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中国生物制药(01177):LM-350“CDH17 ADC”临床试验申请获NMPA批准
智通财经网· 2025-11-18 09:43
Core Viewpoint - China National Pharmaceutical Group's subsidiary, Lixin Pharmaceutical Technology, has received clinical trial approval from the NMPA for its innovative drug LM-350, a CDH17-targeted antibody-drug conjugate (ADC) [1][2] Group 1: Product Development - LM-350 is developed based on Lixin's next-generation LM-ADC™ platform and selectively binds to CDH17, demonstrating strong internalization capabilities [1] - The drug utilizes an IgG1 wild-type configuration and exhibits antibody-dependent cellular cytotoxicity (ADCC) activity [1] - Preclinical studies show significant anti-tumor activity of LM-350 in various xenograft models, particularly in colorectal cancer models resistant to MMAE or irinotecan [1] Group 2: Market Potential - CDH17 is highly expressed in various cancers, including approximately 99% in colorectal cancer, 86% in gastric adenocarcinoma, 79% in esophageal adenocarcinoma, and 50% in pancreatic ductal adenocarcinoma [1] - Gastrointestinal cancers, including colorectal, gastric, pancreatic, and esophageal cancers, represent one of the highest incidence and mortality rates globally, with over 4 million new cases reported in 2022, indicating a significant unmet clinical need [1] Group 3: Regulatory Progress - LM-350 has previously received IND approval from the FDA, with the first patient enrollment in Australia expected by September 2025 [2] - The approval of the clinical trial application in China will accelerate the clinical research process, aiming to provide new treatment options for patients sooner [2]
中国生物制药(01177.HK):LM-350“CDH17 ADC”临床试验申请获NMPA批准
Ge Long Hui· 2025-11-18 09:42
格隆汇11月18日丨中国生物制药(01177.HK)宣布,集团全资附属公司礼新医药科技(上海)有限公司("礼 新医药")自主研发的国家1类创新药LM-350"CDH17抗体偶联药物(ADC)"已获得中国国家药品监督管理 局(NMPA)的临床试验批准。 根据披露,LM-350是基于礼新医药新一代LM-ADC?平台开发的一款靶向CDH17的ADC,能够高度选择 性地结合CDH17,具有很强的内化能力。LM-350采用IgG1野生型构型,同时具备抗体依赖细胞介导的 细胞毒性作用(ADCC)活性。临床前研究显示,LM-350在多个异种移植模型中表现出显著的抗肿瘤活 性,尤其在对MMAE耐药或伊立替康耐药的结直肠癌移植瘤模型中效果突出。 ...
中国生物制药:LM-350“CDH17 ADC”临床试验申请获NMPA批准
Zhi Tong Cai Jing· 2025-11-18 09:41
中国生物制药(01177)发布公告,集团全资附属公司礼新医药科技(上海)有限公司(礼新医药)自主研发的 国家1类创新药LM-350"CDH17抗体偶联药物(ADC)"已获得中国国家药品监督管理局(NMPA)的临床试 验批准。 CDH17在多种肿瘤侵袭转移中发挥重要作用,并在约99%的结肠癌、86%的胃腺癌、79%的食管腺癌、 50%的胰腺导管腺癌中高表达。消化道肿瘤(包括结直肠癌、胃癌、胰腺癌、食管癌等)是全球发病率和 死亡率最高的癌症种类之一,2022年全球新发患者数量超过400万人,存在巨大的尚未被满足的临床需 求。 此前,LM-350已获得美国食品药品监督管理局(FDA)的IND批件,并于2025年9月在澳大利亚完成首例 患者入组。随着此次中国临床试验申请的获批,礼新医药将加速推进中国临床研究,致力于尽早为患者 提供全新的治疗选择。 LM-350是基于礼新医药新一代LM-ADC平台开发的一款靶向CDH17的ADC,能够高度选择性地结合 CDH17,具有很强的内化能力。LM-350采用IgG1野生型构型,同时具备抗体依赖细胞介导的细胞毒性 作用(ADCC)活性。临床前研究显示,LM-350在多个异种移植模 ...
