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4888 東証マザーズ(医薬品)

ステラファーマ

新規上場会社紹介レポート

(公開日 2021.04.27)

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STELLA PHARMA(4888 TSE Mothers)

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Future growth speed depends on popularity of its cancer treatment method, BNCT

Bio-Venture Developing Cancer Radiotherapy Using Boron-based Drug
STELLA PHARMA is a bio-venture that develops a new cancer treatment method called boron neutron capture therapy (BNCT). The origin of the company goes back to when Tomoyuki Asano, the Chairman & CEO of the company, worked for STELLA CHEMIFA (4109 TSE First Section). He started development of BNCT by focusing on the technology to obtain a high concentration of boron isotope (10B), which was held by STELLA CHEMIFA. STELLA PHARMA was established as STELLA CHEMIFA’s subsidiary in June 2007.

BNCT is a method to treat cancer by destroying only the cancer cells through making the cancer cells absorb the 10B compound, a stable isotope of boron, and irradiating thermal neutrons on them.

As this destroys cancer cells that selectively concentrate 10B, the impact on normal tissues around the cancer cells is small, and is said to offer better quality of life after the session due to having less side effects compared to other treatment methods.

BNCT is a drug-device combination product that combines the administration of the 10B compound and irradiation through a thermal neutron irradiation device using accelerators.

As natural boron only contains around 20% 10B, the raw material of the compound, it is necessary to concentrate 10B to make the boron compound to be used for BNCT. Since STELLA CHEMIFA is the company holding this concentration technology, STELLA PHARMA exclusively acquires highly concentrated 10B from STELLA CHEMIFA. STELLA PHARMA’s product, Steboronine®, is a pharmaceutical manufactured using Borofalan containing highly concentrated 10B as the active pharmaceutical ingredient. Furthermore, its manufacturing is entrusted to an external company.

Possibility of Ordinary Loss to Continue
Regarding the company’s business performance, ordinary loss is continuing since the fiscal year ended December 2016 and the corporate plan for the fiscal year ended March 2021 is also an ordinary loss. The company received approval to manufacture and sell Steboronine® as a medicine in March 2020 and as its sales is now posted on net sales starting from fiscal year ended March 2021, it could be said that there are prospects for securing profit if only looking at the sales of Steboronine® for head and neck cancer in Japan. However, as the company plans to continue its investments concerning the expansion of applicable diseases and overseas developments, ordinary loss is forecasted to continue for the next several years.

概要(レポートから抜粋)

ステラファーマ(以下、同社)は、ホウ素中性子捕捉療法(BNCT)と呼ばれる、放射線治療の一種で新しいがん治療法を開発するバイオベンチャーである。

現代表取締役会長の浅野智之氏が、ステラケミファ(4109東証一部)に在籍中に、ステラケミファが保有していたホウ素同位体の高濃縮技術に着目して開発を始めたのが発端であり、実用化の要件が揃ったことで、ステラケミファの子会社として07年6月に同社は設立された。

ホウ素中性子補足療法(BNCT)は、ホウ素の安定同位体であるホウ素10(B-10)を含む物質をがん細胞に取り込ませ、熱中性子を照射することでがん細胞だけを破壊するというがんの治療法で、放射線治療に分類されるもののひとつである。以下の原理に基づいている。

(1)熱中性子自体は細胞破壊能力が小さい。
(2)B-10の原子核は熱中性子を吸収しやすく、熱中性子を吸収した時の細胞を破壊する能力が大きい。ただし、影響を及ぼす範囲が極めて短い。

B-10を選択的に集積させたがん細胞だけを破壊するため、がん細胞のまわりの正常組織への影響が少なく、他の治療法に比べて副作用が少なく、術後のQOL(Quality of Life、生活の質)が良好とされている。

BNCTは、B-10を含む薬剤の投与と、加速器を伴う熱中性子照射装置による照射がそろって成立するコンビネーションプロダクトである。

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