Bimiralisib

10月28日，经2025年第四次临时股东大会审议通过，华大智造将通过美国子公司MGI US LLC及Complete Genomics,Inc.，与瑞士生物科技企业Swiss Rockets AG（简称“Swiss Rockets”）达成具有战略意义的技术授权合作。根据《授权许可协议》，华大智造将CoolMPS测序技术相关专利、商标、专有技术和软件以独占许可/普通许可的方式有偿授权给Swiss Rockets，用于在除亚太及大中华区以外的全球市场开发、生产和商业化相关产品。这意味着，华大智造在全球化道路上迈出了里程碑式的全新步伐：通过“技术出海”的模式，借助合作伙伴强大的本地资源与研发实力充分释放CoolMPS测序技术的价值，与华大智造已成熟产品化的StandardMPS测序技术形成协同，为全球生命科学界提供更多的工具选择与解决方案。此项授权合作也标志着，中国生命科学仪器领域首次实现了“技术出海”，从“产品输出”向“技术输出”跃迁，为全球生命科学的创新注入新的活力。这不仅彰显了华大智造自有技术的竞争力，更印证了国际市场对中国生命科技的认可与期待。华大智造执行副总裁刘健表示：“我们很欣喜能与志同道合的Swiss Rockets携手，让CoolMPS技术在全球测序生态实现更大的赋能。Swiss Rockets在生命科学多个领域的研发创新走在前沿，尤其是在肿瘤学和传染病领域。我们相信，双方的紧密结合，将有力促进测序应用的延展与渗透，催生出更多改善人类生命健康的创新性成果。”Swiss Rockets首席执行官Vladimir Cmiljanovic表示：“我们很高兴能获得华大智造CoolMPS的技术授权，这将助力Swiss Rockets通过尖端技术推进肿瘤学与传染病领域的创新。CoolMPS测序技术与我们现有的药物研发管线和诊断平台相辅相成，可进一步强化我们为患者和公众提供精准诊疗方案的能力。”为了保障终端产品的顺利开发并实现商业化，华大智造为Swiss Rockets提供CoolMPS测序技术的转移、产品研发及商业化技术支持。Swiss Rockets将面向美国、欧洲等市场，提供基于CoolMPS技术的基因测序仪及试剂耗材。同时，Swiss Rockets还将采用CoolMPS测序技术开发经济、高效的疾病预防与健康管理方案，推动精准医疗与长寿医学的发展。作为生命科技核心工具的提供方，华大智造已成为全球首个同时拥有大规模商业量产级短读长与长读长测序产品的企业，并实现了对“激发光”“自发光”“不发光”三种技术路径基因测序产品的全方位战略布局。截至2025年6月30日，华大智造已走向六大洲110多个国家和地区，在全球服务累计超过3,560用户。未来，依托坚实的技术体系与先进的工具方案，华大智造仍将持续推进全球战略布局，携手全球生态伙伴共拓生命科学的无限可能、加速创新成果的应用转化，为行业产业发展和人类生命健康贡献源源不断的硬核力量。关于CoolMPS测序技术CoolMPS测序技术是华大智造的高通量测序技术之一，部分相关专利权与深圳华大生命科学研究院共同持有。其核心在于采用未标记的可逆终止子进行聚合反应，并通过特异性抗体识别来实现碱基判读。相比于传统的荧光直接标记核苷酸技术，抗体识别的优势在于无需对碱基进行化学修饰，新合成链上的碱基保持天然状态，避免了因去除荧光标记而产生的疤痕对后续聚合效率和荧光信号的干扰，有利于DNA聚合酶高效、稳定地进行连续聚合；同时，由于单个抗体可偶联多个荧光分子，显著增强了检测信号强度，使得相同拷贝数的DNA纳米球（DNB）能够获得更强的荧光信号和更高的信噪比，从而有效提升了测序数据的准确性，提升了测序读长。关于Swiss RocketsSwiss Rockets是一家位于瑞士巴塞尔的创新型生物科技平台企业，旗下汇聚了多家在细分领域领先的生物技术公司，多个业务板块在临床研发与商业合作上均取得显著进展。Swiss Rockets子公司Torqur AG研发的皮肤癌前病变药物bimiralisib在II期临床中展现出优异疗效，对早期病变的清除率高达92%；子公司Rocketvax的新冠疫苗研发项目在2024年获得了美国国立卫生研究院（National Institutes of Health）的资金支持。近期，Swiss Rockets与美国公共卫生领域上市公司Emergent BioSolutions达成了战略合作。由 Emergent 主导Rocketvax四个针对传染病、癌症及自身免疫性疾病的在研管线候选药物在美国的生产及商业化工作。··(华大智造)

BASEL, Switzerland--(BUSINESS WIRE)--Torqur AG, subsidiary of Swiss Rockets incubator and a clinical-stage company advancing targeted therapies in oncodermatology and oncology, announced the results of the full Phase 2 proof-of-concept study results of topical bimiralisib gel (2%) for the treatment of actinic keratosis (AK) at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, the largest dermatology conference in Europe. The randomized, multi-center study evaluated topical bimiralisib gel as a field-directed treatment for AK on the face, scalp, and/or back of hands. Results demonstrated substantial efficacy and a favorable safety profile, supporting further clinical development: Efficacy: 92% of complete or near complete response with Olsen grade 1 patients, and overall, 52% of patients in the 2-week period and 71% in the 4-week period achieved an Investigator’s Global Assessment (IGA) score of 0–1 (complete or partial clearance). All patients experienced some degree of lesion clearance after the initial treatment period. Clearance was seen in Olsen grade 1 and grade 2 AK lesions. Subanalysis