The AIDS treatment drug KM-023, which has been steadily increasing in sales after approval in China, has opened up opportunities for market share expansion.
On the 14th, Kainosmed announced that the AIDS treatment drug KM-023, developed by the company, has been developed in China under the name ACC008 (brand name: Fubangde®) and has been selected as a priority review drug by the Center for Drug Evaluation (CDE) of the National Medical Products Administration.
Through this selection, it is expected that early product approval will be possible by switching treatment to ACC008 for patients already being treated with other existing drugs. According to the priority review track procedure in China, the result of product approval is expected to be obtained within about five months from the date of application submission for product approval. If switching treatment from existing drugs to ACC008 becomes possible, prescriptions will be available for long-term patients who had been relying solely on imported treatments, enabling rapid market share capture.
ACC008 is the only single-tablet drug produced as an AIDS treatment in China by Kainosmed’s Chinese partner, Jiangsu Aidea Pharmaceutical. Unlike existing treatments, its greatest advantage is safety due to the absence of side effects. It meets several conditions for market dominance, including equivalent or superior efficacy at low doses, price competitiveness, and ease of administration.
ACC008 had previously obtained product approval in January for prescriptions for newly diagnosed AIDS patients without prior treatment experience. In August, its indication was expanded to include existing AIDS patients with long-term experience using other treatments. In a Phase 3 comparative clinical trial with Genvoya, ACC008 demonstrated excellent therapeutic efficacy, including AIDS virus suppression, outstanding safety in switching from other treatments to ACC008, and long-term viral suppression effects, which led to its selection as a priority review candidate.
A Kainosmed official stated, “Our partner Jiangsu Aidea Pharmaceutical plans to soon submit an application for product approval following the designation of ACC008 as a priority review drug, and is also working to include ACC007 (combination tablet) and ACC008 (single tablet) in the national medical insurance reimbursement list. The prescription range of our developed AIDS treatment drugs is expanding in China from newly diagnosed patients to those with prior drug experience, and through various channels such as inclusion in national medical insurance and centralized national procurement lists, we expect to penetrate the AIDS treatment market in China and rapidly increase market share starting next year.” He added, “If we proceed to enter the European market, we also have high expectations for securing a cash cow through a 45% royalty on sales during the exclusive sales period after approval.”
Meanwhile, Kainosmed also announced that the domestic clinical trial for multiple system atrophy (MSA) of its major pipeline KM-819 and the Phase 2 Parkinson’s disease clinical trial in the United States are progressing smoothly.
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