On 9 April 2026, Sihuan Pharmaceutical Holdings Group Ltd. (SIHUAN PHARM) announced that its non-wholly-owned subsidiary, Xuanzhu Biopharmaceutical Co., Ltd. (stock code: 02575.HK), has signed an exclusive licensing and supply agreement with Boston Oncology CGT Holding Co. Limited covering 21 Middle East and North Africa (MENA) markets. The agreement involves two proprietary oncology therapies—Bireociclib (Xuan Yue Ning) for HR+/HER2- advanced breast cancer and Dirozalkib (Xuan Fei Ning) for ALK-positive advanced non-small cell lung cancer (NSCLC).
Under the terms, Xuanzhu Biopharm will receive an upfront payment and additional regulatory and commercial milestone payments that together may exceed US$100.00 million. The company will also earn royalties based on a fixed percentage of product sales in the licensed territory and will supply finished products to Boston Oncology at agreed prices.
Management highlighted the transaction as a key step in executing the Group’s “innovation driven, global development” strategy. Leveraging Boston Oncology’s registration, promotion and distribution capabilities in the MENA region, Xuanzhu Biopharm aims to accelerate the commercial rollout of its two lead oncology assets, diversify revenue streams and expand global brand recognition.
Product profiles
• Bireociclib (CDK2/4/6 inhibitor) – First CDK2/4/6 inhibitor approved in China. – Indications: combination with fulvestrant (approved May 2025), monotherapy for HR+/HER2- advanced or metastatic breast cancer (May 2025), and combination with aromatase inhibitors for first-line treatment (March 2026). – Included in China’s National Basic Medical Insurance Drug List from 1 January 2026. – Demonstrates multi-target synergy and reduced hematological toxicity versus traditional CDK4/6 inhibitors.
• Dirozalkib (next-generation ALK inhibitor) – Approved August 2025 for ALK-positive locally advanced or metastatic NSCLC in treatment-naïve patients. – Engineered for strong ALK binding, activity against resistance mutations (e.g., G1202R, I1171N) and effective blood-brain barrier penetration.
Partner profiles
• Boston Oncology, headquartered in Cambridge, Massachusetts with regional operations in Riyadh, specializes in localized development, production and manufacturing of oncology drugs and biosimilars for the MENA market. • Xuanzhu Biopharm, listed on the HKEX in October 2025, operates dual R&D platforms for small molecules and biologics, with pipelines spanning oncology, digestion and NASH. • SIHUAN PHARM, listed since 2010, pursues a two-wheel strategy across medical aesthetics and biopharmaceuticals, supported by an extensive R&D and commercialization infrastructure.
The voluntary disclosure aims to update investors on the Group’s latest strategic progress; it contains no promotional claims regarding the use of the products.
Comments