Koka Life Sciences Secures RMB 350 Million in Pre-C Round to Accelerate Pivotal Clinical Trials of Cardiac Valve Devices

VCBeat learned firsthand that,Kokai (Nantong) Life Sciences Co., Ltd. (hereinafter referred to as "Kokai Life Sciences") announced that it has secured RMB 350 million in its Pre-C funding round.This round of financing was led by BOCG Blue Ocean Capital and the Shanghai Free Trade Zone Fund, with follow-on investments from Zhangke Herun Fund, Xingzheng Capital, Huayi Capital, Nantong Industry Holding Group, Jointown (Chuchang Investment), and the Shenzhen Major Industrial Investment Fund. Existing shareholder Guozhong Capital continued to increase its investment. The proceeds from this round will be used to accelerate the ongoing large-scale clinical trial program for existing cardiac valves, sustain investments in clinical trial applications and confirmatory clinical trials for heart valves, advance the R&D of the subsequent innovative product pipeline, and support potential strategic partnerships.

According to reports, Kokai Life Sciences is an innovative Chinese enterprise dedicated to the research and development of therapeutic products for structural heart disease. The company has developed multiple cardiovascular interventional products with proprietary intellectual property rights. Currently, several of its products have completed design finalization and undergone multiple rounds of animal testing, preliminarily verifying their safety and efficacy. Notably, the company’s first interventional product, the LIFECLIP® mitral valve repair system, entered the formal clinical trial phase for regulatory registration in July this year.

Transcatheter valve intervention is another highly promising sector in interventional therapy following the TAVR industry. As the industry is still in its early stages, the gap between companies in China and overseas is relatively narrow. In the future, leading Chinese-produced enterprises are expected to emerge in the valve intervention market, capturing shares of the vast markets both in China and overseas. The world's first transcatheter mitral valve intervention product, MitraClip, has been commercially available for over a decade. Having evolved through four generations and treated more than 100,000 patients, it has become the most widely adopted mitral valve therapy. We anticipate that edge-to-edge repair technology will continue to lead the sector in the short to medium term.

Targeting patients with mitral regurgitation who are at high or prohibitive surgical risk, contraindicated for surgery, or unable to tolerate surgical intervention, Kokai Life Sciences has independently developed the LIFECLIP® Mitral Valve Repair System. Built upon the edge-to-edge repair principle, this repair device is specifically tailored for Chinese patients. To date, multiple patients have been enrolled in clinical studies with the product. Postoperative outcomes demonstrate a significant improvement in mitral regurgitation severity, with no complications observed, preliminarily confirming the clinical safety and efficacy of LIFECLIP®.

From a clinical product development perspective, in addition to LIFECLIP® successfully progressing through R&D and entering clinical trials, Kokai Life Sciences’ flagship transfemoral mitral valve repair system KokaClip® and transfemoral replacement valve KokaValve® both possess unique technical advantages and features. Both have passed ethical review and are about to enter clinical trials. The company also maintains a mitral annuloplasty repair technology platform, and its mitral annuloplasty production facility has received project approval from Zhangjiang Park. With a solid technical foundation in product innovation and portfolio development, coupled with flexible and diverse R&D methodologies, the company continuously develops more novel medical devices produced in China, bringing benefits to a wide range of patients with valvular heart disease.

Mr. Yang Feng, Founder of BOCG Blue Ocean Capitalstated: “Cardiovascular diseases, particularly heart valve diseases, are among the leading causes of morbidity and mortality worldwide, and significant unmet clinical needs remain. As a medical device company with a global vision, Kokai Life Sciences possesses a team with extensive industry experience and outstanding R&D and innovation capabilities in the field of structural heart health. BOCG Blue Ocean Capital is highly honored to lead this round of investment. Together with new and existing shareholders, we will jointly support Kokai in continuously innovating within the medical device sector, accelerating the clinical development and commercialization of its products, and providing patients worldwide with safer and more effective medical devices and treatment options.”

Mr. Wu Jianping, General Manager of the Shanghai Pilot Free Trade Zone FundStated: “We have been closely monitoring advancements in cutting-edge medical device technologies and are highly optimistic about the potential of valve repair systems, as well as the broad prospects for the transcatheter mitral valve repair system LIFECLIP® in clinical application. Kokai Life Sciences has accumulated profound expertise in heart valves and related fields, and is a medical device technology company with outstanding R&D capabilities. The Shanghai Free Trade Zone Fund is steadfastly committed to supporting and accompanying enterprises. We are deeply honored to grow alongside it and make greater contributions to the development of China's medical device industry!”

Head of Keherun Fund, Zhangstated: "We maintain a long-term positive outlook on the development of China's innovative medical devices and will continue to strategically invest in cutting-edge technological pathways within the medical device sector. Kokai Life Sciences boasts an exceptional R&D team and has developed a globally leading mitral valve repair system, while also making forward-looking strategic investments in valve replacement technologies. We look forward to Kokai Life Sciences becoming a world-class industry leader, delivering breakthrough products in heart valve therapies, and bringing new hope to patients as soon as possible."

Mr. Xiang Jun, Vice President of Xingzheng Innovation Capitalstated: "With advancements in medical device technology, the unique advantages in the field of valve repair systems are becoming increasingly prominent. Leveraging its leading practical experience in mitral valve repair system development and robust innovation capabilities, the Kokai Life Sciences team is emerging as one of the leading enterprises in this sector in China. Over the past three years, Kokai Life Sciences has achieved growth beyond expectations, demonstrating exceptional performance across multiple dimensions including pipeline R&D, clinical development, manufacturing readiness, commercial operations, and financing capabilities. We are delighted to participate in the company's accelerated development and look forward to Kokai Life Sciences continuing to leverage technological innovation as its core foundation to lead the industry and benefit humanity."

