从全球研发的追随者，到新治疗格局的开创者，中国创新药正在完成一场深刻的蜕变。如今，中国创新 药管线与上市新药数量已占据全球总量的三分之一。巨变背后，是一批以长期主义为信仰、坚持创新的 本土生物医药企业。 康方生物正是这样的企业代表。它的故事，记录的不仅是一家企业的成长，更是中国创新药如何以技术 定力、战略耐性与全球视野，最终在全球前沿刻下中国坐标。在其不断向上攀登的历程中，广州不仅是 一个站点，更是支撑其快速产业化、链接临床资源、贯通创新链条的关键土壤。 01/ 双抗锋芒十年亮剑 2012年，夏瑜与几位同样拥有海外工作经历的好友，共同在广东中山创立了康方生物。当时，中国的创 新药产业正处于萌芽阶段。 两年之后，全球首个PD-1抑制剂上市。也正是在这一时期前后，海内外大量生物医药企业将研发力量 投入到PD-1领域。然而，初来乍到的康方生物却将目光聚焦在了当时少有人涉足的肿瘤免疫下一代产 品赛道——双抗，并在公司成立初期，就投入了巨大资源打造端对端全方位的药物开发平台（ACE）和 双特异性抗体开发技术平台（TETRABODY）技术。 这是一个技术上充满挑战的决定。与单靶点的PD-1不同的是，双抗药物是"一药双靶" ...

康方生物科学家正在进行细胞工艺实验。 受访者供图 从全球研发的追随者，到新治疗格局的开创者，中国创新药正在完成一场深刻的蝶变。如今，管线与上 市新药数量已占据全球总量的三分之一。巨变背后，是一批以长期主义为信仰、坚持创新的本土生物医 药企业。 康方生物正是这样的企业代表。它的故事，记录的不仅是一家企业的成长，更是中国创新药如何以技术 定力、战略耐性与全球视野，最终在全球前沿刻下中国坐标。在其不断向上攀登的历程中，广州不仅是 一个站点，更是支撑其快速产业化、连接临床资源、贯通创新链条的关键土壤。 战略 双抗锋芒 十年亮剑 2012年，夏瑜与几位同样拥有海外工作经历的好友，共同在广东中山创立了康方生物。当时，中国的创 新药产业正处于萌芽阶段。 两年之后，全球首个PD-1抑制剂上市。初来乍到的康方生物却将目光聚焦在了当时少有人涉足的肿瘤 免疫下一代产品赛道——双抗，并在公司成立初期，就投入了巨大资源打造端对端全方位的药物开发平 台(ACE)和双特异性抗体开发技术平台(TETRABODY)技术。 这是一个技术上充满挑战的决定。与单靶点的PD-1不同的是，双抗药物是"一药双靶"，在分子设计、稳 定性和生产工艺上的复杂度 ...

Core Viewpoint - The company has decided to delay the global offering and listing of its H-shares due to market conditions, with a commitment to timely information disclosure regarding future developments [1] Group 1: Financial Performance and Collaborations - The significant increase in net profit for 2024 is primarily attributed to a major licensing collaboration with BMS, raising concerns about the sustainability of long-term profitability due to potential "one-time revenue" perceptions [1] - The company has received an upfront payment of $800 million from BMS, which is non-refundable and non-offsettable, with actual amounts subject to bank fees [1] - The company is eligible for additional payments of up to $250 million for recent or contingent milestones, and up to $7.1 billion for achieving specific development, registration, and sales milestones [1] Group 2: Clinical Development Pipeline - The company has successfully developed three core clinical assets in Phase III (iza-bren, T-Bren, and SI-B001) and 14 early-stage core clinical assets, including 8 ADC drugs and 4 GNC drugs [2] - Over 90 clinical trials are being conducted globally, with more than 80 trials in China and 10 in the United States [2] Group 3: Specific Drug Developments - Iza-bren is a first-in-class dual-target ADC that has initiated over 40 clinical trials for more than 10 types of tumors, with significant trials ongoing in both the U.S. and China [3] - T-Bren is an innovative ADC targeting HER2, currently undergoing 14 clinical trials, including 5 Phase III trials, demonstrating significant anti-tumor efficacy [4]

