Kunshi Biologics Secures Tens of Millions in Pre-A Financing to Advance IND Filing for Third-Generation CAR-M Therapy

VCBeat learned at the first time that, 2024Year2Month, ROC ROCK Biotechnology, which focuses on macrophage-based drug therapy for solid tumors, has completedPre-ARound financing of tens of millions of RMB, this round of financing is managed by Ronghui Group's management companyGuozhu CapitalLead investor,Jiaxing Deshi Private Equity Fund Management Co., Ltd.ContinuousAdditionalInvestResources，Riemann-HypothesisContinue to Serve asThis roundExclusive Financial Advisor.

This is a new round of financing for ROC ROCK Biotechnology following the angel round at the end of 2022. The funds will mainly be used for the IND application of the clinical pipeline RR-M01 and the construction of the delivery vector production base of Rock Roc Biotechnology Co., Ltd in Qingdao. The pioneering pipeline RR-M01 has successfully entered the IIT clinical research stage in 2023. ROC ROCK Biotechnology will continue to promote the research, development, and application of CAR-M cell therapy, providing safer and more effective treatment options for patients with solid tumors, improving their quality of life, and extending their survival period.

According to WHO (World Health Organization) data, there were 19.758 million new cancer cases globally in 2021, of which approximately 1.305 million were new cases of hematological tumors, accounting for less than 10%. The remaining 90% were new cases of solid tumors. Based on market data and the Delphi expert judgment method, by 2025, the sales revenue of China's anti-tumor drug market is estimated to be between 224.2 billion and 294.5 billion yuan, with drugs for solid tumors representing a huge economic market volume.

ROC ROCK Biotechnology is a biotechnology company focused on the research, development, and production of macrophage-based drugs targeting solid tumors. The company is committed to promoting the industrialization of macrophage drugs in the field of targeted solid tumor therapy. With multiple pipelines in place, the company focuses on the treatment of solid tumors, covering indications for 90% of solid tumor types. Its lead pipeline, RR-M01, is a third-generation chimeric antigen receptor macrophage (CAR-M) drug independently developed for HER2-positive solid tumors. Indications for RR-M01 include recurrent and refractory solid tumors such as HER2-positive ovarian cancer, gastric cancer, breast cancer, cervical cancer, endometrial cancer, lung cancer, and pancreatic cancer.

ROC ROCK Biotechnology's independently developed third-generation CAR-M originated in 2010. It added the cytokines necessary for the autologous proliferation and activation of macrophages in tandem to the original CAR, enhancing the persistence of CAR-M in vivo, altering the tumor microenvironment, and further strengthening the phagocytosis, tumor-killing, and antigen-presenting capabilities of macrophages. In 2023, ROC ROCK Biotechnology, in collaboration with the Affiliated Hospital of Xuzhou Medical University, launched an Investigator Initiated Trial (IIT) for the RR-M01 pipeline. The primary objective of this study is to evaluate the safety and efficacy of CAR-M cell therapy in treating HER2-overexpressing recurrent and refractory ovarian cancer.

RR-M01 Pipeline Successfully Enters IIT Clinical Research Stage in 2023 Due to Its Safety, Uniqueness, and Maturity: The World’s First Third-Generation Chimeric Antigen Receptor Macrophage Drug to Reach the IIT Phase

Dr. Yin Xiushan, Chairman of ROC ROCK BiotechnologyExpressed: heartfelt gratitude to Guozhu Capital for its recognition and trust in ROC ROCK Biotechnology, as well as to the existing shareholder Deshi Capital for its long-term trust and support. This round of financing will help advance the clinical development of the company’s key project pipelines. We will invest more energy and resources to accelerate the research and clinical application of CAR-M cell therapy technology. Since its inception, ROC ROCK Biotechnology has remained true to its original mission, shouldering the responsibility as a leader in the solid tumor treatment field, continuously increasing R&D investment, and concentrating top global scientific research forces to provide solid tumor treatment solutions at the fastest speed possible, offering safer and more effective options for cancer patients across China and even globally. Currently, the third-generation chimeric antigen receptor macrophage (CAR-M) drug RR-M01 injection independently developed by ROC ROCK Biotechnology has achieved 100% localization in process technology, meeting national strategic requirements for biopharmaceutical enterprises. In April 2023, ROC ROCK Biotechnology completed construction of its GMP production workshop, and within just six months successfully administered the first dose to a subject in its IIT project, marking the official entry of ROC ROCK Biotechnology into the clinical research stage.

