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CHENGDU, China, March 26, 2025 /PRNewswire/ -- March. 25, 2025, Keymed Biosciences Inc. (HKEX: 02162) announced its annual results of 2024, along with a corporate update. Rapid development of our pipeline products Stapokibart (CM310) (IL-4Rα antibody) Three new drug applications of Stapokibart for the treatment of moderate-to-severe atopic dermatitis (AD) in adults, chronic rhinosinusitis with nasal polyposis (CRSwNP) and seasonal allergic rhinitis have been approved by the NMPA. By the end of 2024, Stapokibart resisted strong sales and recorded revenue of approximately RMB40 million within three and a half months. In September 2024, the new drug application of Stapokibart injection for the treatment of moderate-to-severe atopic dermatitis in adults was approved by the NMPA. The phase III clinical study results indicated that at week 52, the rates of achieving EASI-75 for the Stapokibart group and the placebo-to-Stapokibart group were 92.5% and 88.7%, respectively. The EASI-90 response rates were 77.1% and 65.6%, respectively. The rates of achieving an IGA score of 0 or 1 point with a reduction of ≥ 2 points from baseline were 67.3% and 64.2%, respectively. Additionally, the rates of achieving a weekly average reduction of ≥ 4 points from baseline in the daily PP-NRS score were 67.3% and 60.5%, respectively. Long-term treatment with Stapokibart can consistently improve dermatitis symptoms and quality of life in subjects with moderate-to-severe AD. During the maintenance period, only one subject (0.9%) experienced a relapse. In December 2024, the new drug application of Stapokibart injection for the treatment of chronic rhinosinusitis with nasal polyps was approved by the NMPA. The study results showed that the data from the Phase III clinical trial was positive. Compared to the placebo, Stapokibart significantly reduced nasal polyps (NPS improvement of 2.3 from baseline) and alleviated nasal congestion (NCS improvement of 0.7 from baseline) after 24 weeks. The differences were highly statistically significant (P < 0.0001). Additionally, it effectively relieved rhinosinusitis, restored sense of smell, improved nasal symptoms, and enhanced quality of life. In February 2025, the new drug application of Stapokibart injection for the treatment of seasonal allergic rhinitis was approved by the NMPA. We advanced and completed the data unblinding and statistical analysis for the Phase III clinical study of Stapokibart injection for the treatment of seasonal allergic rhinitis (SAR). The study findings demonstrate that during the pollen season, in comparison with the standard treatment group, which consists of nasal spray hormones combined with antihistamine drugs, the administration of Stapokibart for two weeks effectively controls the typical nasal allergic symptoms of patients, including runny nose, nasal congestion, nasal itching, and sneezing. The least-squares mean (LSMean) of the inter-group difference is -1.3, and its 95% confidence interval (CI) is also -1.3, indicating a highly significant statistical difference (P = 0.0008). This difference far exceeds the minimal clinically important difference (MCID) of 0.23, clearly demonstrating substantial clinical benefits. Moreover, Stapokibart can effectively alleviate ocular allergic symptoms such as eye itching or burning, eye tearing or watering, and eye redness. It comprehensively enhances the quality of life of patients and exhibits excellent safety. In February 2024, we launched a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection in adolescent subjects with moderate-to-severe AD. In May 2024, we initiated a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection in subjects with nodular prurigo. As of the date of this announcement, the patient enrollment for this clinical study is in progress. In June 2024, the long-term efficacy and safety data from the Phase III clinical trial of Stapokibart injection for the treatment of moderate-to-severe AD were presented by way of oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024. In October 2024, the full text of the 52-week efficacy and safety data of the Phase III clinical study was published in the《Allergy》, the top international journal in allergy and immunology field. CMG901/AZD0901 (Claudin 18.2 ADC) AstraZeneca has conducted multiple clinical studies regarding CMG901 (AZD0901) for the indications of gastric cancer, pancreatic cancer and biliary tract cancer, including the Phase III clinical trial for 2L+ gastric cancer, Phase II clinical trial for 1L gastric cancer, Phase II clinical trial for 1L pancreatic cancer, and Phase II clinical trial for 2L+ biliary tract cancer. In June 2024, the data from the Phase I clinical study of CMG901 (AZD0901) in the treatment of advanced G/GEJ cancer were presented by way of oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. On 6 January 2025, the data from the Phase I clinical study was released on the international authoritative oncology journal, The Lancet Oncology. The clinical data indicated that the median progression free survival (mPFS) for all 93 patients with Claudin 18.2-high expressing G/GEJ cancer was 4.8 months, and the median overall survival (mOS) was 11.8 months. CM313 (CD38 antibody) In 2024, we initiated and advanced a multi-center, open-label Phase I/II clinical study. In June 2024, a research paper titled "A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia" was published in The New England Journal of Medicine. 95.5% of patients achieved a platelet count of ≥50 × 109/L within 8 weeks upon the first acceptance of CM313 infusion, and the durable platelet count response rate (defined as a platelet count of ≥50 × 109/L observed six or more times among the final eight platelet counts) was 63.6%. In July 2024, we completed Phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of CM313 injection in subjects with SLE. We plan to initiate a Phase II clinical study in the first half of 2025. In 2024, we initiated a randomized, double-blinded, placebo-controlled Phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of CM313(SC) injection in subjects with primary immune thrombocytopenia. The first patient was enrolled and dosed in November 2024. We initiated a randomized, double-blinded, placebo-controlled Phase II clinical study to evaluate the safety and efficacy of CM313(SC) injection in subjects with IgA nephropathy in early 2025. As of the date of this announcement, preparations for patient enrollment are underway for this study. CM512 (TSLP x IL-13 bispecific antibody) We have initiated a randomized, double-blinded, single/multiple dose-escalation, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacokinetics and immunogenicity of CM512 in healthy subjects and patients with moderate-to-severe atopic dermatitis, with enrollment of the first subject completed in September 2024. The overseas Phase I clinical trial evaluating CM512 for the treatment of asthma was initiated in the first quarter of 2025. CM336 (BCMAxCD3 bispecific antibody) Continuously proceeded with a multi-center, open-label Phase I/II clinical study to assess CM336 injection in treating patients with relapsed or refractory multiple myeloma. As of the date of this announcement, the product is currently in the dose-expansion phase of Phase I/II clinical study. In December 2024, the latest data of the phase I/II clinical study of CM336 for relapsed or refractory multiple myeloma was presented as a poster at the 66th American Society of Hematology (ASH) Annual Meeting. CM383 (Aβ protofibrils antibody) As of the date of this announcement, the enrollment of all subjects in the Phase Ia clinical study of CM383 in healthy subjects was completed; In November 2024, the enrollment of the first subject in Phase Ib clinical study of CM383 in patients with mild cognitive dysfunction of Alzheimer's disease origin and mild Alzheimer's disease was completed. CM518D1 (CDH17 ADC) We submitted IND application to CDE, and planned to conduct a multi-center, open-label Phase I/II clinical trial for evaluation of CM518D1 in treatment of patients with advanced solid tumors. CM355/ICP-B02 (CD20 x CD3 bispecific antibody) We are conducting a Phase I/II clinical trial in China to assess the safety, tolerability, PK, and the preliminary anti-tumor activity of CM355 in r/r NHL. Dose escalation of the intravenous infusion formulation ("IV") was completed and the subcutaneous formulation ("SC") is being evaluated. Our preliminary data of both IV and SC formulations have shown good efficacy of CM355 in patients with follicular lymphoma ("FL") and DLBCL. CM350 (GPC3 x CD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical study in 2024 to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CM350 in patients with advanced solid tumors. As of the date of this announcement, the product is currently in the dose-escalation of Phase I/II clinical study. CM369/ICP-B05 (CCR8 antibody) We are conducting a Phase I trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and relapsed/refractory NHL. Dose escalation of CM369 has been escalated up to 450 mg in solid tumor and 600 mg in NHL, CM369 was well tolerated with no DLTs nor ≥grade3 TRAEs observed. The preliminary results demonstrated a favorable PK profile with sufficient exposure for target coverage and regulatory T-cell depletion. CM380 (GPRC5D×CD3 bispecific antibody) Preclinical studies indicated that CM380 had favorable antitumor effects and was well tolerated. As of the date of this announcement, we are planning to conduct a multi-center, open-label Phase I/II clinical study for evaluation of CM380 in treatment of patients with relapsed or refractory multiple myeloma. Financial and Business Highlights Actively explore diversified BD models to maximize the global value of the pipeline. In July 2024, Chengdu Keymed entered into a license agreement with Belenos Biosciences,Inc. The license agreement grants Belenos the exclusive rights to develop, manufacture,and commercialize the Group's drug candidates CM512 and CM536 globally (excluding the Greater China region). In return, Chengdu Keymed shall receive an upfront and nearterm payment of US$15 million, and iBridge HK shall receive approximately 30.01% of the equity interest in Belenos as consideration. Subject to achievement of certain development, regulatory and commercial milestones, Chengdu Keymed may also receive additional payments up to US$170 million. As of the date of this announcement, Belenos is planning to initiate a Phase I clinical trial evaluating CM512 for the treatment of asthma. In November 2024, Chengdu Keymed and Platina Medicines Ltd ("PML") entered into an exclusive license agreement. The license agreement grants PML the exclusive right to develop, manufacture and commercialize CM336 globally excluding Mainland China, Hong Kong, Macau and Taiwan. In return, the Group shall receive an upfront and near-term payment of US$16 million and a minority equity interest in Ouro Medicines, LLC ("Ouro Medicines") as part of the consideration. Ouro Medicines is the parent company of PML and owns 100% of the equity interest in PML. The Group may also receive additional payments of up to US$610 million subject to achievement of certain clinical, regulatory and commercial milestones and is also entitled to receive tiered royalties on net sales of CM336 and related products from PML. In January 2025, Chengdu Keymed entered into an exclusive out-license agreement with Timberlyne Therapeutics, Inc. The license agreement grants the target company the exclusive right to develop, manufacture and commercialize CM313 globally (excluding Mainland China, Hong Kong, Macau and Taiwan). In return, the Group shall receive an upfront and near-term payment of US$30 million and equity interest of the target company, being the largest shareholder of this company. The Group may also receive additional payments up to US$337.5 million subject to achievement of certain sales and development milestones. The Group is also entitled to receive tiered royalties on net sales from the target company. In January 2025, Chengdu Keymed, Beijing InnoCare and the Joint Venture have entered into the Agreement with Prolium for the development and commercialization of CM355. Under the terms of the Agreement, Prolium will have the exclusive right to develop, register, manufacture, and commercialize CM355 globally in non-oncology indications and in oncology indications outside of Asia. Rapid expansion of workforce and production facilities As of December 31, 2024, we had 1,300 full-time employees in total, including over 240 employees engaging in commercialization and nearly 400 employees engaging in drug discovery and clinical operations. We will continue to recruit talents to meet the growing needs of commercialization, research and development, clinical, production and operation of the Company. As of the date of this announcement, the production capacity of our production base has reached 20,000 litres in total, and all the designs thereof are in compliance with the requirements of cGMP of the NMPA and FDA. Financial highlights As of December 31, 2024, the Company generated a total annual revenue of RMB 430 million, representing a 21% year-on-year increase. This includes about RMB 40 million in sales revenue from Stapokibart over three and a half months and RMB 390 million in licensing revenue from BD agreements. Throughout 2024, the company continued advancing its differentiated pipeline development and clinical research, with R&D expenditures reaching approximately RMB 730 million, a 23% year-on-year increase. The company maintained a strong cash position with total cash on hand of approximately RMB 2.1 billion. Moving forward, Keymed will continue to establish, and refine its technology platforms, rapidly advancing the development of pipeline candidates in China and globally. The company will comprehensively drive the commercialization of approved product and indications. Concurrently, Keymed will proactively explore strategic partnerships worldwide to accelerate global patient access to its drug candidates through diversified BD models. The company plans to further recruit talent in commercial sales, clinical development, and manufacturing, expand cGMP-compliant production capacity, reduce costs, enhance operational efficiency, and remain committed to developing, producing, and commercializing innovative therapies that are globally competitive, high-quality, and affordable for patients worldwide. SOURCE Keymed WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

过去几年，中国自免市场的热度曾经一度被进口产品垄断把持。 其中，IL-4Rα单抗市场的国产替代上，外企产品度普利尤单抗在2023年全球销售额首度突破百亿美元，在全球范围内一度没有对手，而今，终于迎来了中国本土自免领军企业的强有力挑战。 康诺亚旗下康悦达®（司普奇拜单抗）半年时间连续实现重大突破，顶着全球第二、国产首个IL-4Rα单抗的光环上市后，一连获批成人中重度特应性皮炎、慢性鼻窦炎伴鼻息肉、季节性过敏性鼻炎三项适应症，并以极快速度打开了商业化局面。 最新披露的财报显示，截止2024年底，康悦达®3个半月内实现销售收入约4000万元。 康悦达®登上自免创新药角逐舞台，只是康诺亚走向成熟的一个侧影。过去一段时间，除康悦达®外，康诺亚多项高潜力管线取得突破性进展，多个创新成果发表于国际顶级期刊，并与全球知名投资机构合作，以NewCo创新模式四度出海，引领中国BD新风潮，人才团队不断壮大，生产基地建设快速推进，生产能力持续升级。 成立仅8年的康诺亚仍然年轻，但已在跨越式的向综合性生物制药公司加速转型，不断走向成熟。 中国乃至全球自免及肿瘤市场，正在迎来一位中国本土王者出场。 冲刺中国自免之王 天下武功，唯快不破。康诺亚在实现IL-4Rα单抗国产化上的速度有目共睹，拿下同靶点国产首个获批之后，半年时间连批三项适应症，为满足中国自免患者临床需求迅速打开了局面。 康悦达®首个获批的成人中重度特应性皮炎适应症背后，是一个中国特应性皮炎患者需求未被充分满足的巨大市场。据沙利文预测，2024年中国特应性皮炎市场规模将达15.33亿美元，2024至2030期间年复合增长率CAGR为18.6%，2030年中国特应性皮炎市场预计达到42.59亿美元。 而目前在中国，包含康悦达®在内仅有两款生物制剂获批上市，康悦达®具备与进口产品掰手腕的实力。 从机制上看，与头号竞争对手度普利尤单抗相比，康悦达®依赖空间表位与靶点结合，这个表位与IL-4、IL-13结合位点邻近甚至重合，这就保证了在阻断IL-4Rα信号传导方面，司普奇拜单抗相较于同类药物会表现更优。 疗效方面，康悦达®首剂快速起效，1天缓解瘙痒，2周实现各部位皮损一致全面获益；单药6周头颈显著改善，12周快速达标，16周实现强效应答，其中单药16周EASI-75的应答率为66.9%，达到IGA评分为0/1分且较基线下降≥2分的受试者比例为44.2%；单药52周，EASI-75应答率高达92.5%，EASI-90应答率高达77.1%；单药52周能够持续缓解瘙痒，实现无痒缓解。 而已公布的度普利尤单抗治疗中国成人中重度特应性皮炎的3期临床试验数据显示：16周时，度普利尤单抗组达到EASI-75应答率为57.3%，达到IGA评分达到0/1分且较基线下降≥2分的受试者比例为26.8%。 仅从16周数据来看，康悦达®疗效更加显著，而且康悦达®还提出了更高的治疗目标概念。与此同时，相比度普利尤单抗头颈部位效果不理想和结膜炎发生率高的情况来看，康悦达®在这两方面都有所提升，对全身各部位作用特别是头颈部的改善效果明显，结膜炎发生率低。但由于并不是头对头研究，入组患者的情况等可能存在一定的区别，直接对比两项临床试验数据并不十分科学，有待进一步深入研究。 成人中重度特应性皮炎适应症之外，2024年2月，康诺亚已经启动康悦达®治疗青少年中重度特应性皮炎的Ⅲ期临床研究，进一步拓展康悦达®适用的特应性皮炎患者年龄层。 在重点的特应性皮炎适应症之外，康诺亚差异化布局中国未满足临床需求的适应症，康悦达®获批的季节性过敏性鼻炎、慢性鼻窦炎伴鼻息肉适应症抢在外企之前实现中国首发，开拓中国特色需求蓝海。 当下正是过敏季，很多人都因为花粉过敏、飞絮过敏等而苦不堪言，康悦达®作为全球首个且唯一获批用于治疗季节性过敏性鼻炎的IL-4Rα单抗，为患者提供了一种突破性的治疗选择。 