Ruishun Bio Completes RMB 59 Million Series A+ Financing to Advance Development of Off-the-Shelf DNT Cell Therapies

VCBeat learned第一时间 that recently, Zhejiang Ruishun Biotech Co., Ltd. ("Ruishun Biotech" or "the Company"), a global leader in the development of off-the-shelf universal DNT cell therapies, announced the completion of a 59 million RMB A+ round of financing. This follows the company’s previous A round financing of 137 million RMB completed in the fourth quarter of last year. This round of financing was led by...Yuecai Medical Fund、Baidu VenturesIncluding new and existing investors.

This round of funding will be used for Zhejiang Ruishun Biotech Co., Ltd.Development of Ready-to-Use DNT Cell Series Drugs, accelerating the confirmatory Phase II clinical trial of RC1012 injection for the treatment of relapsed/refractory acute myeloid leukemia (r/rAML), the IND application for new clinical indications of RC1012 injection and CD19-CAR-DNT cell products, and the preclinical research of new product pipelines;Headquarters of Zhongshan Life Science Park in Guangdong, R&D Center in Shanghai, and New Preparation Center in Keqiao, Shaoxingetc.Construction of the SiteandExpansion of the R&D Teametc.

Zhejiang Ruishun Biotech Co., Ltd. is committed to the mission of "Caring for Life, Benefiting Humanity" and "Developing Innovative Cellular Medicines Affordable for the Common People." The company focuses on the research and development of off-the-shelf universal immune cell products based on the DNT cell technology platform and is a pioneer in off-the-shelf universal DNT immune cell therapy worldwide.

Zhejiang Ruishun Biotech Co., Ltd. develops a series of products based on the DNT cell technology platform, derived from peripheral blood mononuclear cells of healthy donors.Has a significant specific killing effect on various tumor cells such as AML.Clinical studies conducted have demonstrated that allogeneic DNT cells, when infused into patients, do not cause graft-versus-host disease (GvHD) or other severe adverse reactions. They exhibit favorable safety, significant and durable anti-tumor activity, controllable product quality, and hold immense commercial potential for the development of off-the-shelf universal DNT cell products.

Previously, the fresh preparation of "RC1012 Injection," submitted by Ruichuang Biotechnology Co., Ltd. (hereinafter referred to as "Ruichuang Bio"), a wholly-owned subsidiary of Zhejiang Ruishun Biotech Co., Ltd., was approved by the National Medical Products Administration (NMPA) in November 2020 for Phase I clinical trial registration. This is the first domestically produced universal-type immune cell drug approved in China for clinical trial registration (NMPA Application No.: CXSL2000248, Drug Clinical Trial Approval Notice No.: 2020LP00762).

On August 3, 2022, Ruichuang Biotech received the approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) regarding the application for a change in the formulation process (Acceptance No.: CXSB2200042, Notice No.: 2022LB00372). The change allows the type of cell preparation involved in the ongoing Phase I clinical trial, "RC1012 Injection (main component: DNT cells) for the treatment of relapsed/refractory acute myeloid leukemia (r/r AML)," to be changed from fresh to cryopreserved formulation.

The approval of this supplementary application by the CDE marks "RC1012 Injection" asThe world's first off-the-shelf, non-gene-edited DNT immunocyte therapy product for treating r/r AML, which is a significant advancement in the field of clinical trials for relapsed or refractory acute myeloid leukemia.

Compared with fresh formulations, cryopreserved formulations can be prepared in advance and stored long-term in liquid nitrogen tanks after completing all quality inspection items. This allows patients to receive timely clinical treatment, avoiding the waiting period required for cell preparation in current autologous cell therapies. As a result, patients with rapidly progressing conditions can receive prompt treatment. This is a truly "off-the-shelf universal" non-gene-edited immune cell therapy product. We believe that this product will address current pain points in AML clinical treatment, significantly enhance patient benefits, and generate substantial economic and social benefits.

The company plans to launch its Series B financing in the fourth quarter of this year.

Dr. Liming Yang, Chairman/Chief Scientific Officer of Zhejiang Ruishun Biotech Co., Ltd.Expressed: We are very grateful to domestic well-known investment institutions such as Yuecai Medical Fund and Baidu Ventures, along with other new and existing investors, for their capital injection into Zhejiang Ruishun Biotech Co., Ltd. This will ensure the advancement of clinical trials for our various product pipelines and the continuous entry of new products into the clinical trial stage. As an off-the-shelf allogeneic DNT cell technology platform, it has gradually demonstrated its competitive advantages in terms of safety, efficacy, and quality control—key prerequisites for drug development—from the initial proof-of-concept to the current standardized clinical trial development. We will continue to work diligently and remain committed to the belief of creating the world’s first innovative cell drug, forging ahead to achieve our goals as soon as possible.

Liu Xiang, General Manager of the Medical Health Investment Department of Yuecai Biopharmaceutical FundSaid: "The cell therapy field is currently moving towards 'off-the-shelf universal' and 'solid tumor treatment.' Zhejiang Ruishun Biotech Co., Ltd. focuses on the development of innovative cell therapy products in these two areas. The company’s product R&D process has a leading-edge advantage, and its team possesses outstanding academic research achievements and industrial operation experience. We look forward to the early first-round market launch of Ruishun Biotech's DNT cell therapy products. The Yuecai Biomedical Industry Fund will continue to pay attention to excellent innovation and entrepreneurship teams within the broader health sector, promoting the successful industrialization of first-of-a-kind products in the biomedical and healthcare industry."

BV Baidu Ventures Investment Vice President An FengStated: "The cell therapy industry has now entered the 2.0 era. With the successful launch of the first-generation products, in order to further enhance clinical therapeutic value and application accessibility, the development of a new 'low-cost, universal, off-the-shelf' cell therapy product has become a consensus across the entire industry. Zhejiang Ruishun Biotech Co., Ltd's DNT Cell Injection RC1012 is a universal cell therapy product with international 'first-in-class' potential, which has already demonstrated good safety and efficacy in Phase I clinical trials. As the first universal cell therapy in China to receive IND approval, it is highly likely to be the first to successfully reach the market. Baidu Ventures strongly believes in the company’s future development and will continue to offer support."

BOC Yuet Finance Equity Investment Fund Management (Guangdong) Co., Ltd. was jointly established by Guangdong Yuet Finance Investment Holding Co., Ltd. and BOC Group Investment Co., Ltd. It mainly focuses on five major investment areas: healthcare, new energy, advanced manufacturing, consumer goods, and infrastructure. The cumulative scale of managed funds exceeds 40 billion yuan.

Baidu Ventures is an independent venture capital institution initiated by Baidu Group, with three phases of USD/RMB funds totaling over seven billion US dollars. Baidu Ventures focuses primarily on early-stage pioneering companies in emerging technologies and is dedicated to several major directions such as commercial consumption, healthcare and livelihood, and technological expansion. Relying on the strong support and resource sharing from Baidu Group, Baidu Ventures has strategically positioned itself in the artificial intelligence field. The investment areas currently covered include new energy vehicles, life sciences, enterprise services, smart cities, semiconductors, intelligent industry, and IoT living. Baidu Ventures believes that technology is the guardian of a better life—only finer granularity and more precise and outstanding requirements can foster innovative technologies. Baidu Ventures hopes to have the opportunity to discover more enterprises that integrate innovative technologies into details. We will continue to support enterprises across various fields that contribute value to the advancement of modern human civilization, and together with outstanding enterprises, we will create a beautiful blueprint for society.