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]

文 | vb动脉网 中国医药创新能力正受到全球认可。 国际顶级咨询公司麦肯锡和BCG（波士顿咨询）近期发布的报告中，罕见的将中国医药创新纳入探讨 范畴，用多个维度的数据佐证了中国创新药在各个领域的崛起，并对国内医药产业的创新成色给予肯 定。 此外，由权威生物技术媒体Fierce Biotech每年发布的，旨在评选出当年在生物技术领域最具创新力和发 展潜力的15家新锐公司的"Fierce 15"榜单，普遍被认为是行业创新风向标。可在2025年榜单中，如果按 靶点和适应症来看，大多数入选企业的核心管线国内都有相应对标的企业，这也进一步凸显国内创新的 前瞻性。 | | | | Fierce Biotech Top15 | | | | | 国内对标 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 企业 | Page | | 管线 | | 适应维 | 乾成 | 金星 双城生物 | 管线 MW C01 | 适应接 爱佳财剧 | | | A.119 4.4 25 | 10 0 rust | | | | | | MW-C02 | 意性肿瘤 ...

Core Insights - The article highlights the resurgence of US dollar funds in the Chinese innovative drug market, with significant investments and licensing deals indicating a renewed interest in this sector [1][4][5]. Group 1: Investment Trends - In 2025, Heng Rui Medicine completed a licensing agreement with Braveheart Bio for the HRS-1893 project, with an upfront payment of $65 million and a total deal value of up to $1.013 billion, marking the fourth business development (BD) deal for Heng Rui this year, totaling over $15 billion [1]. - In the first half of 2025, the total value of outbound licensing deals for Chinese innovative drugs reached $48.448 billion, nearing the total for the entire year of 2024, with over 80% of these deals involving US dollar funds [4]. - The return of US dollar funds to the Chinese innovative drug market is characterized by a shift from direct investments to more strategic BD transactions, focusing on specific drug pipelines and products rather than entire companies [13][14]. Group 2: Market Dynamics - The article notes that from 2024 to 2030, major pharmaceutical companies in the US and Europe will face a revenue gap of approximately $360 billion due to patent expirations, prompting them to seek acquisitions in the Chinese innovative drug sector to fill this void [9]. - The quality of Chinese innovative drugs has significantly improved, with over 1,250 new drugs entering the research phase in 2024, closely approaching the number in the US [11]. - The competitive landscape has intensified, with not only US dollar funds but also European, Middle Eastern, and East Asian capital increasingly targeting Chinese innovative drug assets, leading to heightened competition for quality investments [12]. Group 3: Strategic Shifts - US dollar funds are transitioning from a broad investment strategy to a more focused approach, emphasizing "certainty first" in their investment decisions, which includes a preference for assets with clear international market potential [13][14]. - The NewCo model is gaining traction, allowing for deeper collaboration between US dollar funds and Chinese innovative drug companies, sharing risks and benefits more equitably [15][16]. - The article suggests that the current environment presents a strategic opportunity for Chinese innovative drug companies to leverage US dollar fund investments while maintaining a focus on original innovation and enhancing the value of their drug pipelines [23][24].

Core Viewpoint - 康诺亚-B (02162) has initiated its first Phase III clinical trial for the dual antibody drug CM336, which aims to treat relapsed or refractory multiple myeloma (R/R MM) patients who have previously undergone at least two lines of treatment [1] Group 1: Company Developments - 康诺亚's stock price increased by over 5% during trading, currently reported at 74.80 HKD with a trading volume of 89.07 million HKD [1] - The Phase III trial for CM336 is a randomized, open-label, multi-center study involving 280 patients [1] - The primary endpoint of the study is progression-free survival (PFS) [1] Group 2: Clinical Trial Background - CM336 has previously completed a Phase I/II study for R/R MM, where 23 patients were evaluated for efficacy [1] - In the dose escalation cohort, the objective response rates (ORR) for the ≤5mg, 20-40mg, and 80-160mg groups were 17%, 71%, and 80% respectively [1] - The rates of stringent complete response or complete response in these groups were 17%, 71%, and 60% respectively [1]

Core Viewpoint - Connaissance-B (02162) has initiated its first Phase III clinical trial for CM336, a dual antibody drug, which has led to a significant increase in its stock price, reflecting positive market sentiment towards the company's progress in drug development [1] Company Summary - Connaissance-B's stock price rose over 5% during trading, closing at 75.4 HKD with a trading volume of 87.53 million HKD [1] - The Phase III trial for CM336 is a randomized, open-label, multi-center study involving 280 patients, aimed at evaluating the drug's efficacy and safety in treating relapsed or refractory multiple myeloma (R/R MM) patients who have previously undergone at least two lines of treatment [1] - The primary endpoint of the study is progression-free survival (PFS) [1] Clinical Trial Summary - CM336 has previously completed a Phase I/II study for R/R MM, where 23 patients were evaluated for efficacy [1] - Results from the earlier study indicated that at a median follow-up of 12.1 months, the objective response rates (ORR) for the ≤5 mg, 20-40 mg, and 80-160 mg groups were 17%, 71%, and 80% respectively [1] - The rates of strict complete response or complete response among patients in these groups were 17%, 71%, and 60% respectively [1]