临床研究显示，康悦达®首次用药2天后，过敏性鼻炎的鼻塞症状快速缓解；4天后，鼻部整体症状显著改善。第一次治疗后，近一半患者达到轻度甚至完全缓解状态。第二次治疗后，近90%患者眼部症状达到轻度甚至完全缓解状态。 2024年12月，康悦达®治疗慢性鼻窦炎伴鼻息肉的药品上市许可申请获国家药监局批准，为国内首个治疗慢性鼻窦炎伴鼻息肉的生物制剂。 临床研究显示，康悦达®首次用药2周后，鼻息肉显著缩小；用药4周后，嗅觉明显恢复；治疗24周，81%的患者鼻息肉大小减半（NPS评分较基线改善≥2分），70%的患者实现鼻腔通气（NCS评分较基线改善≥1分）；治疗52周，90%的患者鼻息肉大小减半，86%的患者实现鼻腔通气。 快速推进适应症落地之外，康诺亚在过去一年中在商业化团队建设及产能建设上加足马力，为康悦达®的商业化快速放量做足了准备。 目前，康诺亚已有员工约1300名，其中商业化团队240余人，能够支持不断增长的产品商业化销售。与此同时，康诺亚成都生产基地产能持续提升，现有总产能约20000升，保障后续包括康悦达®在内的多条管线临床用药及商业化放量，生产基地设计符合国家药监局、美国FDA、欧盟EMA的cGMP规定。 这之外，康悦达®还有今年谈判进入医保放量的预期，后续商业化前景可期。 引领BD出海新风潮 重磅创新产品势如破竹之外，康诺亚过去1年多时间在BD上也势头强劲，以NewCo创新模式四度出海，总交易金额近17亿美元，不止吸引了奥博资本、TPG、贝恩资本、Venrock、Abingworth、RTW Investments等众多全球知名投资机构参与合作，更吸引了GSK这样的大型跨国药企参与支持，引领了中国创新药NewCo出海的新风潮。 细致分析康诺亚这4次NewCo出海，呈现出了几点新风貌： 首先是NewCo产品足够创新，4款NewCo出海创新药中有3款都是双抗产品，在2024年至今中国NewCo出海的5款双抗产品中占据3席，充分引领了双抗NewCo出海的风潮，而与Timberlyne Therapeutics合作的CD38单抗CM313也相当独特，主要开发方向除了CD38单抗常见的多发性骨髓瘤，还有近年来被证明有跨界可能的自免适应症，具有成为Best-in-class的潜力。 其次是产品偏早期，CM536处于临床前阶段，CM512处于申报临床阶段，CM336及CM355处于临床Ⅰ/Ⅱ期阶段，而CM313处于临床Ⅱ期阶段，这种“早”一方面显示出了康诺亚产品的创新成色，合作伙伴愿意在更早期参与到康诺亚创新产品的开发历程中，另一方面也显示出康诺亚的国际化战略眼光，更早通过多元化BD模式，最大化管线全球价值。 最后一点，也是最值得关注的一点，康诺亚尽管通过NewCo找到了国际化合伙伙伴，但仍然深度乃至主导创新产品的国际化进程。 与康诺亚NewCo合作开发商业化CM512及CM536两款双抗新药的Belenos由康诺亚和世界级医疗保健基金奥博资本共同成立，康诺亚作为主要股东，持股30%，陈博博士当选Belenos董事。 与康诺亚NewCo合作开发商业化CM313的Timberlyne，为康诺亚与生物医药行业知名基金贝恩资本、Abingworth、Venrock共同创立，A轮融资1.8亿美金，康诺亚仍为Timberlyne最大股东，拥有其25.79%的股权。 借助NewCo的创新方式，康诺亚在保证深度参与创新管线国际化的同时，实现了国际化效率最大化。而能够采用如此多元化的BD模式，康诺亚也不是一蹴而就的，而是厚积薄发的成果。 早在2023年2月23日，康诺亚就与知名跨国药企阿斯利康达成总金额高达11.88亿美元的重磅BD交易，阿斯利康引进康诺亚的Claudin 18.2 ADC产品CMG901/AZD0901。 2024年6月，CMG901(AZD0901)治疗晚期胃癌/胃食管结合部腺癌的I期临床研究最新数据在2024年美国临床肿瘤学会(ASCO)年会上以口头报告形式发布。2025年1月6日，该临床I期数据在国际权威肿瘤学期刊《The Lancet Oncology》上发表。研究结果显示，所有93例Claudin 18.2高表达胃癌/胃食管结合部腺癌受试者的中位无进展期(mPFS)为4.8个月，中位总生存期(mOS)为11.8个月。凭借优秀的临床数据，CMG901(AZD0901)已经进入全球临床Ⅲ期。 能进一步吸引更多国际资本及企业参与NewCo，是康诺亚不断积累能力并在合作伙伴验证的结果。 而通过NewCo模式，也能助力康诺亚的研发及人才储备与海外接轨，并通过与全球顶尖团队的交流、互动与合作，锻炼团队的国际化能力，为后续海外业务扩张进一步做好人才、经验方面的准备。 不内卷，研发更加创新 康诺亚之所以能够连续4次NewCo出海成功，除了积极探索多元化BD模式最大化管线全球价值的先进BD策略，更大的底气源于先进的研发理念策略，以及由此搭建和验证的研发平台能力。 不同于更多Biotech热衷于内卷同质化的靶点及疾病领域，并且将研发重点局限于本土市场，康诺亚从建立之初就明确了“避开内卷，专注差异化”的研发策略，建立了新型T细胞重定向（nTCE）双抗平台、创新抗体工程平台、抗体偶联技术平台等专有平台，着眼于搭建有全球竞争力的创新药管线。 事实上，康诺亚也践行了当初着眼于全球创新的研发策略。目前，康诺亚管线主要覆盖自免及肿瘤两大领域，已经有10多款处于不同研发阶段的关键候选药物，在国产同类别取得中国及/或美国IND批准的药物中，进度常位列前三位。 也是因为康诺亚在研管线研发进度领先，才吸引了众多国际资本和跨国公司积极合作参与这些创新药的国际化进程。 而随着创新管线逐步验证康诺亚搭建技术平台的能力，康诺亚进一步打造更丰富、更创新(如未成药靶点)的研发产品管线，并且在自己所专注的自免与肿瘤领域跨界联动，寻找跨界创新的机会。 在未成药靶点创新探索上，CM518D1和CM369具有相当的代表性。 CM518D1是康诺亚最新公布的用于消化道肿瘤的CDH17 ADC药物。CDH17靶点尚未成药，特异性高表达于消化道肿瘤，且定位于肿瘤细胞表面，便于识别，促癌机制明确，潜力巨大，全球进展最快的也仅处于临床I期。 而康诺亚已向CDE递交CM518D1临床试验申请，并计划开展治疗晚期实体瘤I/II期临床试验。 CM369是CCR8抗体药物，CCR8靶点目前全球范围内也尚未有药物上市。目前正在持续推进CM369治疗晚期实体瘤及复发/难治性非霍奇金淋巴瘤的I期临床研究。 而在潜在大适应症阿尔兹海默症，康诺亚也敢于尝试布局Aβ单抗CM383 ，通过更明确的机制创新，挑战全球已经上市的三款Aβ单抗。 2024年11月，CM383治疗阿尔茨海默病源性轻度认知功能障碍和轻度阿尔茨海默病的 Ib 期临床研究已经完成首例受试者入组。 在创新性地将肿瘤药物机制引入自免领域方面，康诺亚研究CD38单抗通过清除病理性浆细胞靶向自免疾病根源，开创性地将CM313拓展到系统性红斑狼疮、免疫性血小板减少症等自免疾病。据《新英格兰医学杂志》发表文章显示，CM313对难治性免疫性血小板减少症患者的治疗应答率高达95%，表现出快速且持续的疗效反应。 在更多差异化创新和适应症上市的推动下，康诺亚快速迈入2.0发展新阶段，向国内自免王者之位持续进阶。 而康诺亚所走过的进阶之路，也对行业有启示与借鉴意义：中国创新药行业已经走过了Me-Too、Fast-Follow阶段，光靠内卷是没有前途的，在国际化竞争中，只有像康诺亚这样坚持长期主义，着眼于全球未满足的临床需求，持续不断精进，研发Best-in-class、First-in-class的创新药，才能不断迭代进化，长成具有国际视野和能力的Biopharma。 声明：此篇文章受众仅为医药、医疗等健康产业专业伙伴，仅供医学药学专业人士使用，不构成投资建议，不针对普通消费大众。