Dong Xijie, General Manager of Qingdao Guozhu Asset Management Co., Ltd.Statement: As the lead investor in this round, we have high expectations for ROC ROCK Biotechnology's innovative R&D capabilities and development prospects in the field of cellular biology. Cell therapy, as an innovative technology in the medical field, offers personalized treatment that targets the pathological characteristics of patients more precisely compared to traditional surgery and radiochemotherapy for solid tumors, improving treatment efficacy. At the same time, it reduces damage to normal cells during the treatment process, lowers side effects and adverse reactions, further enhancing patients' quality of life. ROC ROCK Biotechnology has demonstrated tremendous potential in the CAR-M treatment of solid tumors. With over two decades of research experience in macrophages, the team has achieved breakthroughs in four major self-developed platform technologies, positioning ROC ROCK to potentially leapfrog competitors on the global solid tumor track. It is an innovative enterprise worthy of trust and investment. Qingdao Guozhu Asset Management Co., Ltd looks forward to a long-term collaboration with ROC ROCK Biotechnology to jointly advance the progress of cellular medicine.

As the exclusive financial advisor for this round of financing,Dr. Li Chaoxing, Chairman of Riemann-HypothesisWe have long been paying attention to and systematically analyzing the prospects of CGT in clinical applications. The CAR-M cell drug development that ROC ROCK Biotechnology focuses on is supported by the mature CAR technology and also benefits from the natural immune phagocytosis and distribution evolution advantages of macrophages, which provides more precise and thorough clearance capabilities for solid tumors in different tissues. The core team of ROC ROCK Biotechnology has long been committed to basic research in cellular immunity and has deep accumulation in the development and differentiation of macrophages, laying a more solid foundation for future R&D of CAR-M cell drug series with better tissue specificity and versatility. This is also the reason why Riemann-Hypothesis invested in incubation and continuously served as the exclusive financial advisor of ROC ROCK Biotechnology. Riemann-Hypothesis hopes to continue close collaboration with ROC ROCK Biotechnology in the future to jointly promote the use of CAR-M cell therapy to benefit more patients.

Qingdao Guozhu Asset Management Co., Ltd. (Guozhu Capital) was established in December 2019, engaging in equity investment, asset management, and industrial-financial services through state guidance and market-oriented operations. The company focuses on technological innovation and medical innovation, leveraging its fund cluster to optimize industrial investments while actively expanding its network of partners. It introduces high-quality collaborators to the Shibei District of Qingdao, promoting mutual growth. The company has become a key partner for top private equity firms like Shenzhen Capital Group, CDH Investments, and SAIF Partners within northern state-owned enterprises. Furthermore, it has fostered deep collaborations with leading industry groups such as China Mechanical Engineering Research Capital, SAIC Motor, CITIC Healthcare, BGI Group, and Far Eastern Group, initiating multiple industrial investment funds. Aligned with the strategic planning of Shibei District in Qingdao, the company concentrates on the "Two Belts, Three Zones" development layout and the "2+6" distinctive industry system, empowering industrial upgrades and investment attraction through capital. It provides robust investment and financing support for building a prosperous, beautiful, and happy modern international urban district.

ROC ROCK Biotechnology, incubated in Berlin, Germany, was founded in Shenzhen, China in April 2021. It has currently completed a tripartite layout that includes the Shenzhen Information Center in China, the Suzhou Production Center in China, and the Berlin International Center abroad. ROC ROCK Biotechnology is a biomedically strategic high-tech enterprise established by Chinese scientists who returned from Europe, in collaboration with PhDs from leading institutions such as Sweden’s Karolinska Institutet, the European Molecular Biology Laboratory, the German National Center for Molecular Medicine, and various pharmaceutical companies. The company leverages over a decade of cutting-edge scientific research achievements from its team. ROC ROCK Biotechnology focuses on macrophage-based immunotherapy, actively advancing the research and development and industrialization of the innovative CAR-M (Chimeric Antigen Receptor Macrophages) technology, aiming to build a world-leading closed-loop industrial chain and position Chinese domestic enterprises at the forefront of the global macrophage-based solid tumor treatment field.