Core Insights - T cell engagers (TCEs) are gaining popularity among multinational corporations (MNCs) as a promising direction in immunotherapy, comparable to the previous surge in antibody-drug conjugates (ADCs) [1][4] - TCEs activate T cells to target tumor cells, offering advantages in convenience, accessibility, and production costs over personalized CAR-T therapies [1][4] - The TCE market is projected to grow significantly, from $400 million in 2020 to $30 billion by 2024, and reaching $110.1 billion by 2034 [4] Group 1: Market Dynamics - TCEs have achieved breakthroughs in hematological malignancies, with nine TCEs approved for various blood cancer indications by July 2025, contributing to a market exceeding $10 billion [4] - The development of TCEs for solid tumors is progressing, with innovative drugs like Amgen's Tarlatamab showing promising results [4][5] - TCEs are also being explored for autoimmune diseases, with early data indicating potential efficacy in conditions like rheumatoid arthritis [5] Group 2: Competitive Landscape - Over 150 TCE pipelines are currently in development in China, with a focus on key target combinations such as CD3/BCMA and CD3/CD19, aligning with global trends [6][29] - Companies like Vailizhi Bio and Kangnuo are making significant strides in TCE development, with comprehensive strategies covering hematological, solid tumors, and autoimmune diseases [8][11] - The competitive landscape is characterized by diverse strategies, with companies leveraging unique platforms and technologies to differentiate their offerings [20][23] Group 3: Company Strategies - Vailizhi Bio has adopted a three-dimensional strategy focusing on hematological cancers, solid tumors, and autoimmune diseases, supported by its LeadsBody platform [8][9] - Kangnuo's strategy involves extensive overseas licensing of its TCE assets, which may impact its long-term pipeline strength [11][13] - Shimai Pharmaceutical is addressing the challenges of solid tumor treatment through innovative platforms, aiming to establish itself as a leader in the TCE space [21][23] Group 4: Future Outlook - The TCE sector is expected to continue evolving, with a focus on overcoming technical challenges such as tumor microenvironment penetration and long-term safety validation [29] - The integration of TCEs with other therapies, such as ADCs and PD-1 inhibitors, is seen as essential for achieving competitive advantages in the market [29]

Core Viewpoint - The article discusses recent developments in the pharmaceutical industry, particularly focusing on new drug applications and innovations in cancer treatment, highlighting the competitive landscape and market potential for various companies involved in drug development [5][12][20]. Group 1: New Drug Applications - From May 24 to May 30, the National Medical Products Administration received applications for 9 new chemical drugs and biological products from 6 listed companies [5]. - Companies such as Heng Rui Medicine, Hansoh Pharmaceutical, and Kangfang Biotech each submitted 2 clinical applications, while others like Canaan and Bai Jie Shen Zhou submitted 1 application each [6]. Group 2: Key Innovations in Cancer Treatment - Kangning Jereh's KN035, a subcutaneous PD-L1 inhibitor, has been submitted for clinical trials, potentially becoming the first of its kind globally. It targets multiple indications, with 3 applications already submitted and 7 ongoing clinical studies [12][13]. - KN035 offers advantages over traditional intravenous methods, including better patient compliance and reduced costs, which could enhance its market share [13]. - The competitive landscape includes existing PD-L1 inhibitors like Merck's Atezolizumab and AstraZeneca's Durvalumab, with KN035 targeting different cancer types [14]. Group 3: Dual Antibody Developments - Kangfang Biotech's AK104, a PD-1/CTLA-4 dual-specific antibody, has received approval for clinical trials, with 13 indications currently in phase II trials [17]. - The dual antibody approach is gaining traction due to the limitations of existing PD-1/L1 therapies, which have low efficacy rates in solid tumors [18]. - The market for dual antibodies is expected to grow significantly, with 217 candidates in various clinical stages globally [19]. Group 4: COVID-19 Vaccine Developments - CanSino's inhaled COVID-19 vaccine is in phase II trials and is applying for emergency use, which could enhance public acceptance due to its non-invasive administration method [20][21]. - Sinovac has expanded the emergency use of its vaccine to children aged 3 and above, with positive safety and efficacy results from clinical trials [24][25].

