China Bio-Pharma: Enters Cooperation Agreement with Stella Pharma on Boron Neutron Therapy Drug

China Bio-Pharma Holdings Limited announced on August 12 that the company, Pengbo (Hainan) Boron Neutron Medical Technology Co., Ltd., and Japan's Stella Pharma Corporation signed a legally binding Master Cooperation Agreement on August 11, 2026, to jointly advance the development and commercialization of Steboronine in China. Steboronine is described in the announcement as the world's first approved boron neutron therapy drug, applied in Boron Neutron Capture Therapy (BNCT).

Under the agreement, the cooperation between the two parties is divided into a development phase and a commercialization phase. During the development phase, the cooperation aims to leverage real-world data, real-world evidence, and real-world studies generated by the China Bio-Pharma Group to facilitate Stella Pharma in obtaining and maintaining, as soon as possible, marketing approval from the National Medical Products Administration (NMPA) for Steboronine for the treatment of head and neck cancer; after Stella Pharma obtains marketing and manufacturing approval from the Japanese government for Steboronine for meningioma, the relevant China filings may also be extended to the meningioma indication.

Stella Pharma has granted the China Bio-Pharma Group an exclusive, non-transferable, non-sublicensable, royalty-free license to use its prior data package for the development of Steboronine in China, excluding manufacturing activities. The China Bio-Pharma Group will act as the filing agent on behalf of Stella Pharma in submitting relevant regulatory filings to the National Medical Products Administration. During the development phase, Stella Pharma shall not appoint any third party other than the Group as the domestic agent and general import agent for Steboronine in China.

In the commercialization phase, upon Stella Pharma obtaining approval from the National Medical Products Administration, Pengbo (Hainan) will automatically become the exclusive domestic agent for Steboronine in China; China Bio-Pharma or its designated controlled entity will automatically become the exclusive general import agent and distributor for the drug in China. Stella Pharma will supply Steboronine to Pengbo (Hainan), China Bio-Pharma, or their designated entities for distribution and sale within China. The exclusive distribution right has an initial term of ten years from the date of NMPA approval, and may be automatically renewed for successive five-year periods upon the achievement of specific procurement targets.

According to the announcement, the Master Cooperation Agreement takes effect from the date of signing and remains in force until ten years after Stella Pharma obtains NMPA approval; if the exclusive distribution term is extended, the agreement term will be extended accordingly. If Stella Pharma fails to obtain NMPA approval within ten years from the date of the agreement, the agreement term will terminate upon the expiry of that ten-year period.

China Bio-Pharma stated that the Pengbo Hainan Boron Neutron Hospital, its flagship project located in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, commenced trial operations in February 2026, began its first patient treatments in March 2026, and had completed dozens of treatments as of the announcement date. The company stated that this cooperation will advance the regulatory approval and commercialization process of Steboronine in China and accelerate its upstream positioning in boron neutron therapy.

Original announcement: