2024年2月21日，思路迪医药（3D Medicines，1244.HK）与科弈（浙江）药业科技有限公司(以下简称“科弈药业”)战略合作签约仪式在上海举行。思路迪医药董事长兼CEO龚兆龙博士与科弈药业董事长兼CEO吴国祥博士签署战略合作协议，本次合作旨在对思路迪医药恩维达®(恩沃利单抗，Envafolimab)与科弈药业KY-0118联用展开探索，此外未来双方还将在科弈药业双靶点CAR-T产品权益、全球临床试验研究等多方面探讨进一步合作。
On February 21, 2024, the strategic cooperation signing ceremony between 3D Medicines (1244.HK) and Novatim Immune Therapeutics (Zhejiang) Co., Ltd. (hereinafter referred to as "Novatim") was held in Shanghai. Dr. Gong Zhaolong, the chairman and CEO of 3D Medicines, and Dr. Wu Guoxiang, the chairman and CEO of Novatim, signed the strategic cooperation agreement. This cooperation aims to explore the combination of 3D Medicines' Envidra® (Envovalimab) and Novatim's KY-0118. In addition, in the future, the two parties will also discuss further cooperation in multiple aspects such as the rights of Novatim's dual-target CAR-T products and global clinical trial research.
KY-0118是科弈药业第一款从源头自主研发的核心产品靶向PD-1的突变性IL-2融合蛋白，其独到的设计思路发挥了新一代激动剂（Next Generation Agonist）的作用，在同领域中研发进度与罗氏（Roche）同处于全球第一梯队。KY-0118单药使用已经在临床上展示一定的有效性，联合PD-L1单抗在动物试验中能将KY-0118单药抑瘤率69.2%或者PD-L1单药的抑瘤率65.7%提升至100%，在动物模型中肿瘤完全消退。
KY-0118 is the first core product independently developed by Novatim, a mutant IL-2 fusion protein targeting PD-1. Its unique design concept has exerted the effect of a next generation agonist, and its research progress in the same field is on par with Roche, ranking among the top globally. The single use of KY-0118 has demonstrated certain effectiveness in clinical trials. When combined with PD-L1 monoclonal antibody, it can increase the tumor suppression rate of KY-0118 alone from 69.2% or that of PD-L1 alone from 65.7% to 100%, achieving complete tumor regression in animal models.
科弈药业董事长兼CEO吴国祥博士表示
思路迪医药的恩维达®是全球首个上市的皮下注射PD-L1抑制剂，目前在全球范围开展多中心、多适应症的单药及各类联用临床试验。KY-0118与恩维达®联用的合作，不管是在机理上还是目前已有的实验数据上，都明显展示出1+1＞2的结果，未来将共同探索更多肿瘤免疫治疗方案合作及加快产品上市进度的可能性，实现优势互补。
双方的战略合作，也获得了科弈药业落地政府浙江省安吉县的大力支持，未来双方将充分利用科弈药业已落地安吉的主体优势和行业影响力，为安吉生命健康产业发展做出更大贡献。
Dr. Wu Guoxiang, the chairman and CEO of Novatim, stated
Enveda® of 3D Medicines is the world's first approved subcutaneous PD-L1 inhibitor. Currently, it is undergoing multi-center and multi-indication clinical trials as a monotherapy and in various combinations worldwide. The collaboration of KY-0118 with Enveda® in combination therapy has demonstrated a result of 1+1>2 both in terms of mechanism and existing experimental data. In the future, it will jointly explore more possibilities for tumor immunotherapy cooperation and accelerate the progress of product launch, achieving complementary advantages.
The strategic cooperation between the two parties has also received strong support from the government of Anji County, Zhejiang Province, where Novatim has been established. In the future, the two parties will fully leverage the main advantages and industry influence of Novatim that have already been established in Anji to make greater contributions to the development of the life and health industry in Anji.
思路迪医药董事长兼CEO龚兆龙表示
科弈药业从源头自主研发的大分子药物KY-0118单药使用已经在全国8家中心开展针对晚期实体瘤的临床实验，初步显示一定有效性，与联合PD-L1单抗联用临床试验也即将在全球同步开展。本次和科弈药业KY-0118联用合作，是一个非常好的先行契机，属于双方深化战略合作的初步探索，也有助于加快恩维达®新适应症上市。
科弈药业拥有强大的自主研发和产品创新化能力，思路迪医药在药品开发方面经验丰富，双方将就产品全球权益合作和全球临床研究开展等多方位合作，加快探索更优的肿瘤免疫治疗方案，帮助肿瘤患者活得更久更好。
Gong Zhaolong, the chairman and CEO of 3D Medicines, said
Novatim has independently developed a large-molecule drug, KY-0118, at its source. This drug has been used alone in clinical trials targeting advanced solid tumors in 8 centers across the country. Preliminary results indicate certain effectiveness. A clinical trial combining KY-0118 with PD-L1 monoclonal antibody is also about to be conducted simultaneously worldwide. This collaboration with Novatim on the KY-0118 combination is a very promising opportunity. It represents an initial exploration of deepening strategic cooperation between the two parties and also helps accelerate the market launch of Envidar® for new indications.
Novatim has a strong ability in independent research and product innovation. Shididi Medicine has rich experience in drug development. The two parties will carry out multi-faceted cooperation in areas such as global product rights cooperation and global clinical research, to accelerate the exploration of better tumor immunotherapy solutions and help cancer patients live longer and better.
Regarding 3D Medicines Inc.
3D Medicines Inc. is an innovative pharmaceutical company that has entered the commercialization stage and focuses on the field of tumor treatment. With the vision of "helping cancer patients live longer and better", the company develops anti-tumor drugs in response to the trend of chronicization in tumor treatment. On December 15, 2022, the company officially listed on the main board of the Hong Kong Stock Exchange, with the stock abbreviation: 3D Medicines and the stock code: 1244.
The company's product line includes 12 innovative drugs with clinical value. Among them, 8 have entered the clinical development or commercialization stage. The new drug Envida, a subcutaneous injection of PD-L1 single-domain antibody, has been approved for marketing by the National Medical Products Administration. The company's over 200-person international team has extensive experience in drug discovery, preclinical research, clinical development, application for marketing approval, and commercialization. Multiple indications have received orphan drug designation or priority review from the FDA and NMPA. 3D Medicines adheres to the patient-centered principle and provides more treatment options for global cancer patients.
For more information, please visit: http://www.3d-medicines.com
Regarding Novatim
Novatim Immune Therapeutics (Zhejiang) Co., Ltd. was established in 2018. It is a biopharmaceutical technology enterprise specializing in the research and clinical application of innovative drugs for tumor immunotherapy. The company, based on clinical needs and its focus on tumor immunotherapy, has established research platforms such as the dual-function antibody platform, the nano-bispecific ADC platform, and the enhanced dual-target CAR-T platform. Through breakthroughs at the level of key technologies, it has developed nearly 10 FIC/BIC products.
The first core product independently developed by Novatim from the source, the targeted PD-1 mutant IL-2 fusion protein - KY-0118 injection, features a unique design concept that enables the function of a new generation of agonists. It is a new type of targeted IL-2 product that specifically activates CD8+ T cells. It is known that in the same field, the research progress of this product is on par with Roche and is at the forefront of the first tier. Currently, clinical trials are being conducted at the General Hospital of the People's Liberation Army as the central unit. The preliminary clinical trial data have demonstrated good safety and significant effectiveness.
