Haihe Biopharma Co., Ltd. (hereinafter “Haihe”) and Taiho Pharmaceutical Co., Ltd. (hereinafter “Taiho”) (“HaiHe”) announced today that the two companies have entered into an exclusive license agreement regarding the development, manufacturing and commercialization of the PI3Kα (phosphatidylinositol 3-kinase alpha)inhibitor risovalisib (international nonproprietary name; development code: CYH33).

海和生物制药有限公司（以下简称“海和”）与大鹏药品工业株式会社（以下简称“大鹏”）今日宣布，两家公司已就PI3Kα（磷脂酰肌醇3-激酶α）抑制剂Risovalisib（国际非专利名称；研发代码：CYH33）的开发、生产和商业化达成独家许可协议。

Risovalisib is currently being submitted for manufacturing and marketing approval in Japan as a treatment for ovarian clear cell carcinoma by Haihe Biopharma K.K., a fully owned affiliate of Haihe..

里索瓦利西（Risovalisib）目前正由海和生物制药株式会社（Haihe Biopharma K.K.，海和的全资子公司）在日本提交用于治疗卵巢透明细胞癌的生产和上市批准申请。

Under the license agreement, Haihe will receive an upfront payment, development and sales milestone payments, and royalties based on sales revenue from Taiho, and Taiho will obtain exclusive rights in Japan to develop, manufacture and commercialize risovalisib.

根据许可协议，海和将获得首付款、开发和销售里程碑付款，以及基于大鹏制药销售额的特许权使用费，而大鹏制药将获得在日本开发、制造和商业化利索伐利司的独家权利。

Risovalisib is a novel, selective PI3Kα inhibitor developed by Haihe. In Japan, Haihe Biopharma K.K. submitted a New Drug Application in August 2025 for the anticipated indication of 'advanced or recurrent ovarian clear cell carcinoma harboring

Risovalisib是一种新型的、选择性的PI3Kα抑制剂，由海和生物开发。在日本，海和生物医药株式会社于2025年8月提交了新药申请，预期适应症为“携带特定基因特征的晚期或复发性卵巢透明细胞癌”。

PIK3CA

PIK3CA

gene mutations that has progressed after chemotherapy.' Risovalisib was granted orphan drug designation by the Ministry of Health, Labour and Welfare in June 2025 in Japan.

基因突变在化疗后进展。'Risovalisib于2025年6月在日本被厚生劳动省授予孤儿药资格。

Dr. Jian Ding from Haihe,  stated,

海河的丁健博士表示，

We are pleased to announce that we are entering into a partnership with Taiho, one of the leading oncology companies in Japan, regarding the PI3Kα inhibitor risovalisib. We hope our collaboration will be able to provide a promising treatment option for patients with ovarian clear cell carcinoma and other PI3Kα-associated diseases..

我们很高兴地宣布，我们将与日本领先的肿瘤公司之一大鹏制药就PI3Kα抑制剂risovalisib建立合作伙伴关系。我们希望我们的合作能够为卵巢透明细胞癌和其他PI3Kα相关疾病的患者提供一种有前景的治疗选择。

Masayuki Kobayashi, President and Representative Director of Taiho, stated,

Kobayashi Masayuki，Taiho公司的总裁兼代表董事表示，

We are pleased to announce that we will be entering into this partnership with Haihe, with whom we have already built a strong collaborative relationship. Through risovalisib, a new treatment option for patients with ovarian clear cell carcinoma, we will continue to work together with Haihe to further contribute to patients and healthcare professionals..

我们很高兴地宣布，我们将与海和建立合作伙伴关系，我们已经与海和建立了牢固的合作关系。通过risovalisib这一卵巢透明细胞癌患者的新治疗选择，我们将继续与海和携手合作，进一步为患者和医疗专业人员做出贡献。

About PI3Kα

关于PI3Kα

PI3Kα is protein that regulates key physiological processes such as cell proliferation, survival and metabolism. The function of PI3Kα is jointly regulated by the

PI3Kα是一种调节细胞增殖、存活和代谢等关键生理过程的蛋白质。PI3Kα的功能受到以下因素的共同调节：

PIK3CA

PIK3CA

(encoding the catalytic subunit) and PIK3R1 (encoding the regulatory subunit) genes. Mutations of both genes can lead to abnormal PI3Kα function, thereby causing a variety of diseases.

（编码催化亚基）和PIK3R1（编码调节亚基）基因。这两个基因的突变都可能导致PI3Kα功能异常，从而引发多种疾病。

In the field of cancer, activating mutations or gene amplification of

在癌症领域，激活突变或基因扩增

PIK3CA

PIK3CA

, as well as inactivating mutations or gene deletions of PIK3R1, can lead to overactivation of PI3Kα, promoting the occurrence and development of tumors such as breast cancer, ovarian clear cell carcinoma, and colorectal cancer. Therefore, PI3Kα becomes an important target for cancer targeted therapy..

