自2024年下半年以来，TCE（T细胞衔接器，T cell-engager）逐渐成为MNC的BD心头好。诸多重磅TCE交易相继授出，出海盛况丝毫不逊于当年的ADC技 术。 所谓TCE是一种特殊双抗，一端（或两端）连接TAA（肿瘤相关抗原）定位肿瘤细胞，另一端连接T细胞的CD3表位，激活T细胞，发挥T细胞的肿瘤杀伤 作用。相比ADC用细胞毒素杀伤，TCE双抗本质是激活T细胞的免疫疗法，对靶点表达量要求更低、但肿瘤特异性要求更高。 与个性化、定制化的CAR-T疗法相比，"现货"型TCE双抗在便利性、可及性和生产成本上都具备优势。因此，我们看到，TCE双抗正在作为下一代免疫治 疗的核心方向重构肿瘤与自免疾病治疗格局。 这一潜力赛道中，国内药企百花齐放，进入规模化竞争阶段，形成差异化竞争梯队，既有技术平台驱动的管线深耕，也有全球化BD合作的价值释放。 一场技术革新风暴即将到来，谁会从众多参与者中杀出重围？这一过程中又会否诞生中国创新药的新王呢？ 01 TCE为何起风？ 过去的几十年中，治疗性抗体早已成为肿瘤治疗的关键组成部分，显著提高了疗效。如曲妥珠单抗治疗晚期HER2阳性乳腺癌，利妥昔单抗治疗B细胞淋 巴瘤。然而， ...

每经记者｜陈星 实习生 林姿辰 每经编辑｜魏官红 . . ● 下注射P KI "康氏兒貞 0.000 • ● ● 。 0 。 · ● . . 'e ● . in ● 0 o o : o . . 0° .' · . 。 C 0 . . . . o C :00 l 'es o. · · .. .. ● 0 《掘金创新药》由每日经济新闻联合丁香园Insight数据库共同推出，旨在解读新药研发进展与趋势，剖析产品竞争力与市场前景，洞察医药资本脉络，见证 医药产业高质量发展。 根据丁香园Insight数据库统计，5月24日到5月30日，国家药品监督管理局药品审评中心共收到6家上市公司提交的9个化学新药、生物制品新药申请。 一周新药申请 本周，恒瑞医药（600276.SH）、翰森制药（03692.HK）、康方生物-B（09926.HK）各申报2个临床申请；康宁杰瑞制药-B（09966.HK）、海思科 （002653.SZ）和百济神州（06160.HK）各递交1个临床申请。 注射用 化学药物 HR18034 HSK16149 化学药物 胶囊 HS-10376 化学药物 片 治疗用 AK109 注射液 生物制品 注射用 化学 ...

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]

Core Insights - The global multi-center phase III clinical study HARMONi for AK112 (Evosinib) has successfully met its primary endpoint of progression-free survival (PFS) [1][2] - Evosinib is the world's first PD-1/VEGF dual antibody, showing potential to replace Merck's PD-1 drug, Pembrolizumab, based on its superior PFS results in previous studies [1][2] - The study included 438 patients, with a significant portion (38%) from North America and Europe, indicating a diverse patient demographic [2] Group 1 - The HARMONi study demonstrated a statistically significant improvement in PFS with a hazard ratio (HR) of 0.52, while the overall survival (OS) showed a positive trend but did not reach statistical significance with an HR of 0.79 (p=0.057) [2] - The updated data from Summit Therapeutics revealed an improved OS HR of 0.78 (95% CI: 0.62–0.98, p=0.0332) after a median follow-up of 13.7 months, indicating a notable enhancement in survival outcomes [3] - The results from the international HARMONi study align with the domestic HARMONi-A study, showcasing consistent clinical performance in both PFS and OS, highlighting Evosinib's global market potential [4] Group 2 - The chairman of the company expressed strong confidence in AK112 despite the stock price fluctuations, emphasizing the importance of clinical validation in the development of dual antibodies [2][3] - The study's findings underscore the therapeutic advantages of Evosinib, including rapid efficacy and effective disease control, as well as a favorable immune therapy tail effect [4] - The data from the North American cohort showed significant survival benefits, with the control group having a median OS of 14.0 months and an HR of 0.70, further supporting the drug's efficacy [3]

Core Viewpoint - CICC maintains the profit forecast for Kangfang Biopharma (09926) for 2025 and 2026, reiterating an outperform rating and raising the target price by 87.5% to HKD 225.00, indicating a 33.1% upside potential [1] Group 1: Financial Performance - The company's 1H25 revenue reached CNY 1.412 billion, representing a year-on-year growth of 37.75%, aligning with CICC's expectations [1] - The sales revenue of core products in 1H25 was CNY 1.402 billion, with a year-on-year increase of 49.2%, and a gross margin of 79.25%. The sales and marketing expense ratio decreased by 7.1 percentage points year-on-year to 47.80% [2] Group 2: Product Development and Clinical Trials - The final analysis of the HARMONi-A trial demonstrated statistically significant overall survival (OS) benefits for AK112 in treating 2L EGFRm NSCLC, with an OS hazard ratio of 0.80 and a maturity of 52%. This result highlights AK112's potential to significantly improve patient survival in a market with unmet clinical needs [3] - AK112 has 13 ongoing registration/Phase III clinical trials globally, covering indications beyond lung cancer. In the lung cancer domain, it has 8 registration/Phase III studies, with 4 achieving clinical endpoints. Additional trials are underway for various cancers, including biliary cancer and triple-negative breast cancer [4]

Group 1 - The innovative drug market in China is experiencing a surge, with the total amount of License out transactions for innovative drugs expected to reach nearly $66 billion by the first half of 2025, surpassing the total BD transaction amount for 2024 [1] - The immune system drug market is the second largest prescription drug market globally, with an increasing proportion of BD transactions. The share of tumor pipeline overseas licensing transactions decreased from 72% in 2023 to 61% in 2024, while the share of metabolic and autoimmune drugs increased from 12% to 25% [1][2] - The autoimmune disease market is gaining attention due to its large unmet medical needs, with the global treatment market projected to reach $119.35 billion by 2027 [2] Group 2 - The immune drug market has evolved since the introduction of TNFα inhibitors, with new targets emerging, including interleukin classes and JAK/Tyk2 inhibitors. The competition in clinical and commercial stages is intensifying, with a focus on precision treatment [5][7] - Bispecific antibody drugs are gaining traction in the treatment of autoimmune diseases, offering the ability to target two different antigens simultaneously, which may lead to more effective disease management [7][8] - The first bispecific antibody drugs in the autoimmune field are expected to create a new wave of growth, with companies like 康诺亚 leading the development [23] Group 3 - 康诺亚's core product, CM310, is the first domestically approved IL-4Rα antibody drug, with significant market potential in treating various allergic diseases. Its success in entering the medical insurance negotiation at the end of the year is crucial for its market performance [13][16] - The company has a strong pipeline in the autoimmune field, with CM310 expected to generate substantial sales, potentially reaching 5 billion yuan by 2030 [23] - 康诺亚 is also advancing in the oncology sector with its ADC drug CMG901, which is in the lead for clinical development among competitors [19][23] Group 4 - 康诺亚 has successfully engaged in multiple NewCo agreements, indicating its potential for international expansion and valuation growth in the innovative drug sector [22] - The NewCo model provides a favorable environment for domestic biotech companies, allowing them to secure cash flow and mitigate risks while advancing their research and clinical trials [22] - The recent licensing deal with GSK, which includes a $500 million upfront payment and up to $12 billion in milestone payments, highlights 康诺亚's strong position in the market [12]