Key Takeaways from China Biopharma Trip Industry Overview - The trip focused on the Chinese biopharmaceutical industry, highlighting the rapid development of local biotech companies and their competitive landscape in drug discovery and clinical R&D [3][5][9]. Core Insights 1. **Rapid Development of Biotech Companies**: Local Chinese biotech firms have shown a remarkable pace of development, with examples like Pyrotech achieving clinical proof-of-concept in 4 years and Hengrui progressing from preclinical studies to IND acceptance in 6 months [3]. 2. **Factors Driving Speed**: Key factors contributing to this accelerated development include streamlined decision-making, a concentrated ecosystem of contract research organizations (CROs), strong fundamental research, and experienced clinical investigators [3]. 3. **Licensing and Partnerships**: Chinese biotech companies generally prefer licensing out their products, but more mature firms are increasingly seeking co-development and co-commercialization agreements, as seen with Innovent's partnership with Takeda [4]. 4. **Pipeline Diversity**: Companies visited exhibited broad pipelines across multiple disease areas, with a notable focus on antibody-drug conjugates (ADCs) and a competitive landscape characterized by intense pressure [5]. 5. **Obesity Market Developments**: Eccogene is optimistic about its obesity drug ECC5004, while Innovent noted rapid uptake of mazdutide, indicating strong competition in the obesity segment [7]. 6. **Vaccine Market Challenges**: Zhifei highlighted ongoing challenges in the vaccine market due to vaccine hesitancy and pricing pressures, complicating commercialization efforts [8]. Competitive Landscape 1. **ADC Focus**: Nearly half of the companies visited are engaged in ADC research, particularly in oncology, indicating China's emergence as an ADC hub [5]. 2. **Emerging Therapies**: Companies are exploring bispecific/trispecific antibodies and new-generation cell therapies, with a focus on innovative approaches to cancer treatment [5][31]. 3. **Market Dynamics**: The Chinese pharmaceutical market is valued at $160-180 billion, with the innovative market growing at 20-30% annually, expected to reach $50-60 billion in five years [23]. Company-Specific Highlights 1. **3SBio and Pfizer**: 3SBio expressed optimism regarding its PD-1xVEGF bispecific antibody program, with plans for multiple trials to establish the compound as a backbone therapy [9]. 2. **Kelun Biotech**: Kelun is advancing its TROP2 targeting ADC, sac-TMT, with expectations of significant peak sales based on recent clinical data [10]. 3. **Hengrui's Lp(a) Program**: Hengrui is encouraged by Phase 2 data for its Lp(a) targeted oral small molecule drug, which could transform cardiovascular disease treatment [10]. 4. **Zhifei's Gardasil Challenges**: Zhifei reported difficulties in the vaccine market, particularly with Gardasil, due to pricing pressures and vaccine hesitancy [10]. Additional Observations - **Regulatory Environment**: Sanofi noted that early-stage R&D in China is 50% cheaper and 60% faster than in the US, with plans to invest more in local partnerships [23]. - **Pricing Dynamics**: The conversation with obesity experts revealed insights into pricing dynamics and the competitive landscape for obesity treatments [7]. Conclusion The trip underscored the dynamic nature of the Chinese biopharma industry, characterized by rapid innovation, strategic partnerships, and a competitive landscape that poses both opportunities and challenges for local and multinational companies [3][5][23].

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]

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(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 ...

