Core Viewpoint - China National Pharmaceutical Group's subsidiary, Lixin Pharmaceutical Technology, has successfully completed the first patient enrollment in the Phase I clinical trial of its innovative drug LM-2417, marking the entry of this therapy into clinical development [1][2]. Group 1: Product Development - LM-2417 is a dual-specific antibody targeting NaPi2b and 4-1BB, developed using Lixin Pharmaceutical's proprietary conditionally activated 4-1BB platform [2]. - The mechanism of LM-2417 allows for precise activation of immune cells in the tumor microenvironment, enhancing anti-tumor effects while potentially reducing non-specific immune activation toxicity [2]. - Preclinical data indicate that LM-2417 can induce durable anti-tumor immune memory and shows significant synergistic effects when combined with other immunotherapy drugs [2]. Group 2: Clinical Research - The ongoing clinical study is an open-label, dose-escalation, and dose-expansion Phase I/II trial assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of LM-2417 as a monotherapy or in combination with other anti-tumor drugs in patients with advanced malignant solid tumors [2]. - The company aims to expedite the clinical research process to provide new immunotherapy options for patients [2].

格隆汇9月23日丨中国生物制药(01177.HK)宣布，公司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-2417"NaPi2b/4-1BB双特异性抗体"在中国开展的I期临床试验已顺 利完成首例患者入组，标志着这一创新疗法正式进入临床开发阶段。 本次临床研究为一项注射用LM-2417单药或联合其他抗肿瘤药物在晚期恶性实体肿瘤患者中的安全性、 耐受性、药代动力学特徵以及初步疗效的开放标签、剂量递增和剂量扩展的I/II期临床研究。集团将继 续快速推进项目的临床研究，期待早日为患者带来免疫治疗临床用药新选择。 LM-2417是礼新医药基於其自主研发的条件激活型4-1BB平台开发的一款NaPi2b/4-1BB双抗，能够特异 性结合肿瘤细胞表面的NaPi2b及免疫细胞表面的4-1BB。该机制可实现免疫细胞在肿瘤微环境中的精准 激活，从而增强抗肿瘤效应。与传统4-1BB激动剂不同，LM-2417通过NaPi2b依赖性方式选择性激活4- 1BB信号通路，有望显著降低非特异性免疫激活引发的毒性风险。 临床前数据表明，LM-2417不仅能诱导持久的抗肿瘤免疫记忆，还在与其他免疫治疗药物 ...

9月23日，港股三大指数集体收跌，继上周四刷新阶段新高后持续回落，恒生科技指数一度大跌至2.6%，最终收跌1.45%，恒生指数跌0.7%险守26000点，国 企指数跌0.86%。 | 名称 | | 最新价 | 涨跌额 | 涨跌幅 | | --- | --- | --- | --- | --- | | 恒生科技指数 | | 6167.06 | -90.85 | -1.45% | | 800700 | Marrow | | | | | 国企指数 | | 9290.34 | -80.39 | -0.86% | | 800100 | Municipan | | | | | 恒生指数 | | 26159.12 | -185.02 | -0.70% | | 800000 | Manrow | | | C 簡容口 | | 行业热力图 v | 频流板块 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | 汽车 | 生物技术 -1.02% | 地产发展商 -1.76% | | 药品 -2.36% | | 银行 | + ...

