Agreements reached under this partnership
Business alliance- 1
STELLA PHARMA CORPORATION, CBSH and Pengbo will jointly promote a real-world study using real-world data obtained in the Hainan Island medical special zone, with the aim of obtaining NMPA approval for the Company's drug in mainland China.
- 2
CBSH, Pengbo or a party designated by either company will act as the applicant to the regulatory authorities as the domestic agent in China, and will be responsible for securing the resources necessary to obtain approval in mainland China and promoting development activities.
- 3
Meanwhile, as the overseas marketing authorization holder, the Company will provide the quality, nonclinical, clinical and other data required for the NMPA application that it owns and manages, and will support the approval process.
- 4
The Company will appoint Pengbo exclusively as its domestic agent in mainland China.
- 5
A corporation designated by CBSH will serve as the general import agent, and a framework will be established for imports and sales in mainland China.
- 6
The Company and Pengbo will jointly establish pharmaceutical regulatory systems, including quality management, safety management and traceability systems.
- 7
The agreement also sets out provisions concerning the term and extension of the general import agency arrangement, as well as the basic terms for matters necessary to advance development, applications and sales preparations in mainland China.
These are items that the documents state the two companies will work on. The lines above and below represent arrangements between the two companies.
The impact of this matter on results for the fiscal year ending March 2027 is expected to be minor. Over the medium to long term, the Company expects it to contribute to business expansion and increased corporate value.
| Item | Details |
|---|---|
| Name of alliance partner | China Biotech Services Holdings Limited (CBSH), Pengbo (Hainan) Boron Neutron Medical Technology Co., Ltd. (Pengbo) |
| Alliance partner's business activities | CBSH's BNCT business. Pengbo is a CBSH subsidiary that operates a BNCT center in the Hainan Bo'ao Lecheng International Medical Tourism Pilot Zone. |
| Type of alliance | Business alliance |
| Details of the alliance | STELLA PHARMA CORPORATION, CBSH and Pengbo will jointly promote a real-world study using real-world data obtained in the Hainan Island medical special zone, with the aim of obtaining NMPA approval for the Company's drug in mainland China., CBSH, Pengbo or a party designated by either company will act as the applicant to the regulatory authorities as the domestic agent in China, and will be responsible for securing the resources necessary to obtain approval in mainland China and promoting development activities., Meanwhile, as the overseas marketing authorization holder, the Company will provide the quality, nonclinical, clinical and other data required for the NMPA application that it owns and manages, and will support the approval process., The Company will appoint Pengbo exclusively as its domestic agent in mainland China., A corporation designated by CBSH will serve as the general import agent, and a framework will be established for imports and sales in mainland China., The Company and Pengbo will jointly establish pharmaceutical regulatory systems, including quality management, safety management and traceability systems., The agreement also sets out provisions concerning the term and extension of the general import agency arrangement, as well as the basic terms for matters necessary to advance development, applications and sales preparations in mainland China. |
| Contract Period | The agreement sets out provisions concerning the term and extension of the general import agency arrangement, but the specific term, expiration date and automatic renewal provisions are Not disclosed. |
| Numerical Targets under the Partnership | The parties aim to obtain NMPA approval in mainland China, but numerical targets for sales, market share, volume and other metrics, as well as the timing for achieving them, are Not disclosed. |
| Contract Date | 12 August 2026 |
| Impact on Business Performance | The impact of this matter on results for the fiscal year ending March 2027 is expected to be minor. Over the medium to long term, the Company expects it to contribute to business expansion and increased corporate value. |
Items this document does not state (15)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The agreement is intended to position the expansion of BNCT in mainland China as a growth opportunity, advance the approval application by using real-world data obtained in the Hainan Island medical special zone together with clinical data from Japan, and secure sales channels following approval.