#Japan #Tokyo #Taiho Pharmaceutical #Risovalisib #Haihe Biopharma

Taiho Pharmaceutical and Haihe Biopharma's New Collaboration

On October 23, 2023, Taiho Pharmaceutical Co., Ltd., based in Chiyoda, Tokyo, announced a significant partnership with Haihe Biopharma Co., Ltd., headquartered in Shanghai, China. This collaboration pertains to the exclusive licensing of a promising drug, Risovalisib (development code CYH33), aimed at treating ovarian clear cell carcinoma.

Risovalisib, a selective PI3Kα inhibitor, is currently under regulatory review in Japan by Haihe's subsidiary, Haihe Pharmaceutical Co., Ltd., for approval as a novel treatment for this aggressive form of cancer. This licensing agreement enables Taiho Pharmaceutical to obtain exclusive rights for the development, manufacturing, and commercialization of Risovalisib in Japan. In return, Haihe Biopharma will receive an upfront payment, milestone payments related to development and sales, and royalties based on sales performance.

Understanding Risovalisib and Its Potential

Risovalisib is distinguished as a new selective PI3Kα inhibitor, a critical target in cancer therapy due to its involvement in several malignant processes. Specifically, it is designed for patients with ovarian clear cell carcinoma (OCCC), which frequently presents with mutations in the PIK3CA gene. This cancer type is notably rare and aggressive, occurring in an estimated 3,500 patients annually in Japan. The PIK3CA gene mutations are implicated in the tumorigenesis and progression of OCCC, making it a vital target for innovative treatments like Risovalisib.

As of August 2025, Haihe Pharmaceutical plans to submit an application for manufacturing and marketing authorization in Japan for Risovalisib. Furthermore, earlier this year in June, the Japanese Ministry of Health, Labour and Welfare recognized the drug as an orphan drug, highlighting its potential in addressing unmet medical needs.

Taiho Pharmaceutical's President, Masayuki Kobayashi expressed his enthusiasm over this collaboration, emphasizing the importance of collaborating with an established leader like Haihe Biopharma to provide new therapeutic options for patients affected by ovarian clear cell carcinoma. He stated, “We are thrilled to partner with Haihe Biopharma, which we have worked collaboratively with in the past. We hope that Risovalisib will offer new treatment opportunities for OCCC patients.”

Jian Ding, an Academician at Haihe Biopharma, echoed this sentiment, praising Taiho as a leading company in Japan's oncology sector and expressing his eagerness in working together to improve treatment outcomes for patients suffering from OCCC and other PIK3α-related disorders.

The Relevance of PI3Kα in Cancer

The phosphatidylinositol 3-kinase alpha (PI3Kα) protein plays a pivotal role in regulating essential physiological processes, including cellular proliferation, survival, and metabolism. Mutations in the PIK3CA and PIK3R1 genes can lead to aberrations in PI3Kα function, which are often observed in various cancers, including breast cancer, OCCC, and colorectal cancer.

Research has consistently demonstrated direct correlations between PIK3CA mutations and increased cancer aggressiveness, further establishing PI3Kα as a crucial target for cancer therapeutics. Additionally, the involvement of these mutations extends beyond oncology, suggesting broader implications in various diseases, as confirmed by extensive genomic studies.

Ovarian Clear Cell Carcinoma: A Unique Challenge

Ovarian clear cell carcinoma is a rare and highly malignant subtype of epithelial ovarian cancer, with patients typically showing resistance to existing therapies, including platinum-based chemotherapies. The need for effective treatments is pressing, given that established standard treatments are lacking for recurrent OCCC, resulting in a significantly poorer prognosis compared to other more common types of ovarian cancer.

The high frequency of PIK3CA mutations, reported at approximately 30-40% in OCCC cases, prompts researchers to consider this gene as a viable target for novel treatment approaches. Studies indicate that these mutations often occur in specific exons, triggering further activation of PI3Kα and promoting tumor growth. Thus, PI3Kα stands as a promising target for future OCCC therapies.

Company Profiles

Taiho Pharmaceutical

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is dedicated to enhancing public health through innovative research and the development of therapeutic solutions. Focused primarily on oncology and immunological diseases, Taiho is recognized as a leading company in Japan and is actively expanding its global reach. Taiho's commitment extends to improving patients' quality of life through consumer healthcare products. More information can be found at Taiho Pharmaceutical.

Haihe Biopharma

Haihe Biopharma is a global R&D-driven pharmaceutical company based in China, specializing in the development of innovative oncology therapies. The company aims to provide safe and effective treatment options for cancer patients worldwide and has a robust pipeline led by its recently established Japanese R&D base, Haihe Pharmaceutical Co., Ltd.

Taiho and Haihe's partnership marks a significant step towards offering vital new treatment options for patients facing serious health challenges, particularly in the realm of oncology.

With continued research and development, the combination of expertise from both companies aims to set new standards in cancer care and patient outcomes.