Xuanzhu Biopharm seals exclusive Thailand deal with Innobic for Bireociclib commercialisation through 2036

Bulletin Express
Sep 03

Xuanzhu Biopharmaceutical Co., Ltd. (Xuanzhu Biopharm; stock name: XUANZHUBIO-B) has entered into a tri-party commercial agreement with Thailand-based Innobic (Asia) Co., Ltd. and Hong Kong-registered ZaoAn International Trading Co., Ltd. to market Bireociclib Tablets in Thailand until 30 June 2036.

Under the agreement, Xuanzhu Biopharm grants Innobic (Asia) and ZaoAn International exclusive rights to import, promote, sell and distribute Bireociclib in Thailand. Innobic (Asia) will serve as the Marketing Authorisation Holder, managing regulatory submissions to the Thai Food and Drug Administration (TFDA) and overseeing local commercial operations. ZaoAn International assumes intermediary and primary payment responsibilities for product purchases, while Xuanzhu Biopharm will supply finished product at agreed prices.

Commercial terms feature: • Up-front and milestone licence fees payable by Innobic (Asia) to Xuanzhu Biopharm upon contract signing and upon TFDA approval. • Contractual minimum annual purchase quantities. • Joint and several liability of Innobic (Asia) and ZaoAn International for their obligations.

The partnership targets Thailand, a key member of the Pharmaceutical Inspection Convention and Co-operation Scheme (PIC/S), as Xuanzhu Biopharm accelerates its expansion across Southeast Asia to enhance product reach and corporate brand value.

Bireociclib (trade name: Xuan Yue Ning) is China’s first CDK2/4/6 inhibitor. Approved by the National Medical Products Administration in May 2025 for use with fulvestrant and as monotherapy in HR+/HER2- advanced or metastatic breast cancer, it gained a further indication in March 2026 for combination with aromatase inhibitors as first-line endocrine therapy. Both 2025 approvals were added to China’s National Basic Medical Insurance Drug List effective 1 January 2026. The drug’s multi-target mechanism is designed to curb tumour proliferation while reducing the hematologic toxicity typical of traditional CDK4/6 inhibitors.

Innobic (Asia) is a wholly owned subsidiary of PTT Public Company Limited, Thailand’s largest state-owned energy conglomerate, which reported revenue exceeding USD80.00 billion and a market capitalisation above USD33.00 billion. ZaoAn International, established in Hong Kong in September 2021, specialises in cross-border pharmaceutical trade.

Xuanzhu Biopharm cautions that TFDA approval timelines and subsequent licence-fee and purchase-order payments remain subject to regulatory and commercial outcomes. As the agreement represents routine revenue-generating activity, it does not constitute a notifiable transaction under Chapter 14 of the Hong Kong Listing Rules.

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