Core Viewpoint - The company reported a significant increase in revenue for the first half of 2025, with a total income of 499 million yuan, representing a year-on-year growth of 812%, while the loss narrowed to 78.79 million yuan, a decrease of 77% compared to the previous year [1] Group 1: Financial Performance - The company's cash and cash equivalents reached 2.796 billion yuan, reflecting a 30% increase [1] - Revenue from the core pipeline product, Supqi Baidankang (IL-4Rα antibody), for three adult indications was approximately 169 million yuan in the first half of 2025 [1] Group 2: Product Development and Market Position - Supqi Baidankang has received approval for three adult indications: moderate to severe atopic dermatitis (AD), chronic rhinosinusitis with nasal polyps (CRSwNP), and seasonal allergic rhinitis (SAR), with approvals expected in September and December 2024, and January 2025 respectively [2] - The company is the first in China and one of only two globally to have an approved IL-4Rα antibody, which positions it favorably in the competitive landscape [2] - The company’s injection pen is under review, with expectations for new drug application (NDA) for adolescent moderate to severe AD and nodular prurigo in the first half of 2026, further expanding its market reach [2] Group 3: Pipeline and Future Prospects - The company has multiple products approaching commercialization, with a rich pipeline that supports long-term growth [2] - In the oncology field, CM336, the first BCMA/CD3 bispecific antibody in China, is expected to file for NDA in the second half of 2026 [3] - CMG90, the first CLDN18.2 ADC globally, has received orphan drug designation from the FDA and is in phase three clinical trials, with NDA expected in the second half of 2026 [3] - The company is also developing CM512, a long-acting TSLPXIL-13 dual blocker, targeting multiple allergic diseases, which has a half-life of 70 days, potentially improving patient compliance [3] - The company has a diverse preclinical pipeline targeting various diseases, including autoimmune diseases, urticaria, Alzheimer's disease, muscle wasting, and tumors, laying a solid foundation for long-term development [3] Group 4: Investment Outlook - The company is a leader in innovative autoimmune drugs in China, with strong competitive advantages in multiple innovative drug fields [3] - The core pipeline has been launched, gradually entering a phase of revenue generation, while innovative pipelines have completed several business development deals abroad, potentially expanding into global markets [3] - Revenue projections for 2025-2027 are 880 million, 1.5 billion, and 2.24 billion yuan, with year-on-year growth rates of 106%, 70%, and 49% respectively [3]

Core Insights - The article discusses the challenges faced by patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and seasonal allergic rhinitis (SAR), highlighting the limitations of traditional treatments and the emergence of innovative therapies like Dupilumab [1][2][3] Group 1: Patient Challenges - Many patients with CRSwNP and SAR experience inadequate treatment outcomes, with about 50% of CRSwNP patients facing recurrence of symptoms despite standardized medical and surgical interventions [1] - A significant percentage of patients with moderate to severe SAR do not achieve effective symptom control even when using potent nasal corticosteroids and antihistamines [1][3] Group 2: Innovative Treatment Development - The approval of Supilumab (康悦达) by the National Medical Products Administration (NMPA) for CRSwNP in December 2024 marks a significant advancement in treatment options [2] - Supilumab is the first IL-4Rα biological agent approved for SAR, expanding its therapeutic applications [2][3] Group 3: Clinical Efficacy - In clinical trials, Supilumab demonstrated significant efficacy, with 72% of patients showing notable reduction in nasal polyps within two weeks of treatment, and 81% achieving at least a 50% reduction by 24 weeks [3][4] - For SAR, 52% of patients achieved nasal airflow within four days of treatment, and 84% reported mild or no nasal symptoms after four weeks [4] Group 4: Market Potential - The global market for IL-4Rα-targeted drugs is projected to grow significantly, with estimates reaching $12.2 billion by 2024 and $28.7 billion by 2030, reflecting a compound annual growth rate of 15.2% [5] - The competitive landscape is evolving, with domestic companies like 康诺亚 gaining traction in the IL-4Rα drug market, challenging established players [5][6] Group 5: Future Directions - 康诺亚 is actively exploring additional indications for Supilumab, including adolescent atopic dermatitis and nodular prurigo, aiming to address unmet clinical needs and reduce treatment costs [9][11] - The company is also developing a diverse pipeline of therapies, including second-generation bispecific antibodies and ADCs, to enhance treatment options for various diseases [10][11]