Core Viewpoint - The MSCI China Healthcare Index has increased by 59.5% year-to-date, outperforming the MSCI China Index by 24%, but has recently experienced a correction of approximately 10% since early October, indicating that some stocks are undervalued and still attractive for investment [1] Group 1: Market Performance - The MSCI China Healthcare Index has shown a significant year-to-date increase of 59.5% [1] - This index has outperformed the MSCI China Index by 24% [1] - The healthcare sector has seen a recent correction, with a decline of about 10% since early October [1] Group 2: Investment Recommendations - The report highlights several companies with "buy" ratings, including: - 3SBio (01530) - Genscript Biotech (02273) - Junshi Biosciences (02367) - WuXi AppTec (02268) - Innovent Biologics (01801) - China Biologic Products (01177) [1] Group 3: Market Outlook - The capital market is expected to see a recovery in financing activities [1] - There is an anticipated expansion in the overseas trading scale of innovative drugs [1] - Domestic demand for innovative drug research and development is expected to rebound [1] - The U.S. entering a rate-cutting cycle may lead to a recovery in the performance of CXO companies in the second half of the year [1] - The clinical development of authorized innovative drug pipelines overseas is expected to be a significant catalyst for the innovative drug sector [1]

Core Viewpoint - The MSCI China Healthcare Index has increased by 59.5% year-to-date, outperforming the MSCI China Index by 24%, but has recently experienced a correction of approximately 10% since early October, indicating potential investment opportunities in undervalued stocks [1] Group 1: Market Performance - The MSCI China Healthcare Index has shown a significant year-to-date increase of 59.5% [1] - This index has outperformed the MSCI China Index by 24% [1] - The healthcare sector has seen a recent correction, with a decline of about 10% since early October [1] Group 2: Investment Recommendations - Certain stocks are considered undervalued and attractive, including: - 3SBio Inc. (01530) - Genscript Biotech Corporation (02273) - Junshi Biosciences (02367) - WuXi AppTec Co., Ltd. (02268) - Innovent Biologics, Inc. (01801) - China National Pharmaceutical Group (01177) - All the mentioned stocks have been given a "Buy" rating [1] Group 3: Market Outlook - The capital market is expected to see a recovery in financing activities [1] - There is an anticipated expansion in the trading scale of innovative drugs overseas [1] - Domestic demand for innovative drug research and development is expected to rebound [1] - The U.S. entering a rate-cutting cycle may lead to a recovery in the performance of CXO companies in the second half of the year [1] - The clinical development of authorized innovative drug pipelines overseas is expected to be a significant catalyst for the innovative drug sector [1]

Core Insights - Sino Biopharmaceutical Limited and Shanghai MediTrust Health Technology Group signed a strategic cooperation agreement to enhance access to innovative drugs and commercial insurance, aiming for drug-insurance integration [1][5] Company Overview - Sino Biopharm generates annual revenue of approximately RMB 30 billion and ranks 38th among the Top 50 Global Pharmaceutical Companies, with a pipeline of over 120 innovative drugs [3] - MediTrust Health focuses on transforming China's healthcare payment system, leveraging AI and data-driven solutions to improve the "diagnosis-treatment-payment" journey [7] Strategic Goals - The partnership aims to explore AI, data collaboration, and innovative payment solutions to set new benchmarks for industry coordination [4] - The collaboration aligns with the "Healthy China 2030" strategy, enhancing drug accessibility and creating a win-win ecosystem for the pharmaceutical and insurance sectors [5] Financial Impact - MediTrust Health has serviced approximately 393 million commercial health insurance policies, achieving cumulative savings of RMB 6.7 billion in out-of-pocket costs for patients [7]