，以及PIK3R1的失活突变或基因缺失，均可导致PI3Kα的过度活化，促进乳腺癌、卵巢透明细胞癌、结直肠癌等肿瘤的发生与发展，因此，PI3Kα成为肿瘤靶向治疗的重要靶点。

In addition, activating mutations of

此外，激活突变

PIK3CA

PIK3CA

or inactivating mutations of PIK3R1 are also associated with the occurrence of various non-tumor diseases, further highlighting the important role of PI3Kα in various diseases.

或PIK3R1的失活突变也与各种非肿瘤疾病的发病有关，进一步凸显了PI3Kα在多种疾病中的重要作用。

About ovarian clear cell carcinoma and

关于卵巢透明细胞癌和

PIK3CA

PIK3CA

gene mutations

基因突变

Ovarian clear cell carcinoma (OCCC) is a rare , highly aggressive subtype of epithelial ovarian cancer. Compared to the more common serous ovarian carcinoma, OCCC exhibit distinct molecular features and has significantly lower response rates to platinum-based chemotherapy. For recurrent OCCC, no standardized treatment regimen exists, and its prognosis for it is markedly worse than that of serous ovarian carcinoma, highlighting a significant unmet clinical need..

卵巢透明细胞癌 (OCCC) 是一种罕见且高度侵袭性的上皮性卵巢癌亚型。与更为常见的浆液性卵巢癌相比，OCCC 表现出独特的分子特征，并且对铂类化疗的反应率显著较低。对于复发性 OCCC，目前尚无标准化的治疗方案，其预后明显比浆液性卵巢癌差，凸显了亟待满足的临床需求。

Genomic studies have revealed that

基因组研究揭示了

PIK3CA

PIK3CA

mutations are highly prevalent in OCCC. These mutations are predominantly enriched in exon 9 (helical domain) and exon 20 (kinase domain), leading to aberrant activation of PI3Kα and its downstream signaling pathways, which drive OCCC tumorigenesis and progression. Therefore, PI3Kα represents a promising therapeutic target for OCCC..

OCCC中普遍存在突变，这些突变主要集中在外显子9（螺旋结构域）和外显子20（激酶结构域），导致PI3Kα及其下游信号通路的异常激活，从而驱动OCCC的发生和发展。因此，PI3Kα代表了OCCC的一个有前景的治疗靶点。

About Haihe Biopharma Co., Ltd.

关于海河生物医药科技有限公司

Haihe Biopharma Co., Ltd. is a global, innovation-driven biopharmaceutical company headquartered in China, with operational hubs in the United States and Japan. The company is dedicated to the development of cutting-edge anti-cancer therapies. With fully integrated capabilities spanning drug discovery, development, manufacturing, and commercialization, Haihe Biopharma aims to deliver life-saving treatments to cancer patients around the world and features a globally minded management and R&D team focused on in-house innovation.

海和生物制药有限公司是一家总部位于中国、业务遍及全球的创新驱动型生物制药公司，在美国和日本设有运营中心。该公司致力于开发前沿的抗癌疗法。海和生物制药具备覆盖药物发现、开发、生产及商业化的全方位整合能力，旨在为全球癌症患者提供挽救生命的治疗方案，并拥有一支注重内部创新、具有全球视野的管理与研发团队。

Currently, Haihe Biopharma has two approved products: Gumarontinib (INN), approved in both China and Japan, and paclitaxel oral solution (RMX3001/DHP107), approved in China, along with a robust pipeline of additional drug candidates. .

目前，海和生物已有两款获批产品：谷美替尼（INN），在中国和日本均获批；以及紫杉醇口服溶液（RMX3001/DHP107），在中国获批，同时还有多款药物候选品的强力研发管线。

About Taiho Pharmaceutical Co., Ltd. (Japan)

关于大鹏制药株式会社（日本）

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (https://www.otsuka.com/en/), is an R&D-driven specialty pharma focusing on the fields of oncology and immune-related diseases. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology, in particular, Taiho Pharmaceutical is known as a leading company in Japan for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts.

大鹏制药是大冢控股有限公司（https://www.otsuka.com/en/）的子公司，是一家以研发为导向的专业制药公司，专注于肿瘤学和免疫相关疾病领域。其企业理念体现为一句承诺：“我们致力于改善人类健康，为充满笑容的社会做出贡献。”特别是在肿瘤学领域，大鹏制药因开发创新型抗癌药物而被誉为日本的领先企业，凭借其广泛的全球研发工作，这一声誉正在迅速扩大。

In areas other than oncology, as well, the company creates and markets quality products that effectively treat medical conditions and can help improve people’s quality of life. Always putting customers first, Taiho Pharmaceutical also aims to offer consumer healthcare products that support people’s efforts to lead fulfilling and rewarding lives.

在肿瘤学以外的其他领域，该公司也创造和销售有效治疗疾病并有助于改善人们生活质量的优质产品。大鹏制药始终将客户放在首位，还致力于提供支持人们过上充实、有意义生活的消费者保健产品。

For more information about Taiho Pharmaceutical, please visit https://www.taiho.co.jp/en/ .

有关大鹏制药的更多信息，请访问 https://www.taiho.co.jp/en/。

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