Market Overview - Hong Kong's three major indices opened slightly higher but fell throughout the day, with the Hang Seng Index closing down 0.7% at 26,159.12 points and a total turnover of HKD 294.56 billion [1] - The Hang Seng Tech Index dropped 1.45% to 6,167.06 points, indicating weakness in the tech sector [1] Blue Chip Performance - HSBC Holdings (00005) rose 1.31% to HKD 108.6, contributing 28.6 points to the Hang Seng Index [2] - Other notable blue chips included New Oriental-S (09901) up 1.85% and CITIC Limited (00267) up 1.5%, while CSPC Pharmaceutical Group (01093) and China Biologic Products (01177) saw declines of 4.73% and 4.46%, respectively [2] Sector Highlights - Large tech stocks generally declined, with Tencent down 0.86% and Xiaomi dropping over 1%, while Alibaba saw a slight increase of 0.13% [3] - Gold stocks continued to rise, with Tongguan Gold (00340) up 6.38% as international gold prices reached new highs, with London gold hitting USD 3,759.16 per ounce [3] - Banking stocks showed resilience, with Chongqing Rural Commercial Bank (03618) up 2.94% and other banks also posting gains, reflecting improved performance expectations in the banking sector [4] Cryptocurrency Sector - Cryptocurrency-related stocks faced significant declines, with Guotai Junan International (01788) down 11.57% following regulatory actions from the China Securities Regulatory Commission [5][6] Notable Stock Movements - Yunzhihui Technology (01037) surged 103.23% after announcing a strategic partnership in humanoid robotics [7] - Different Group (06090) saw a 43.96% increase on its debut, focusing on high-end parenting products [8] - Shankai Holdings (00412) rose 22.25% after announcing a share buyback plan [9] - Liqin Resources (02245) reached a new high, up 14.29%, due to favorable cobalt export policies in the Democratic Republic of Congo [10] - China Rare Earth Holdings (03788) increased by 12.53% after announcing a share issuance to support gold mining projects [11] - Zhejiang Shibao (01057) rose 12.27% as it prepares for mass production of advanced steering technologies [12]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完 整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚賴該等內 容而引致的任何損失承擔任何責任。 （於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 自願公告 LM-2417「NaPi2b/4-1BB雙特異性抗體」完成中國I期臨床首例患者入組 中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本公 司全資附屬公司禮新醫藥科技（上海）有限公司（「禮新醫藥」）自主研發的國家1類創新藥LM-2417 「NaPi2b/4-1BB雙特異性抗體」在中國開展的I期臨床試驗已順利完成首例患者入組，標誌著這一創新 療法正式進入臨床開發階段。 NaPi2b由SLC34A2基因編碼，屬於II型鈉依賴性磷酸鹽轉運蛋白SLC34家族成員之一，在機體磷酸鹽 穩態調控中發揮重要作用。NaPi2b在高級別漿液性卵巢癌、輸卵管癌、原發性腹膜癌，以及甲狀腺 癌、乳腺癌和非鱗狀非小細胞肺癌等多種惡性腫瘤中呈高表達，而在正常組織中分佈有限，因此被 ...

Industry Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The Chinese innovative drug industry has established a trend towards global commercialization, supported by a pyramid structure of leading and quality enterprises, indicating strong sustainability in industry development [2]. - The underlying logic of the current cycle is that Chinese innovative drugs possess global competitiveness, shifting from domestic sales to international licensing and commercialization, thus opening up commercial space and maturing the ecosystem [2]. - The focus on differentiated mechanisms or high clinical value "good molecules" remains a core interest for international buyers, with early data being crucial for entering licensing windows [2]. Current Situation - The Chinese innovative drug industry is entering a phase of realization, driven by support from capital markets, policies, and talent [3]. - The industry has developed self-sustaining capabilities through business development (BD) licensing and drug commercialization [3]. - Comprehensive policy support for "true innovation" has been established, enhancing the industry's growth [3]. Future Outlook - Continued collaboration among academia, industry, and research will enhance the output of first-in-class (FIC) molecules, with China becoming one of the most efficient countries in the drug development pathway [4]. - Higher innovation levels are expected to further unlock commercial value, indicating a promising future for the industry [4]. Investment Recommendations - Focus on global blockbuster products: companies such as BeiGene, Kelun-Biotech, Innovent Biologics, and others are highlighted as key players [5]. - Attention to global best-in-class (BIC) potential companies, including EdiGene, Zai Lab, and others, is recommended [5]. - Domestic blockbuster products and asset values of companies like Hengrui Medicine and others are also suggested for consideration [5].

Group 1 - The company is covered for the first time by Guojin Securities, which gives a "buy" rating and forecasts revenue of 33.41 billion, 37.17 billion, and 41.70 billion yuan for 2025, 2026, and 2027 respectively, with year-on-year growth of +15.75%, +11.24%, and +12.21% [1] - The net profit attributable to the parent company is projected to be 4.63 billion, 4.75 billion, and 5.28 billion yuan for the same years, with year-on-year growth of +32.17%, +2.75%, and +11.17% [1] - The company has a solid position as a leading pharmaceutical player, with a steady increase in revenue and operating profit, and a significant rise in R&D investment, which accounted for 18.1% of revenue in H1 2025, up from 11.1% in 2020 [1] Group 2 - The company acquired Lixin Pharmaceutical for approximately 500 million USD, enhancing its oncology product pipeline [2] - The drug Anlotinib has been approved for 9 indications, and its combination with PD-1 has shown superior results in head-to-head trials against other treatments [2] - The company aims to license out innovative products as a key strategic goal, with promising candidates in oncology and respiratory fields, potentially generating recurring revenue from business development transactions starting in 2025 [3]