Summary of Sino Biopharmaceutical (1177.HK) Conference Call Company Overview - **Company**: Sino Biopharmaceutical - **Ticker**: 1177.HK - **Industry**: Pharmaceuticals, Biotech, and Medtech Key Points Product Sales Growth - Management reported an encouraging trend in product sales growth in 3Q, showing acceleration compared to 1H25, primarily driven by new products such as gasorasib (KRAS G12C), factor Ⅶa, and meloxicam [2][3] - Earnings growth is expected to outpace topline growth due to investment gains [2] Financial Highlights - A milestone payment of **US$300 million** from Merck to LaNova has been received, which will be recorded in 2H25 after sharing **25%** with Genscript and tax deductions [2] - The company has a cost advantage of **20%-50%** lower than peers due to scale effects of large pharma [2] Regulatory and Market Considerations - For biosimilar VBP, management expressed low expectations for nationwide execution due to potential supply issues and a shift in policymakers' focus towards drug quality [2] - Smooth progress was noted in NRDL renewal negotiations for anlotinib, KRAS G12C, and PD-1 [2] Business Development Goals - The company aims to close a major licensing deal with upfront payments exceeding **US$100 million** by the end of 2025, emphasizing improved experience in business development negotiations [3] - Promising assets in the pipeline include: - **LM-108**: Potential first-in-class CCR8 mAb - **AP025 (FGF21)**: Global rights obtained from Ampsource Bio, potentially better efficacy for MASH, could be developed with GLP-1 - **PD-1/IL2**: Targeting IND in 2026 with a potentially better safety profile - **EGFR/cMET bispecific antibody**: Phase 1 clinical data readout expected in 2026 - **PD-1/CTLA-4 bispecific**: Broader therapeutic window anticipated [3] Price Target and Risks - The 12-month SOTP-based price target is **HK$6.19**, with a current price of **HK$7.12**, indicating a downside of **13.1%** [7][8] - Key downside risks include: - Broader price cuts on the generics portfolio - Delays in regulatory approvals for key products - Low returns on R&D investments due to resource allocation issues - Below-expectation ramp-up of innovative drugs [7] Market Capitalization and Financial Metrics - Market capitalization stands at **HK$134.4 billion** (approximately **US$17.3 billion**) [8] - Revenue projections for the next few years are as follows: - **2024**: **28,866.2 million RMB** - **2025E**: **33,640.4 million RMB** - **2026E**: **35,858.2 million RMB** - **2027E**: **38,682.4 million RMB** [8] Analyst Ratings - The company is rated as a "Buy" by Goldman Sachs, with a focus on its innovative pipeline and growth potential [8] Additional Considerations - The report includes disclosures regarding potential conflicts of interest due to Goldman Sachs' business relationships with the company [4][17] - Analysts emphasize the importance of considering this report as one of several factors in investment decisions [4]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 中國生物製藥有限公司 呈交日期: 2025年11月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01177 | 說明 | - | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 30,000,000,000 | HKD | | 0.025 HKD | | 750,000,000 | | 增加 / 減少 (-) | | | 0 | | | HKD | | 0 | | 本月底結存 | | 30,000,000,000 | | HKD | | 0.025 HKD | | 750,000,000 | 本月底法定/註冊股本總額： ...

Core Insights - The 12th China Healthcare Summit, co-hosted by BioCentury and BayHelix, highlighted the significant acquisition of Lixian Pharmaceutical by China National Pharmaceutical for approximately $1 billion, earning the "Company of the Year" award for 2025 [1][2] - The summit showcased the record-breaking foreign licensing deals in China's innovative drug sector, surpassing $100 billion for the first time in a single year, reflecting the growing maturity of China's biopharmaceutical technology [1] Group 1: Acquisition Highlights - The acquisition of Lixian Pharmaceutical by China National Pharmaceutical is noted as a rare instance of a domestic company acquiring a local innovator within China's evolving biotech ecosystem [2] - This deal grants China National Pharmaceutical access to eight clinical projects, including a dual-target PD-1x VEGF antibody, which has already attracted significant global interest [2][3] - The acquisition is viewed as a milestone in the history of China's biopharmaceutical development, marking a key sign of the industry's maturation and upgrade [2] Group 2: R&D Progress - Following the acquisition, Lixian Pharmaceutical has accelerated its R&D progress, with two indications for the new drug LM-302 (CLDN18.2ADC) included in the breakthrough therapy category by the National Medical Products Administration [3] - The dual-target antibody LM-24C5 has received approval to commence Phase II clinical trials for advanced solid tumors, while the ADC drug LM-350 has successfully completed patient enrollment in a Phase I trial in Australia [3]