Genovate Biotechnology (listed biotech stock) announced on the evening of October 1 that, over the next two years, it and its investment partners plan to advance three products to the submission and approval stage with the U.S. FDA or Japan PMDA, requiring substantial funding for production, manufacturing, and marketing channel planning. To support this, Genovate has launched a private placement, issuing 80,000 shares to attract strategic partners and expand its market presence.

Genovate stated that its management team has always adhered to pharmaceutical industry fundamentals, continuously developing new products in Taiwan and overseas, and producing high-quality, innovative medicines for domestic and international patients. However, following the recent public tender offer by Janssen Biotech to acquire Genovate shares, concerns have arisen because the tender offer prospectus did not clearly specify the “plans for continuing the acquired company’s operations,” leaving uncertainty about whether Janssen’s involvement might alter or even terminate Genovate’s long-term strategic plans.

The company emphasized that any major shift in business direction at this stage could hinder the steady advancement of long-term strategies and adversely affect existing shareholders’ interests. Therefore, Genovate is initiating the private placement to consolidate strategic partners and pursue international opportunities, ensuring a sustainable development plan for the biotech sector.

Over the next two years, Genovate and its investment partners will advance three products to the FDA or PMDA submission and approval stage. To execute this, funding is required for production, manufacturing, and marketing, motivating the current private placement to attract strategic partners and expand market potential.

The three major initiatives are as follows:

1. New Injection Facility in Hsinchu Biomedical Park: On June 12, 2023, Genovate obtained approval from the National Science and Technology Council’s Hsinchu Science Park Administration to build a new injection facility in the Fourth Biomedical Building of the Zhubei Biomedical Park, with an estimated investment exceeding NT$1.2 billion. The facility will support the co-development of Bevacizumab injections combined with NaviFUS for the treatment of recurrent brain cancer in collaboration with Haoyu. Genovate will handle the biosimilar production of Bevacizumab injections and develop new therapeutic applications.
   
2. Flagship Product PMR: PMR is in the final NDA submission preparation stage with the U.S. FDA. To ensure successful manufacturing and commercialization in the U.S., Genovate began discussions two years ago with domestic partners that operate FDA-compliant GMP facilities in the U.S., establishing close collaboration to support PMR’s international market entry.
   
3. Immune Cell Therapy: Recognized as a key focus of the biotech industry, Genovate invested in Junten Bio in Japan earlier in 2025, primarily to support its world-leading candidate JB-101. JB-101 has received SAKIGAKE Designation from the Japanese Ministry of Health, Labour and Welfare (MHLW), accelerating regulatory review, and is currently in the final stage of pivotal clinical trials in Japan. PMDA approval is expected next year. Genovate has secured exclusive rights for development, manufacturing, and sales in Taiwan and plans to introduce JB-101 locally to benefit liver transplant patients, potentially allowing lifelong independence from immunosuppressants.
   

Genovate emphasized that its core competencies include GMP manufacturing, dosage form development, clinical trial design and execution, and regulatory strategy and approval. The private placement will follow regulatory procedures under “Guidelines for Private Placement of Securities by Public Companies” and attract legally defined strategic investors. By integrating upstream and downstream partners’ technologies, Genovate aims to accelerate product commercialization, expand its market internationally, and enhance shareholder value through strategic funding and close future collaboration.

Resource: 健亞私募引進策略夥伴 三大計畫加速產品進入國際市場