院士擎舵 科创逐浪破局——2025华夏大健康产业发展暨康复服务大会即将重磅启幕
Hua Xia Shi Bao· 2025-11-14 13:40
Core Insights - The "2025 China Health Industry Development and Rehabilitation Service Conference" will focus on technological innovation in the health sector, aligning with the "14th Five-Year Plan" to enhance self-reliance in health technology [2][5] - The health industry in China has seen significant growth, expanding from 7.4 trillion yuan to 12.3 trillion yuan over five years, with advancements in AI medical applications and CAR-T therapies [2][5] Academic Leadership - The conference will feature prominent academic figures, including academician Fan Daiming, who will discuss integrated medicine and its relevance to the "14th Five-Year Plan" [5][6] - Fan's presentation will focus on breakthroughs in the diagnosis and treatment of digestive diseases, emphasizing the importance of integrated prevention and management [5][6] Industry Practices - Over 50 leading companies from various sectors of the health industry will participate, covering innovative drug development, medical devices, healthcare services, health management, and digital health [8][9] - The conference will include roundtable discussions addressing key industry issues, such as investment opportunities in innovative drugs and the commercialization of brain-computer interfaces [9][10] Innovation and Collaboration - The event will facilitate direct interactions between experts and companies to address technological challenges and foster collaboration [6][12] - A showcase area will feature over 20 representative companies displaying their latest technologies and core products, enhancing visibility for industry innovations [12][13] Authoritative Results and Reports - The conference will release significant reports, including the "2025 China Health Industry White Paper" and the "Hua Xia ESG Dandelion 50-30 Index 2025 Annual Report," providing valuable insights and benchmarks for the industry [13][15] - The ESG report will evaluate 50 A-share companies and 30 H-share growth companies based on environmental, social, and governance criteria, supporting sustainable development in the health sector [13][15] Future Directions - The conference aims to create a continuous service platform for the health industry, ensuring that innovative practices and authoritative findings are effectively implemented [16][17] - The event will gather experts, industry leaders, and investment representatives to collaboratively shape the future of the health industry in China [16][17]
中藥股異動解密:7元關口成多空決勝關鍵
Ge Long Hui· 2025-11-14 12:12
Core Viewpoint - The Hong Kong pharmaceutical sector, particularly Chinese medicine stocks, is experiencing significant market activity, with China Traditional Chinese Medicine (01177) trading between 7 and 7.8 HKD, indicating strong investor interest [1] Technical Analysis - The stock is currently in a critical triangular consolidation phase, with a short-term support level at 7.05 HKD and a strong support level at 7.00 HKD. Resistance levels are at 7.76 HKD and 7.90 HKD [1] - The stock price is above the 10-day moving average (MA10) of 7.05 HKD but is constrained by the 30-day (MA30) at 7.38 HKD and the 60-day (MA60) at 7.85 HKD, indicating a mid-term trend still in recovery [1] - Various technical indicators show mixed signals: RSI is at a neutral level of 53, momentum indicators suggest a potential bottoming out, and MACD indicates a buy signal, while overall technical indicators provide a sell signal with a strength of 8 [1] Support and Resistance Analysis - The 7.00 HKD level is identified as a crucial psychological barrier; breaching this level could trigger technical selling pressure. Conversely, breaking above 7.76 HKD could lead to a challenge of the higher target at 7.90 HKD [3] - The probability of an upward movement is estimated at 54%, with a 5-day volatility of 9.4%, suggesting good trading opportunities in the current price range [3] Derivative Market Performance - Recent performance in the options market shows strong upward movement in derivative products related to Chinese medicine stocks. For instance, on November 12, a 7.66% increase in the underlying stock led to a 30% rise in UBS call option 17735 and a 27% increase in Societe Generale call option 17698 [3] Investment Opportunities - For bullish investors, HSBC call option 18513 with a strike price of 8.77 HKD offers a leverage of 3.9 times, while Huatai call option 18530 with a strike price of 8.88 HKD provides a leverage of 4.3 times, making them attractive for cost-effective investment [6] - For bearish investors, Macquarie put option 20163 with a strike price of 6.666 HKD, despite having a lower leverage of 1.8 times, is the highest among similar products, suitable for those with a cautious outlook [6] Market Sentiment and Future Outlook - The current policy environment for the pharmaceutical sector is becoming clearer, raising questions about the valuation recovery opportunities for Chinese medicine stocks. The ability of the 7.00 HKD level to serve as a solid foundation for a new market rally is under consideration [10]
港股创新药ETF(159567)跌1.12%,成交额22.14亿元
Xin Lang Cai Jing· 2025-11-14 10:14
