On April 9, 2026, Xuanzhu Biotech Co., Ltd. (hereinafter referred to as "Xuanzhu Biotech") and Boston Oncology CGT Holding Co. Limited (hereinafter referred to as "Boston Oncology") jointly announced that they had entered into exclusive licensing and supply agreements for two Class 1 innovative drugs independently developed by Xuanzhu Biotech: Bireociclib Tablet (brand name: Xuanyuening®) and Dirozalkib Tablet (brand name: Xuanfeining®).

Under the terms of the officially signed agreement, Boston Oncology will be granted an exclusive license to develop, register, and commercialize (including import, export, marketing, promotion, distribution, and other commercial activities within the MENA region) two products across more than 20 countries in the Middle East and North Africa. Xuanzhu Biotech will receive an upfront payment from Boston Oncology, subsequent regulatory and commercial milestone payments potentially exceeding US$100 million, as well as royalty payments calculated as a fixed percentage of total sales within the authorized region. Xuanzhu Biotech shall supply the products to Boston Oncology at the agreed
supply prices to support future commercial development activities for both drugs in the authorized area.
This collaboration represents another key strategic move by Xuanzhu Biotech in expanding its presence in overseas markets. By leveraging the licensee's established pharmaceutical registration, commercialization, and distribution networks in the Middle East and North Africa regions, the company can accelerate the market launch and commercialization of pilocarpine tablets and diloxacin tablets across authorized territories, thereby enhancing the global reach and brand influence of its innovative drugs. Additionally, compliance with this agreement will generate sustained milestone payments and royalty revenues, optimizing the company's revenue structure and serving the overall interests of both the company and all shareholders. Previously, the company had secured exclusive licensing agreements for pilocarpine tablets with other partners in five countries within the Eurasian Economic Union. Going forward, the company will continue to expand regional licensing of mature pharmaceutical products worldwide to achieve a diversified global presence.
Regarding Pirrolizide Tablets
Piroxicil Tablets (brand name: Xuanyuening®), as the first approved CDK2/4/6 inhibitor in China, features a unique multi-target synergistic mechanism of action, offering significant advantages such as potent inhibition of tumor cell proliferation and markedly reduced hematological toxicity commonly associated with conventional CDK4/6 inhibitors. Piroxicil Tablets were approved by the China National Medical Products Administration in May 2025 and March 2026, respectively, for use in combination with fluvistatin in patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer who experienced disease progression after prior endocrine therapy; as monotherapy in HR+/HER2-advanced or metastatic breast cancer patients who developed disease progression after receiving two or more prior endocrine therapies plus one chemotherapy regimen; and in combination with an aromatase inhibitor (AI) as first-line treatment for HR+/HER2-advanced breast cancer, making it the first and only CDK2/4/6 inhibitor approved for monotherapy indication in China. In December 2025, both indications for Piroxicil Tablets approved in May 2025 were included in the National Essential Medicines List for Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance (2025), effective January 1, 2026.
Regarding Diluoke Tablets
Diloxacin Tablets (brand name: Xuanfeining®), as a new-generation ALK inhibitor, exhibits stronger affinity for the ATP-binding site within the ALK kinase domain and demonstrates potent inhibitory activity against common resistance mutations in both first-generation and most second-generation ALK-TKIs, including G1202R and I1171N. Additionally, it achieves significant intracranial antitumor efficacy through efficient penetration of the blood-brain barrier. Diloxacin Tablets were approved by the China National Medical Products Administration in August 2025 as a monotherapy for ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who have not received prior treatment with an anaplastic lymphoma kinase (ALK) inhibitor.
Regarding the licensed partner:
Boston Oncology CGT Holding Co. Limited is headquartered in Cambridge, Massachusetts, USA, with a regional center in Riyadh, Saudi Arabia. The company specializes in the localized development and manufacturing of oncology drugs and biosimilars. Through drug licensing agreements, technology transfer, and regional production, it introduces high-quality products and manufacturing systems to the Middle Eastern market, continuously enhancing the local supply of essential therapeutic agents and fostering collaborative growth within the regional pharmaceutical industry.
About Xuanzhu Biology:
Xuanzhu Biotech (Stock Code: 02575.HK) is an innovative pharmaceutical company rooted in China with a global vision, focusing on major disease areas such as digestive disorders, oncology, and non-alcoholic fatty liver disease. The company is dedicated to the research, development, production, and commercialization of Class 1 new drugs based on core proprietary technologies. It boasts a top-tier R&D team, with key members possessing extensive experience in new drug development. As a cutting-edge player in commercially viable innovative drugs driven by R&D and AI empowerment, the company has established a unique product pipeline that encompasses small-molecule chemical drugs, large-molecule biologics, antibody-drug conjugates, and more—a rarity in China. Guided by unmet clinical needs, the company strives to become a leading innovative pharmaceutical enterprise with comprehensive capabilities in independent R&D, production, and sales.