据医药魔方Info报道，9月18日，全球临床试验收录网站显示，康诺亚的CM336启动了首个III期研究。 该药物是康诺亚旗下首款进入III期阶段的双抗药物。此次启动的III期研究是一项随机、开放标签、多中 心临床试验（n=280），旨在评估CM336单药对比研究者选择的标准治疗方案治疗既往至少接受过二线 治疗的复发或难治性多发性骨髓瘤（R/R MM）患者的有效性和安全性。研究的主要终点为无进展生存 期（PFS）。 此前，CM336已完成一项针对R/R MM的I/II期研究。在剂量递增队列中，23例患者可评估疗效。结果显 示，中位随访12.1个月时，≤5mg组、20-40mg组和80-160mg组患者的客观缓解率（ORR）分别为17%、 71%和80%，实现严格的完全缓解或完全缓解的患者比例分别为17%、71%和60%。 来源：新浪港股 康诺亚-B（02162）盘中涨超5%，截至发稿，股价上涨3.75%，现报74.80港元，成交额8907.02万港元。 ...

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]