GenCore BioPharma Secures Nearly RMB 100 Million Series A Funding to Accelerate Global Clinical Development of TRT Therapeutics

On July 26, 2024, Bivision Pharmaceuticals, a biotechnology company specializing in integrated visualized diagnosis and treatment-targeted radionuclide therapy (TRT), announced the completion of its Series A financing round. The round was co-led by Huajin Investment and Huajin Avenue Investment Co., Ltd., with participation from Tigermed, while existing investors Gaorong Ventures and Lichen Capital continued their investment.

The financing proceeds will be primarily used to fund the global Phase I/II clinical trials of JH02, the Investigational New Drug (IND) applications and clinical development of 68Ga-JH03/177Lu-JH04 in China and the United States, as well as preclinical research on multiple subsequent innovative pipeline candidates and international collaborations.

Bivision Pharmaceuticals, established in 2021 by four seasoned scientists specializing in targeted radiopharmaceuticals, possesses extensive experience in the development and successful commercialization of multiple innovative radiopharmaceuticals. The company is dedicated to developing next-generation Targeted Radionuclide Therapy (TRT) to improve patients’ quality of life.

Targeted radiopharmaceuticals couple targeting molecules with radionuclides via linking agents, enabling precise delivery to systemic lesions. Through the decay of radionuclides, these agents facilitate the integration of visualized diagnosis and therapy.

To date, Bivision Pharmaceuticals has established a proprietary technology platform for the development of targeted radiopharmaceuticals, dedicated to ligand screening, modulation of coupling factors (J-Linker), and clinical translation. Through its J-Linker multifunctional conjugation platform, the company can effectively increase drug exposure at disease sites while reducing exposure in other organs, thereby delivering enhanced therapeutic efficacy and a wider safety margin for Bivision Pharmaceuticals’ pipeline candidates.

In July 2023, JH02, a therapeutic candidate independently developed by Bivision Pharmaceuticals with global rights, officially received implicit approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration to initiate clinical trials. This milestone made Bivision Pharmaceuticals the first company in China to obtain regulatory approval for dual filings in both China and the United States within the targeted radionuclide therapy (TRT) pipeline. In December 2023, the first patient was successfully dosed in the Phase I clinical trial of JH02. JH02 is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Compared with similar foreign products, JH02 demonstrates significant advantages, including enhanced safety, superior efficacy, and a more streamlined manufacturing process, offering promising new therapeutic options for patients.

Furthermore, Bivision Pharmaceuticals' multi-indication theranostic molecule for solid tumors⁶⁸Ga-JH03/¹⁷⁷Lu-JH04 has also entered the IND application phase.

Dr. Yu Haihua, Founder and CEO of Bivision Pharmaceuticals, stated, “Successfully closing this financing round in the current counter-cyclical environment fully demonstrates the recognition by renowned investment institutions of Bivision Pharmaceuticals’ technology platform and team. We extend our sincere gratitude to our new shareholders for their support and affirmation, as well as to our existing shareholders for their consistent trust and continued support. We remain committed to advancing the global R&D of our dual-driven pipeline, focusing on both Best-in-class (BIC) and First-in-class (FIC) assets, with the aim of delivering novel and effective therapeutic agents to patients at the earliest opportunity, thereby addressing unmet clinical needs.”

Huajin Investment stated, “We are deeply honored to participate in Bivision Pharmaceuticals’ current funding round. Targeted Radionuclide Therapy (TRT) represents a significant innovation in targeted oncology treatment. TRT drugs combine the properties of radionuclides with the precision of targeted therapies, offering new possibilities for cancer treatment. With the maturation of the radionuclide raw material supply chain and improved convenience in clinical administration, the TRT sector holds immense development potential. The founding team of Bivision Pharmaceuticals is an experienced and pragmatic R&D group dedicated to TRT drug development, known for its efficiency. Their unique technology platform will drive continuous product innovation. Huajin looks forward to collaborating closely with the company, integrating resources from all parties, and fully supporting the growth of Bivision Pharmaceuticals.”