Investment Rating - The industry investment rating is "Strong Outperform" [2] Core Insights - The report emphasizes the potential of TSLP-targeted bispecific antibodies in addressing unmet needs in the autoimmune sector, particularly in asthma and atopic dermatitis [4][6] - The success of Dupilumab (Dupi) illustrates the demand for long-acting, multi-indication therapies in a market characterized by high patient numbers and chronic conditions [5][15] - The report identifies a significant market opportunity driven by high disease prevalence and the need for new therapeutic options [5][15] Summary by Sections High Disease Prevalence Creates Market Opportunities - The report highlights the large patient populations for conditions like asthma and atopic dermatitis, with millions affected, indicating a substantial market for new treatments [14][15] - Existing therapies have unmet needs, particularly in terms of long-acting formulations and improved efficacy [18][19] Focus on Bispecific Antibodies - The report suggests prioritizing bispecific antibodies that target TSLP and IL-13, as they have shown clinical promise in enhancing efficacy and expanding patient populations [6][22] - Companies such as 康诺亚, 信达生物, 荃信生物, and 联邦制药 are identified as key players in this space [6] Respiratory Diseases and Bispecific Antibodies - In the respiratory disease sector, particularly asthma and COPD, the report notes the need for long-term management and the potential of bispecific antibodies to address this challenge [25][37] - The market for asthma biologics is projected to reach approximately $7.5 billion by 2023, with significant growth expected [25][28] Clinical Data and Efficacy - The report discusses the clinical efficacy of various biologics, noting that Dupilumab and Tezepelumab have shown significant improvements in asthma control and quality of life [34][35] - The combination of TSLP and IL-4R is highlighted as a promising therapeutic strategy, with early clinical data supporting its potential [37][47]

Summary of the Conference Call for Sanofi Pharmaceutical Company Overview - **Company**: Sanofi Pharmaceutical - **Date**: September 25, 2025 - **Industry**: Pharmaceutical, specifically oncology and biopharmaceuticals Key Points and Arguments Clinical Research and Product Development - Sanofi's CFL2 platform is conducting 4 domestic Phase 2/3 clinical studies covering various cancer indications, including non-small cell lung cancer (NSCLC) [2][3] - The Phase 3 clinical trial for first-line NSCLC is benchmarked against PD-1 K, indicating active exploration in tumor treatment [2][3] - The company has achieved a collaboration agreement with Pfizer worth $60.5 billion, along with a $100 million investment, highlighting global recognition of its innovation capabilities and international product potential [2][3] - The PD-1 VEGF dual antibody drug 707 has set a domestic record for licensing amounts [2] Financial Performance - Revenue growth from 5.3 billion RMB in 2019 to 9.1 billion RMB in 2024, with a compound annual growth rate (CAGR) of 11% [2][6] - Gross margin remains stable at over 80%, with 2024 gross profit projected to reach 7.8 billion RMB [6] - The core product, TEBIO, is the only commercialized TPO product globally, generating over 5 billion RMB annually and maintaining a strong market position [2][5] Market Trends and Competitive Landscape - The global interest in PD-L1 VEGF dual antibodies is increasing, with companies like Summit, Kanyin, BMS, and Merck showing significant engagement in this area [4][9] - Sanofi is advancing multiple innovative pipelines, including PD1 and HER2 dual antibodies, with projected revenues reaching 10 billion, 11 billion, and 12.2 billion RMB in the coming years [4][13] Product Performance - TEBIO's revenue increased from 2.3 billion RMB in 2019 to 5 billion RMB in 2024, with a market share of approximately 30% in the platelet production market [12] - The hair growth product, Mandi, has maintained rapid growth, with a market share exceeding 70% and revenue projected to rise from 250 million RMB in 2019 to 1.35 billion RMB in 2024 [12] - New products, including Claretone cream for acne and oral paclitaxel, are expected to enter commercialization, with peak sales potential estimated at 10 billion RMB [5][14] Future Outlook - Sanofi's future development potential is significant, with validated innovative assets and a solid market position for core products [13] - The company is actively pursuing multiple innovative pipelines, which are in various clinical stages, expected to yield outstanding data and drive growth [13] - The internal business is projected to generate revenues of 10 billion, 11 billion, and 12.2 billion RMB in the next few years, maintaining a buy rating [13] Additional Products and Market Contributions - Other products like EPO and Yisai Psaipin are contributing to revenue, with several in late-stage clinical or approval phases [14] - The introduction of Semaglutide for weight management will further enrich the product line [14] Conclusion Sanofi Pharmaceutical demonstrates strong growth potential through its innovative drug development, solid financial performance, and strategic collaborations, positioning itself favorably in the competitive pharmaceutical landscape.

