CH BIOTECH SER (08037.HK): Enters master cooperation agreement with Stella Pharma to develop and commercialize Steboronine®, world's first approved BNCT drug, in China
NewTimeSpace News: On 12 August 2026, China Biotech Services Holdings Limited (stock code: 08037) announced that the Company, Pengbo (Hainan) Boron Neutron Medical Technology Co., Ltd. and STELLA PHARMA CORPORATION entered into a legally binding master cooperation agreement on 11 August 2026 for the development and commercialization of Steboronine® in China. Steboronine® is the world's first approved drug for boron neutron capture therapy (BNCT), and the agreement represents the next phase of cooperation following the memorandum of understanding signed on 8 May 2025, marking a strategic step for the Group to introduce advanced BNCT technology into the Chinese market.
Under the development phase, the parties aim to leverage the real-world data (RWD), real-world evidence (RWE) and real-world studies (RWS) generated by the Group to facilitate Stella Pharma in obtaining and maintaining marketing approval from the National Medical Products Administration (NMPA) for Steboronine® for head and neck cancer, and subsequently for meningioma upon Stella Pharma obtaining marketing and manufacturing approval from the Japanese government for that indication. Stella Pharma has granted the Group an exclusive, non-transferable, non-sublicensable and royalty-free licence to develop Steboronine® in China using its prior data package (excluding manufacturing activities), with the Group acting as application agent to submit regulatory filings to the NMPA. During the development phase, Stella Pharma may not appoint any third party other than the Group as the domestic agent and general import agent for Steboronine® in China. In addition, if Stella Pharma obtains NMPA approval and commences clinical trials of the next-generation product within the term of the agreement, the Group will enjoy a three-month priority commercialization right on terms no less favourable than those offered to any third party.
Under the commercialization phase, upon Stella Pharma obtaining NMPA approval, Pengbo (Hainan) will automatically become the exclusive domestic agent of Steboronine® in China, and the Company (or its designated controlled entity) will automatically become the exclusive general import agent/distributor, with Stella Pharma supplying the drug for distribution and sale within China. The initial term of the exclusive distribution right is ten years from the date of NMPA approval, renewable automatically for five years each time upon meeting certain procurement targets.
The master cooperation agreement is effective from the signing date until ten years after Stella Pharma obtains NMPA approval; if the exclusive distribution term is extended, the term of the agreement will be extended accordingly. If Stella Pharma fails to obtain NMPA approval within ten years from the date of the agreement, the term will terminate upon expiry of that ten-year period.
In this regard, the Group's flagship Pengbo Hainan Boron Neutron Hospital, located in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, commenced trial operation in February 2026 and started treating patients in March 2026, completing dozens of treatments to date. By introducing Steboronine® at the hospital, the Group provides BNCT services to cancer patients, and the cooperation is expected to consolidate the Group's business in China, accelerate its upstream positioning in the BNCT industry and strengthen its future competitiveness.
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