Ms. Tong Zhang, Investment Manager at Guozhong Capitalstated: “The Kokai Life Sciences team demonstrates robust capabilities in its R&D pipeline and has earned recognition from leading investment institutions in China. In 2020, it was selected as a potential unicorn enterprise in China by GEI. Consistent with our established investment philosophy, Guozhong has made successive follow-on investments in the company, striving to honor our commitment to accompany its growth as a long-term partner. We will continue to join hands with Kokai Life Sciences to contribute to the advancement of human health.”

Kokai (Nantong) Life Sciences Co., Ltd. was established in September 2018. It is a high-tech enterprise integrating the R&D, production, and sales of medical devices, specializing in the structural heart disease field. The company develops systematic solutions for valvular heart diseases tailored to different patient populations, diverse clinical needs, and various application scenarios. Anchored by a core technical team of R&D professionals repatriated from the United States and Germany, the company boasts decades of development and research experience in the cardiac medical field. Its technological capabilities maintain an absolute leading position in China and are fully aligned with the world’s most advanced cardiac treatment technologies. In 2021, the company was selected for the "Top 100 Innovative Medical Devices in China," organized by the Zhong Nanshan Medical Foundation and other institutions, and was previously recognized as a "GEI China Potential Unicorn Enterprise" in 2020.

BOCG Blue Ocean Capital focuses on growth-stage and M&A investments in innovative biopharmaceutical and medical device companies within the healthcare sector. The core team possesses extensive international experience in scientific research, industry operations, and investment, manages multiple dual-currency RMB and USD funds, and has been repeatedly recognized with industry accolades for its investment track record. Committed to deep investment and value creation, BOCG Blue Ocean Capital drives positive transformations for portfolio companies and generates long-term value for investors through highly effective investment management. Recent investment cases include HighTide Therapeutics, a clinical-stage biopharmaceutical company dedicated to the R&D of innovative novel drugs for chronic liver diseases, gastrointestinal disorders, and metabolic conditions; Suzhou Ribo Biotechnology Co., Ltd. (Ribo Life Science), a biopharma R&D enterprise specializing in oligonucleotide innovative technologies and the development of oligonucleotide therapeutics; and Bo’an Biotech, a comprehensive biopharmaceutical company focused on therapeutic antibody development, with core expertise in oncology, autoimmune diseases, pain management, and endocrine disorders.

Against the new national backdrop of establishing pilot free trade zones, comprehensively deepening reform, and expanding opening-up, the Shanghai FTZ Fund is China’s first FTZ-themed investment fund, approved and established by the Administrative Committee of the China (Shanghai) Pilot Free Trade Zone. Co-initiated and established in 2015 by a financial holding group under the Ministry of Finance alongside key entities responsible for developing the core functions of Shanghai as an international financial, shipping, and trade center, the Fund emphasizes industry-finance integration and central-local cooperation. It serves as a market-oriented comprehensive investment platform that efficiently aggregates industrial and financial resources within the Shanghai FTZ and the Yangtze River Delta region.

Xingzheng Innovation Capital Management Co., Ltd. (hereinafter referred to as "Xingzheng Capital") is a wholly-owned private equity investment fund subsidiary established by Industrial Securities Co., Ltd. (SH: 601377). Formerly the Direct Investment Department of Industrial Securities, it managed its first equity investment fund through financial advisory services in 2008, was approved to conduct direct investment business in 2010, and officially became a subsidiary of Industrial Securities in April 2010. With a registered capital of RMB 700 million, the company is registered in Fuzhou, Fujian Province, and its business scope covers private equity investment fund business.

The Zhangke Herun Fund is managed by Zhangjiang Sci-Tech Investment, a wholly-owned subsidiary of Zhangjiang Group. The fund primarily focuses on high-quality enterprises with growth potential in life and health-related industries, including innovative drugs, medical devices, and healthcare services. Backed by the Pudong Sci-Tech Innovation Fund of Funds as its cornerstone investor, the Zhangke Herun Fund operates as a sub-fund that integrates social capital and professional expertise through market-oriented investment and management. By employing a more market-aligned mechanism and an optimized investment process, the fund aims to meet the growing financing demands of sci-tech SMEs, thereby driving leapfrog development in technological innovation.

Guozhong Capital currently manages two operating funds under the National SME Development Fund. Its subsidiary, Guozhong Venture Capital (i.e., Shenzhen Guozhong Venture Capital Management Co., Ltd.), manages the first operating fund of the National SME Development Fund, while Guozhong Changrong (i.e., Shenzhen Guozhong Changrong Asset Management Co., Ltd.) manages the Phase II Fund. The combined assets under management (AUM) exceed RMB 10 billion. Advocating a research-first investment philosophy that integrates research with investment, Guozhong Capital leverages in-depth industry chain research to guide its investment decisions. It focuses on opportunities within strategic emerging industries, targeting outstanding enterprises in sectors including big data, cloud computing, cybersecurity, and enterprise services; semiconductors, electronic information technology, and artificial intelligence; new consumption and internet applications; new energy vehicles and intelligent driving; new materials, new energy, ecological conservation, and smart equipment; as well as biomedicine and healthcare.