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HB0043 in the United States, marking a significant advancement in the treatment of autoimmune diseases [1] Group 1: Product Development - HB0043 is a recombinant humanized IgG1 bispecific antibody targeting both IL-17A and IL-36R, demonstrating high binding and blocking activity [1] - The drug is developed for treating various difficult-to-treat autoimmune diseases, showing stronger efficacy than monoclonal antibodies in animal models for conditions like atopic dermatitis, idiopathic pulmonary fibrosis, diabetic nephropathy, and neutrophilic asthma [1] - HB0043 is the world's first bispecific antibody targeting IL-17A and IL-36R, potentially overcoming the limitations of existing single-target therapies [1] Group 2: Market Potential - Current IL-17A inhibitors and IL-36R monoclonal antibodies have shown positive effects in multiple indications, but their single-dimensional intervention may still be insufficient for some patients [1] - HB0043's innovative dual-target approach is expected to be widely applicable in various Th17 and IL-36 related immune-mediated diseases, showcasing a first-in-class advantage with broad potential [1]

Investment Rating - The report indicates a positive outlook for the atopic dermatitis (AD) market, highlighting significant unmet medical needs and potential for new therapies, particularly in small molecules and biologics [4][10][12]. Core Insights - Atopic dermatitis is a chronic, recurrent inflammatory skin disease characterized by severe itching, affecting approximately 600-700 million patients globally, with around 67 million in China, indicating a substantial unmet demand for effective treatments [1][18][20]. - Recent advancements in small molecules and biologics have marked a new phase in AD treatment, with several new products entering the market, although the number remains limited [1][10][32]. - JAK inhibitors have shown excellent efficacy but come with safety concerns, while TYK2 inhibitors are emerging as a promising new option due to their selective action and potentially better safety profile [2][11][12]. - Biologics targeting IL-4Rα and IL-13 have demonstrated significant efficacy in improving skin lesions, with IL-31 showing strong itch relief capabilities [3][12][13]. - The development of dual/multi-target antibodies is seen as a new strategy to enhance treatment efficacy by combining the advantages of different targets [4][13][21]. Summary by Sections Investment Highlights - The AD market has immense potential, with a pressing need for effective therapies [4][10]. - The patient population is large, with over 600 million affected globally, necessitating urgent treatment options [1][18]. Disease Characteristics - AD is characterized by chronic inflammation and severe itching, significantly impacting patients' daily lives [1][14]. - The disease burden is heavy, with a complex pathogenesis involving multiple factors, primarily driven by Th2-type inflammation [21][24]. Current Treatment Landscape - Traditional therapies have safety concerns, leading to a shift towards biologics and small molecules [32][35]. - JAK inhibitors are the most approved class of drugs for AD, but they carry black box warnings due to safety issues [11][12]. - Emerging therapies, particularly TYK2 inhibitors, show promise for better safety and efficacy [2][11]. Biologics and Emerging Therapies - Currently approved biologics include IL-4Rα, IL-13, TSLP, and IL-31, with ongoing research into additional targets [3][12][13]. - Dual/multi-target antibodies are being explored to improve treatment outcomes and extend dosing intervals [4][13][21]. Market Potential - The report emphasizes the significant market potential for AD treatments, with projected growth driven by increasing patient numbers and the introduction of innovative therapies [4][10][20].

Core Viewpoint - Company maintains a "buy" rating for Kangfang Biopharma, projecting revenue growth from 34.19 billion to 85.77 billion CNY from 2025 to 2027, supported by strong commercialization and clear overseas clinical data [1] Group 1: Financial Performance - In H1 2025, Kangfang Biopharma achieved revenue of 14.12 billion CNY, a year-on-year increase of 37.75%, with product sales revenue reaching 14.01 billion CNY, up 49.20% [2] - R&D expenses were 7.31 billion CNY, increasing by 23.06%, while sales and management expenses rose by 29.84% and 34.00%, respectively [1] Group 2: Product Development and Clinical Trials - The commercialization of core dual antibodies, Kadunil and Ivosidenib, is driving revenue growth, with expectations for further performance increases as new products and indications are approved [2] - Ivosidenib's OS data presented at the WCLC 2025 showed significant improvement, with an OSHR of 0.70 in the North American population, indicating a strong survival benefit [2][3] - Ongoing clinical trials for Ivosidenib include various cancer types, with a focus on expanding indications, which could enhance its market potential [3]