Core Insights - The Hong Kong Innovative Drug ETF (159567) closed down 1.12% with a trading volume of 2.214 billion yuan on November 14, 2024 [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of November 13, 2024, the fund's latest share count was 9.665 billion shares, with a total size of 8.579 billion yuan, reflecting a year-to-date increase of 2344.51% in shares and 2170.81% in size [1] Fund Performance - The current fund manager, Ma Jun, has achieved a return of 69.74% since taking over on January 3, 2024 [2] - The fund's top holdings include companies such as BeiGene, CanSino Biologics, Innovent Biologics, and others, with significant weightings in the portfolio [2] Trading Activity - Over the past 20 trading days, the ETF has accumulated a trading volume of 28.057 billion yuan, averaging 1.403 billion yuan per day [1] - Year-to-date, the ETF has recorded a total trading volume of 251.214 billion yuan, with an average daily trading volume of 1.196 billion yuan [1]
创新药概念走势强劲 三生制药(01530.HK)涨超10%
Mei Ri Jing Ji Xin Wen· 2025-11-13 07:52
Core Viewpoint - The Hong Kong innovative drug sector is experiencing strong performance, with significant stock price increases for several companies in the industry [1] Company Performance - Sanofi Pharmaceutical (01530.HK) increased by 10.11%, reaching HKD 33.76 [1] - Innovent Biologics (02096.HK) rose by 7.52%, trading at HKD 14.02 [1] - BeiGene (06160.HK) saw a 7.34% increase, with shares priced at HKD 228.2 [1] - China Biologic Products (01177.HK) gained 6.79%, now at HKD 7.39 [1] - I-Mab (01801.HK) experienced a 6.37% rise, with shares at HKD 92.7 [1]
创新药概念走势强劲 三生制药涨超10% 百济神州涨超7%
Zhi Tong Cai Jing· 2025-11-13 07:43
Group 1 - The innovative drug sector has shown strong performance, with notable stock increases for companies such as Sangamo Therapeutics (up 10.11%), Innovent Biologics (up 7.52%), BeiGene (up 7.34%), China Biologic Products (up 6.79%), and I-Mab (up 6.37%) [1] - In Q3, the innovative drug sector reported a revenue growth of 1.98% year-on-year and a net profit attributable to the parent company increased by 7.25% year-on-year [1] - Despite adjustments since September, the overall trend for the innovative drug industry remains positive, supported by domestic policy and the Federal Reserve entering a rate-cutting cycle, with a significant number of licensing deals expected in the next six months to a year [1] Group 2 - Guotai Junan Securities noted that the innovative drug sector continued to experience high revenue growth and profitability turnaround in Q3, indicating a long-term positive development trend for China's innovative drug industry [2] - The explosive growth in business development (BD) transactions has been a key highlight in recent years for the domestic innovative drug sector [2] - For most domestic innovative drugs, external licensing is often just the starting point for global development, with the progress of partners in overseas development and subsequent global clinical data readings enhancing the commercial certainty of products in the global market [2]
港股异动 | 创新药概念走势强劲 三生制药(01530)涨超10% 百济神州(06160)涨超7%
智通财经网· 2025-11-13 07:36
Group 1 - The innovative drug sector shows strong performance, with notable stock price increases for companies such as 三生制药 (up 10.11%), 先声药业 (up 7.52%), and 百济神州 (up 7.34%) [1] - In Q3, the innovative drug sector's revenue grew by 1.98% year-on-year, while net profit attributable to shareholders increased by 7.25% year-on-year [1] - Despite adjustments since September, the overall trend for the innovative drug industry remains positive, supported by domestic policies and the Federal Reserve entering a rate-cutting cycle [1] Group 2 - The innovative drug sector continued to experience high revenue growth and profitability turnaround in Q3, indicating a long-term positive development trend [2] - The surge in business development (BD) transactions highlights the growth potential of the Chinese innovative drug industry [2] - For most domestic innovative drugs, external licensing is often just the starting point for global development, with subsequent clinical data enhancing commercial certainty in global markets [2]
公募基金港股持仓 聚焦高成长性资产
Zheng Quan Ri Bao· 2025-11-12 23:12
Group 1 - Public funds have significantly increased their allocation to Hong Kong stocks, with the investment market value reaching 1.362211 trillion yuan by the end of Q3 2025, a 43.09% increase from 951.985 billion yuan at the end of Q2 2025 [1] - The market value of equity and index funds in Hong Kong stocks reached 1.231653 trillion yuan and 701.284 billion yuan, reflecting increases of 45.02% and 73.07% respectively [1] - The surge in public fund holdings in Hong Kong stocks indicates a structural transformation in asset allocation, driven by the attractiveness of technology and value stocks [1] Group 2 - The influx of funds into Hong Kong ETFs is attributed to three main reasons: valuation advantages compared to A-shares, the convenience and low cost of ETF trading, and risk diversification benefits [2] - The top Hong Kong stocks that public funds increased their holdings in include SenseTime-W, Alibaba Health, China Biologic Products, and others, primarily in the information technology and healthcare sectors [2] - A total of 38 cross-border ETFs attracted a net inflow of 49.561 billion yuan in Q3, with a year-to-date net inflow of 72.642 billion yuan as of November 12 [2]