Huajin Avenue Investment Co., Ltd. stated, “TRT drugs have demonstrated unique advantages in tumor diagnosis and targeted therapy, making this field one of the hottest areas of research. The core team at Bivision Pharmaceuticals possesses extensive experience in TRT drug development, with its lead candidate JH02 having simultaneously received Investigational New Drug (IND) approval in both China and the United States and entered the clinical trial phase. We believe that Bivision Pharmaceuticals will leverage its exceptional team and advanced TRT drug development platform to continuously drive R&D innovation, develop more TRT drugs, and enable more cancer patients to benefit from advancements in biopharmaceutical technology.”

Dr. Liu Jingyi of Gaorong Ventures stated, “Bivision Pharmaceuticals boasts a world-class international R&D team and a global perspective on innovation. Since its establishment, the company has rapidly advanced its Best-in-Class (BIC) pipeline while maintaining highly efficient progress in First-in-Class (FIC) research and development. Its PSMA-targeted prostate cancer project has received Investigational New Drug (IND) approval in both China and the United States, with clinical progress ranking among the top tier domestically. It has the potential to become the first domestic BIC innovative drug in this field, and its other FIC pipeline candidates also hold significant potential for global expansion. We are firmly optimistic about Bivision Pharmaceuticals’ development prospects in targeted radiopharmaceuticals and look forward to delivering better, more accessible innovative therapies to cancer patients.”

Huajin Investment is an investment platform under Huafa Group, a leading state-owned enterprise in Zhuhai and one of China’s Top 500 Enterprises. As the largest comprehensive corporate group in Zhuhai, Huafa Group reported total assets exceeding RMB 732 billion by the end of 2023, ranking 169th among the “Top 500 Chinese Enterprises.” It has been selected as one of the “Double Hundred Enterprises” for State-Owned Enterprise Reform by the State Council and recognized as a national benchmark. In the field of industrial investment, Huafa Group focuses on core sectors such as semiconductors, new energy, and healthcare. Its investment entities include platforms such as Huajin Capital, Infinity Equity, Zhuhai Science and Technology Innovation Investment, and Zhuhai Fund. In 2023, Huajin Capital ranked 15th in Zero2IPO’s “Top 100 Private Equity Firms in China.” To date, Huafa Group has invested in over 400 industry-leading and high-growth innovative companies, with total investments exceeding RMB 36 billion; 107 of these portfolio companies have either gone public or passed listing reviews. Huafa Group’s portfolio includes Gokin Solar, Aiko Solar, Qinghai Lihao, Zhuhai CosMX, Changyuan Lico, Mengu Li, Qizhong Technology, Jingsheng Shares, Chipsea Technologies, MGI Tech, Mabwell Therapeutics, Frontier Biotechnologies, Kintor Pharmaceutical, Haisco Pharmaceutical, and others.

Huajin Avenue Investment Co., Ltd. is a wholly-owned subsidiary of Huajin Securities, with its headquarters in Shanghai. As a core member of the financial industry cluster under Zhuhai Huafa Group, Huajin Securities is a fully licensed securities company. Leveraging the strategic location of Hengqin, Zhuhai, it has established a development positioning characterized by “regional focus, industrial focus, distinct features, and high-quality assets.” In recent years, Huajin Securities has won numerous industry awards, including “Most Growth-Oriented Securities Company of the Year” and “Outstanding Brokerage Firm of the Year,” steadily enhancing its market position. It currently operates nearly 20 branch offices and more than 30 brokerage business outlets across China. Huajin Securities provides high-quality, comprehensive services to support national strategic priorities and actively contributes to the development of the real economy.

Lichen Investment is composed of a professional team with years of experience in industry and investment, focusing on early-stage investments in the innovative biopharmaceutical sector. Guided by the imperative to meet unmet clinical needs, we aim to partner with enterprises and entrepreneurs possessing independent intellectual property rights and globally leading technologies. By growing together with our partners, we strive to develop optimal products and solutions that deliver tangible clinical benefits, thereby benefiting patients and society.

Gaorong Ventures, established in 2014, specializes in early-stage and growth-stage investments, with a focus on innovative ventures in emerging technologies, healthcare, the internet, and new consumption sectors. To date, 24 companies invested in or held by Gaorong have completed their initial public offerings, with many growing into industry leaders, including Pinduoduo, BOSS Zhipin, Roborock, Huya Live, and ProfoundBio. Gaorong remains committed to the healthcare sector, identifying and supporting leading enterprises in areas such as new drug development, medical devices and diagnostics, digital health, and healthcare services.