Core Viewpoint - Company is positioned as a leading player in the biopharmaceutical industry, with a strong focus on innovation and growth in revenue and profit margins [1][2][3] Group 1: Financial Projections - Company is expected to achieve revenues of 334.12 billion, 371.66 billion, and 417.04 billion CNY in 2025, 2026, and 2027 respectively, representing year-on-year growth of +15.75%, +11.24%, and +12.21% [1] - Projected net profit attributable to shareholders is 46.26 billion, 47.53 billion, and 52.84 billion CNY for the same years, with year-on-year growth of +32.17%, +2.75%, and +11.17% [1] - Earnings per share (EPS) are forecasted to be 0.25, 0.25, and 0.28 CNY for 2025, 2026, and 2027 [1] Group 2: Strategic Developments - Company has acquired Lixin Pharmaceutical for approximately 500 million USD, enhancing its oncology product pipeline [2] - The acquisition includes key products such as LM-299 and LM-305, which have been licensed to major pharmaceutical companies [2] - Anlotinib has been approved for 9 indications, showing promising results in head-to-head trials against competitors [2] Group 3: Innovation and R&D Focus - Company has significantly increased R&D investment, with 18.1% of revenue allocated to R&D in the first half of 2025, up from 11.1% in 2020 [1] - The number of approved innovative products has reached 19, with innovative product revenue accounting for 44.4% of total revenue in the first half of 2025 [1] - Company aims to leverage its innovative products, such as CDK2/4/6 inhibitors and HER2 bispecific antibodies, to establish a competitive edge in the international market [3]

Market Overview - A-shares opened higher on September 23 but subsequently declined, with major indices experiencing varying degrees of drop, notably the North Securities 50 Index down by 3.05% and the Shanghai Composite Index down by 1.23%, falling below the 3800-point mark [2] - The banking sector showed resilience, being one of the few sectors to rise, with notable gains from Nanjing Bank and Xiamen Bank, and Agricultural Bank and Construction Bank both increasing by over 3% [2] New Stock Performance - The newly listed stock YouSheng Co. saw a significant surge, with its price increasing by over 90% during the morning session [3] - YouSheng Co. specializes in the design, development, production, sales, and service of aluminum alloy automotive components, focusing on lightweight parts for electric vehicles and contributing to energy efficiency in fuel vehicles [3] - The company has established long-term partnerships with leading electric vehicle manufacturers such as Tesla, GAC Group, NIO, BAIC New Energy, Geely Group, and Seres [3] Hong Kong Market Dynamics - The Hong Kong market also experienced a downturn, with the Hang Seng Index dropping over 1% [4] - Cloud Wisdom Technology saw its stock price soar, with an increase of over 120% in the morning session, following a previous rise of 133.96%, resulting in a total price increase of over four times within two trading days [4] - The surge was attributed to a memorandum of understanding for potential strategic cooperation in humanoid robotics with UBTECH Robotics, focusing on global sales, marketing, and after-sales service [4][5]

Group 1 - The Hong Kong stock market for innovative drugs is experiencing a correction, with the Hong Kong Stock Connect Innovative Drug ETF (520880) opening high but closing down 1.74%, with a trading volume exceeding 1.4 billion yuan [1] - Major constituent stocks are declining, with Yimeng Biotech-B down over 7%, China National Pharmaceutical Group down over 4%, and CSPC Pharmaceutical Group down over 3% [1] Group 2 - The Chief Executive of the Hong Kong SAR proposed the establishment of a "Greater Bay Area Clinical Trial Collaboration Platform" and a "Real-World Research and Application Center" to accelerate the approval and commercialization of innovative drugs [3] - The National Medical Products Administration announced an optimized clinical trial review and approval process, with eligible applications to be completed within 30 working days [3] Group 3 - Despite short-term market fluctuations, the long-term logic of the innovative drug industry remains strong, transitioning from quantity to quality, with a focus on profitable products and companies by 2025 [4] - The industry is witnessing a recovery in demand, continuous supply-side clearing, and a trend towards domestic substitution, with mergers and acquisitions helping companies grow stronger [4] - The innovative drug sector's sustainability is supported by ongoing trends of "innovation + internationalization," enhancing China's global competitiveness in innovative drugs [4] Group 4 - The Hong Kong Stock Connect Innovative Drug ETF (520880) is the first ETF tracking the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, focusing 100% on innovative drug research and development [5]