38 HKD based on a cautious approach using both PS and PB valuation methods [1] Group 2: Product Pipeline and Development - Lepu Biopharma has developed a diverse pipeline of oncology products, focusing on immunotherapy, ADC targeted therapy, and oncolytic virus drugs [1] - The cornerstone of the company's immunotherapy is an anti-PD-1 antibody candidate, with advanced ADC technology being utilized for innovative drug development [1] Group 3: Regulatory Approvals and Clinical Trials - MRG003 has received priority review qualification from the CDE for the treatment of R/MNPC, with an NDA submission expected in March 2025 [2] - MRG003 has also been included in the list of breakthrough therapy drugs by the NMPA for use in combination with PD-1 antibody for specific cancer indications [2]

Core Viewpoint - Cathay Securities has initiated coverage on Lepu Biopharma-B (02157) with a "Buy" rating, projecting significant revenue growth from 2025 to 2027, driven by a robust product pipeline and imminent approval of MRG003 [1][2] Group 1: Financial Projections - Revenue forecasts for Lepu Biopharma are set at 853 million, 1.204 billion, and 1.665 billion yuan for 2025, 2026, and 2027 respectively [1] - The company is assigned a 2025 price-to-sales (PS) ratio of 23X, leading to a reasonable valuation of 10.87 yuan/11.81 HKD [1] - A price-to-book (PB) ratio of 25X is also applied, resulting in a valuation of 9.55 yuan/10.38 HKD [1] Group 2: Product Pipeline and Development - Lepu Biopharma has established a diverse pipeline in oncology, focusing on immunotherapy, ADC targeted therapy, and oncolytic virus drugs [1] - The cornerstone of its immunotherapy is the anti-PD-1 antibody candidate, with advanced ADC technology being utilized for innovative drug development [1] - The company is also exploring combination therapies involving PD-L1 and ADC drugs [1] Group 3: Regulatory Approvals - MRG003 has received priority review qualification from the CDE for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/MNPC) and is expected to be approved domestically soon [2] - MRG003, in combination with the PD-1 antibody, has been officially included as a breakthrough therapy by the NMPA for specific treatment indications [2]

Company Overview - Argenx SE is a global biotechnology company founded in 2008, focused on developing innovative immunotherapies for severe autoimmune diseases using its proprietary SIMPLE Antibody™ platform [1] - The core product, VYVGART (efgartigimod alfa), is a novel neonatal Fc receptor (FcRn) blocker approved for treating generalized myasthenia gravis (gMG) in multiple countries, with plans for further indications [1] - Sales of VYVGART grew from $400 million in 2022 to $2.19 billion in 2024, demonstrating strong commercialization capabilities, and the company achieved its first annual profit in 2024 with a net income of $833 million [1] Financial Performance - Argenx's financial performance shows explosive growth, reflecting the successful commercialization of VYVGART [2] - Revenue increased from $401 million in 2022 to $2.252 billion in 2024, representing a compound annual growth rate (CAGR) of 136% [3][18] - The company transitioned from a net loss of $710 million in 2022 to a profit of $833 million in 2024, driven by scale effects, improved operational efficiency, and tax benefits [4] Product Commercialization - VYVGART's net sales in 2024 reached $2.186 billion, with the U.S. accounting for approximately 86.56% of sales [4] - The product is available in various formulations, including intravenous (VYVGART IV) and subcutaneous (VYVGART SC, branded as Hytrulo), enhancing patient convenience [5][7] - VYVGART SC, approved in June 2023, allows for at-home administration, significantly improving patient convenience and expected to contribute over 30% of sales by 2025 [7] Market Expansion and Penetration - Argenx is actively expanding VYVGART into additional indications, with gMG as the core indication approved in over 30 countries [8] - The company is conducting clinical trials for 15 additional autoimmune diseases, with a focus on expanding market penetration [9] - As of 2024, an estimated 15,000 patients globally have received VYVGART treatment, indicating significant growth potential in a market with approximately 60,000-80,000 gMG patients [9] Clinical Efficacy and Patient Acceptance - VYVGART has shown strong clinical efficacy, with 98.1% of patients experiencing significant improvement in MG-ADL scores [13] - Patient satisfaction is high, with over 90% expressing satisfaction with nursing case management services and nearly 80% willing to recommend the treatment [12] Competitive Landscape - Argenx faces competition from major players like AstraZeneca and UCB, but VYVGART maintains a strong market position due to its unique mechanism and clinical advantages [15] - The product's rapid onset of action and good safety profile provide a competitive edge in the autoimmune disease treatment market [16] Investment Highlights - Argenx presents strong investment potential with a current market valuation of approximately $40-45 billion and expected revenue growth rates of 50-70% in the short term [18] - The company has a robust financial position with $3.4 billion in cash and no long-term debt, supporting its growth strategy [18] - The management team has demonstrated strong execution capabilities and a clear strategic vision for future growth [18]

21世纪经济报道记者周潇枭 见习记者张旭 海南报道 面朝烟波浩瀚南海、背靠中国广袤腹地，海南自古便是海上丝绸之路的黄金枢纽。如今，海南迎来了新 一轮的机遇期。在"十四五"规划收官之年，2025年12月18日，海南自贸港将迎来全岛封关运作的历史性 时刻。 近日，21世纪经济报道记者跟随"活力中国调研行"采访团来到海南，感受海南自贸港从制度建设到产业 发展的最新脉搏。 从走访调研情况来看，海南自贸港"4321"制度体系已初步建成，经济外向度显著提升。 其中，"4"指人流、物流、资金流和数据流四类要素进出更为便利；"3"指货物贸易、服务贸易和投资三 大领域加快开放；"2"指企业和个人税收优惠力度持续加大；"1"指以海南自贸港法这一专门法律为基础 的法治保障不断完善。 在经济外向度方面，5年来，海南实际使用外资年均增长14.6%，累计突破千亿元；货物贸易、服务贸 易持续增长，经济外向度提高至35%。全岛加工增值内销免关税政策效应凸显，内销货值增长3倍。可 免签入境海南国家扩大至85个，同境外39个自贸区（港）建立伙伴关系。 一条条落在实处的优惠政策，吸引了越来越多企业来到海南落户；一个个产业集群的发展，给海南注入 了 ...