Kunstone Biotech Secures Tens of Millions in Pre-A+ Financing, Achieves Major Breakthrough with Lead Pipeline

VCBeat learned at the first time,ROC ROCK BiotechnologySuccessfully completed byQingdao Yinghai Antai Equity Investment Partnership (Limited Partnership)Exclusive Investment of Tens of Millions of RMB in Pre-A+ Round Financing. This round of funding will accelerate the clinical trials and commercialization process of multiple products of the company, injecting strong momentum into the company’s future development. Previously, the company successfully completed an angel round led by Deshi Capital and a Pre-A round led by Huizhu Medical, with cumulative financing nearing 100 million RMB, demonstrating the high recognition from the capital market for ROC ROCK Biotechnology.

ROC ROCK Biotechnology, founded in 2021, is a clinical-stage company focused on the research and development of macrophage-based drugs for cancer and chronic diseases. It is also the only company in the world with a technology platform that integrates live cell factors in series and features gene editing, biomaterials, and synthetic biology-driven engineered macrophage technologies. The company has successively received honors such as National High-tech Enterprise, Key Leading Talent in Science and Technology of Suzhou Industrial Park, Science and Technology SME, Innovative SME, and Jiangsu Province Private Science and Technology Enterprise, and has undertaken national "Challenge Leader" technical research projects.

Since its establishment,ROC ROCK BiotechnologyFocus on the development and clinical application of macrophage-based drugs for cancer and chronic diseases, and actively promote the research and development and industrialization of Chimeric Antigen Receptor Macrophages (CAR-M). A preparation room meeting GMP standards with cleanliness laboratory specifications (B+A) has been established in Suzhou Industrial Park, and multi-center collaborations have been initiated with multiple global institutions to advance 9 CAR-M cell drug pipelines.

ROC ROCK Biotechnology has accumulated rich experience in macrophage engineering modification, bioinformatics analysis, and immune cell transdifferentiation. It has mastered several key CAR-M technologies, including engineered macrophage modification, CAR design, and viral vector modification, overcoming the challenge of difficult macrophage transduction. In the field of innovative therapies for solid tumors, it continues to make breakthroughs and steadily advances multiple important pipelines.

• HER2-Targeted Solid Tumor Pipeline:In 2023, clinical research was initiated at the Affiliated Hospital of Xuzhou Medical University, with the first patient enrolled in December of the same year. By the end of 2024, a total of 7 patients had been enrolled. In 2025, the focus will be on screening HER2+++ patients with peritoneal metastasis to accelerate progress toward the registration clinical stage. Concurrently, ethical approval will be completed at Jinan Junxin Tumor Hospital. Currently, somatic cell filing is underway, with plans to enroll the first patient at this center by June 2025.

  
  

• C-MET Target Pancreatic Cancer Pipeline:It has passed the ethical review of Peking Union Medical College Hospital, and the somatic cell filing process is proceeding in an orderly manner. The first patient enrollment is planned to start in June 2025.

  
  

• Prostate Cancer Pipeline:By the end of 2024, the project will be completed at a large hospital in Suzhou City, Jiangsu Province. It is currently in the ethical review stage, with an estimated enrollment of 3-5 patients by 2025.

ROC ROCK Biotechnology drives multi-target clinical layout with high execution efficiency, strictly adheres to ethical and regulatory requirements, and is committed to providing more precise treatment options for cancer patients, continuously strengthening its industry competitiveness.

ROC ROCK Biotechnology's Leading Pipeline RR-M01 Injection is an innovative drug meticulously developed for solid tumors. Its creation stems from the research team’s in-depth study and relentless exploration of cancer pathogenesis. Through a unique mechanism of action, RR-M01 Injection has the potential to precisely target cancer cells, inhibiting their growth and spread while minimizing damage to normal cells.

Compared with traditional treatment methods, RR-M01 injection has demonstrated higher efficacy and fewer side effects in preclinical studies, offering cancer patients a more effective and safer treatment option. To ensure the smooth progress of the RR-M01 injection IND application, the ROC ROCK Biotechnology research and development team worked day and night, conducting extensive preclinical research with outstanding results. The plan is to officially submit the application to regulatory authorities in 2025, with approval expected to be obtained in 2026.

ROC ROCK Biotechnology is dedicated to focusing on cell drugs targeting solid tumors, aiming to successfully launch two innovative drugs within 5-6 years. This will allow China to take the global lead in the field of macrophage therapy for solid tumors and become a leader in CAR-M, while relentlessly striving to extend the lifespan of each solid tumor patient by 24 years.

Sun Yahao, Head of Yinghai Antai InvestmentRepresentation: Yinhai Antai's strategic investment in ROC ROCK Biotechnology not only reflects the in-depth layout of the frontier track of macrophage therapy but also demonstrates the capital market's high recognition of ROC ROCK Biotechnology's technical barriers and commercialization prospects. As an investment institution focused on equity investment, Yinhai Antai's capital injection this time will accelerate the IND application process of ROC ROCK Biotechnology’s core pipeline RR-M01 and provide strong support for multi-center clinical research of pipelines such as C-MET targeted pancreatic cancer. What the investors value is not only ROC ROCK Biotechnology's globally leading CAR-M technology platform and nine differentiated pipeline layouts but also its team’s two-decade-long technical accumulation and precise clinical advancement capabilities in the macrophage field. This deep coupling of capital and technology will help China overtake on the curve in the field of solid tumor cell therapy, provide Chinese solutions for unmet global clinical needs, and assist domestic pharmaceutical enterprises in going global.

Chairman of ROC ROCK Biotechnology, Yin XiushanStatement: First of all, we would like to express our heartfelt gratitude to both new and existing shareholders for their comprehensive recognition and unwavering support of ROC ROCK Biotechnology and its team. Solid tumors and chronic diseases are two major global health challenges at present. Macrophages hold tremendous potential and unique advantages in addressing these issues. As a pioneering company in macrophage drug development, ROC ROCK Biotechnology has been deeply engaged in the field of macrophages for over 20 years, consistently adhering to fundamental technological innovation and utilizing platforms to accelerate the clinical progress of its pipelines. This round of financing will support the IND application for our M01 pipeline this year, as well as the initiation of a clinical trial targeting pancreatic cancer in collaboration with Peking Union Medical College Hospital. Meanwhile, our macrophage-based drugs targeting liver and lung fibrosis are also proceeding smoothly.