showed that patients with Olsen grade 2 also had significant clearance with 48% complete or near complete response . Safety: Treatment was well tolerated , with related adverse events being generally local skin reactions with the vast majority being mild (only four grade 2 events), all resolving without intervention. Retreatment during the optional extension phase for up to 8 weeks was feasible without any significant or new safety concerns. Further improvements of lesions were noted with additional cases of complete clearance . The Phase 2 study enrolled 46 patients across two leading Swiss dermatology centers: University Hospital Basel (Prof. A. Navarini) and Lausanne University Hospital (Prof. O. Gaide). Dr. Vladimir Cmiljanovic, CEO of Torqur AG, said: “Presenting these Phase 2 results at Europe’s most prestigious dermatology congress is a tremendous milestone. The high rates of clearance and consistently favorable tolerability profile underscore bimiralisib’s potential to become a new standard for patients with actinic keratosis. We are now preparing for the pivotal Phase 3 clinical trials and discussing with potential partners to bring this therapy closer to patients worldwide.” Prof. Dr. Alexander Navarini, Chairman of Dermatology at University Hospital Basel and Lead Principal Investigator, commented: “These results show that bimiralisib gel 2% has both efficacy and safety across different grades of actinic keratosis. This represents a promising new non-invasive option for patients, addressing a significant unmet need in dermatology.” Prof. Dr. Olivier Gaide, Head of the Center of Excellence for Skin Cancer and Melanoma at Lausanne University Hospital and Principal Investigator, added: “With actinic keratosis being the most common precancerous skin condition, these data highlight the great potential of this targeted topical therapy to counter progression to squamous cell carcinoma.” Actinic keratosis affects more than 10% of Europeans and is considered the most common pre-cancerous dermatological condition driven by an overactive PI3K/mTOR pathway. Bimiralisib gel is a selective pan-PI3K/mTOR inhibitor and offers a new mechanism-based approach to treat early-stage skin lesions effectively and safely. About Torqur AG (www.torqur.com) Torqur AG is an innovative Swiss clinical-stage biotechnology company dedicated to advancing next-generation therapies in oncology and dermatology. Its lead product, bimiralisib, is a selective pan-PI3K/mTOR inhibitor with applications across cancer and dermatological indications. Torqur AG is a fully owned subsidiary of Swiss Rockets AG (www.swissrockets.com), the leading biotechnology incubator and accelerator of Switzerland, headquartered in Basel. Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the clinical development, potential regulatory approval, and future commercialization of bimiralisib. Forward-looking statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. Torqur AG undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.